Artikel
Secukinumab Provides Rapid and Sustained Reductions in Dactylitis and Enthesitis in Patients with Psoriatic Arthritis: Analysis of Data from the Phase 3 Randomised, Multicentre, Double-blind, Placebo-controlled FUTURE 2 study
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Autoren
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Bruce Kirkham
- Guys and St. Thomas´NHS Foundation Trust, UK, London, UK
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Vaishali Bhosekar
- Novartis Healthcare Pvt Ltd, Hyderabad, Indien
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Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
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Kunal Gandhi
- Novartis Pharmaceuticals Corporation, East Hanover, USA
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Corine Gaillez
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: Dactylitis and enthesitis are common debilitating manifestations of psoriatic arthritis (PsA) [1].Secukinumab has previously been reported to reduce the number of dactylitic digits and enthesitis sites in patients (pts) with PsA, with a greater proportion of pts achieving complete resolution of dactylitis and enthesitis than placebo (PBO) at Week (Wk) 24 [2], [3].
Objective: To evaluate the effects of secukinumab on dactylitis and enthesitis through Wk 52 in FUTURE 2 (NCT01752634).
Methods: The study design from FUTURE 2 has been reported previously [2]. The proportions of pts with resolution of dactylitis and enthesitis at Wk 24 and Wk 52 were secondary and exploratory endpoints, respectively; additional measures were dactylitic digit and enthesitis counts. Post-hoc analyses included Kaplan Meier (KM) analysis to achieve resolution of enthesitis and dactylitis and proportion of pts with resolution of dactylitis and enthesitis by baseline (BL) severity.
Results: Of the 397 pts randomized, 138 (35%) and 253 (64%) had dactylitis and enthesitis, respectively, at BL. KM curves indicate that median time to resolution in dactylitis and enthesitis was Wk 4 for secukinumab 300 and 150 mg. At Wk 24, a greater proportion of secukinumab-treated pts achieved complete resolution of dactylitis and enthesitis than PBO (P<0.05); more secukinumab-treated pts had complete resolution of symptoms at Wk 52 than Wk 24. Improvements at Wk 24 and 52 were observed regardless of BL severity. A sustained decrease in mean changes from BL to Wk 24 and 52 in dactylitis and enthesitis count were shown in those pts with symptoms at BL (Table 1 [Tab. 1]), with improvements versus PBO observed by Wk 4 (P<0.05).
Conclusion: Secukinumab demonstrated a rapid resolution of dactylitis and enthesitis as early as Wk 4 and this was sustained up to Wk 52. A higher proportion of pts achieved complete resolution and reduced mean counts of dactylitis and enthesitis at Wk 52 than Wk 24.
References
- 1.
- Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii14-7.
- 2.
- McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, van der Heijde D, Landewé R, Conaghan PG, Gottlieb AB, Richards H, Pricop L, Ligozio G, Patekar M, Mpofu S; FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Sep 19;386(9999):1137-46. DOI: 10.1016/S0140-6736(15)61134-5
- 3.
- Kirkham B, McInnes IB, Mease P, Kremer J, Kandala S, Pricop L, Mpofu S. THU0421 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). Ann Rheum Dis. 2015;74:351.
