Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis-Phase 3 Trial Report
Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis, according to the results of two phase III trials, CIMPASI-1 and CIMPASI-2 published in the Journal of the American Academy of Dermatology (JAAD).
Certolizumab pegol, is the only Fc-free, PEGylated anti-tumor necrosis factor biologic. Consequently, it is not expected to undergo FcRn-mediated transfer across the placenta, showing the minimal placental transfer of CZP from mothers to infants.
Alice B. Gottlieb et al. conducted the 2 phase 3 trials CIMPASI-1 and CIMPASI-2, to evaluate the efficacy and safety of CZP compared with placebo in the treatment of moderate-to-severe chronic plaque psoriasis.
Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. The primary outcome was week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear).
Key study findings:
- Treatment with CZP 400 mg or 200 mg every 2 weeks led to significantly greater PASI 75, PGA 0/1, and PASI 90 responder rates at week 16 than treatment with placebo in patients with moderate-to-severe chronic plaque psoriasis.
- At week 16 in CIMPASI-2, PASI 100 responder rates were 18.8% for CZP 400 mg every 2 weeks, 15.4% for CZP 200 mg every 2 weeks, and 1.8% for placebo, and by week 48, they improved to 38.3% and 31.4% for CZP 400 mg every 2 weeks and CZP 200 mg every 2 weeks, respectively.
- Pooled data for PASI 100 showed responder rates of 14.4% for CZP 400 mg every 2 weeks, 12.7% for CZP 200 mg every 2 weeks, and 0.9% for placebo through week 16.
- At week 48, PASI 100 response rates in the pooled population were 34.5% for CZP 400 mg every 2 weeks and 28.5% for CZP 200 mg every 2 weeks.
The study concluded that compared with treatment with placebo, treatment with either CZP dose was also associated with significant and clinically meaningful improvements in health-related quality of life through week 16, which was maintained through week 48.
Psoriasis is a common chronic, immune-mediated inflammatory disease. Patients with more severe psoriasis are often treated with systemic medications, phototherapy, and biologic agents, but not all patients tolerate or respond to currently available therapies, and some might have contraindications.
For reference log on to https://doi.org/10.1016/j.jaad.2018.04.012