In the latest Phase 3 study of ixekizumab, it proved safe and effective to treat adults with ankylosing spondylitis (AS). Plus, data from three Phase 3 studies demonstrate certolizumab pegol’s potential to treat adults with psoriasis.
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Explore This IssueApril 2018
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Ixekizumab Efficacious & Safe for AS
In a Phase 3 study, ixekizumab (Taltz) met primary and key secondary endpoints for safety and efficacy to treat AS, or radiographic axial spondyloarthritis (axSpA).1 This trial, known as COAST-V, was placebo controlled, included an active control arm with patients taking adalimumab and evaluated patients who were biologic disease-modifying anti-rheumatic drug (bDMARD) naive.
In the COAST-V study, statistically significant improvements in AS signs and symptoms were seen in the ixekizumab-treated patients. Signs and symptoms were measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society (ASAS) 40 response at Week 16 compared with placebo-treated patients. The ASAS40 was used to measure the primary endpoint, rather than the ASAS 20, which is the most commonly used standard endpoint in AS clinical trials.
During the trial, no new safety signals were noted. Additionally, the most common adverse events were consistent with adverse events that occurred during Phase 3 clinical trials that investigated ixekizumab for use in patients with active psoriatic arthritis and moderate to severe plaque psoriasis.
At present, ixekizumab is approved by the U.S. Food and Drug Administration to treat adults with active psoriatic arthritis or moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Certolizumab Pegol & Psoriasis
Three pooled subanalyses from the ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT highlight the potential versatility of certolizumab pegol for treating psoriasis. The findings were presented at the American Academy of Dermatology Annual Meeting in February.2
Study patients were randomized into three groups to receive 400 mg certolizumab pegol every two weeks (n=342), 200 mg certolizumab pegol every two weeks after a 400 mg loading dose at Weeks 0, 2 and 4 (n=351) or placebo every two weeks (n=157). The patients were 18 years of age or older, who had a diagnosis of moderate to severe psoriasis for at least six months, a PASI of at least 12 and at least 10% of their body surface area affected. Patients also had to have a physician’s global assessment (PGA) [5-point scale] of at least three with no prior certolizumab pegol (or etanercept in CIMPACT) use or no more than two biologics previously used.3