RT Journal Article
SR Electronic
T1 WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 615
OP 621
DO 10.3899/jrheum.210543
VO 49
IS 6
A1 Conaghan, Philip G.
A1 Dworkin, Robert H.
A1 Schnitzer, Thomas J.
A1 Berenbaum, Francis
A1 Bushmakin, Andrew G.
A1 Cappelleri, Joseph C.
A1 Viktrup, Lars
A1 Abraham, Lucy
YR 2022
UL http://www.jrheum.org/content/49/6/615.abstract
AB 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 III 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 (OA), administered subcutaneously every 8 weeks. Patients with moderate-to-severe OA of the hip or knee completed the WOMAC and patient global assessment of OA (PGA-OA) at regular timepoints. 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 OA of the hip or knee. [ClinicalTrials.gov: NCT02697773, NCT02709486, and NCT02528188]