Disclosures: Thomas J. Schnitzer, MD, PhD: AstraZeneca (Products/Services: No) (Consultant/Advisory Board)Galapagos (Products/Services: No) (Consultant/Advisory Board)GlaxoSmithKlilne (Products/Services: No) (Consultant/Advisory Board)Lilly (Products/Services: No) (Consultant/Advisory Board, Research Grant or Support)PFizer (Products/Services: No) (Consultant/Advisory Board, Research Grant or Support)

Objective: To evaluate treatment response to tanezumab.

Design: Pooled analysis of 2 randomized, double-blind, placebo-controlled trials.Setting : Multicenter clinical trials NCT02697773 (16-week treatment, 24-week safety follow-up) and NCT02709486 (24-week treatment, 24-week safety follow-up).Participants : Adults (N&#3f1545) with moderate-to-severe osteoarthritis of the knee or hip and history of inadequate response to standard analgesics.

Interventions: Subcutaneous placebo or tanezumab (2.5 or 5mg) every 8 weeks. Some patients in study NCT02697773 received tanezumab 2.5mg at baseline and 5mg at Week 8; they are included in the tanezumab 5mg group in the current analysis.

Main Outcome Measures: The proportions of patients with ≥30%, ≥50%, ≥70% or ≥90% improvement in WOMAC[a] Pain score, relative to baseline, at Week 16 were estimated by logistic regression. Improvements of ≥30% (moderate) or ≥50% (substantial) are often reported as clinically important.

Results: Overall, 84.1% of patients had a knee as the index joint and 77.1% had a Kellgren-Lawrence grade of 3 or 4 (which describes radiographic severity of osteoarthritis) for the index joint. Mean (standard deviation) WOMAC Pain scores were 6.9 (1.1) in all treatment groups at baseline. The proportion of patients achieving ≥30% (68.0%–69.4% versus 55.6%), ≥50% (36.8%, 51.8%–51.9% versus 36.8%), or ≥70% (27.9%–29.8% versus 20.7%) was significantly greater in both tanezumab groups compared with the placebo group (all P < 0.05). The proportion of patients achieving ≥90% improvement was significantly greater in the tanezumab 2.5mg group (10.7%; P < 0.05), but not in the tanezumab 5mg group (9.1%), compared with the placebo group (6.0%).Conclusions: A greater proportion of patients achieved clinically important improvement in pain at Week 16 with tanezumab than with placebo, with little difference between the 2.5mg and 5mg tanezumab doses. Funded by Pfizer and Lilly. [a]WOMAC© 1996 Nicholas Bellamy. WOMAC® is a registered trademark of Nicholas Bellamy (CDN, EU, USA).

Level of Evidence: Level I

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/clinically-important-improvement-in-osteoarthritis-pain-at-week-16-after-subcutaneous-administration-of-tanezumab-a-pooled-analysis/