Subcutaneous vs Intravenous Tanezumab for Knee, Hip Osteoarthritis
Participants were adults with knee osteoarthritis and pain scores ≥4 on a 0 to 10 scale at screening.
Intravenous (IV) and subcutaneous (SC) administration of tanezumab may provide similar analgesia and tolerability in patients with hip or knee osteoarthritis, according to an analysis of 2 placebo-controlled studies published in the Journal of Pain Research.
Participants in the first study were adults with knee osteoarthritis and pain scores ≥4 at screening on the 0 to 10 numerical rating scale and ≥5 at baseline.
Investigators randomly assigned this study population to receive placebo SC plus placebo IV (n=150), 2.5 mg tanezumab SC plus placebo IV (n=150), 5 mg tanezumab SC plus placebo IV (n=150), 10 mg tanezumab SC plus placebo IV (n=200), or 10 mg tanezumab IV plus placebo SC (n=200), all of which were administered at 8-week intervals. In the second study, patients with moderate to severe hip or knee osteoarthritis were randomly assigned to receive 2.5 mg (n=230), 5 mg (n=222), and 10 mg (n=226) tanezumab SC.
The first study observed changes from baseline to week 8 in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) pain scores ranging from −3.59±0.26 to −3.89±0.32, respectively, with tanezumab vs −2.74±0.25 with placebo. Changes in Patient's Global Assessment from baseline to week 8 were −0.90 to −1.08 with tanezumab and −0.78 with placebo.
In the second study analysis, tanezumab SC was not found to be superior or inferior to IV administration. A greater percentage of patients treated with 5 mg and 10 mg tanezumab experienced ≥30%, ≥50%, ≥70%, and ≥90% improvements in the WOMAC Pain score compared with 2.5 mg tanezumab; however, no statistical analyses were performed to determine significance. Overall, 1.4% to 5.2% of the patient population discontinued therapy because of adverse events.
Clinical hold on study duration and enrollment resulted in the lack of statistical analyses, which limits the ability to determine whether significant efficacy differences exist between tanezumab and placebo. Also, these preliminary findings require validation with further longitudinal studies that include a greater population to determine clinical applicability.
"[T]he data provide preliminary evidence that the efficacy and safety of SC tanezumab is generally similar to IV administration in patients with OA pain," concluded the study authors.
Birbara C, Dabezies EJ Jr, Burr AM, et al. Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis. J Pain Res. 2018;11:151-164.