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Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.
Please see Important Safety Information, including BOXED WARNING on Serious Infections, Malignancy, and Thrombosis.
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Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

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Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

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Moderate to Severe

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Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

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Intermediate, Posterior and Panuveitis

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For moderate to severe rheumatoid arthritis (RA) in adult
MTX-IR patients1

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Get started with the
Enrollment & Prescription Form

Download the RINVOQ Complete Enrollment & Prescription Form
Commercial Access
Commitment to working toward 100% commercial patient access Commitment to working toward 100% commercial patient access Commitment to working toward 100% commercial patient access

For patients with commercial insurance, preferred coverage* could mean:

  • PREDICTABLE ACCESS for commercial patients
  • STANDARD PRIOR AUTHORIZATION (PA) AND APPEALS PROCESS, potential for one-time PA/appeal approval

*Formulary Definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non‑preferred tier which may result in a higher out‑of‑pocket cost. Preferred/Step 1 means the product is placed on the plan's preferred formulary. Non‑preferred products require a higher out‑of‑pocket cost or step edit, or are placed on a higher tier.

Access means the product is covered and not NDC blocked. Restrictions may apply.

Based on formulary status under the pharmacy benefit.

†Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

See HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

Please see HUMIRA full Prescribing Information.

Commercial patients not yet covered are eligible to RINVOQ from RINVOQ Complete Commercial patients not yet covered are eligible to RINVOQ from RINVOQ Complete Commercial patients not yet covered are eligible to RINVOQ from RINVOQ Complete
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NURSE
AMBASSADORS*

Empower patients

Our Nurse Ambassadors are the heart of RINVOQ Complete and HUMIRA Complete

Nurse Ambassadors provide 1:1 support to help patients start and stay on track with their prescribed treatment plan, including:

  • Help patients understand the importance of following the treatment plan prescribed by their healthcare professional.
  • Committed to answering questions throughout the experience to help limit treatment disruptions.
  • Answer patients’ insurance questions and connect them with additional insurance expertise.
  • Identify ways for patients to save on prescription costs.
Talk to us

ACCESS
SPECIALISTS

Insurance support when needed

  • Resource with expertise on Medicare and commercial plans at a national, local, and program level so that they can educate on potential options to consider based on each patient’s unique financial situation.
  • Can educate on payer prior authorization and appeal processes so you can determine the best access option for each patient’s unique situation.
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ACCESS & SAVINGS

Help with access &
treatment affordability

COMPLETE can help your commercial patients save: 

  • With the Complete Savings Card, your eligible commercially insured patients may pay as little as $5 per month.†
  • Complete may help eligible commercially insured patients experiencing initial coverage delays or denials access their prescribed therapy at no charge while coverage is established.‡
See HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

Please see HUMIRA full Prescribing Information.

Empowering Patients
Nurse Ambassadors, In Their Own Words

Transcript

Have questions or need support over the phone?

Call 1-877-COMPLETE (1‑800‑274‑6867)

*Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional about any treatment-related questions, including further referrals.

†RINVOQ Complete: Terms and Conditions apply. This benefit covers RINVOQ™ (upadacitinib) alone or for RINVOQ plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: Available to patients with commercial prescription insurance coverage for RINVOQ who meet eligibility criteria. Co pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government funded healthcare program, patient will no longer be able to use the RINVOQ Complete Savings Card and patient must call RINVOQ Complete at 1.800.2RINVOQ to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the RINVOQ Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out of pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html

Arava and Plaquenil are registered trademarks of their respective owners.

HUMIRA Complete: Terms and Conditions apply. This benefit covers HUMIRA® (adalimumab) alone or, for rheumatology patients, HUMIRA plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: Available to patients with commercial prescription insurance coverage for HUMIRA who meet eligibility criteria. Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the HUMIRA Complete Savings card and patient must call HUMIRA Complete at 1-800-4HUMIRA to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the HUMIRA Complete Program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out of pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html

Arava and Plaquenil are registered trademarks of their respective owners.

‡Program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ™ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.

Commitment to working toward 100% commercial patient access Commitment to working toward 100% commercial patient access Commitment to working toward 100% commercial patient access

Help patients get the support they need to start and stay
on track with their prescribed treatment

Practice Forms and Resources
Patient Forms and Resources

PRACTICE FORMS AND RESOURCES

To enroll a patient in RINVOQ Complete:

1

Fill out the form with your patient
This form enrolls your patient and can be used to initiate a prescription with your patient’s preferred specialty pharmacy.

2

Fill out the patient support prescription in Section 6
This may help your commercially insured patients get access to RINVOQ if they experience a delay or denial in their insurance coverage.*

3

Fax the form to 1-678-727-0690 and to the patient's chosen specialty pharmacy
You will receive a call from an Access Specialist to discuss next steps. In addition, fax the form to your patient’s specialty pharmacy if using the Pharmacy Prescription in Section 9.

4

Inform your patient that they have been enrolled
Let your patient know that they will be receiving a call from their Nurse Ambassador.

Get started with the enrollment & prescription form

RINVOQ Complete Enrollment & Prescription Form
HUMIRA Complete Enrollment & Prescription Form
See HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

Please see HUMIRA full Prescribing Information.

*Program is not available to patients receiving prescription reimbursement under any federal, state, or government‑funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government‑funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ™ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.

PATIENT FORMS AND RESOURCES

Once you and your patient fill in the Enrollment and Prescription Form, simply fax it to RINVOQ Complete or HUMIRA Complete and inform your patient that they will be receiving a call from their Nurse Ambassador. If you complete the Pharmacy Prescription, also fax it to your patient’s chosen specialty pharmacy.

Download the enrollment & prescription form

RINVOQ Complete Enrollment & Prescription Form
HUMIRA Complete Enrollment & Prescription Form
See HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

Please see HUMIRA full Prescribing Information.

ADDITIONAL RESOURCES

Benefits Verification Chart
Insurance Comparison Booklet
Complete app

COMPLETE APP

Track treatment

The Complete App helps patients stay on track with their prescribed RINVOQ or HUMIRA treatment by helping them:

  • Access additional resources, including a savings card for those that are eligible
  • Set up medication reminders
  • Log symptoms
  • Log medication lot number and medication expiration date
Download on the App Store
Get it on Google Play
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COMPLETEPRO.COM

Streamline the Rx process

CompletePro.com enables seamless enrollment into RINVOQ Complete and HUMIRA Complete, and helps streamline the prescription process for your patients.

 

With CompletePro.com, you can:

  • Request benefits verifications
  • Complete and submit prior authorizations
  • Send prescriptions to the patient’s specialty pharmacy of choice, with the option to include a savings card
  • Receive alerts for annual reauthorizations and renewals
  • Track and monitor where patients are in the prescription process

Learn more about streamlining the prescription process with Complete Pro:

Transcript

Register now at COMPLETEPRO.COM

Downloadable resources Downloadable resources Downloadable resources

RINVOQ ACCESS AND REIMBURSEMENT FORMS

RINVOQ Complete is here to help your patients get timely access to RINVOQ. Along with requesting information from a RINVOQ Complete Access Specialist, you can download the forms you need to get started.

Templates

Appeals Letter
Formulary Exception Letter
Tiered Exception Letter
HIPAA Authorization Form
Medical Necessity Letter

INSTRUCTIONS

Here you can download helpful guidelines and tips for completing these templates.

Prior authorization instructions
Appeals letter instructions
Letter of medical necessity instructions

This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.

BILLING AND CODING

Coding Guide

SPECIALTY PHARMACY

Specialty Pharmacy Guide
See HUMIRA Access and Reimbursement Forms
See HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

Please see HUMIRA full Prescribing Information.

RINVOQ SAFETY DATA

Review the well-studied safety profile of RINVOQ,
including both short- and long-term analyses

SEE SAFETY PROFILE
SAFETY PROFILE
DOSING & MOA

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-UPAD-190033

Please see full Prescribing Information.

