27 Nov Upadacitinib for Rheumatic Condition Ankylosing Spondylitis

MedicalResearch.com Interview with:

Dr. Pangan

Aileen Lorenzo Pangan MD
Executive Medical Director
AbbVie

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.

Citation:

ABSTRACT NUMBER: 2728 • 2019 ACR/ARP Annual Meeting

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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Last Updated on November 27, 2019 by Marie Benz MD FAAD