The European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol) therapy, Belgian biopharmaceutical company UCB has announced.
The extension allows Cimzia’s use for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Emmanuel Caeymaex, head of immunology and executive vice president, Immunology Patient Value Unit, UCB, said: “With the recent European Commission marketing authorisation for Cimzia in psoriasis, UCB is making an exciting entry into immuno-dermatology.”
The CIMPASI-1 and -2 and CIMPACT trials demonstrated the efficacy and safety of the treatment in this setting. Pooled data from CIMPASI-1 and CIMPASI-2 – pivotal Phase 3 clinical trials of certolizumab pegol in psoriasis – showed that patients maintained their clinical response from week 16 through week 48. [1]
Additional pooled data from these two studies also found that higher proportions of certolizumab pegol-treated patients achieved improvements in the Psoriasis Area Severity Index (PASI), as well as improved scores in important quality of life measures versus placebo at week 16. [2, 3] Reductions in absolute PASI were further consolidated through week 48. [4]
An additional analysis of pooled data from these studies assessed the efficacy of certolizumab pegol up to 48 weeks across patient subgroups, including body weight, disease duration and prior biologic therapy, finding clinically meaningful efficacy across these patient populations. [5]
The results for all pooled data were observed with both maintenance dose regimens of 200 mg and 400 mg of certolizumab pegol administered every two weeks.
References
[1] K. Reich, A. Blauvelt, D. Thaci, et al. Durability of Response in Certolizumab Pegol-Treated Patients Over 48 Weeks in CIMPASI-1 & 2 Trials. Presented at IFPA 2018, Stockholm, Sweden, June 27-30.
[2] A.B. Gottlieb, A. Blauvelt, D. Thaci, et al. Durable Reduction in Absolute PASI with Certolizumab Pegol in Patients with Chronic Plaque Psoriasis. Presented at IFPA 2018, Stockholm, Sweden, June 27-30.
[3] D. Thaci, A.B. Gottlieb, K. Reich, et al. Certolizumab Pegol Improves Patient-Reported Outcomes in Chronic Plaque Psoriasis Over 1 Year. Presented at IFPA 2018, Stockholm, Sweden, June 27-30.
[4] A.B. Gottlieb, A. Blauvelt, D. Thaci, et al. Durable Reduction in Absolute PASI with Certolizumab Pegol in Patients with Chronic Plaque Psoriasis. Presented at IFPA 2018, Stockholm, Sweden, June 27-30.
[5] K. Reich, A. Blauvelt, D. Thaci, et al. Certolizumab Pegol Is Effective for Chronic Plaque Psoriasis Across Patient Subgroups. Presented at IFPA 2018, Stockholm, Sweden, June 27-30.
