Background/Purpose:  Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, has been evaluated and approved for the treatment of moderate to severe psoriasis, active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is commonly associated with psoriasis, PsA and AS.^1,2 The risk of CD in moderate to severe psoriasis patients (pts) is ~2–4-fold higher than that in the general population,^1,3,4 occurring at a rate of up to 0.25 cases per 100 pt-years.⁴ CD has been reported at a rate of 0.06 cases per 100 pt-years among pts with PsA,³ and 0.7 cases per 100 pt-years among placebo-treated pts in AS trials.⁵ Endoscopic subclinical inflammation occurs in up to 50% of AS pts.² Here, we report the incidence of CD and UC among secukinumab-treated pts in the psoriasis, PsA, and AS clinical trial programs.

Methods:  This analysis included data from 10 Phase II and Phase III studies in moderate to severe psoriasis, 2 Phase III studies in active PsA, and 2 Phase III studies in active AS, pooled per indication. Most studies included short-term, placebo treatment arms; 1 psoriasis study included an etanercept active comparator arm. Pts with prior history of, but not active, IBD could be enrolled. Study durations varied; data from all pts receiving ≥1 secukinumab dose up to Week 52 (psoriasis studies) or Week 112 visit (PsA/AS studies) were included. Data are reported as crude frequency rates (%) in the short-term (Week 12 in the psoriasis studies and Week 16 in the PsA/AS studies) and exposure adjusted incidence rates (EAIR; per 100 pt-years) over the entire treatment period.

Results:  Overall, 3430, 974, and 571 pts received ≥1 secukinumab dose in the psoriasis, PsA, and AS studies, respectively. Adverse events of CD or UC were reported infrequently amongst secukinumab-treated pts in both the short- and long-term treatment periods (Table). Rates of CD and UC were similar across the psoriasis and PsA cohorts, and rates with secukinumab were similar to those seen with etanercept in psoriasis pts. Across all indications, there was no dose dependency with respect to the incidence of CD or UC with secukinumab, and no pattern in time-to-onset (data not shown).

Conclusion:  Events of CD and UC in the 14 clinical studies were reported infrequently in secukinumab-treated pts with psoriasis, PsA, or AS; rates were similar across the psoriasis and PsA cohorts. EAIR rates of CD and UC observed in secukinumab-treated pts are consistent with those reported in the literature in psoriasis, PsA, and AS populations. References: 1. Li et al. Ann Rheum Dis 2013;72:1200–5; 2. Rudwaleit et al. Best Pract Res Clin Rheumatol 2006;20:451–71; 3. Egeberg et al. Br J Dermatol 2016; E-pub ahead of print; 4. Scosyrev & Primatesta. Poster P068, 5th Congress of the Psoriasis International Network, 7–9 July 2016, Paris, France; 5. Braun et al. Arthritis Rheum 2007;57:639–47

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ACR Meeting Abstracts - https://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/