• Clin J Pain · Apr 2023

    Examining the Relationships Among Treatment, Pain, and Physical Function in Patients with Osteoarthritis: A Mediation-Modeling Approach.

    • Lucy Abraham, Robert H Dworkin, Dennis C Turk, John D Markman, David A Williams, Andrew G Bushmakin, Jerry A Hall, David C Semel, Joseph C Cappelleri, and Ruoyong Yang.
    • Pfizer R&D UK Limited, Surrey, UK.
    • Clin J Pain. 2023 Apr 1; 39 (4): 159165159-165.

    ObjectivesTo better understand the relationships among treatment, pain, and physical function (PF).MethodsData were collected from 2 published randomized clinical trials of osteoarthritis patients who received tanezumab or a placebo. PF was measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) PF domain. Pain (WOMAC pain domain) was a mediator of the effect of treatment on PF. A set of mediation models were investigated. Variables were treatment (tanezumab vs placebo), WOMAC pain domain, and WOMAC PF domain. Cross-sectional mediation models were assessed separately at different weeks. Longitudinal mediation models used data from all weeks simultaneously. Results could identify a steady-state period.ResultsThe cross-sectional and longitudinal mediation models showed a stable indirect effect of treatment through the pain on PF across time, indicating that a pseudo-steady-state model was appropriate. Therefore, the longitudinal steady-state mediation models were used with all available data assuming relationships among variables in the model being the same at all time points; results showed that the indirect effect of the treatment on PF was 77.8% in study 1 (NCT02697773) and 74.1% in study 2 (NCT02709486), both P <0.0001, whereas the direct effect was 22.2% for study 1 ( P = 0.0003) and 25.9% for study 2 ( P = 0.0019).DiscussionAt least 75% of the treatment effect of tanezumab on physical functioning can be explained by the improvements in pain. However, tanezumab had an additional effect on physical functioning (~25%) that, was independent of improvements in pain. Such independent effects are of considerable interest and require further research to determine their mechanisms.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.

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