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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

塞库金单抗 医学 安慰剂 银屑病性关节炎 内科学 队列 胃肠病学 外科 关节炎 病理 替代医学
作者
Laura C. Coates,Philip J. Mease,Laure Gossec,Bruce Kirkham,Bintu Sherif,Corine Gaillez,Shephard Mpofu,Steffen Jugl,Chetan S. Karyekar,Kunal K. Gandhi
出处
期刊:Arthritis Care and Research [Wiley]
卷期号:70 (10): 1529-1535 被引量:42
标识
DOI:10.1002/acr.23537
摘要

Objective To evaluate minimal disease activity ( MDA ) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study. Methods Patients 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 ( PRO s), including health‐related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders. Results Overall, 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. Conclusion A 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 PRO s, including QoL, through 2 years.
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