Minimal Disease Activity Among Active Psoriatic Arthritis Patients Treated With Secukinumab: 2-Year Results From a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study

被引:36
作者
Coates, Laura C. [1 ]
Mease, Philip J. [2 ,3 ]
Gossec, Laure [4 ,5 ]
Kirkham, Bruce [6 ]
Sherif, Bintu [7 ]
Gaillez, Corine [8 ]
Mpofu, Shephard [8 ]
Jugl, Steffen M. [8 ]
Karyekar, Chetan [9 ]
Gandhi, Kunal K. [9 ]
机构
[1] Univ Oxford, Oxford, England
[2] Swedish Med Ctr, Seattle, WA USA
[3] Univ Washington, Seattle, WA 98195 USA
[4] UPMC Univ Paris 06, GRC UPMC 08, Sorbonne Univ, Paris, France
[5] Hop La Pitie Salpetriere, AP HP, Paris, France
[6] Guys & St Thomas NHS Fdn Trust, London, England
[7] RTI Hlth Solut, Res Triangle Pk, NC USA
[8] Novartis Pharma AG, Basel, Switzerland
[9] Novartis Pharmaceut, E Hanover, NJ USA
关键词
TRIAL;
D O I
10.1002/acr.23537
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
ObjectiveTo evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study. MethodsPatients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [anti-TNF]-naive and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at weeks 16, 24, 52, and 104. Function and patient-reported outcomes (PROs), including health-related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders. ResultsOverall, 28% of patients (27 of 98) and 23% (23 of 100) achieved MDA at week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9 of 94) with placebo. In the anti-TNF-naive cohort, a higher proportion of patients achieved MDA at week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus with placebo (3%). At week 16, 27.1% of MDA responders (16 of 59) achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8 of 27] and 26% [6 of 23], respectively) versus placebo (22% [2 of 9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to nonresponders through 2 years. ConclusionA greater proportion of patients achieved MDA with secukinumab versus placebo at week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.
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收藏
页码:1529 / 1535
页数:7
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