Incidence of inflammatory bowel disease in patients treated with secukinumab: pooled analysis of 21 randomized controlled Phase III and IV clinical trials of psoriasis, psoriatic arthritis, and ankylosing spondylitis

Presenters: Schreiber S¹, Colombel JF², Feagan BG³, Blauvelt A⁴, Reich K⁵, Deodhar A⁶, McInnes IB⁷, Porter B⁸, Gupta AD⁹, Pricop L⁸, Fox T¹⁰

Affiliations: ¹Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany; Institute of Clinical Molecular Biology, University of Kiel, Germany; ²Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; ³University of Western Ontario, Ontario, Canada; ⁴Oregon Medical Research Center, Portland, Oregon; ⁵Dermatologikum Hamburg and Georg-August-University, Göttingen, Germany; ⁶Oregon Health & Science University, Portland, OR; ⁷Institute of Infection Immunity and Inflammation, University of Glasgow, Glasgow, UK; ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ; ⁹Novartis Healthcare Pvt. Ltd., Hyderabad, India; ¹⁰Novartis Pharma AG, Basel, Switzerland

Background/Objective: Inflammatory bowel disease (IBD) such as Crohn’s disease (CD) and ulcerative colitis (UC) are common comorbidities associated with psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Compared to the general population, epidemiological studies have shown that patients with psoriasis or PsA are at a 2- to 4-fold increased risk of developing CD and a 2- to 3-fold increased risk of developing UC. Additionally, in patients with AS, there is a 3- to 5-fold increased risk of IBD compared with the general population. Secukinumab is approved for the treatment of psoriasis, PsA, and AS and is a fully human monoclonal antibody that neutralizes interleukin-17A. Here, we report the pooled incidence of IBD, CD, and UC in patients with psoriasis, PsA, or AS who received IL-17A inhibition with secukinumab. The data reported herein are based on results from 21 Phase III/IV clinical trials of secukinumab for psoriasis, PsA, or AS.

Methods: This analysis evaluated pooled data from 14 Phase III and one Phase IV psoriasis trials, three Phase III PsA trials, and three Phase III AS trials. Patients with a history of IBD but not active IBD were eligible for enrollment in these trials. Data from all patients that received at least one dose of secukinumab were included in this analysis. IBD reporting includes cases of CD, UC, and IBD not otherwise specified (NOS).

Results: A total of 7,355 patients receiving secukinumab were assessed for the presence of IBD: 5,181 with psoriasis, 1,380 with PsA, and 794 with AS. Over the entire treatment period, the mean total exposure to secukinumab was 10,416.9 patient-years in patients with psoriasis, 3,866.9 patient-years in patients with PsA, and 1,943.1 patient-years in patients with AS. The exposure-adjusted incidence rate (EAIR) per 100 patient-years (95% confidence interval [CI]) of CD, UC, and IBD NOS in secukinumab-treated patients were 0.05 [0.02, 0.11], 0.13 [0.07, 0.23], and 0.01 [0.00, 0.05], respectively, in the psoriasis studies; 0.08 [0.02, 0.23], 0.08 [0.02, 0.23], and 0.05 [0.01, 0.19], respectively in the PsA studies; and 0.4 [0.2, 0.8], 0.2 [0.1, 0.5], and 0.1 [0.0, 0.3], respectively, in the AS studies. Additionally, the incidence of IBD, CD, and UC did not increase over time.

Conclusion: Pooled data from 21 studies indicated that the observed exposure-adjusted incidence rates of IBD, CD, and UC with secukinumab were low and did not increase over time in patients with moderate-to-severe plaque psoriasis, PsA, or AS.

Funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland.