Session Title: Virtual Poster Hall
Session Time: None. Available on demand.
Disclosures: Erik Shaw, DO: BDSI (Products/Services: Yes) (Consultant/Advisory Board)Boston Scientific (Products/Services: Yes) (Consultant/Advisory Board)Pfizer/Lilly (Products/Services: Yes) (Consultant/Advisory Board)SPR Therapeutics (Products/Services: Yes) (Consultant/Advisory Board)
Objective: Assess significant improvements in pain and physical function after tanezumab treatment in patients with osteoarthritis (OA).
Design: Randomized controlled trials. Setting : International outpatient clinics. Participants : Study 1(NCT02697773) & study 2 (NCT02709486) enrolled patients with moderate-to-severe OA pain of the knee/hip with history of insufficient pain relief or intolerance to acetaminophen, oral NSAID, and either tramadol or opioids. Study 3 (NCT02528188) enrolled patients taking a stable dose of NSAID prior to enrollment.
Interventions: Subcutaneous (SC) tanezumab (2.5 mg or 5 mg, SC Q8 week, with a titrated dose [2.5 to 5 mg] at Week 8 in study 1) and either placebo (studies 1 and 2) or oral NSAIDs BID (study 3).
Main Outcome Measures: Co-primary endpoints: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function, and Patient’s Global Assessment of Osteoarthritis (PGA-OA) at Weeks 16 or 24. Safety through Week 24.
Results: In total, 4541 patients were evaluated. In study 1, tanezumab 2.5 mg and 2.5/5 mg led to improvements versus placebo for all co-primary endpoints at Week 16. Improvements were seen at Week 2. In study 2, tanezumab 2.5 mg led to improvements versus placebo for WOMAC pain and physical function and tanezumab 5 mg led to improvements for all three co-primary endpoints at Week 24. In study 3, tanezumab 5 mg (but not 2.5 mg) led to improvements in WOMAC Pain and Physical Function (but not PGA-OA) at Week 16 versus NSAIDs. Conclusions: Treatment with tanezumab 2.5 mg and 5 mg led to consistent improvements in WOMAC Pain and Physical Function versus placebo at Weeks 16 and 24. Improvements were observed at Weak 2 and persisted to Week 16. Compared with NSAIDs, tanezumab 5 mg (but not 2.5 mg) led to improvements in WOMAC Pain and Physical Function at Week 16.
Level of Evidence: Level II
To cite this abstract in AMA style:Shaw E, Ekman E, Schnitzer T, Hall JA, Tive L, Semel D, Darcy YM. A Summary of Improvement in Pain and Physical Function After Subcutaneous Tanezumab Treatment in Patients with Osteoarthritis [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/a-summary-of-improvement-in-pain-and-physical-function-after-subcutaneous-tanezumab-treatment-in-patients-with-osteoarthritis/. Accessed September 20, 2021.
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