RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis

– Approval backed by two Phase 3 clinical studies where RINVOQ (15 mg, once daily) showed efficacy across multiple measures of disease activity in active psoriatic arthritis (PsA) with a safety profile consistent with that seen in rheumatoid arthritis (RA) [1]

– RINVOQ helps to improve joint pain, swelling and stiffness, as well as fatigue, and prevent further joint damage for patients with active PsA

– Milestone marks the second FDA-approved indication for RINVOQ following rheumatoid arthritis in 2019

NORTH CHICAGO, IL, USA I December 14, 2021 I 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

• Across both SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials, patients treated with RINVOQ 15 mg achieved higher ACR50 responses (38% and 32%, respectively) at week 12 compared to placebo (13% and 5%, respectively).
• Patients treated with RINVOQ 15 mg across the SELECT-PsA 1 and SELECT-PsA 2 clinical trials achieved higher ACR70 responses (16% and 9%, respectively) compared to placebo (2% and 1%, respectively) at week 12.
• Treatment with RINVOQ 15 mg resulted in improvement in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis.
• In SELECT-PsA 1, treatment with RINVOQ 15 mg significantly inhibited the progression of structural joint damage (-0.02 change from baseline) compared to placebo (0.23) as assessed by the change from baseline in modified Total Sharp Score (mTSS) at week 24.

Physical Function^1-3

• Across SELECT-PsA 1 and SELECT-PsA 2 clinical trials, patients treated with RINVOQ 15 mg showed significant improvement in physical function from baseline compared to placebo as assessed by HAQ-DI at week 12.

Fatigue^1-3

• In both Phase 3 clinical trials, patients receiving RINVOQ 15 mg experienced significantly greater improvement from baseline in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score, at Week 12 compared to placebo.

Skin Response^1-3

• Treatment with RINVOQ 15 mg resulted in improvement in skin manifestations in patients with PsA. However, RINVOQ has not been studied in and is not indicated for the treatment of plaque psoriasis.

Safety^1-3

• Overall, the safety profile observed in patients with active PsA treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. During the 24-week placebo-controlled period, the most common adverse events reported with RINVOQ 15 mg were upper respiratory tract infection and blood creatine phosphokinase elevations. The frequencies of herpes zoster and herpes simplex were 1.1% and 1.4%, respectively, with RINVOQ 15 mg and 0.8% and 1.3%, respectively, with placebo. A higher incidence of acne and bronchitis was also observed in patients treated with RINVOQ 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively).
• RINVOQ may cause serious side effects, including:
  • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
  • Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.
  • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen. Current or past smokers are at higher risk.
  • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers.
  • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.

Other serious side effects include tears in the stomach or intestines and changes in certain laboratory test results.

Ease of Use and Access

• Designed to help accommodate the physical limitations of people living with rheumatic diseases, the packaging for RINVOQ includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access. This packaging design was awarded the Arthritis Foundation Ease of Use Commendation.⁴
• AbbVie continues to work closely with key stakeholders to support patient access to RINVOQ, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to $5 per month for eligible, commercially-insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ to qualifying patients. For more details, please visit AbbVie.com/myAbbVieAssist.

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

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.

References:

1. RINVOQ^® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
2. McInnes, I, et al. (2021). Trial of Upadacitinib and Adalimumab for psoriatic arthritis. New England Journal of Medicine, 384(13), 1227–1239. https://doi.org/10.1056/nejmoa2022516.  
3. Mease, P. J., et al. (2020). Upadacitinib for psoriatic arthritis refractory to biologics: Select-PSA 2. Annals of the Rheumatic Diseases, 80(3), 312–320. https://doi.org/10.1136/annrheumdis-2020-218870.
4. RINVOQ. Arthritis Foundation. Available at: https://www.arthritis.org/partnership/ease-of-use-products/rinvoq#:~:text=The%20Arthritis%20Foundation’s%20Ease%20of,easy%20to%20use%20for%20everyone.
5. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
6. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on: September 10, 2020.
7. Rodrigo Valdes-Rodriguez, M.D., Shawn G. Kwatra, M.D., Gil Yosipovitch, M.D. (2018). Itch in Psoriasis: From Basic Mechanisms to Practical Treatments. Psoriasis Forum,Volume: 18a issue: 3,page(s): 110-117.
8. Mease, P. J., Gladman, D. D., Papp, K. A., Khraishi, M. M., Thaci, D., Behrens, F., Alvarez, D. (2014) Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol, 69(5), 729-735.
9. Burmester G.R., 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 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
10. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 17, 2020.
11. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on August 17, 2020
12. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed: June 2021.
13. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT – PsA 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on August 17, 2020.
14. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed: June 2021.
15. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed: June 2021.
16. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed: June 2021.

SOURCE: AbbVie