Cimzia

Cimzia (certolizumab pegol) is a drug approved for the treatment of several inflammatory conditions. Its indications include reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. It is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval for plaque psoriasis was granted on May 24, 2018.

In clinical trials for plaque psoriasis, Cimzia demonstrated significant efficacy. For instance, 79% of patients achieved an sPGA 0 or 1 at Week 12 with 210 mg q2wk dosing, compared to 4% in the placebo group. Similarly, 78% of patients achieved PASI75 at week 16, while placebo groups showed rates of 4%, 7%, or 19% at week 12 or 16 across different studies. Statistical superiority to placebo was observed with p-values <0.001.

Regarding safety, the most common adverse reactions had an incidence of ≥7%. The malignancy rate (excluding non-melanoma skin cancer) in Cimzia-treated patients (psoriasis) was 0.5 per 100 subject-years, which was comparable to 0.6 per 100 patient-years in placebo-treated patients across various conditions. Lymphoma cases were reported, including 1 case in Cimzia-treated patients for Crohn's disease and other investigational uses, and 1 Hodgkin's lymphoma case in Cimzia PsO clinical trials.