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

Philip G Conaghan, Lucy Abraham, Lars Viktrup, Paul Cislo, Philip G Conaghan, Lucy Abraham, Lars Viktrup, Paul Cislo

Abstract

Background: To 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.

Methods: Subcutaneous 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.

Results: Of 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).

Conclusions: These pooled analyses showed that health status, non-work activities, and work productivity were significantly improved following tanezumab administration, compared with placebo.

Trial registration: ClinicalTrials.gov: NCT02697773, NCT02709486.

Keywords: Daily activities; EQ-5D; Health status; Nerve growth factor; Osteoarthritis; WPAI; Work productivity.

Conflict of interest statement

PGC has done consultancies or speakers bureaus for AbbVie, AstraZeneca, EMD Serono, Flexion Therapeutics, Galapagos, Gilead, Novartis, and Pfizer. LA and PC are employees of Pfizer with stock and/or stock options. LV is an employee of Eli Lilly and Company and owns stock in Lilly.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The pooling strategy. Data from Study 1 (NCT02697773) [14] dose-titration group (tanezumab 2.5 mg at baseline, tanezumab 5 mg at week 8) were pooled with the Study 2 (NCT02709486) [15] tanezumab 5 mg group for analyses at week 16. RCT, randomized controlled trial; SC, subcutaneous
Fig. 2
Fig. 2
EQ-5D-5L responses at baseline and week 16. Observed data. All patients completed the EQ-5D-5L. Statistical analysis of dimension responses was not conducted. Sample sizes at baseline: n = 513 (placebo), n = 513 (tanezumab 2.5 mg), n = 517 (tanezumab 5 mg). Sample sizes at week 16: n = 453 (placebo), n = 481 (tanezumab 2.5 mg), n = 482 (tanezumab 5 mg)

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