Artikel
No Increase in 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
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Autoren
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Stefan Schreiber
- Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin I, Kiel
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Bruce E. Sands
- Academic Medical Center / University of Amsterdam, Amsterdam, Niederlande
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Dominique Baeten
- Academic Medical Center/University of Amsterdam, Clinical Immunology and Rheumatology, Amsterdam, The Netherlands
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J. Q. Huang
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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Kunal Gandhi
- Novartis Pharmaceuticals Corporation, East Hanover, USA
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Chetan Karyekar
- Novartis Pharmaceuticals Corporation, East Hanover, USA
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Todd Fox
- Novartis Pharma AG, Basel, Schweiz
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Corine Gaillez
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: Secukinumab (an IL-17A-inhibitor) has been evaluated and approved for the treatment of moderate to severe PsO, active PsA and active AS. IBD, including CD and 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; The rate of CD among placebo (Pbo) treated pts in AS trials has been reported as 0.7 cases per 100 pt-years [3].
Objective: To assess the incidence of CD and UC among secukinumab -treated pts in the PsO, PsA, and AS clinical trial programs.
Methods: This analysis included data from 14 Phase 2 and 3 studies PsO (10), PsA (2) and AS (2), pooled per indication. Most studies included short-term, Pbo treatment arms; 1 PsO 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 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 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 secukinumab-treated pts. Rates of CD and UC were similar across the PsO and PsA cohort, and rates with secukinumab were similar to those seen with etanercept in PsO pts. There was no dose dependency with respect to the incidence of CD or UC with secukinumab, and no pattern in time-to-onset.
Conclusion: Events of CD and UC in the 14 clinical studies were reported infrequently in secukinumab-treated pts with PsO, PsA, or AS; rates were similar across the PsO and PsA cohorts. EAIR rates of CD and UC observed in secukinumab-treated patients are consistent with those reported in the literature in PsO, PsA, and AS pts.
Table 1 [Tab. 1]
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