Article
Secukinumab is Effective in Reducing Dactylitis and Enthesitis Using Multiple Measures in Patients with Psoriatic Arthritis: Data From a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study (FUTURE 2)
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Authors
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Jürgen Wollenhaupt
- Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg
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Bruce Kirkham
- Guys and St. Thomas´NHS Foundation Trust, UK, London, UK
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Iain McInnes
- University of Glasgow, Glasgow, England
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Philip Mease
- Swedish Medical Center and University of Washington, Seattle, United States of America
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Joel M. Kremer
- Albany Medical College, The Center for Rheumatology, Albany, United States of America
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Sekhar Kandala
- Novartis Healthcare, Hyderabad, India
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Luminita Pricop
- Novartis Pharmaceuticals Corporation, New Jersey, USA
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Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Published: | September 1, 2015 |
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Outline
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Introduction: Dactylitis and enthesitis are common disabling manifestations of psoriatic arthritis (PsA) that have been reported according to multiple methods of assessment. Several measures of dactylitis and enthesitis were utilized in the phase 3 FUTURE 2 secukinumab study (NCT01752634) [1] and are reported here.
The objective is to evaluate the effects of subcutaneous (s.c.) secukinumab on dactylitis and enthesitis through Week (Wk) 24 in FUTURE 2.
Methods: 397 adults with active PsA were randomized to s.c. secukinumab (300, 150 or 75 mg) or PBO at baseline, Wk 1, 2, 3, 4 and then every 4 wks thereafter. The primary endpoint was ACR20 response at Wk 24. The proportions of pts with resolution of dactylitis and enthesitis at Wk 24 (of those with these conditions at baseline) were secondary endpoints. Additional measures utilized in this study were dactylitis counts, Leeds Dactylitis Index (LDI), and Leeds Enthesitis Index (LEI).
Results: At baseline, 138 pts (35%) had dactylitis and 253 pts (64%) had enthesitis. At Wk 24, comparing secukinumab 300 mg and 150 mg vs PBO respectively, 56.5% and 50.0% vs 14.8% of pts had complete resolution of dactylitis, and 48.2% and 42.2% vs 21.5% had complete resolution of enthesitis. Corresponding reductions in LDI, LEI and mean dactylitis counts were observed.
Conclusion: Across multiple methods of assessment, secukinumab 300 and 150 mg s.c. reduced the number of dactylitic digits and enthesitis sites in pts with PsA and was associated with a greater proportion of patients achieving complete resolution of dactylitis/enthesitis compared with PBO.
