AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

- Submissions supported by Phase 3 study in which upadacitinib (RINVOQ®) demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo

- No new safety risks were observed compared to the known safety profile of upadacitinib

- AbbVie has also submitted results from two studies of upadacitinib in adult patients with ankylosing spondylitis (AS) to request label enhancements in the European Union (EU)

- RINVOQ is approved for use in active psoriatic arthritis (PsA), moderate to severe active rheumatoid arthritis (RA), moderate to severe atopic dermatitis (AD) and active AS in the EU, and for PsA and RA in the US

NORTH CHICAGO, IL, USA I January 7, 2022 I AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approvals for upadacitinib (RINVOQ®, 15 mg once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). The applications are supported by the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial.

In the SELECT-AXIS 2 trial (Study 2), evaluating the efficacy and safety of upadacitinib in adult patients with nr-axSpA, upadacitinib met its primary and most ranked secondary endpoints.1 Treatment with upadacitinib 15 mg once daily resulted in reductions in signs and symptoms of nr-axSpA, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14 versus placebo.1

"Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life,"2 said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "AbbVie is committed to working with the FDA and EMA to make upadacitinib available as a treatment option for patients living with this disease."

In addition, AbbVie has requested label enhancements for upadacitinib in the European Union (EU) to include adult patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs), based on the results of the Phase 3 SELECT-AXIS 2 clinical trial (Study 1), as well as two-year results of the Phase 2/3 SELECT-AXIS 1 clinical trial.1,3 AbbVie also provided these data to the FDA in support of the agency's ongoing review of the supplemental New Drug Application (sNDA) for upadacitinib in AS.

The safety data observed in these patients with AS or nr-axSpA were generally consistent with the known safety profile of upadacitinib. No new safety risks were identified.1,3,4,5

About axSpA
Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage.6 It consists of two subsets that have been clinically defined as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).6 In ankylosing spondylitis, patients have definitive structural damage of the sacroiliac joints visible on x-rays.6 Non-radiographic axial spondyloarthritis is clinically defined by the absence of definitive x-ray evidence of structural damage to the sacroiliac (SI) joint by plain x-ray.6

About SELECT-AXIS 1 and SELECT-AXIS 2 trial programs1,4,5,7
SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active ankylosing spondylitis who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of RINVOQ in subjects who completed Period 1. Primary results from SELECT-AXIS 1 were previously announced in November 2019 with 2-year results presented in November 2021. More information on this trial can be found at www.clinicaltrials.gov (NCT03178487).

SELECT-AXIS 2 was conducted as a master study protocol that contains two standalone studies with randomization, data collection, analysis and reporting conducted independently. The Phase 3, randomized, placebo-controlled, double-blind studies are evaluating the efficacy and safety of upadacitinib compared with placebo on reduction of signs and symptoms in adult participants with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). More information on this trial can be found at www.clinicaltrials.gov (NCT04169373).

In all studies, the primary endpoint was the percentage of subjects achieving an ASAS40 response after 14 weeks of treatment.

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-2.8 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 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 Use of RINVOQ in AS is not approved by FDA and its safety and efficacy remain under review. Use of RINVOQ in nr-axSpA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

RINVOQ U.S. Uses and Important Safety Information7
RINVOQ is a prescription medicine used to treat adults with:

  • Moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
  • Active psoriatic arthritis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

Please click here for the Full Prescribing Information and Medication Guide.

EU Indications and Important Safety Information about RINVOQ™ (upadacitinib)

Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Ankylosing spondylitis
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

See RINVOQ full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

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, Instagram, YouTube and LinkedIn.

References:
1 AbbVie. Data on File: ABVRRTI73013.
2 Axial Spondyloarthritis. Arthritis Foundation. Available at: https://www.arthritis.org/diseases/ankylosing-spondylitis. Accessed December 2021. 
3 AbbVie. Data on File: ABVRRTI73012
4 RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; December 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
5 van der Heijde D, Deodhar A, Maksymowych W, Sieper J, Van den Bosch F, Kim T, Kishimoto M, Ostor A, Combe B, Sui Y, Duan Y, Chu A, Song I. Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-upadacitinib-in-patients-with-active-ankylosing-spondylitis-2-year-results-from-a-randomized-double-blind-placebo-controlled-study-with-open-label-extension/. Accessed December 21, 2021.
6 Deodhar AA, Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.
7 Van der Heijde D, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. The Lancet 2019; 394: 2108-2117.
8 RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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: November 2021.
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: November 2021.
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: November 2021.
13 A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed: November 2021.
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: November 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: November 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: November 2021.

SOURCE: AbbVie

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