Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study

Abstract

Objective: To report the 5-year efficacy and safety of secukinumab in the treatment of patients with psoriatic arthritis (PsA) in the FUTURE 1 study (NCT01392326).

Methods: Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab entered a 3-year extension phase. Results are presented for key efficacy endpoints for the secukinumab 150-mg group (n = 236), including patients who escalated from 150 to 300 mg (approved doses) starting at week 156. Safety is reported for all patients (n = 587) who received 1 dose or more of study treatment.

Results: Overall, 81.8%% (193 of 236) of patients in the secukinumab 150-mg group completed 5 years of treatment, of which 36.4% (86 of 236) had dose escalation from 150 to 300 mg. Sustained improvements were achieved with secukinumab across all key efficacy endpoints through 5 years. Overall, 71.0%/51.8%/36.3% of patients achieved American College of Rheumatology (ACR) 20/50/70 responses at 5 years. Efficacy improved in patients requiring dose escalation from 150 to 300 mg and was comparable with those who did not require dose escalation. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years for any secukinumab dose were serious infections (1.8), Crohn's disease (0.2), Candida infection (0.9), and major adverse cardiac events (0.5).

Conclusion: Secukinumab provided sustained improvements in the signs and symptoms in the major clinical domains of PsA. Efficacy improved for patients requiring dose escalation from 150 to 300 mg during the study. Secukinumab was well tolerated with no new safety signals.

© 2019 The Authors. ACR Open Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Figures

Figure 1

Patient disposition during the extension phase.

Figure 2

ACR20/50/70 responses up to 5 years in the secukinumab 150‐mg group. To show the full 5‐year efficacy, results are shown for the group of patients who were originally randomized to secukinumab 150 mg during the core study and entered the extension study in the secukinumab 150 mg group; patients who switched from placebo to secukinumab 150 mg at weeks 16 and 24 are not included in these figures. ACR 20/50/70, American College of Rheumatology criteria for 20%/50%/70% improvement in disease activity.

Figure 3

American College of Rheumatology (ACR) and Psoriasis Area and Severity Index (PASI) responses up to 56 weeks after dose escalation from 150 to 300 mg. Before escalation is defined as the last assessment done on or before patient took the escalated dose. Patients who entered the extension phase in the secukinumab 150‐mg group (including patients who switched from placebo to secukinumab 150 mg at weeks 16 and 24) and who had both pre‐ and all postdose escalation assessments data available are included in the analysis for ACR (n = 126) and PASI (n = 80) responses.