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Objective   To define meaningful within-patient change (MWPC) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Methods   Data were analyzed separately from 3 phase 3 clinical trials (ClinicalTrials.gov:  NCT02697773 ,   NCT02709486 ,   NCT02528188 ) of tanezumab, a novel treatment intended for the relief of signs and symptoms of moderate-to-severe osteoarthritis, administered subcutaneously every 8 weeks. Patients with moderate-to-severe osteoarthritis of the hip or knee completed the WOMAC and Patient Global Assessment of Osteoarthritis (PGA-OA) at regular time points. A repeated measures longitudinal model with change in WOMAC Pain, Physical Function or Stiffness domain score as the outcome and change in PGA-OA as the anchor was used to establish MWPC for WOMAC domains.Results   In the 3 studies there were 688, 844, and 2948 subjects available for analyses, respectively. Analysis showed that a linear relationship between changes in WOMAC domains and changes in PGA-OA was supported and justified. Moreover, the relationships between these changes were very similar for 2 trials and close for the third. The estimated MWPC for the 3 WOMAC domains were from 0.84–1.16 (0–10 numerical rating scale) and from 12.50–16.23%, depending on study and domain, that corresponded to a 1-category change on PGA-OA. For a 2- category change those values were from 1.68–2.31 and from 25.01–32.46%, respectively.Conclusion   These results establish MWPCs for WOMAC domains, at the individual patient level, for patients with moderate-to-severe osteoarthritis of the hip or knee.

WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee