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

Jonas K Eriksson, Johan K Wallman, Heather Miller, Ingemar F Petersson, Sofia Ernestam, Nancy Vivar, Ronald F van Vollenhoven, Martin Neovius, Jonas K Eriksson, Johan K Wallman, Heather Miller, Ingemar F Petersson, Sofia Ernestam, Nancy Vivar, Ronald F van Vollenhoven, Martin Neovius

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.

Trial registration: ClinicalTrials.gov NCT00764725.

© 2016, American College of Rheumatology.

Figures

Figure 1
Figure 1
Flow chart of the Swedish Pharmacotherapy trial and number of included study subjects in the present study. DAS28 = Disease Activity Score based on 28‐joint count; ITT = intention‐to‐treat; y = year; mITT = modified intention‐to‐treat.
Figure 2
Figure 2
Time to discontinuation of biologic agent treatment in infliximab plus methotrexate (MTX) (switching from infliximab to another biologic agent within 90 days was not considered as a discontinuation), and time to biologic agent treatment start in conventional treatment and MTX responders. Conventional treatment: sulfasalazine and hydroxychloroquine plus MTX; MTX responder: nonrandomized patients who had a favorable Disease Activity Score based on 28‐joint count response to MTX after the run‐in period.
Figure 3
Figure 3
Mean days on sick leave and disability pension per 90‐day period in relation to day of randomization for randomized patients, end date of the run‐in period for nonrandomized methotrexate (MTX) responders as well as for their general population comparators (upper chart), and adjusted mean differences between infliximab plus MTX and conventional treatment (lower chart). Error bars indicate standard errors (upper chart) and 95% confidence intervals (lower chart). * = adjusted for work‐loss days the year before randomization. General population: comparators matched 5:1 by age, sex, education level, and place of residence; conventional treatment: sulfasalazine and hydroxychloroquine plus methotrexate; MTX responders: nonrandomized patients who had a favorable Disease Activity Score based on 28‐joint count response to MTX after the run‐in period.
Figure 4
Figure 4
Mean accumulated sick leave and disability pension days over 7 years for randomized patients as well as for the nonrandomized methotrexate (MTX) responders and their general population comparators. Error bars indicate standard errors. General population: comparators matched 5:1 by age, sex, education level, and place of residence; conventional treatment: sulfasalazine and hydroxychloroquine plus methotrexate; MTX responders: nonrandomized patients who had a favorable Disease Activity Score based on 28‐joint count response to MTX after the run‐in period.

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Source: PubMed

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