Regulatory Decision Summary for Cimzia

The clinical package for the indication of plaque psoriasis included 2 Phase 2 and 3 Phase 3 trials (n=1112 patients exposed to Cimzia) to assess the safety and efficacy of Cimzia at two dose levels (200 mg every two weeks [Q2W] and 400 mg Q2W). In the three Phase 3 efficacy trials, Cimzia at both doses was shown to be superior to placebo for primary (Psoriasis Area and Severity Index (PASI) 75 and Physicians Global Assessment [PGA] response) and key secondary (PASI 90, PASI 100, Dermatology Life Quality Index) endpoints. Subjects taking Cimzia reached a clinically and statistically significant difference from placebo from 4 weeks onward, and effect was maintained over extended duration of treatment. Among patients that were PASI 75 responders at Week 16, about 15% lost PGA and/or PASI 75 response by Week 48 despite remaining on the same Cimzia dose. Development of anti-drug antibodies showed a significant effect on efficacy. There was also an association with decreased efficacy in patients in the highest body weight categories.

The safety profile of Cimzia was consistent with its use in other patient populations and with other anti-tumor necrosis factor (anti-TNF) drugs. In the first 16 weeks of treatment, patients receiving the higher Cimzia dose (400 mg Q2W, the dose level recommended for treatment of psoriasis in this application) had more treatment-emergent adverse events and serious adverse events than those patients receiving the lower dose (200 mg Q2W). Over time, the differences between the two dose levels of Cimzia became minimal.

Overall, the benefit-risk profile for Cimzia in patients with plaque psoriasis is considered favourable.