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Data on file, AbbVie Inc. Payer reported lives. April 2020.
Defy expectations
Head-To-Head Data
Clinical Trial Overview
Vs TNFi + MTX
Vs T-Cell Inhibitor + csDMARDs
Clinical Remission
Clinical Trial Overview
Remission Data
Long-term Remission Data
Radiographic Inhibition
Clinical Trial Overview
Radiographic Response
Long-term Radiographic Response
Safety Profile
Data Up to 12 Months
Long-term Exposure Data
Monitoring & Dose Interruptions
Important Safety Information
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©2020 AbbVie Inc. North Chicago, IL 60064. If you have any questions about this website that have not been answered, click here. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.

US-MULT-200461

US-MULT-200808

IMPORTANT SAFETY INFORMATION & INDICATION FOR
HUMIRA® (adalimumab)1

INDICATION1

Rheumatoid Arthritis (RA): HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Juvenile Idiopathic Arthritis (JIA): HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Psoriatic Arthritis (PsA): HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Ankylosing Spondylitis (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab..

Pediatric Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.

Plaque Psoriasis (Ps): HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Please see full Prescribing Information

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

 

 

Footnotes and Definitions

ACR=American College of Rheumatology; csDMARD=conventional synthetic disease-modifying antirheumatic drug; EOW=every other week; IR=inadequate responder; MTX=methotrexate; QD=once per day; RA=rheumatoid arthritis




ACR Response Criteria1,2

ACR response criteria incorporate physician and patient assessments, as well as acute inflammatory, pain, and physical function measures.

ACR response criteria incorporate physician and patient assessments, as well as acute inflammatory, pain, and physical function measures.

 

American College of Rheumatology Response Criteria American College of Rheumatology Response Criteria American College of Rheumatology Response Criteria

ACR=American College of Rheumatology; CRP=C‍-‍reactive protein; HAQ‑Dl=health assessment questionnaire disability index

Reference:

1. Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993;36(6):729-740.
2. Uhlig T, Haavardsholm EA, Kvien TK. Comparison of the Health Assessment Questionnaire (HAQ) and the modified HAQ (MHAQ) in patients with rheumatoid arthritis. Rheumatology. 2006;45(4):454‑458.

 

US-MULT-200095

Study Design & Baseline Characteristics

SELECT-COMPARE

Adults with moderately to severely active RA who had an inadequate response to MTX1

SELECT-COMPARE: Study design SELECT-COMPARE: Study design SELECT-COMPARE: Study design

 

 

aX-ray imaging was performed at these time points; Week 14 for non-responder patients, who were rescued.2,3
bRescue criteria: At Weeks 14, 18 and 22 if <20% improvement in TJC and SJC vs baseline; at Week 26 all remaining PBO patients were switched to RINVOQ, and patients receiving RINVOQ or ADA were switched to ADA or RINVOQ, respectively, if CDAI>102
cStarting at Week 26, initiation or change in background RA medication(s) including corticosteroids, NSAIDs, or acetaminophen was permitted.4
dStarting at Week 48, patients who failed to show ≥20% improvement in TJC and SJC compared to baseline at 2 consecutive visits were removed from the study.5
eAt Week 48, initiation or change in csDMARDs was allowed, however not all patients received background MTX.5
fPatients continued treatment with RINVOQ or ADA in a blinded manner until the last patient completed the Week 48 visit and received open-label treatment thereafter.8

PRIMARY ENDPOINT1

  • ACR20 response: RINVOQ 15 mg + MTX vs Placebo + MTX at Week 12

SELECT RANKED SECONDARY ENDPOINTS2

At Week 12 vs Placebo + MTX:

  • Change from baseline in DAS28-CRP
  • Change from baseline in HAQ-DI
  • Change from baseline in SF-36 (PCS)
  • Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
  • Proportion of patients achieving DAS28-CRP<2.6 (CR)

At Week 12 vs Adalimumab + MTX:

