RINVOQ™ (upadacitinib) | For Healthcare Professionals

Our Products

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.

Rheumatology

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Please see Important Safety Information, including BOXED WARNING on Serious Inflections, Malignancy, and Thrombosis.

Moderate to Severe

Rheumatoid Arthritis

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Please see Important Safety Information, including BOXED WARNING on Serious Inflections, Malignancy, and Thrombosis.

Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Dermatology

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Moderate to Severe

Chronic Plaque Psoriasis

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

US-IMM-190099

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

RINVOQ met ALL primary (ACR20, ACR50, or ΔDAS28-CRP at Week 12 or 14) and ranked secondary endpoints across clinical trials.^1-4 See results below

Explore the Data

*Formulary definitions: 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. Coverage means placed on formulary without a 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.
^†Based on formulary status under the pharmacy benefit.
National commercial coverage as of April 2020.
Data on File, AbbVie Inc. Payer-reported lives. April 2020.

ACR=American College of Rheumatology; DAS28=disease activity score 28 joints; IR=intolerance or inadequate response; MTX=methotrexate

discover superiority data in separate head-to-head trials vs. 2 biologics

VIEW HEAD-TO-HEAD DATA

Watch Now

In clinical trials, RINVOQ met all primary and ranked
secondary endpoints²

Primary Endpoint Results
(Week 12 or 14)

52*

68*

64*

65*

71*

-2.00

-2.52^†

SELECT‑EARLY
(Study RA‑I):^1,5
48‑week, randomized, double‑blind, active comparator‑controlled study of 947 adult patients with moderate to severe RA who were MTX‑naïve.

SELECT‑MONOTHERAPY
(Study RA‑II):^1,6
14‑week, randomized, double‑blind, active comparator‑controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX.

SELECT‑NEXT
(STUDY RA‑III)^1,7
12‑week, randomized, double‑blind, placebo‑controlled study of 661 adult patients with moderate to severe RA who had an inadequate response to csDMARDs.

SELECT‑BEYOND
(Study RA‑V):^1,8
12‑week, randomized, double‑blind, placebo‑controlled study of 499 adult patients with moderate to severe RA who have had an inadequate response or intolerance to bDMARDs.

SELECT‑COMPARE
(Study RA‑IV):^1,9
48‑week, randomized, double‑blind, active comparator‑controlled study of 1629 adult patients with moderate to severe RA who had an inadequate response to MTX.

SELECT‑CHOICE³
24‑week, randomized, double‑blind, active comparator‑controlled, study of 612 adult patients with moderate to severe RA who have had an inadequate response or intolerance to bMARDs.

RINVOQ is a once-daily JAK inhibitor¹

Separate Head‑To‑Head Trial Results vs 2 Biologics^3,9

RINVOQ + csDMARDs demonstrated superiority in ranked secondary endpoints at Week 12:

‑ vs HUMIRA + MTX (ACR50, HAQ‑DI, pain reduction) in SELECT‑COMPARE

‑ vs ORENCIA® (abatacept) + csDMARDs (DAS28‑CRP<2.6) in SELECT‑CHOICE

See Head-to-Head Data

Durable remission, even without MTX^1,10,12

DAS28-CRP<2.6* at Week 12 or 14, with response rates up to 84 weeks

*Does not mean drug-free remission or complete absence of disease activity

See Remission Data

Radiographic inhibition, even without MTX^1,13

∆mTSS at Week 24 or 26 with responses observed up to 96 weeks^†

^†RINVOQ is not indicated for
MTX-naïve patients

See Radiographic Data

Safety data from 5 robust Phase 3 trials^1,‡

>4350 patients across treatment arms,^14,§ >4500 patient‑years, ~3.5 years maximum and 2 years median long‑term exposure to RINVOQ 15 mg as of 6/30/19¹¹

See Safety Profile

Commitment to exceptional access and patient support

>95% preferred national commercial coverage^15,ǁ,¶ and 1:1 support to help patients start and stay on track with their prescribed treatment plan

See Access & Support

Please see HUMIRA full Prescribing Information.

^‡SELECT‑MONOTHERAPY, SELECT‑EARLY, SELECT‑NEXT, SELECT-COMPARE and SELECT‑BEYOND
^§RINVOQ 15 mg; upadacitinib 30 mg; methotrexate; HUMIRA (adalimumab); placebo
^ǁFormulary defintions: 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. Coverage means placed on formulary without a 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.
^¶Based on formulary status under the pharmacy benefit.

