Drugs Xagena
The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adult patients with active psoriatic arthritis ( PsA ).
Psoriatic arthritis is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons, and usually occurs in combination with psoriasis. In most people with psoriatic arthritis, psoriasis develops before joint problems. When hands and feet are affected in psoriatic arthritis, nail changes can occur, as well as swelling in the fingers and toes ( dactylitis ).
Psoriatic arthritis affects approximately 0.24% of the population worldwide; up to 30% of the estimated 7.5 million psoriasis patients in the U.S. will develop psoriatic arthritis. Research suggests that nearly one in four people with psoriasis in the U.S. may have undiagnosed psoriatic arthritis.
FDA approval of Cimzia for active psoriatic arthritis is based on data from the RAPID-PsA study, an ongoing, Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Certolizumab pegol in 409 patients with active and progressive adult onset psoriatic arthritis.
Patients received a loading dose of Cimzia 400 mg at weeks 0, 2 and 4 or placebo, followed by either Cimzia 200 mg every other week, Cimzia 400 mg every 4 weeks, or placebo every other week.
Patients were evaluated for signs and symptoms of psoriatic arthritis using the ACR20 response at week 12 and for structural damage using the modified Total Sharp Score ( mTSS ) at week 24.
ACR20, 50, and 70 response rates at weeks 12 and 24 were higher for each Cimzia dose group relative to placebo. Patients treated with Cimzia 200 mg every other week demonstrated greater reduction in radiographic progression compared with placebo-treated patients at week 24, as measured by change from baseline in total modified mTSS Score. Patients treated with Cimzia 400 mg every four weeks did not demonstrate greater inhibition of radiographic progression at week 24, compared with placebo-treated patients. Treatment with Cimzia also resulted in improvement in skin manifestations in patients with psoriatic arthritis. However, the safety and efficacy of Cimzia in the treatment of patients with plaque psoriasis has not been established.
Adverse events occurred in 62% of patients in the Certolizumab pegol group ( combined dose ) compared to 68% of patients in the placebo group. Serious adverse events occurred in 7% of patients in the Certolizumab pegol group ( combined dose ) compared to 4% of patients in the placebo group. The safety profile for patients with psoriatic arthritis treated with Cimzia was similar to the safety profile seen in patients with rheumatoid arthritis and in patients with previous experience with Cimzia. ( Xagena )
Source: UCB, 2013
XagenaMedicine_2013
