Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis

Abstract

AbstractBackgroundTo evaluate the impact of tanezumab on health status, non-work activities, and work productivity in a pooled analysis of two large phase 3 osteoarthritis (OA) studies.MethodsSubcutaneous tanezumab (2.5 mg and 5 mg) was tested in double-blind, placebo-controlled, 16-week (NCT02697773) and 24-week (NCT02709486) clinical trials in patients with moderate-to-severe OA of the hip or knee. At baseline and week 16, all patients completed EQ-5D-5L and the Work Productivity and Activity Impairment-OA (WPAI-OA) activity impairment item. Those currently employed also completed WPAI-OA work time missed, impairment while working, and overall work impairment items. Between-group differences in least squares (LS) mean changes from baseline at week 16 were tested using analysis of covariance.ResultsOf 1545 pooled patients, 576 were employed at baseline. Improvements in EQ-5D-5L index value at week 16 were significantly greater for the tanezumab 2.5-mg group (difference in LS means [95% confidence interval (CI), 0.03 [0.01, 0.05];p = 0.0083) versus placebo. Percent improvements (95% CI) in activity impairment (− 5.92 [− 8.87, − 2.98];p < 0.0001), impairment while working (− 7.34 [− 13.01, − 1.68];p = 0.0112), and overall work impairment (− 7.44 [− 13.22, − 1.67];p = 0.0116) at week 16 were significantly greater for the tanezumab 2.5-mg group versus placebo. Results for the tanezumab 5-mg group were generally comparable to the tanezumab 2.5-mg group, although, compared with placebo, percent improvement (95% CI) in work time missed was significantly greater for the tanezumab 5-mg group (− 3.40 [− 6.47, − 0.34];p = 0.0294), but not the tanezumab 2.5-mg group (− 0.66 [− 3.63, 2.32];p = 0.6637).ConclusionsThese pooled analyses showed that health status, non-work activities, and work productivity were significantly improved following tanezumab administration, compared with placebo.Trial registrationClinicalTrials.gov: NCT02697773, NCT02709486.