Abstract
OBJECTIVE: To compare long-term work loss in methotrexate-refractory early rheumatoid arthritis (RA) patients randomized to the addition of infliximab or conventional combination treatment. METHODS: This study was a multicenter, 2-arm, parallel, randomized, active-controlled, open-label trial. RA patients with <1-year symptom duration were recruited from 15 rheumatology clinics in Sweden between 2002-2005. Patients who did not achieve low disease activity after 3-4 months of methotrexate therapy were randomized to the addition of infliximab or conventional combination treatment with sulfasalazine plus hydroxychloroquine. Yearly sick leave and disability pension days >7 years after randomization were retrieved from nationwide registers kept by the Swedish Social Insurance Agency. RESULTS: Of 210 working-age patients, 109 were randomized to infliximab (mean age 48.4 years, 73% women) and 101 to conventional treatment (mean age 48.7 years, 77% women). The year before randomization, the mean number of annual work days lost was 127 in the infliximab arm and 118 in the conventional treatment group (mean difference 9 [95% confidence interval (95% CI) -23, 39]). Compared to the year before randomization, the mean changes at 7 years were -25 days in the infliximab and -26 days in the conventional treatment group (adjusted mean difference 10 [95% CI -25, 46]). The cumulative mean for work-loss days was 846 in the infliximab group and 701 in the conventional treatment group (adjusted mean difference 104 [95% CI -56, 284]). CONCLUSION: Long-term work loss improved significantly in early RA patients randomized to infliximab plus methotrexate or conventional combination therapy. No difference was detected between strategies, and the level of work-loss days remained twice that observed in the general population.