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NORTH CHICAGO, Ill. , Dec. 14, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. 1
"The efficacy of RINVOQ in relieving the many manifestations of psoriatic arthritis is well-characterized in two large, long term clinical studies," said Michael Severino , M.D., vice chairman and president, AbbVie. "This new approval underscores our mission to deliver a portfolio of therapies that can help more people with rheumatic diseases achieve disease control."
The FDA approval is supported by data from two pivotal Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which assessed the efficacy, safety and tolerability of RINVOQ in patients with PsA. 2,3 In both studies, the safety profile in patients with active PsA treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis.
"Many adults still struggle to find a treatment option that helps them lower their disease activity," said Iain McInnes , professor of medicine and Versus Arthritis professor of rheumatology at University of Glasgow , U.K., and lead investigator of the SELECT-PsA 1 trial. "With this FDA approval, RINVOQ has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals."
Across SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials, RINVOQ met its primary endpoint of ACR20 at week 12 with patients taking RINVOQ 15 mg achieving significantly higher ACR20 responses (71% and 57%, respectively) versus placebo (36% and 24%, respectively). 2,3
Joint Efficacy 1-3
Physical Function 1-3
Skin Response 1-3
Other serious side effects include tears in the stomach or intestines and changes in certain laboratory test results.
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About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. 5 In PsA, the immune system causes inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints. 5,6 PsA affects about 30% of people with psoriasis. 7,8
About SELECT-PsA 1 1,2
SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, active comparator- and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg every other week, or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving, percentage of patients achieving a static Investigator Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a 2-point improvement from baseline at week 16; percentage of patients achieving PASI 75 response at week 16; inhibition of radiographic progression at week 24 per the change from baseline in mTSS; the percentage of patients achieving MDA at week 24; percentage of participants with resolution of enthesitis at week 24; change from baseline in FACIT-F questionnaire at week 12; and percentage of patients with resolution of dactylitis at week 24. These are not all of the secondary endpoints. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 2 1,3
SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment vs placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).
About RINVOQ ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. 1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers and adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ 15 mg is also approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 9-16
RINVOQ U.S. Uses and Important Safety Information 1
RINVOQ is a prescription medicine used to treat adults with:
It is not known if RINVOQ is safe and effective in children under 18 years of age.
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I do or tell my HCP AFTER starting RINVOQ?
What are the common side effects of RINVOQ? These include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex, bronchitis, nausea, cough, fever, and acne. These are not all the possible side effects of RINVOQ.
How should I take RINVOQ? RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg extended-release tablets.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for the Full Prescribing Information and Medication Guide .
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .
Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.