Article
Secukinumab Inhibits Radiographic Progression in Patients with Psoriatic Arthritis: Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study (FUTURE 1)
Search Medline for
Authors
-
Jürgen Rech
- Universitätsklinikum Erlangen, Medizinische Klinik 3, Rheumatologie und Immunologie, Erlangen
-
D. van der Heijde
- Leiden University Medical Center, The Netherlands, Leiden, Netherland
-
Robert Landewé
- Academic Medical Center, Department of Internal Medicine, Division of Rheumatology, Amsterdam, Heerlen, The Netherlands
-
Philip Mease
- Swedish Medical Center and University of Washington, Seattle, United States of America
-
Iain McInnes
- University of Glasgow, Glasgow, England
-
Philip Conaghan
- University of Leeds, Section of Musculoskeletal Disease, Leeds, United Kingdom
-
Luminita Pricop
- Novartis Pharmaceuticals Corporation, New Jersey, USA
-
Gregory Ligozio
- Novartis Pharmaceuticals Corporation, East Hanover, United States of America
-
Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
-
Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Published: | September 1, 2015 |
|---|
Outline
Text
Introduction: The objective is to investigate the effect of secukinumab, a human anti–interleukin-17A monoclonal antibody, on radiographic progression in PsA patients (pts) in the FUTURE 1 study (NCT01392326).
Methods: 606 adults with active PsA were randomized to secukinumab or placebo (PBO). Pts on secukinumab received 10 mg/kg i.v. loading dose at baseline, Week (Wk) 2 and Wk 4, then either 75 mg s.c. or 150 mg s.c. every 4 wks from Wk 8. PBO was given on the same schedules. At Wk 16, PBO pts who had ≥20% reduction in both tender and swollen joint count (responders) remained on PBO until Wk 24, and non-responders were re-randomized to secukinumab 75 or 150 mg. The van der Heijde modified total sharp scores (mTSS), and erosion and joint space narrowing (JSN) scores were determined at baseline, Wks 16/24 (depending on clinical response) and 52. Assessment of no structural progression, defined as a change in mTSS from baseline to Wk 24 of ≤0.5, was included as an exploratory endpoint.
Results: Secukinumab significantly inhibited radiographic progression at 24 wks; mean changes in mTSS from baseline to Wk 24 were 0.08 (pooled secukinumab doses), 0.13 (10 IV→150 SC) and 0.02 (10 IV→75 SC) vs 0.57 for PBO. Inhibition of joint structural damage was sustained with secukinumab through Wk 52. Inhibition of radiographic progression was demonstrated in PBO pts who switched to secukinumab; mean changes in mTSS from Wk 24 to Wk 52 were 0 (150 mg) and –0.16 (75 mg). The proportion of pts with no disease progression from baseline to Wk 24 was 82.3% and 92.3% for secukinumab 75 mg and 150 mg groups vs 75.7% for PBO. The proportion of pts with no disease progression was sustained in the secukinumab groups (85.7% and 85.8%) through Wk 52 and increased in pts initially randomized to PBO following active treatment (86.8%).
Conclusion: Sustained inhibition of radiographic disease progression was observed with secukinumab through Wk 52. Switching to secukinumab inhibited radiographic disease progression in pts initially randomized to PBO.
