Session Title: Virtual Poster Hall
Session Time: None. Available on demand.
Disclosures: Thomas Schnitzer, MD, PhD: Lilly (Products/Services: Yes) (Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)Pfizer (Products/Services: Yes) (Consultant/Advisory Board, Research Grant or Support)
Objective: Assess efficacy of the nerve growth factor antibody tanezumab in patients with osteoarthritis, including in subgroups of interest.
Design: Pooled post-hoc analysis of two randomized, placebo-controlled trials. Setting : International outpatient clinics. Participants : Patients with moderate-to-severe knee or hip osteoarthritis. Subgroups were categorized by gender, baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score, BMI, and Kellgren-Lawrence (KL) Grade in the index joint.
Interventions: Subcutaneous placebo (n=514), tanezumab 2.5mg (n=514), or tanezumab 5mg (n=517) at baseline and week 8. As part of a dose-titration design, 219 patients in the 5mg arm received a 2.5mg dose at baseline.
Main Outcome Measures: Change from baseline to week 16 in WOMAC Pain, WOMAC Physical Function, and Patient Global Assessment of Osteoarthritis (PGA-OA) scores.
Results: In the overall population, both doses of tanezumab significantly improved WOMAC Pain, WOMAC Physical Function, and PGA-OA scores at week 16 compared to placebo. Least squares (LS) mean (95% CI) improvements over placebo in WOMAC Pain were -0.7 (-0.95, -0.37; p < 0.0001) for tanezumab 2.5mg and -0.7 (-0.99, -0.41; p < 0.0001) for tanezumab 5mg. LS mean (95% CI) improvements over placebo in WOMAC Physical Function were -0.7 (-1.00, -0.42; p < 0.0001) for tanezumab 2.5mg and -0.8 (-1.08, -0.50; p < 0.0001) for tanezumab 5mg. LS mean (95% CI) improvements over placebo in PGA-OA were -0.2 (-0.30, -0.09; p < 0.001) for tanezumab 2.5mg and -0.3 (-0.36, -0.15; p < 0.0001) for tanezumab 5mg. In subgroups based on gender, age, baseline WOMAC Pain, BMI, and KL grade in the index joint, improvements in WOMAC Pain, WOMAC Function, and PGA, were numerically greater and often nominally statistically significant in the tanezumab groups compared with placebo. Conclusions: Subcutaneous tanezumab significantly improved pain, function, and PGA-OA in the overall population. Changes in pain, function, and PGA-OA favored tanezumab over placebo in the subgroups, though caution should be used when interpreting these data due to low patient number in some subgroups.
Level of Evidence: Level I
To cite this abstract in AMA style:Schnitzer T, Berenbaum F, Kivitz AJ, Viktrup L, Johnston E, Yang R, Brown M, West C, Tive L, Semel D. Efficacy of Subcutaneous Tanezumab for the Treatment of Osteoarthritis: A Pooled Analysis of the Overall Patient Population and Subgroups of Interest from 2 Randomized, Placebo-controlled Trials [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/efficacy-of-subcutaneous-tanezumab-for-the-treatment-of-osteoarthritis-a-pooled-analysis-of-the-overall-patient-population-and-subgroups-of-interest-from-2-randomized-placebo-controlled-trials/. Accessed July 30, 2021.
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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/efficacy-of-subcutaneous-tanezumab-for-the-treatment-of-osteoarthritis-a-pooled-analysis-of-the-overall-patient-population-and-subgroups-of-interest-from-2-randomized-placebo-controlled-trials/