The two studies were to be carried out for five years, but both were stopped prematurely at Week 90 and Week 89, respectively. Patients who received OKZ for six or more months in the open-label extension were considered to have completed the studies. Measures of efficacy improved in the open-label extension for patients who switched from placebo to OKZ. Disease activity in each treatment group decreased.
Treatment-emergent adverse events occurred in 88–95% of patients in both studies. Reactions included upper respiratory and other infections, arthralgia, diarrhea, stomatitis, cough and injection site pain. OKZ was tolerated, with an expected safety profile, and reductions in disease activity were sustained to Week 48.
Secukinumab Receives 2 New Approvals: PsA & AS
Secukinumab (Cosentyx) was approved by the FDA in January for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).3
Secukinumab was initially FDA approved in 2015 to treat adult patients with moderate to severe plaque psoriasis. Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. It is administered as a subcutaneous injection.
These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA. Patients were either biologic treatment-naive or had an inadequate response or were intolerant to anti-tumor necrosis factor alpha (TNF-α) therapies. Primary study endpoints in these trials were achieving statistically significant improvements (vs. placebo) in the signs and symptoms of PsA and AS, measured by a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, and by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 20) at Week 16, respectively.
More than 9,600 patients used secukinumab in the clinical trial programs for many uses, with more than 15,000 psoriasis patients treated post-marketing. No new safety signals have been identified. The most common adverse reactions in clinical trials were diarrhea, nasopharyngitis and upper respiratory tract infection.4
Cosentyx is available as a 150 mg/mL solution for injection in a single-use Sensoready pen, as 150 mg/mL solution for injection in a single-use prefilled syringe and as 150 mg in a lyophilized powder for injection in a single-use vial for reconstitution for healthcare professional use only.
Dosing Recommendations for Cosentyx
AS: With a loading dose, administer 150 mg SC at Weeks 0, 1, 2, 3 and 4, and every four weeks thereafter. Without a loading dose, administer 150 mg subcutaneously every four weeks.