ACR=American College of Rheumatology; CRP=C-reactive protein; csDMARDs=conventional synthetic disease-modifying antirheumatic drugs; DAS28=disease activity score 28 joints; HAQ‑DI=health assessment questionnaire disability index; JAK=Janus kinase; mTSS=modified total Sharp score; MTX=methotrexate

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

RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
Data on File. ABVRRTI68885.
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.
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(Suppl 1):1011.
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.
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.
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.
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.
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 3, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
Fleischmann RM, Song I‑H, Enejosa JV, 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.
Cohen S, Van Vollenhoven R, Curtis J. et. al. Safety Profile of Upadacitinib Up to 3 Years of Exposure in Patients With Rheumatoid Arthritis. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
Smolen J, Emery P, Rigby W, et al. Upadacitinib as Monotherapy in Patients With Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks from the SELECT‑MONOTHERAPY Study. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
Peterfy C, Strand V, Genovese M, et al. Radiographic Outcomes in Patients With Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate. Results at 2 Years From the SELECT‑COMPARE and SELECT‑EARLY Studies. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
Cohen S, Van Vollenhoven R, Winthrop K, et al. Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analyses from the SELECT Phase 3 Clinical Program. Poster presented at: The European Congress of Rheumatology, 12‑15 June 2019, Madrid, Spain.
Data on file, AbbVie Inc. Payer‑reported lives. April 2020.

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.

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 INFORMATION¹

SERIOUS INFECTIONS

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.

MALIGNANCY

THROMBOSIS

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

Neutropenia

Lymphopenia

Anemia

Lipids

Liver enzyme elevations

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

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

Our Products

Rheumatology

Moderate to Severe

Rheumatoid Arthritis

Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Dermatology

Moderate to Severe

Chronic Plaque Psoriasis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

In clinical trials, RINVOQ met all primary and ranked secondary endpoints2

RINVOQ is a once-daily JAK inhibitor1

Separate Head‑To‑Head Trial Results vs 2 Biologics3,9

Durable remission, even without MTX1,10,12

Radiographic inhibition, even without MTX1,13

Safety data from 5 robust Phase 3 trials1,‡

Commitment to exceptional access and patient support

See how UPADAC Complete provides an exceptional access and patient support experience

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

MALIGNANCY

THROMBOSIS

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

Study Design & Baseline Characteristics

SELECT‑EARLY

Primary Endpoint1

Ranked Secondary Endpoints3,8

Select prespecified nonranked endpoints2,3,9,10

Data Limitations

Baseline Characteristics3

REFERENCES

SELECT-MONOTHERAPY

Primary Endpoint1

Select Ranked Secondary Endpoints3,6

SELECT PRESPECIFIED NONRANKED ENDPOINTS3,6

Data Limitations

Baseline Characteristics3

REFERENCES

SELECT-COMPARE

PRIMARY ENDPOINT1

SELECT RANKED SECONDARY ENDPOINTS2

SELECT PRESPECIFIED NONRANKED ENDPOINTS3,9,10

DATA LIMITATIONS

BASELINE CHARACTERISTICS3,11

REFERENCES

SELECT-NEXT

Primary Endpoint1

Select Ranked Secondary Endpoints5,6

Select Prespecified nonranked endpoints6

Data Limitations

Baseline Characteristics5

REFERENCES

SELECT-BEYOND

In clinical trials, RINVOQ met all primary and ranked
secondary endpoints²

RINVOQ is a once-daily JAK inhibitor¹

Separate Head‑To‑Head Trial Results vs 2 Biologics^3,9

Durable remission, even without MTX^1,10,12

Radiographic inhibition, even without MTX^1,13

Safety data from 5 robust Phase 3 trials^1,‡

See how UPADAC Complete provides an exceptional access
and patient support experience

IMPORTANT SAFETY INFORMATION & INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

Primary Endpoint¹

Ranked Secondary Endpoints^3,8

Select prespecified
nonranked endpoints^2,3,9,10

Baseline Characteristics³

Primary Endpoint¹

Select Ranked Secondary Endpoints^3,6

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,6

Baseline Characteristics³

PRIMARY ENDPOINT¹

SELECT RANKED SECONDARY ENDPOINTS²

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,9,10

BASELINE CHARACTERISTICS^3,11

Primary Endpoint¹

Select Ranked Secondary Endpoints^5,6

Select Prespecified nonranked endpoints⁶

Baseline Characteristics⁵

Primary Endpoint¹

Ranked Secondary Endpoints^6,7

Select Prespecified nonranked endpoints⁷

Baseline Characteristics⁶

Primary Endpoint¹

Ranked Secondary Endpoints¹

Baseline Characteristics¹

ACR Response Criteria^1,2

PRIMARY ENDPOINT¹

SELECT RANKED SECONDARY ENDPOINTS²

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,9,10

BASELINE CHARACTERISTICS^3,11

Primary Endpoint¹

Select Ranked Secondary Endpoints^3,6

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,6

Baseline Characteristics³

Primary Endpoint¹

Ranked Secondary Endpoints^3,8

Select prespecified
nonranked endpoints^2,3,9,10

Baseline Characteristics³

Primary Endpoint¹

Select Ranked Secondary Endpoints^5,6

Select Prespecified nonranked endpoints⁶

Baseline Characteristics⁵

Primary Endpoint¹

Ranked Secondary Endpoints^6,7

Select Prespecified nonranked endpoints⁷

Baseline Characteristics⁶

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

INDICATION¹

IMPORTANT SAFETY INFORMATION¹