PsA patients show sustained improvement at two years with secukinumab, clinical trial shows.
For patients with active psoriatic arthritis, secukinumab treatment can be effective in reducing clinical problems and improving quality of life for patients, a new study reported.
Researchers writing in the Sept. 7 issue of Arthritis Care & Research analyzed results from the FUTURE-1 study to determine whether secukinumab is both effective and safe. Results from the 2-year, randomized, double-blind, placebo-controlled, multi-center trial indicate it is an efficient long-term psoriatic arthritis treatment that inhibits radiographic disease progression.
This study is the first of its kind for secukinumab. The interleukin 17A inhibitor has previously demonstrated success in treating inflammatory diseases, including psoriatic arthritis, psoriasis, and ankylosing spondylitis.
In this study, researchers showed secukinumab is effective across many psoriatic arthritis domains for two years, including signs and symptoms, disease activity, quality of life, physical function, skin symptoms, dactylitis, and enthesitis. Of the 606 original participants, 476 (78.5 percent) completed the full study.
“Secukinumab provided sustained improvements at two years across multiple clinical domains in the treatment of patients with active psoriatic arthritis, including very little radiographic progression in patients maintained on treatment for two years,” researchers wrote. “The safety profile of both doses of secukinumab showed no new or unexpected safety signals during this time.”
Participants were divided into three groups: one receiving a baseline 10mg/kg, followed by 150 mg/kg every two to four weeks; one receiving baseline 10 mg/kg, followed by 75 mg/kg every two to four weeks; and a placebo group.
ACR20 response rates at two years for the 150 mg and 75 mg group, respectively, were 66.8 percent and 58.6 percent. PASI 75 response rates were 74.6 percent and 63.0 percent, respectively for the same timeframe. By study’s end, 84.3 percent of the 150 mg group and 83.8 percent of the 75 mg group demonstrated no radiography disease progression.
A small number of patients experienced adverse events, however. Two died from stroke or other cardiovascular reasons. Others developed or exhibited nasopharyngitis, candida infections, neutropenia, Chron’s disease, heart attacks, stroke, malignant or undetermined tumors, basal cell carcinoma, and prostate cancer.
The study was limited, researchers said, because it lacked a long-term compactor, the majority of placebo recipients switched to secukinumb during the study, and the treatments following the switch were open-label.
Secukinumab investigations are continuing in the FUTURE-2 study currently underway. Researchers involved are looking at the impact of a 300 mg subcutaneous dose alongside the 150 mg or 75 mg given to psoriatic arthritis patients. The 24-week study goal is to identify any dose-related effects.
Arthur Kavanaugh, MD, Philip J Mease, MD, et. al.
"Secukinumab for long-term treatment of psoriatic arthritis: 2-year follow-up from the FUTURE-1 study."
Arthritis Care and Research
. Sept. 7, 2016. DOI 10.1002/acr.23111