  • ACR50 response (superiority)
  • Change from baseline in Patient's assessment of pain (superiority)
  • Change from baseline in HAQ-DI (superiority)

At Week 26 vs Placebo + MTX:

  • Change from baseline mTSS

SELECT PRESPECIFIED NONRANKED ENDPOINTS3,9,10

  • ACR20/50/70 response rates and change from baseline in individual ACR components at all visits (except those that were ranked timepoints)
  • Proportion of patients achieving CR based on DAS28-CRP, DAS28-ESR, SDAI, CDAI, and Boolean criteria at all visits (except those that were ranked timepoints)
  • Proportion of patients with no radiographic progression (mTSS ≤0) at Week 26, Week 48, and Week 96
  • Change from baseline in mTSS at Week 24, Week 48, and Week 96
  • Change from baseline in joint space narrowing score and joint erosion score at Week 26, Week 48, and Week 96

DATA LIMITATIONS

Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

SELECT-COMPARE was not designed to evaluate the efficacy of HUMIRA + MTX vs Placebo + MTX. No conclusions regarding this comparison can be made.

BASELINE CHARACTERISTICS3,11

SELECT-COMPARE: Baseline characteristics SELECT-COMPARE: Baseline characteristics SELECT-COMPARE: Baseline characteristics


*Based on prednisone equivalent

Anti‑CCP=anti-cyclic citrullinated peptide; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; ADA=adalimumab; bDMARDs=biological disease‑modifying antirheumatic drugs; CDAI=clinical disease activity index; CR=clinical remission; CRP=C‑reactive protein; DAS28=disease activity score 28 joints; ESR=erythrocyte sedimentation rate; HAQ‑DI=health assessment questionnaire disability index; hsCRP=high sensitivity C‑reactive protein; LDA=low disease activity; mTSS=modified total Sharp score; MTX=methotrexate; NSAIDs=non‑steroidal anti‑inflammatory drugs; PBO=Placebo; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF‑36 (PCS)=short‑form 36 physical component score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale

REFERENCES

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Fleischmann R, Pangan AL, Song I-H, et al. Supplement - Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
3. Fleischmann R, Pangan AL, Song I-H, et al. Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
4. Data on File. ABVRRTI70534.
5. Data on File. ABVRRTI70955.
6. Data on File. ABVRRTI68439.
7. Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis. AbbVie Inc. https://news.abbvie.com/news/upadacitinib-meets-all-primary-and-ranked-secondary-endpoints-including-superiority-versus-adalimumab-in-phase-3-study-in-rheumatoid-arthritis.htm. April 9, 2018. August 15, 2019.
8. Fleischmann R, Song I‑H, Enejosa J, et al. Long‑Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients With Rheumatoid Arthritis: Results at 72 Weeks From the SELECT‑COMPARE Study. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
9. Data On File. ABVRRTI68440.
10. Data on File. ABVRRTI70956. 
11. Fleischmann R, Pangan AL, Mysler E, et al. A Phase 3, Randomized, Double‑Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate. Oral Presentation at: The ACR Annual Meeting 2018, 19–24 October 2018, Chicago, USA.

 

US-MULT-200461

Study Design & Baseline Characteristics

SELECT-MONOTHERAPY

Adults with moderately to severely active RA who had an inadequate response to MTX1

SELECT-MONOTHERAPY: Study design SELECT-MONOTHERAPY: Study design SELECT-MONOTHERAPY: Study design

Upadacitinib 30 mg is not an approved dose.

aPatients on MTX were randomized to receive either RINVOQ 15 mg or upadacitinib 30 mg at Week 143

bStarting at Week 26, patients who did not achieve CDAI ≤10 could have initiated or adjusted corticosteroids, NSAIDS, acetaminophen or ≤2 csDMARDs. Patients who failed to show ≥20% improvement in TJC and SJC compared to baseline at 2 consecutive visits were removed from the study.5

Primary Endpoint1

  • ACR20 response at Week 14

Select Ranked Secondary Endpoints3,6

At Week 14:

  • Change from baseline in DAS28-CRP
  • Change from baseline in HAQ-DI
  • Change from baseline in SF-36 (PCS)
  • Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
  • Proportion of patients achieving DAS28-CRP<2.6 (CR)

SELECT PRESPECIFIED NONRANKED ENDPOINTS3,6

  • ACR50 and ACR70 response at Week 14
  • Proportion of patients achieving CR based on DAS28‑CRP <2.6, DAS28-ESR <2.6, SDAI ≤3.3, CDAI ≤2.8, and Boolean criteria at all visits (except those that were ranked timepoints)

Data Limitations

Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Baseline Characteristics3

SELECT-MONOTHERAPY: Baseline characteristics SELECT-MONOTHERAPY: Baseline characteristics SELECT-MONOTHERAPY: Baseline characteristics

*Prior to receiving study drug. In the control arm, patients continued prior MTX dose as blinded study drug.
†Prednisone equivalent

ACPA=anti‑citrullinated protein antibody; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; CDAI=clinical disease activity index; cMTX=continuous methotrexate; csDMARDs=conventional synthetic disease‑modifying antirheumatic drugs; CR=clinical remission; CRP=C‑reactive protein; DAS28=disease activity score 28 joints; ESR=erythrocyte sedimentation rate; HAQ‑DI=health assessment questionnaire disability index; hsCRP=high sensitivity C‑reactive protein; LDA=low disease activity; MTX=methotrexate; NSAIDs=non‑steroidal anti‑inflammatory drugs; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF‑36 (PCS)=short‑form 36 physical component score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale

REFERENCES

 

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Smolen JS, Pangan AL, Emery P, et al. Supplement - Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT‑MONOTHERAPY): a randomised, placebo‑controlled, double‑blind phase 3 study. Lancet. 2019;393(10188):2303‑2311.
3. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT‑MONOTHERAPY): a randomised, placebo‑controlled, double‑blind phase 3 study. Lancet. 2019;393(10188):2303‑2311.
4. Smolen JS, Emery P, Rigby W, et al. Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis: Results at 48 Weeks from the SELECT‑MONOTHERAPY Study. Poster presented at: The European Congress of Rheumatology, 12‑15 June 2019, Madrid, Spain.
5. Data on File. ABVRRTI68979.
6. Data on File. ABVRRTI68841.

 

US-MULT-200461

Study Design & Baseline Characteristics

SELECT‑EARLY

Adults with moderately to severely active RA who were MTX‑naïve1

SELECT-EARLY: Study design SELECT-EARLY: Study design SELECT-EARLY: Study design

Upadacitinib 30 mg is not an approved dose.

RINVOQ is not indicated for MTX‑naïve patients.

aInitially 947 patients were randomized in the study, but two patients were never dosed.2
bX-ray images of hands and feet obtained at these time points.2
cStarting at Week 12, patients with ≤20% improvement in TJC and SJC compared to baseline at two consecutive visits continued blinded therapy and optimized background RA medications (corticosteroids, NSAIDs, and/or low‑potency analgesics).3,4
dAt Week 26, patients with CDAI≤2.8 continued their original study drug; background medications (NSAIDs, corticosteroids, and/or low‑potency analgesics, and csDMARDs) were optimized in patients with CDAI>2.8 but ≥20% improvement in TJC and SJC; among patients with CDAI >2.8 and <20% improvement in TJC and SJC, RINVOQ 15 mg or upadacitinib 30 mg were added by re‑randomization according to 1:1 ratio for those initially randomized to MTX, and MTX was added for those initially randomized to RINVOQ 15 mg or upadacitinib 30 mg.2,5
eStarting at Week 48, patients who did not achieve ≥ 20% improvement in both TJC and SJC at two consecutive visits were removed from the study. Initiation of or change in background RA medications (NSAIDs, corticosteroids, low potency analgesics, and csDMARDs‑not all patients received background MTX) is allowed at anytime during Period 2.6

