Disclosures: Francis Berenbaum, MD, PhD:
Objective: To assess the effects of gender, age and body mass index (BMI) on the incidence of treatment emergent adverse events (TEAEs) in patients treated with subcutaneous tanezumab ─ a monoclonal antibody against nerve growth factor, in development for the treatment of osteoarthritis.
Design: Pooled data from three randomised, double-blind, placebo-controlled studies. Setting : International outpatient clinics. Participants : Patients with radiographically-confirmed osteoarthritis of the hip or knee, who had inadequate response or could not tolerate, standard of care analgesics (including opioids).
Interventions: In the 16-week Study 1 (NCT01089725), patients received placebo, tanezumab 2.5 mg, 5 mg, or 10 mg at baseline and week 8. Due to FDA clinical holds on trials of NGF antibodies, < 10% of patients received the second dose at week 8. In the 16-week Study 2 (NCT02697773), patients received placebo or tanezumab 2.5 mg at baseline and week 8, or tanezumab 2.5mg at baseline and 5 mg at week 8. In the 24-week Study 3 (NCT02709486), patients received placebo, tanezumab 2.5 mg, or 5 mg at baseline, week 8, and week 16.
Main Outcome Measures: Pooled TEAE data from the treatment period of each study for placebo (n=586), tanezumab 2.5 mg (n=602), 2.5 mg/5 mg (n=219), and 5 mg (n=347) treated patients, examined by age, gender, and BMI subgroups.
Results: The incidence of TEAEs in the overall population was similar or numerically higher in the tanezumab groups compared to placebo, and numerically higher in females across all treatments. There were no consistent differences seen by age or BMI. The most common abnormality in peripheral sensation TEAEs were numerically higher in tanezumab groups vs placebo: paraesthesia (≤7.8% in subgroups) and hypoaesthesia (≤3.9% in subgroups). Serious TEAEs were infrequent but numerically higher with 5 mg tanezumab vs other treatments. Conclusions: The safety profile of tanezumab in the subgroups studied is broadly similar to that seen in the overall study population.
Level of Evidence: Level I
To cite this abstract in AMA style:
Berenbaum F, Bodkin J, Kivitz AJ, Schnitzer T, Brown M, Donevan S, Hickman A, Viktrup L, West C, Yamabe T. Adverse Events in Patients with Osteoarthritis Treated with Subcutaneous Tanezumab: A Pooled Analysis of the Overall Population and Selected Subgroups from Three Randomised Placebo-Controlled Trials [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/adverse-events-in-patients-with-osteoarthritis-treated-with-subcutaneous-tanezumab-a-pooled-analysis-of-the-overall-population-and-selected-subgroups-from-three-randomised-placebo-controlled-trials/. Accessed May 31, 2025.« Back to AAPM&R Annual Assembly 2020
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/adverse-events-in-patients-with-osteoarthritis-treated-with-subcutaneous-tanezumab-a-pooled-analysis-of-the-overall-population-and-selected-subgroups-from-three-randomised-placebo-controlled-trials/