Patients with psoriatic arthritis (PsA) who were treated with secukinumab achieved early and sustained minimal disease activity over 2 years of therapy, along with improved patient-reported outcomes, according to the results of the FUTURE 2 study (ClinicalTrials.gov identifier: NCT01752634) published in Arthritis Care & Research.1
The FUTURE 2 study is an ongoing, multicenter, randomized, double-blind, parallel-group, placebo-controlled study that seeks to evaluate the efficacy and safety of subcutaneous secukinumab in anti-tumor necrosis factor (TNF)-naive and inadequate responder subpopulations of patients with PsA.1
Participants with active PsA were randomly assigned to receive secukinumab 300 mg, 150 mg, 75 mg, or placebo. Patients received weekly treatment for the first 4 weeks, and then every 4 weeks thereafter. Patients receiving placebo were re-randomized based on their clinical response at 16 weeks to receive secukinumab 300 mg or 150 mg.
Patients were considered to have achieved a minimal disease activity response if they met ≥5 of the following criteria: tender joint count ≤1; swollen joint count ≤1; Psoriasis Area and Severity Index score ≤1; patient pain visual analog scale score ≤15; patient global disease activity visual analog scale score ≤20; Health Assessment Questionnaire Disability Index score ≤0.5; or tender entheseal points ≤1.2
At 16 weeks, 28% of patients in the secukinumab 300-mg group and 23% of patients in the secukinumab 150-mg group achieved minimal disease activity, compared with 10% of patients in the placebo group. In the anti-TNF-naive cohort, a higher proportion of participants achieved minimal disease activity at 16 weeks with secukinumab 300 mg and secukinumab 150 mg (34% and 32%, respectively), vs placebo (13%). In the inadequate responder cohort, 15% and 8% of participants achieved minimal disease activity with secukinumab 300 mg and 150 mg, respectively, vs placebo (3%).
Results showed that 27.1% of minimal disease activity responders achieved a very low disease activity response, which was higher in the secukinumab 300-mg group (30%) and secukinumab 150-mg group (26%) vs the placebo group (22%). The minimal disease activity and very low disease activity responses in those treated with secukinumab were sustained through 2 years of therapy. Greater improvements in health-related quality of life outcomes were reported among minimal disease activity responders vs nonresponders over 2 years.
The investigators concluded that both anti-TNF-naive inadequate responder subpopulations of secukinumab-treated patients with PsA achieved early sustained minimal disease activity over 2 years of therapy. Patients who achieved minimal disease activity with secukinumab therapy experienced greater improvements in patient-reported outcomes, including quality of life, fatigue, and social functioning,
- Coates LC, Mease PJ, Gossec L, et al. Minimal disease activity among active psoriatic arthritis patients treated with secukinumab: 2-year results from the FUTURE 2 study [published online February 6, 2018]. Arthritis Care Res (Hoboken). doi: 10.1002/acr.23537
- Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48-53.