Objectives. To evaluate the effects of adalimumab plus MTX (ADA + MTX) vs MTX monotherapy on work-related outcomes in early RA patients with elevated risk of employment loss.
Methods. A post hoc analysis at weeks 26 and 24 from the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab (OPTIMA) and PRevention Of Work Disability (PROWD) trials, respectively, was conducted in MTX-naïve RA patients randomized to ADA + MTX or placebo (PBO) + MTX. Work instability was assessed using the RA-Work Instability Scale (RA-WIS) and work productivity was measured with the Work Productivity and Activity Impairment Questionnaire. Employed patients with a baseline RA-WIS score ≥10, indicating medium to high risk for job loss, were included (OPTIMA, n = 320; PROWD, n = 124).
Results. Patients receiving ADA + MTX in OPTIMA had significantly greater improvements in RA-WIS compared with PBO + MTX (mean change −7.22 vs −5.23, respectively). Significantly higher percentages of patients in the ADA + MTX group experienced improvements in one or more risk category (58 vs 47%) and ≥5 (55 vs 43%), ≥7 (47 vs 35%) and ≥9 (42% vs 26%) points in their RA-WIS score. These trends were seen in PROWD but were not significant. In OPTIMA, patients receiving ADA + MTX showed significant changes in percentage points from baseline vs PBO + MTX in activity impairment, presenteeism and overall work impairment (−32.0 vs −23.7, −24.6 vs −17.1, −27.3 vs −18.3, respectively).
Conclusions. Among early RA patients with elevated risk of employment loss, ADA + MTX therapy was associated with a significant reduction in work instability vs PBO + MTX. Significantly greater percentages of patients receiving ADA + MTX therapy achieved clinically meaningful improvements in their RA-WIS scores.