This article is more than 5 years old. Information may no longer be current.
Secukinumab seen as safe, effective in RA phase 3 trial, but not better than other second-line agents
Click Here to Manage Email Alerts
Secukinumab was safe and effective for patients with rheumatoid arthritis, according to a recently published phase 3 trial; however, it did not demonstrate improved efficacy compared with other second-line agents.
“[Secukinumab] at a dose of 150 mg demonstrated efficacy for the treatment of patients with active [rheumatoid arthritis] RA who had an inadequate response to [tumor necrosis factor] TNF inhibitors,” Francisco J. Blanco, MD, PhD, from Hospital Universitario A Coruña in Spain, and colleagues wrote. “However, no incremental benefit of [interleukin] IL-17A inhibition was seen over other agents currently approved for use in patients in whom TNF inhibitors had failed.” The authors added, “Thus, the extension period of this trial was closed early.”
Blanco and colleagues randomly assigned 551 patients to receive intravenous 10 mg/kg secukinumab (Cosentyx, Novartis) — which is currently approved against psoriatic arthritis and ankylosing spondylitis, but not RA — at baseline and then at weeks 2 and 4 followed by a subcutaneous dose of either 150 mg or 75 mg secukinumab every 4 weeks up to 48 weeks or intravenous abatacept or placebo on the same dosing schedule. Overall, 70.8% of patients completed treatment.
At 24 weeks, investigators found ACR20 response rates were 30.7% for 150 mg secukinumab; 28.3% for 75 mg secukinumab; 42.8% for abatacept; and 18.1% for placebo. The difference was not significant between 75 mg and placebo. In addition, the 75-mg group did not meet any secondary endpoints. Both secukinumab groups did not have any improvement in health assessment questionnaire disability index or ACR50 compared with placebo.
From 24 weeks to 52 weeks, ACR70 responses went from 14% to 17% for 150 mg; 7% to 6% for 75 mg; 17% to 18% for abatacept; and was 7% for placebo after 24 weeks as 52-week data was not available.
Overall, the adverse event rate was 56.6% for 150 mg; 60.6% for 75 mg; 54% for abatacept; and 44.6% for placebo. The serious adverse event rate was 4.4% for 150 mg, 2.2% for secukinumab, 2.9% for abatacept and 4.3% for placebo. The researchers noted this safety profile is comparable to secukinumab in psoriatic arthritis and ankylosing spondylitis.
“These data, along with the findings from phase 2 studies and data related to the use of other anti-IL-17A agents, suggests IL-17A plays a lesser role in the pathogenesis of RA,” the researchers wrote. “Thus, blockade of IL-17A alone may not add to the armamentarium for clinicians in the treatment of patients with RA in whom anti-TNF therapy has failed.” – by Will A. Offit
Disclosures: Blanco reports no relevant financial disclosures. Please see the full study for a list of all other relevant financial disclosures.
Click Here to Manage Email Alerts