Certolizumab pegol plus MTX reduces RA signs and symptoms

Adding certolizumab pegol to methotrexate therapy rapidly and significantly reduces signs and symptoms of RA, researchers report. The international Phase III study randomised 629 patients with RA to the PEGylated tumour necrosis factor inhibitor certolizumab pegol 400mg at weeks 0, 2 and 4, followed by 200mg or 400mg MTX or placebo plus MTX, every two weeks for 24 weeks. Published in the June edition of the Annals of the Rheumatic Diseases, the study found that significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response compared to placebo; rates were 57.3%, 57.6% and 8.7%, respectively. Certolizumab pegol 200mg and 400 mg also significantly inhibited radiographic progression, and mean changes from baseline in modified total sharp scores at week 24 were 0.2 and -0.4, respectively, compared to 1.2 for placebo. Certolizumab pegol treated patients also reported rapid and significant improvements in physical function. Mean changes from baseline in Health Assessment Questionaire Disability Index at week 24 were -0.50 for the treated patients compared to -0.14 for placebo. Most adverse events were mild or moderate, with low incidence of withdrawals due to adverse events, although 5 patients developed TB. “As functional outcomes are associated with structural damage in progressive RA, treatments that can both improve physical function and inhibit joint damage may help prevent long-term disability,” the researchers said. As certolizumab pegol rapidly and significantly ameliorates clinical signs and symptoms of RA, inhibits progression of structural damage and improves physical function and quality of life, it expands the treatment armamentarium for patients with RA, they concluded. Ann Rheum Dis 2009; 68:797-804....