Artikel
Secukinumab improves signs and Symptoms of active psoriatic arthritis in a phase 3 randomized, multicenter, double-blind, placebo-controlled study using a subcutaneous dosing regimen (FUTURE 2)
Suche in Medline nach
Autoren
-
Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
-
Iain McInnes
- University of Glasgow, Glasgow, England
-
Philip Mease
- Swedish Medical Center and University of Washington, Seattle, United States of America
-
Bruce Kirkham
- Guys and St. Thomas´NHS Foundation Trust, UK, London, UK
-
Arthur Kavanaugh
- UCSD, Division of Rheumatology, Allergy and Immunology, La Jolla, United States of America
-
Christopher Ritchlin
- University of Rochester Medical Center, New York, USA
-
Proton Rahman
- Memorial University of Newfoundland, St. John`s, Kanada
-
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 Conaghan
- University of Leeds, Section of Musculoskeletal Disease, Leeds, United Kingdom
-
Alice B. Gottlieb
- Tufts Medical Center, Boston, MA, USA
-
Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
-
Gregory Ligozio
- Novartis Pharmaceuticals Corporation, East Hanover, United States of America
-
Luminita Pricop
- Novartis Pharmaceuticals Corporation, New Jersey, USA
-
Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 1. September 2015 |
|---|
Gliederung
Text
Introduction: Secukinumab, a human anti–IL-17A monoclonal antibody, has demonstrated efficacy with an intravenous loading and subcutaneous (s.c.) maintenance regimen in psoriatic arthritis (PsA) (FUTURE 1; NCT01392326).
The objective is to evaluate the efficacy and safety of s.c. loading and maintenance dosing with secukinumab in FUTURE 2 (NCT01752634), a randomized, double-blind, placebo (PBO)-controlled phase 3 study in patients with active PsA.
Methods: 397 adults with active PsA were randomized to s.c. secukinumab (300, 150 or 75 mg) or PBO at baseline, Week (Wk) 1, 2, 3, 4 and then every 4 wks thereafter. Randomization was stratified by prior exposure to anti-TNF therapy. The primary endpoint was ACR20 response at Wk 24. Secondary endpoints included PASI 75/90, Disease Activity Score 28 using C-reactive protein (DAS28-CRP), Short Form-36 Physical Component Summary (SF-36 PCS), Health Assessment Questionnaire-Disability Index (HAQ-DI), ACR50, dactylitis and enthesitis. Primary and secondary endpoints were included in a hierarchical testing analysis to adjust for multiplicity.
Results: At Wk 24, ACR20 responses were significantly greater with secukinumab 300, 150 and 75 mg than PBO: 54.0%, 51.0% and 29.3% vs. 15.3%, respectively (P < 0.0001 for secukinumab 300 and 150 mg; P < 0.05 for 75 mg vs PBO). Secukinumab 300 and 150 mg also improved secondary endpoints, including significant improvements in PASI 75/90 scores and DAS-28 CRP vs. PBO. Exposure-adjusted rates of treatment-emergent AEs (maximum exposure to secukinumab: 372 days) were 222.2 and 309.3 per 100 pt-years amongst secukinumab (pooled) and placebo-treated subjects, respectively. The respective rates of serious AEs were 7.8 and 8.8.
Conclusion: Secukinumab 300 and 150 mg s.c. demonstrated clinically significant improvements in the signs and symptoms of PsA. The safety profile of secukinumab was satisfactory, suggesting that the drug is thus far well tolerated.
