FUTURE 1 extension results support secukinumab as a long-term treatment option for PsA
medwireNews: Patients with psoriatic arthritis (PsA) who are treated with the interleukin (IL)-17A inhibitor secukinumab experience benefits for up to 3 years, suggest findings from the extension phase of the FUTURE 1 trial.
Previously reported results from the placebo-controlled phase III study demonstrated that patients who were randomly assigned to receive subcutaneous secukinumab 150 mg or 75 mg every 4 weeks after an intravenous loading dose of 10 mg/kg for the first month experienced “rapid, significant and sustained reductions in the signs and symptoms of PsA” over 2 years of treatment, say Philip Mease (Swedish Medical Center and University of Washington, Seattle, USA) and co-investigators.
They explain that patients in the placebo group were re-randomized to one of the secukinumab groups at week 16 or 24, and 460 eligible patients who completed the 2-year core study continued to receive secukinumab in the extension phase of the trial.
Mease and colleagues report in RMD Open that patients originally randomized to the secukinumab 150 or 75 mg groups experienced sustained efficacy during the extension period, with 76.8% and 65.2%, respectively, achieving at least a 20% improvement in ACR criteria (ACR20) at the 3-year follow-up.
ACR20 response rates were sustained until 3 years regardless of prior exposure to tumor necrosis factor (TNF) inhibitors, but higher rates were observed in TNF inhibitor-naïve versus TNF inhibitor-experienced patients, at 81.0% versus 61.5% for the 150 mg dose and 67.3% versus 55.6% for the 75 mg dose.
These findings support the use of secukinumab “as a treatment for patients with PsA naïve to anti-TNF therapy and those who have experienced an inadequate response or intolerance to these agents,” write the researchers.
Furthermore, approximately three-quarters of patients in both groups experienced no radiographic progression – defined as no more than a 0.5-point increase in modified Sharp/van der Heijde score –from baseline to the 3-year follow-up.
In the safety analysis, exposure-adjusted incidence rates of adverse events (AEs) were 158.8 and 128.9 per 100 patient–years in the secukinumab 150 and 75 mg groups respectively. The most commonly reported AEs were infections and infestations, musculoskeletal and connective tissue disorders, and gastrointestinal disorders, which the investigators say were stable over the extension period of the study.
“The safety profile of secukinumab in this trial was consistent with previous reports in patients with PsA and moderate-to-severe plaque psoriasis, with no new no new or unexpected safety signals observed,” they summarize.
The team concludes that their findings “add to the growing body of evidence supporting the use of IL-17 inhibitors in PsA.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group
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