Ixekizumab Promising for AS; Plus Certolizumab Pegol Studied for Psoriasis

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.

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

Patients who received 400 mg certolizumab pegol every two weeks and 200 mg certolizumab pegol every two weeks had a PASI 75 response rate of 80.1% and 74.5%, respectively, compared with 7.5% for placebo-treated patients. The PASI90 response rates were 52.2%, 44.5% and 1.6%, respectively. Both certolizumab pegol results were statistically significant (P<0.0001), as were the PGA 0/1 responder rates.

Certolizumab pegol proved to be effective for treating chronic plaque psoriasis in adults across all baseline disease characteristic subgroups and demographics. Among these subgroups, 200 and 400 mg certolizumab pegol-treated patients had clinically meaningful PASI75, PA 0/1 and PASI90 responses, all of which were greater than placebo-treated patients. At Week 16, both treatment groups had clinically meaningful improvements in the signs and symptoms of psoriasis compared with placebo-treated patients.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Eli Lilly and Company. News release: Lilly announces positive top-line Phase 3 results for Taltz (ixekizumab) in ankylosing spondylitis radiographic axial spondyloarthritis). 2018 Feb 13.
2. UCB. News release: UCB advances psoriasis pipeline with positive data at American Academy of Dermatology Annual Meeting (AAD 2018). 2018 Feb 16.
3. Reich K, et al. Certolizumab pegol is effective for chronic plaque psoriasis across patient subgroups: Apooled subanalysis from ongoing, Phase 3 studies (CIMPASI-1, CIMPASI-2, CIMPACT) [abstract 7692]. 2018 Feb 17.