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OP0113 No Increased Incidence 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
  1. S. Schreiber1,
  2. B.E. Sands2,
  3. A. Deodhar3,
  4. D. Baeten4,
  5. J. Huang5,
  6. K. Gandhi5,
  7. C. Karyekar5,
  8. T. Fox6,
  9. C. Gaillez6
  1. 1Christian-Albrechts-Universität, Kiel, Germany
  2. 2Mount Sinai Hospital, New York
  3. 3Oregon Health & Science University, Portland, United States
  4. 4Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands
  5. 5Novartis Pharmaceuticals Corporation, East Hanover, United States
  6. 6Novartis Pharma AG, Basel, Switzerland

Abstract

Background Secukinumab (SEC), a fully human anti–interleukin-17A monoclonal antibody, has been evaluated and approved for the treatment of moderate to severe psoriasis (PsO), 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 PsO, PsA and AS.1,2 The risk of CD in PsO pts is ∼4-fold higher than that in the general population; this risk is even higher among PsO pts with PsA, reported at a rate of 0.05 cases per 100 pt-years.1 The rate of CD among placebo (Pbo) treated pts in AS trials has been reported as 0.7 cases per 100 pt-years.3 Endoscopic subclinical inflammation occurs in up to 50% of AS patients.2

Objectives To assess the incidence of CD and ulcerative colitis (UC) among SEC-treated pts in the PsO, PsA, and AS clinical trial programs.

Methods This analysis included data from 10 Phase 2 and Phase 3 studies in moderate to severe PsO, 2 Phase 3 studies in active PsA, and 2 Phase 3 studies in active AS, pooled per indication. Most studies included short-term, Pbo treatment arms; 1 PsO study included an etanercept (ETN) active comparator arm. Pts with prior history of, but not active, IBD could be enrolled. Study durations varied; data from all pts receiving ≥1 SEC dose up to Week (Wk) 52 (PsO studies) or Wk 112 visit were included. Data are reported as crude frequency rates (%) in the short-term (Wk 12 in PsO studies and Wk 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 SEC dose in the PsO, PsA, and AS studies, respectively. AEs of CD or UC were reported infrequently amongst SEC-treated pts in both the short- and long-term treatment periods (Table). Rates of CD and UC were similar across the PsO and PsA cohort, and rates with SEC were similar to those seen with ETN in PsO pts. Across all indications, there was no dose dependency with respect to the incidence of CD or UC with SEC, and no pattern in time-to-onset (data not shown).

Conclusions Events of CD and UC in the 14 clinical studies were reported infrequently in SEC-treated pts with PsO, PsA, or AS; rates were similar across the PsO and PsA cohorts. EAIR rates of CD and UC observed in SEC-treated patients are consistent with those reported in the literature in PsO, PsA, and AS pts.

  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. Braun et al. Arthritis Rheum 2007;57:639–47;

  4. Ward et al. AAD 2014. Poster presentation #8233;

  5. Secukinumab US Prescribing Information

Acknowledgement The study was sponsored by Novartis Pharma AG.

Disclosure of Interest S. Schreiber Grant/research support from: Abbvie, AstraZeneca/Medimmune, Boehringer, Celltrion, Ferring, Jansen, Novartis, MSD, Pfizer, Sanofi, Takeda, UCB, Consultant for: Abbvie, Celltrion, Ferring, MSD, Takeda, B. Sands: None declared, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, D. Baeten Grant/research support from: Boehringer Ingelheim, Janssen, MSD, Novartis, Pfizer, Consultant for: AbbVie, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, UCB, J. Huang Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis, C. Karyekar Shareholder of: Novartis, Employee of: Novartis, T. Fox Shareholder of: Novartis, Employee of: Novartis, C. Gaillez Shareholder of: Novartis, Employee of: Novartis

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