Primary Endpoint1

  • ACR50 response at Week 12

Ranked Secondary Endpoints3,8

At Week 12:

  • Change from baseline in DAS28-CRP
  • Change from baseline in HAQ-DI
  • Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
  • Change from baseline in SF-36 (PCS)

At Week 24:

  • Change from baseline in mTSS
  • Proportion of patients achieving DAS28-CRP<2.6 (CR)

Select prespecified
nonranked endpoints2,3,9,10

  • ACR 20/50/70 at all visits (except those that were ranked timepoints)
  • Change from baseline in mTSS at Week 24, Week 48, and Week 96
  • Proportion of patients with no radiographic progression (mTSS ≤0) at Week 24, Week 48, and Week 96
  • Change from baseline in JE and JSN score at Week 24, Week 48, and Week 96

Data Limitations

Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Baseline Characteristics3

SELECT-EARLY: Baseline characteristics SELECT-EARLY: Baseline characteristics SELECT-EARLY: Baseline characteristics

*Prednisone equivalent dose in patients receiving oral glucocorticoids at baseline.

ACPA = anti-citrullinated protein antibody; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; CDAI=clinical disease activity index; CR=clinical remission; CRP=C reactive protein; csDMARDs=conventional synthetic disease-modifying antirheumatic drugs; DAS28=disease activity score 28 joints; HAQ-DI=health assessment questionnaire disability index; hsCRP=high sensitivity C-reactive protein; JE=joint erosion score; JSN=joint space narrowing; LDA=low disease activity; mTSS=modified total Sharp score; MTX=methotrexate; NSAIDs=non-steroidal anti-inflammatory drugs; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF-36 (PCS)=short-form 36 physical component score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale

REFERENCES

 

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Supplement: Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate‑naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT‑EARLY): A Randomized, Double-blind, Active‑comparator, Multi‑center, Multi‑country Trial. Arthritis & Rheumatology. 2020. doi:10.1002/art.41384.
3. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate‑naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT‑EARLY): A Randomized, Double‑blind, Active‑comparator, Multi-center, Multi‑country Trial. Arthritis & Rheumatology. 2020. doi:10.1002/art.41384.
4. Data on File. ABVRRTI70661.
5. Data on File. ABVRRTI68563.
6. Data on File. ABVRRTI70953.
7. Van Vollenhoven R, Takeuchi T, Rischmueller M, et al. Upadacitinib Monotherapy in Methotrexate‑Naïve Patients With Rheumatoid Arthritis: Results at 72 Weeks From SELECT‑EARLY. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E-Congress.
8. Data on File. ABVRRTI68564.
9. Data on File. ABVRRTI70539.
10. Data on File. ABVRRTI70954.

US-MULT-200461

Study Design & Baseline Characteristics

SELECT-NEXT

Adults with moderately to severely active RA who had an inadequate response to csDMARD(s)1

SELECT-NEXT: Study design SELECT-NEXT: Study design SELECT-NEXT: Study design

 

Upadacitinib 30 mg is not an approved dose.

 

aStarting at Week 24, patients who did not achieve CDAI ≤10 could have initiated or adjusted corticosteroids, NSAIDS, acetaminophen or ≤2 csDMARDs. Patients who failed to show ≥20% improvement in TJC and SJC compared to baseline at 2 consecutive visits were removed from the study.4

 

Primary Endpoint1

  • ACR20 response at Week 12

Select Ranked Secondary Endpoints5,6

At Week 12:

  • Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
  • Proportion of patients achieving DAS28-CRP<2.6 (CR)
  • Proportion of patients achieving CDAl≤10 (LDA)

Select Prespecified nonranked endpoints6

  • ACR50 and ACR70 response at Week 12
  • ACR20 response at Week 1

Data Limitations

Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Baseline Characteristics5

SELECT-NEXT: Baseline characteristics SELECT-NEXT: Baseline characteristics SELECT-NEXT: Baseline characteristics

*Based on prednisone equivalent

ACPA=anti‑citrullinated protein antibody; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; bDMARD= biological disease‑modifying anti‑rheumatic drug; CDAI=clinical disease activity index; CR=clinical remission; CRP=C‑reactive protein; csDMARD=conventional synthetic disease-modifying anti-rheumatic drug; DAS28=disease activity score 28 joints; HAQ-DI=health assessment questionnaire disability index; hsCRP=high-sensitivity C-reactive protein; LDA=low disease activity; MTX=methotrexate; NSAIDs=non‑steroidal anti‑inflammatory drugs; PBO=placebo; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale.

REFERENCES

 

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 
2. Burmester GR, Kremer JM, Van den Bosch F, et al. Supplement - Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease‑modifying anti‑rheumatic drugs (SELECT‑NEXT): a randomised, double‑blind, placebo‑controlled phase 3 trial. Lancet. 2018;391(10139):2503‑2512.

3. Burmester GR, Van den Bosch F, Bessette L, et al. Long‑Term Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to csDMARDs: Results at 60 Weeks From the SELECT‑NEXT Study. Poster presented at: The European Congress of Rheumatology, 12‑15 June  2019, Madrid, Spain.
4. Data on File. ABVRRTI68981.
5. Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease‑modifying anti‑rheumatic drugs (SELECT‑NEXT): a randomised, double‑blind, placebo‑controlled phase 3 trial. Lancet. 2018;391(10139):2503‑2512.
6. Data on File. ABVRRTI68843.

 

 

US-MULT-200461

Study Design & Baseline Characteristics

SELECT-BEYOND

Adults with moderately to severely active RA who had an inadequate response or intolerance to bDMARDs1

SELECT-BEYOND: Study design SELECT-BEYOND: Study design SELECT-BEYOND: Study design

 

Upadacitinib 30 mg is not an approved dose.

 

aStarting at Week 24, initiation of or change in corticosteroids, NSAIDs, acetaminophen, and csDMARDs was permitted. Patients not achieving response criteria ≥20% improvement in SJC and TJC at two consecutive visits were removed from the study.4,5

Primary Endpoint1

  • ACR20 response at Week 12

Ranked Secondary Endpoints6,7

At Week 12:

  • Change from baseline in DAS28-CRP
  • Change from baseline in HAQ-DI
  • Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
  • Change from baseline in SF-36 (PCS)

Select Prespecified nonranked endpoints7

  • ACR20, ACR50 and ACR70 response at all visits (except those that were ranked timepoints)
  • ACR20 response at Week 1
  • Proportion of patients achieving CR based on DAS28‑CRP, DAS28‑ESR, SDAI, and CDAI at all visits
  • Proportion of patients achieving Boolean criteria at Week 12

Data Limitations

Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Baseline Characteristics6

SELECT-BEYOND: Baseline characteristics SELECT-BEYOND: Baseline characteristics SELECT-BEYOND: Baseline characteristics

*Oral or parenteral methotrexate (7.5-25 mg per week).
†Data available for 168 patients receiving placebo and 161 patients receiving RINVOQ 15 mg.
‡All combinations allowed except MTX and leflunomide.
§Mean MTX dose calculated only for patients receiving MTX.
‖Based on prednisone equivalent.

ACPA=anti‑citrullinated protein antibodies; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; bDMARDs=biologic disease‑modifying antirheumatic drugs; CDAI=clinical disease activity index; CR=clinical remission; CRP=C‑reactive protein; csDMARD=conventional synthetic disease‑modifying antirheumatic drug; DAS28=disease activity score 28 joints; ESR=erythrocyte sedimentation rate; hsCRP=high‑sensitivity C‑reactive protein; HAQ‑DI=health assessment questionnaire disability index; LDA=low disease activity; MTX=methotrexate; NSAIDs=non‑steroidal anti‑inflammatory drugs; PBO=placebo; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=Simplified disease activity index; SF‑36 (PCS)=36‑item short form health survey physical component score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale

REFERENCES

 

