Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT)
Journal of the American Academy of Dermatology Apr 19, 2018
Lebwohl M, et al. - Experts evaluated the safety and effectiveness of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. As per the data, psoriasis symptoms were improved with both certolizumab regimens with a greater response at the higher dose. Authors did not note any safety signals. Superiority of certolizumab 400 mg to etanercept was observed and 200 mg was noninferior to etanercept
Methods
- Researchers randomized the patients 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks.
- They re-randomized the certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 to certolizumab or placebo for 32 weeks.
- At Week 12, the primary endpoint was responder rate (≥75% reduction in psoriasis area and severity index) vs placebo (primary analysis) and etanercept (secondary analysis).
- Responder rates on various measures vs placebo at Weeks 12, 16, and 48 were secondary endpoints.
- Treatment-emergent adverse events were used to assess the safety.
Results
- As per the data, all endpoints were significantly greater for certolizumab vs placebo with the greatest response seen with 400 mg.
- Findings suggested certolizumab 400 mg to be superior to and 200 mg to be noninferior to etanercept.
- Authors noted the adverse events to be consistent with the anti-tumor necrosis factor class.
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