Infliximab Versus Conventional Combination Treatment and Seven‐Year Work Loss in Early Rheumatoid Arthritis: Results of a Randomized Swedish Trial

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.