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Genovese MC, Fleischmann R, Combe B, et al. Supplement - Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease‑modifying anti‑rheumatic drugs (SELECT‑BEYOND): a double‑blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513‑2524.
3. Genovese MC, Combe B, Hall S, et al. Upadacitinib in Patients With Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: Results at 60 Weeks From the SELECT-BEYOND Study. Poster presented at the European Congress of Rheumatology, 12‑15 June 2019, Madrid, Spain.
4. Data on File. ABVRRTI68669.
5. Data on File. ABVRRTI68670.
6. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease‑modifying anti‑rheumatic drugs (SELECT‑BEYOND): a double‑blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513‑2524.
7. Data on File. ABVRRTI68842.

 

US-MULT-200461

IMPORTANT SAFETY INFORMATION & INDICATION FOR HUMIRA® (adalimumab)1

INDICATION1

HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Please see full Prescribing Information

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

 

 

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Study Design & Baseline Characteristics

SELECT-CHOICE

Adults with moderately to severely active RA and inadequate response or intolerance to bDMARDs.1

SELECT-BEYOND: Study design SELECT-BEYOND: Study design SELECT-BEYOND: Study design

aAfter the initial dose, ORENCIA® IV was administered at 2 and 4 weeks, then every 4 weeks thereafter. The last dose occurred at Week 20. Weight‑based dosing was as follows: <60 kg: 500 mg; 60 - 100 kg: 750 mg; >100 kg: 1000 mg.2
bStarting at Week 12, patients who did not achieve ≥20% improvement in both TJC and SJC compared to baseline at 2 consecutive visits were to have background medication(s) (corticosteroids, NSAIDs, acetaminophen or adding or increasing doses in csDMARD(s)) adjusted or added.1,3

Primary Endpoint1

  • Change from baseline DAS28‑CRP at Week 12 (noninferiority) against a margin of 0.6

Ranked Secondary Endpoints1

At Week 12:

  • Change from baseline in DAS28‑CRP (superiority)
  • Proportion of patients achieving DAS28‑CRP <2.6 (CR) (superiority)

Baseline Characteristics1

SELECT-BEYOND: Baseline characteristics SELECT-BEYOND: Baseline characteristics SELECT-BEYOND: Baseline characteristics

*Did not receive any of the protocol-specified bDMARDs prior to entry.
†Based on prednisone equivalent.

ACPA=anti-citrullinated protein antibody; ACR=American College of Rheumatology; ACR70=improvement of at least 70% in tender joint count, swollen joint joint count, and at least 3 other core criteria; bDMARD=biological disease-modifying anti-rheumatic drug; CDAI=clinical disease activity index; CR=clinical remission; CRP=C-reactive protein; DAS28-CRP=disease activity score 28 joints; ESR=erythrocyte sedimentation rate; EULAR=European League Against Rheumatism; IV=intravenous; LDA=low disease activity; QD=once per day; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF-36 (PCS)=36-item short form health survey physical component score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints

REFERENCES

 

1. Rubbert‑Roth A, Enejosa J, Pangan AL, et al. Efficacy and Safety of Upadacitinib vs Abatacept in Patients With Active Rheumatoid Arthritis and Prior Inadequate Response or Intolerance to Biologic Disease‑Modifying Anti‑Rheumatic Drugs (SELECT‑CHOICE): A Double‑Blind, Randomized Controlled Phase 3 Trial. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
2. Rubbert-Roth A, Enejosa J, Pangan AL, et al. Efficacy and Safety of Upadacitinib vs Abatacept in Patients with Active Rheumatoid Arthritis and Prior Inadequate Response or Intolerance to Biologic Disease‑Modifying Anti‑Rheumatic Drugs (SELECT‑CHOICE): A Double‑Blind, Randomized Controlled Phase 3 Trial. Ann Rheum Dis 2020,79(Supp 1):1011.
3. Data on File. ABVRRTI70957.

 

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INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-UPAD-190033

Please see full Prescribing Information.

REFERENCE

1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.