Efficacy and safety of certolizumab pegol in combination with methotrexate in methotrexate-inadequate responder Chinese patients with active rheumatoid arthritis: 24-week results from a randomized, double-blind, placebo-controlled phase 3 study
Clinical and Experimental Rheumatology Online Mar 22, 2019
Bi L, et al. - In this 24-week, phase 3, double-blind, placebo-controlled study, researchers assessed the effectiveness and safety of certolizumab pegol (CZP) plus methotrexate (MTX) in 430 Chinese subjects with active rheumatoid arthritis (RA). They found that 54.8% of CZP+MTX patients and 23.9% of PBO+MTX patients achieved an ACR20 response at Week 24. They also noted that CZP+MTX cases obtained higher improvements in HAQ-DI, higher ACR50/70 responses and greater DAS28(ESR) remission rate at Week 24. They observed the rapid onset of response to CZP+MTX as early as Week 1 for the utmost clinical, functional and patient-reported outcomes. They noticed comparable incidences of treatment-emergent adverse events (TEAEs) between the treatment arms. But, they reported severe TEAEs by 6.3% of CZP+MTX cases and 2.7% of PBO+MTX cases. They suggested CZP in combination with MTX with an acceptable safety profile.
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