No Increased Risk of IBD Among Secukinumab-Treated Patients with Moderate to Severe Psoriasis in Phase 2 & 3 Clinical Studies

MedicalResearch.com Interview with:

Atul Deodhar, M.D., M.R.C.P. Rheumatology Oregon Health and Science University

Dr. Atul Deodhar

Atul Deodhar, M.D., M.R.C.P.
Rheumatology
Oregon Health and Science University 

MedicalResearch.com: What is the background for this study?

Response: Patients with psoriasis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS) are at an increased risk of developing inflammatory bowel disease (IBD) compared with the general population. It is important that we assess whether new therapies, including the recently approved interleukin-17A (IL-17A) inhibitor, secukinumab, have an acceptable profile in terms of the risk of IBD in patients with psoriasis, PsA, or AS.

MedicalResearch.com: What are the main findings?

Response: This analysis utilized pooled data from 14 clinical trials (4 Phase 2 and 10 Phase 3) to assess the risk of IBD amongst secukinumab-treated patients with psoriasis, PsA, or AS. Reflecting over 5,200 years of secukinumab exposure, this comprehensive evaluation demonstrated that events of Crohn’s disease and ulcerative colitis, the two main forms of IBD, occurred infrequently with secukinumab treatment. Moreover, exposure-adjusted incidence rates of Crohn’s disease or ulcerative colitis observed with secukinumab were within the range of those previously reported in patients with psoriasis, PsA, or AS.

MedicalResearch.com: What should readers take away from your report?

Response: This analysis utilized pooled data from 14 clinical trials (4 Phase 2 and 10 Phase 3) to assess the risk of IBD amongst secukinumab-treated patients with psoriasis, PsA, or AS. Reflecting over 5,200 years of secukinumab exposure, this comprehensive evaluation demonstrated that events of Crohn’s disease and ulcerative colitis, the two main forms of IBD, occurred infrequently with secukinumab treatment. Moreover, exposure-adjusted incidence rates of Crohn’s disease or ulcerative colitis observed with secukinumab were within the range of those previously reported in patients with psoriasis, PsA, or AS.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: The clinical trial programs for secukinumab in psoriasis, PsA, and AS are ongoing. It will be interesting to see longer-term data from these studies, along with data from additional Phase 3 studies, to further assess the long-term risk of IBD in secukinumab-treated patients. Real-world observational data will also be valuable in this regard.

MedicalResearch.com: Is there anything else you would like to add?

Response: Secukinumab is a fully human monoclonal antibody that binds to and inhibits the proinflammatory cytokine IL-17A. It is approved for the treatment of moderate to severe psoriasis, active PsA, and active AS, and should only be prescribed in accordance with its approved indications. Prescribing Information may vary from country to country. Physicians should refer to their local Prescribing Information.  

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Disclosure:  Some funding provided by Novartis

Citation:

Deodhar AA, Schreiber S, Gandhi K, Fox T, Gaillez C, Karyekar C. No Increased Risk of Inflammatory Bowel Disease Among Secukinumab-Treated Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis: Data from 14 Phase 2 and Phase 3 Clinical Studies [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/no-increased-risk-of-inflammatory-bowel-disease-among-secukinumab-treated-patients-with-moderate-to-severe-psoriasis-psoriatic-arthritis-or-ankylosing-spondylitis-data-from-14-phase-2-and-phase-3-c/. Accessed November 28, 2016.

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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