General Information

Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker.

Cimzia is specifically indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Cimzia is supplied as a solution for subcutaneous injection. The recommended dose of Cimzia for adults with moderate-to-severe plaque psoriasis is 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), CIimzia 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week can be considered.

Clinical Results

FDA Approval

The FDA approval of Cimzia for moderate to severe plaque psoriasis was based on three multicenter, randomized, double-blind studies: PS-1, PS-2 and PS-3 which enrolled subjects 18 years of age or older with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Subjects had a Physician Global Assessment (PGA) of ≥ 3 (“moderate”) on a 5-category scale of overall disease severity, a Psoriasis Area and Severity Index (PASI) score ≥ 12, and body surface area (BSA) involvement of ≥ 10%.

Studies PS-1 (234 subjects) and PS-2 (227 subjects) randomized subjects to placebo, Cimzia 200 mg every other week (following a loading dose of Cimzia 400 mg at Weeks 0, 2, and 4), or Cimzia 400 mg every other week. Studies PS-1 and PS-2 assessed the co-primary endpoints of the proportion of patients who achieved a PASI 75 and PGA of “clear” or “almost clear” with at least a 2-point improvement at Week 16. In Study PS-1 PASI 75 was reached by 7% of patients in the placebo arm, 65% of patients in the 200 mg arm; 75% in the 400 mg arm at Week 16. The PGA goal was reached by 4% of the placebo arm, 45% of the patients in the 200 mg arm and 55% in the 400 mg arm. In Study PS-2 PASI 75 was reached by 13% of patients in the placebo arm, 81% of patients in the 200 mg arm; 82% in the 400 mg arm at Week 16. The PGA goal was reached by 3% of the placebo arm, 61% of the patients in the 200 mg arm and 65% in the 400 mg arm.

Study PS-3 randomized 559 subjects to receive placebo, Cimzia 200 mg every other week (following a loading dose of Cimzia 400 mg at Weeks 0, 2, and 4), Cimzia 400 mg every other week up to Week 16, or a biologic comparator (up to Week 12). Study PS-3 assessed the proportion of patients who achieved a PASI 75 at Week 12 as the primary endpoint. PASI 75 at Week 12 was reached by 4%, 69% and 75% of patients in the placebo, Cimzia 200 mg and Cimzia 400 mg arms, respectively.

Side Effects

Adverse effects associated with the use of Cimzia may include, but are not limited to, the following:

upper respiratory tract infection

rash

urinary tract infection

The Cimzia drug label comes with the following Black Box warning: Patients treated with Cimzia are at an increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients.