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

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.