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Self-administered Cosentyx safe, efficacious in PsA
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Self-administered secukinumab was both safe and efficacious, leading to sustained improvements in disease signs and symptoms, among patients with psoriatic arthritis who had not responded to previous first-line therapies, according to findings published in Arthritis Research and Therapy.
In addition, the researchers found that the majority of patients reported that they were satisfied using the autoinjector, which they found easy to use, with no help required.
“Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has shown significant efficacy in the treatment of moderate-to-severe psoriasis and [psoriatic arthritis (PsA)], with a rapid onset of action, sustained responses and a favorable safety profile,” Peter Nash, MD, of the University of Queensland, Brisbane, Australia, and colleagues wrote. “Placebo-controlled, double-blind, phase 3 trials with secukinumab (FUTURE 1 and FUTURE 2) have reported significant improvements in key clinical domains of PsA sustained through week 104 in FUTURE 2 and week 156 in FUTURE 1.”
In the phase 3 FUTURE 3 trial, an ongoing, 3-year study conducted at 74 centers across 12 counties, the researchers assessed the efficacy and safety of secukinumab (Cosentyx, Novartis), self-administered through an autoinjector pen, among patients with PsA over 52 weeks. The researchers recruited 414 patients with active PsA regardless of previous treatment with NSAIDs, nonbiologic disease-modifying anti-rheumatic drugs (DMARDs) or anti-TNF agents. Participants were randomly assigned to receive either 300 mg of secukinumab, 150 mg of secukinumab or placebo.
Treatments were administered at baseline as well as weeks 1, 2, 3, 4 and every 4 weeks thereafter. Patients who received placebo and did not respond were randomly assigned at week 16 into one of the secukinumab treatment groups. Those that responded to placebo were later randomly assigned into a secukinumab group at week 24. The primary endpoint was the proportion of participants who achieved at least 20% improvement, based in the ACR20 at week 24. The researchers measured autoinjector acceptability using a questionnaire.
Overall, 92.1% of patients in the 300-mg group, 91.3% of those in the 150-mg group and 93.4% in the placebo cohort completed 24 weeks. At 52 weeks, 84.9% of the 300-mg group and 79.7% of the 150-mg group remained.
According to the researchers, ACR20 response rates were significantly higher among patients in the secukinumab groups, with 48.2% of the 300-mg group (P < .0001), and 42% of the 150-mg group (P .0001) achieving the response. These responses were sustained through week 52, the researchers wrote. In the placebo group, just 16.1% achieved the ACR20 response at week 24. In addition, 93% of patients reported in the questionnaire that they were satisfied or very satisfied with the autoinjector pen. The treatments were well-tolerated, and there were no new or unexpected safety issues.
“Self-administration of subcutaneous secukinumab provided sustained improvements at 52 weeks across multiple clinical domains in patients with active PsA,” Nash said. “Patients reported high levels of satisfaction with the autoinjector and considered it easy to use and not painful. The safety profile of secukinumab showed no new or unexpected safety signals during this time.” – by Jason Laday
Disclosure: The researchers report funding from Novartis Pharma AG. Nash reports research funding and lecture honoraria from AbbVie, BMS, Celgene, Janssen, Novartis, Pfizer and Roche.
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