SAN FRANCISCO, CA—Long-term efficacy and safety data have confirmed that secukinumab provides sustained improvements in psoriatic arthritis, a study reported at the 2015 ACR/ARHP Annual Meeting.
Previously, results from the Phase 3 randomized FUTURE 1 study showed that secukinumab, an anti-interleukin-17A monoclonal antibody, “provided rapid and significant improvements in key clinical domains of psoriatic arthritis, including signs and symptoms, joint structural damage, physical function, and quality of life,” reported Philip J. Mease, MD, Swedish Medical Center and University of Washington School of Medicine, Seattle, WA.
In FUTURE 1, 606 adults with active psoriatic arthritis were randomly assigned to receive secukinumab 10mg/kg in an intravenous loading dose at baseline, Week 2, and Week 4, and then either 150mg or 75mg subcutaneously every four weeks from Week 8 or placebo. At Week 16, based on clinical response, patients in the placebo arm were re-randomized to receive secukinumab 150mg or 75mg.
At 104 weeks, 476 patients (78.5%) had completed the study, 167 (82.7%) in the 150mg group and 155 (76.7%) in the 75mg group.
In patients treated for up to 104 weeks, “secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains of active psoriatic arthritis,” he noted. In addition, the agent “was well tolerated with a safety profile consistent with that previously reported.”
In the 150mg group, ACR 20/50/70 response rates were 73.9%/46.4%/28.1% and, in the 75mg group, 68.8%/35.5%/22.5%.
“Responses were sustained through Week 104 in patients naïve to anti-TNF therapy and in those with an inadequate response or intolerance to these agents,” Dr. Mease reported. ACR20 response rates in anti-TNF-naïve patients were 80.0% with secukinumab 150mg and 72.9% with 75mg; corresponding rates in anti-TNF-IR patients were 55.3% and 54.8%, respectively.
No radiographic disease progression was observed between baseline and Week 104 in 84.6% of x-ray completers in the 150mg group and 83.9% in the 75mg group.
During the FUTURE 1 study, mean exposure to secukinumab was 627.1 days. Type, incidence, and severity of adverse events were consistent with previous reports; infections and infestations were most commonly observed, at a rate of 67.9 per 100 patient-years. No cases of tuberculosis were observed. The rate of malignant or unspecified tumors was 0.3 per 100-patient years and, for major adverse cardiac events, 0.7; no suicides were recorded.