27 Nov Upadacitinib for Rheumatic Condition Ankylosing Spondylitis
MedicalResearch.com Interview with:
Aileen Lorenzo Pangan MD
Executive Medical Director
MedicalResearch.com: What is the background for this study?
Response: Our ongoing commitment to advancing the standard of care for patients with rheumatic diseases is illustrated by our growing portfolio and the thirty-eight abstracts we presented at this year’s ACR/ARP Annual Meeting, including results from five studies of RINVOQ in rheumatoid arthritis (RA) and primary results from our study in ankylosing spondylitis (AS).
MedicalResearch.com: What are the main findings?
RINVOQ in AS (ankylosing spondylitis)
- Positive results from the Phase 2/3 SELECT-AXIS 1 trial showed twice as many adult patients with active AS treated with RINVOQ™ (upadacitinib; 15 mg, once-daily) achieved the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 versus placebo (52 percent vs 26 percent; p<0.001).
- SELECT-AXIS 1 is the first trial to evaluate the efficacy and safety of RINVOQ in adult patients with active AS who are naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) and had inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).The research presented at this year’s ACR/ARP Annual Meeting have been published concurrently in The Lancet.
- Apart from biologics, there are limited options for patients who have an inadequate response or contraindication to NSAIDs, and results from the trial show that RINVOQ was able to provide significant improvements in the signs and symptoms of disease for patients living with AS.
RINVOQ in RA (rheumatoid arthritis)
- The treatment goal for RA is remission, or low disease activity, in accordance with the ACR guidelines. Despite many available treatment options with various mechanisms of action, many RA patients continue to struggle to achieve durable remission, creating a need for additional treatment options with higher efficacy outcomes. AbbVie presented data further demonstrating more patients treated with RINVOQ achieve clinical remission across multiple measures of remission, such as RAPID3, compared to placebo and methotrexate.Long-term data from the SELECT program, which supported the recent FDA approval of RINVOQ for the treatment of moderate to severe RA, were also presented that demonstrate consistency in efficacy across multiple measures and safety, with or without methotrexate.
- Data were presented indicating those patients who experience an initial insufficient response to either upadacitinib or adalimumab may benefit from switching to the other therapy.
MedicalResearch.com: What should readers take away from your report?
Response: In addition to the recent FDA approval of RINVOQ based on the positive benefit-risk profile demonstrated across one of the largest registrational trials, we are pleased by the SELECT–AXIS 1 results that show the potential for RINVOQ to help even more patients living with rheumatic diseases.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: AbbVie’s expertise and commitment to immunology is rooted in more than two decades of world-class science and an unwavering commitment to make a difference in the lives of patients. Our portfolio of innovative therapies is well positioned to further improve patient care with RINVOQ, recently FDA-approved for the treatment of RA, and HUMIRA, with 10 FDA-approved indications.
Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients with Active Ankylosing Spondylitis
Désirée van der Heijde1, In-Ho Song 2, Aileen Pangan 3, Atul Deodhar 4, Filip Van den Bosch 5, Walter P. Maksymowych 6, Tae-Hwan Kim 7, Mitsumasa Kishimoto 8, Andrea Everding 9, Yunxia Sui 10, Xin Wang 10, Alvina D. Chu 10 and Joachim Sieper 11, 1Leiden University Medical Center, Leiden, Netherlands, 2AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 3AbbVie Inc., North Chicago, 4Oregon Health & Science University, Portland, OR, 5Ghent University Hospital, Ghent, Belgium, 6University of Alberta/CARE ARTHRITIS, Edmonton, AB, Canada, 7Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 8Immuno-Rheumatology Center, St. Luke’s International Hospital, Tokyo, Japan, 9HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, 10AbbVie Inc., Chicago, 11Charité Universitätsmedizin Berlin, Germany, Berlin, Germany
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