UCB announced today that it received approval from Japanese health authorities for CIMZIA® (certolizumab pegol) to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective. The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF treatment option now available for these patients in Japan.
“UCB is thrilled to see the continued expansion of CIMZIA for patient populations with unmet needs in an important market like Japan. This approval and launch provide Japanese psoriasis and psoriatic arthritis patients and their physicians with a highly effective new biologic option that provides durable disease control. This milestone reinforces our commitment to improving care for people living with these challenging psoriatic diseases,” said Emmanuel Caeymaex, Head of Immunology & US Solutions and Executive Vice President, UCB.
The approved dose for CIMZIA in adult patients is 400 mg every 2 weeks. For maintenance dosing, 200 mg every 2 weeks or 400 mg every 4 weeks can be considered. CIMZIA can be administered subcutaneously using the pre-filled syringe or the AutoClicks® Prefilled Pen.
This approval is based on the results of a Phase 2/3 double-blind, comparative study of Japanese patients with moderate-to-severe plaque psoriasis (including psoriatic arthritis), pustular psoriasis and psoriatic erythroderma.
Patients in the study were randomized to receive a 400 mg dose of CIMZIA every two weeks, a 200 mg dose of Cimzia every two weeks (with a starting dose of 400 mg at Week 0, 2 and 4), or placebo. In the 200 mg and 400 mg groups at week 16, 70.8% and 86.8% of patients achieved PASI 75, respectively, and 52.1% and 75.5% of patients achieved PASI 90, respectively. These results were statistically significantly higher than the placebo group (7.7% for PASI 75 and 0.0% for PASI 90) at week 16. 1
In the 200 mg every two weeks, 400 mg every two weeks, and 400 mg every four weeks groups at week 52, 69.2%, 86.3%, and 85.0% of patients achieved PASI 75, respectively, and 57.7%, 84.3%, and 70.0% achieved PASI 90, respectively, demonstrating the durability of response with CIMZIA. The safety profile was similar to safety results observed in non-Japanese psoriasis patients and the approved indication for patients with rheumatoid arthritis. 1
CIMZIA was launched in Japan in March 2013 for rheumatoid arthritis. The product is manufactured and supplied by UCB for exclusive distribution and marketing by Astellas Pharma Inc., and is jointly promoted by UCB Japan and Astellas Pharma Inc. There are approximately 430,000 psoriasis patients in Japan. 2
For the newly approved indication of CIMZIA for psoriasis, UCB Japan will be conducting all promotional activities, thus expanding its dermatology footprint to Japan.