UCB, a global biopharmaceutical company, announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of CIMZIA® (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA). The submission is based on results from two Phase 3 clinical trials, RAPID-C and RAPID-C open-label extension (OLE), which evaluated the efficacy and safety of CIMZIA plus methotrexate (MTX) in Chinese adults with moderate-to-severe active rheumatoid arthritis who had previously experienced inadequate response to MTX. Results concluded that patients experienced greater improvement in relief of the signs and symptoms of RA when CIMZIA was used in combination with MTX, compared with MTX alone.1

While rheumatic diseases are typically less common in Asia than in other parts of the world, RA has a prevalence of 0.41% in China (0.69% in women and 0.11% in men), indicating a need for effective treatment options.2 The results of the RAPID-C and RAPID-C OLE trials demonstrate the potential value of CIMZIA for Chinese patients.3 In addition, due to its unique Fc-free molecular structure, CIMZIA is the only anti-TNF that has robust evidence from conception to late pregnancy and lactation.4  

“This submission reflects UCB’s commitment to bringing our innovative scientific research and treatment solutions to patients with challenging chronic inflammatory diseases like rheumatoid arthritis who are in need. The research we have conducted to support this submission represents a focused approach to identifying options for Chinese patients, whose special treatment needs have not always been thoroughly understood. Combined with our commitment to research and improving patient experience in China and across the globe, today is an important step forward for the treatment of this debilitating condition,” said Emmanuel Caeymaex, Executive Vice President, Immunology Patient Value Unit, UCB.

About RAPID-C

The RAPID-C study enrolled 430 patients, including patients both with and without prior treatment experience with biologic products. Patients were randomized to either 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, or placebo every two weeks. CIMZIA demonstrated statistically significant improvements in the primary endpoint compared to placebo. The primary endpoint was the percentage of patients who achieved a 20% or greater disease improvement from baseline as measured by the American College of Rheumatology response (ACR20) at week 24.  Additionally, all secondary endpoint analyses supported the primary results.  The secondary endpoints included ACR50 and ACR70 response at week 24, as well as change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24.

About RAPID-C OLE

The RAPID-C OLE study continued to assess the safety, tolerability, and efficacy of CIMZIA as additional medication to methotrexate (MTX) in Chinese patients from the RAPID-C study through week 52. Primary endpoints focused on the percentage of patients who experienced treatment-emergent adverse events (TEAE) or serious treatment-emergent serious events (SAE). The improvements observed during the RAPID-C study were maintained through 52 weeks of CIMZIA treatment. Overall, the safety profile in Chinese RA patients is consistent with that observed in previous studies with CIMZIA and the RA indication, and in line with that expected in patients receiving anti-TNFα therapy.

This submission was also supported by the Phase 1 RA0045 clinical trial evaluating the pharmacokinetics and safety of CIMZIA in healthy Chinese subjects.

CIMZIA is not currently marketed in China.