Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study

Abstract

Objectives: To assess long-term efficacy, safety and tolerability of secukinumab up to 104 weeks in patients with active PsA.

Methods: Patients with PsA (n = 397) were randomized to s.c. secukinumab 300, 150 or 75 mg or placebo at baseline, weeks 1, 2, 3 and 4 and every 4 weeks thereafter. Placebo-treated patients were re-randomized to receive secukinumab 300 or 150 mg s.c. from week 16 (placebo non-responders) or week 24 (placebo responders). Exploratory endpoints at week 104 included 20, 50 and 70% improvement in ACR criteria (ACR20, 50, 70); 75 and 90% improvement in the Psoriasis Area Severity Index, 28-joint DAS with CRP, presence of dactylitis and enthesitis and other patient-reported outcomes. For binary variables, missing values were imputed; continuous variables were analysed by a mixed-effects model for repeated measures.

Results: A total of 86/100 (86%), 76/100 (76%) and 65/99 (66%) patients in the secukinumab 300, 150 and 75 mg groups, respectively, completed 104 weeks. At week 104, ACR20 response rates after multiple imputation in the 300, 150 and 75 mg groups were 69.4, 64.4 and 50.3%, respectively. Sustained clinical improvements were observed through week 104 with secukinumab across other clinically important domains of PsA. Responses were sustained through week 104 regardless of prior anti-TNF-α use. Over the entire treatment period the incidence, type and severity of adverse events were consistent with those reported previously.

Conclusion: Secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains in patients of active PsA through 2 years of therapy. Secukinumab was well tolerated, with a safety profile consistent with that reported previously.

Trial registration: ClinicalTrials.gov (https://ichgcp.net/clinical-trials-registry/NCT01752634" title="See in ClinicalTrials.gov">NCT01752634.

Keywords: anti-TNF therapy; biological therapies; efficacy; interleukin; joints; long term; psoriatic arthritis; safety; spondyloarthritis; swelling.

© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Figures

Fig. 1

Patient flow through the study from randomization to week 104 All patients who were randomly allocated to treatment were included in the analysis of efficacy parameters at weeks 24, 52 and 104.

Fig. 2

ACR20, ACR50 and ACR70 response rates up to week 104 Data summaries until week 104 are based on multiple imputation as applied to missing variables. ACR20: at least 20% improvement in the ACR response criteria; ACR50: at least 50% improvement in the ACR response criteria; ACR70: at least 70% improvement in the ACR response criteria.

Fig. 3

ACR20, 50 and 70 response rates by baseline TNF status at weeks 24, 52 and 104 †P < 0.0001; ††P < 0.001; †††P < 0.01; *P < 0.05. P-values at week 24 derived from a logistic regression model with treatment as the factor and baseline weight as a covariate. Missing data were imputed as non-response until week 52. Data until week 52 were reported previously [18]. Data for week 104 are after multiple imputation applied to missing variables. ACR20: at least 20% improvement in the ACR response criteria; ACR50: at least 50% improvement in the ACR response criteria; ACR70: at least 70% improvement in the ACR response criteria; MI: multiple imputation; NRI: non-responder imputation.

Fig. 4

ACR20, ACR50 and ACR70 response rates by baseline MTX use at weeks 24, 52 and 104 †P < 0.0001; ††P < 0.001; †††P < 0.01; *P < 0.05. P-values at week 24 derived from a logistic regression model with treatment as the factor and baseline weight as a covariate. Missing data were imputed as non-response until week 52. Data until week 52 are reported previously [18]. Data for week 104 is after multiple imputation applied to missing variable. ACR20: at least 20% improvement in the ACR response criteria; ACR50: at least 50% improvement in the ACR response criteria; ACR70: at least 70% improvement in the ACR response criteria; MI: multiple imputation; NRI: non-responder imputation.