Adverse events (AE) were comparable among the three groups and the most common serious AEs belonged to the system organ class infections and infestations (4.3% in 200 mg every two week group and none in 400 mg every four week or placebo groups).
*Certolizumab pegol in combination with methotrexate is approved in the European Union as a maintenance regimen of 200 mg every two weeks. The certolizumab pegol dosing regimen of 400 mg every four weeks is not approved in the European Union.
Improved Long-Term Household Productivity and Increased Participation in Family, Social and Leisure Activities
Long-term Benefits of 4-Weekly Certolizumab Pegol and Monotherapy on Household Productivity and Social Participation in Rheumatoid Arthritis: 5 year Results from an Open-Label Extension Study
- Monday, November 12, 2012: 9:00 AM-6:00 PM
- Location: WCC: Poster Hall (Hall B)
Five year results from an open-label extension study of patients originally enrolled in two pivotal trials demonstrated improved household productivity and increased participation in social activities in RA patients treated with certolizumab pegol who continued from baseline over the five years of the study period. The study examined 235 patients taking 400 mg* of certolizumab pegol once every four weeks, as a monotherapy or in combination with MTX or DMARDs, over five years. Household productivity and social participation were assessed through the validated RA-specific Work Productivity Survey.
In both populations analyzed, a reduction in the number of days missed of household work per month was observed over 24 weeks and continued to decrease over time (from baseline 7.4 and 11.1 mean days in the combination and monotherapy groups, respectively, to 1.2 and 1.4 mean days, respectively). Increased participation in social activities was reported in both populations, with a decrease in the number of days missed per month (from baseline 4.4 and 6.2 mean days in the combination and monotherapy groups, respectively, to 0.4 and 0.2 days, respectively).