Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

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

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

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

Power to help
Stop
further
joint damage,
even without mtx1

Achieved ranked secondary endpoint
of mean change from baseline in radiographic progression (ΔmTSS) at Week 26 or 24, with responses observed up to 96 weeks.2-5

RINVOQ is not indicated for MTX‑naïve patients


IR=intolerance or inadequate response; MTX=methotrexate; mTSS=modified total sharp score

Clinical Trial Overview

SELECT-COMPARE: Primary endpoint was ACR20 response at Week 12 MTX-IR

*P≤0.001 RINVOQ vs Placebo

SELECT‑COMPARE (Study RA‑IV) Study Design Intro:1,2
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. The primary endpoint was ACR20 response at Week 12 vs Placebo. Prespecified blinded rescue protocol occurred at weeks 14, 18, 22, or 26.

SELECT-EARLY Study: primary endpoint was ACR50 response at week 12 MTX-naïve

*P≤0.001 RINVOQ vs MTX

RINVOQ is not indicated for MTX-naïve patients

SELECT‑EARLY (Study RA‑I) Study Design Intro:1,3
48‑week, randomized, double‑blind, active comparator‑controlled study of 947 adult patients with moderate to severe RA who were MTX-naïve. The primary endpoint was ACR50 response at Week 12. At Week 26, non‑responding patients were rescued according to prespecified criteria. 

Radiographic inhibition
even
without mtx1-3,6

SELECT‑COMPARE: Radiographic Response: Week 26

SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26)

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

SELECT-COMPARE results are based on random coefficient model.b Data observed after rescue are not included in the analysis.

SELECT‑EARLY: Radiographic Response: Week 24

SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24)

RINVOQ is not indicated for MTX‑naïve patients

Please see HUMIRA full Prescribing Information.

Radiographic inhibition
even
without mtx up to 96 weeks1,4,5,7

SELECT-COMPARE
Radiographic Response: mTSS

Subgroup Analysis (As Observed)

SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26)

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

Subgroup Analyses:5 Prespecified subgroup analyses include data for patients that were not rescued, had both baseline and follow-up X-rays, and were reported as observed (AO), without imputation for missing data.

SELECT-EARLY
Radiographic Response: mTSS

Subgroup Analysis (As Observed)

SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24)

RINVOQ is not indicated for MTX‑naïve patients

SELECT-COMPARE: Radiographic Response - mTSS4,5
up to 96 Weeks
Subgroup Analysis (As Observed)

SELECT-COMPARE: Radiographic Response mTSS SELECT-COMPARE: Radiographic Response mTSS SELECT-COMPARE: Radiographic Response mTSS

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

For change from baseline in mTSS least squares mean estimator was based on an ANCOVA model with treatment and prior bDMARD as fixed factor and baseline value as a covariate.5

Please see HUMIRA full Prescribing Information.

SELECT-EARLY: Radiographic Response - mTSS4,7
up to 96 Weeks
Subgroup Analysis (As Observed)

SELECT-EARLY: Radiographic Response mTSS SELECT-EARLY: Radiographic Response mTSS SELECT-EARLY: Radiographic Response mTSS

RINVOQ is not indicated for MTX‑naïve patients

For change from baseline in mTSS least squares mean estimator was based on an ANCOVA model with treatment and geographic region as fixed factor and baseline value as a covariate.5

Educational Speaker Program Webinar

SELECT‑EARLY

Watch as Dr. Stephen Hall discusses RINVOQ efficacy and safety information from the SELECT‑EARLY study.

SELECT-EARLY Study Design

Video 1/4

Background information on the Phase 3 clinical program for RINVOQ and study details for SELECT‑EARLY.

SELECT-EARLY Results

Video 2/4

A look at the primary endpoint and ranked secondary endpoint results of the SELECT‑EARLY study.

SELECT-EARLY Safety Data

Video 3/4

In this chapter, the SELECT-EARLY safety data including rates of adverse events are explored.

SELECT-EARLY Highlights

Video 4/4

A summary of the SELECT‑EARLY study and important safety information.

RINVOQ SAFETY DATA

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

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 INFORMATION

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 druginduced 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.

Dosage Forms and Strengths: RINVOQ is available in 15 mg extended-release tablets.

US-UPAD-190033

Please see full Prescribing Information.

Please see full Prescribing Information.

REFERENCES

  1. RINVOQ [package insert]. North Chicago IL: AbbVie Inc.
  2. 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.
  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. 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.
  5. Data on File. ABVRRTI70892.
  6. Data on File. ABVRRTI68980.
  7. Data on File. ABVRRTI70900.

 

INDICATION & LIMITATION OF USE1

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
INFORMATION & INDICATION1

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 immunosuppressants

INDICATION & LIMITATION OF USE1

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
INFORMATION & INDICATION1

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 immunosuppressants

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 INFORMATION

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 druginduced 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.

Dosage Forms and Strengths: RINVOQ is available in 15 mg extended-release tablets.

US-UPAD-190033