Medical writing support was provided by Matt Soulsby, PhD, of Engage Scientific Solutions and was funded by Pfizer and Eli Lilly and Company. CONFLICT OF INTEREST STATEMENT TJS reports clinical research study support from Pfizer, Eli Lilly and Company, Regeneron, Galapagos, Taiwan Liposome Corporation, and Anika Therapeutics and has served as a consultant or on an advisory board for Pfizer, Eli Lilly and Company, Glaxo-Smith Kline, AstraZeneca, Noven, Galapagos, and Merck. FB has received grants through his institution from TRB Chemedica, MSD, and Pfizer; has worked as a consultant to Novartis, MSD
Résumé
Aim
To assess impact of pre-specified patient characteristics on efficacy and safety of subcutaneous tanezumab in patients with osteoarthritis (OA).
Methods
Data were pooled from two (efficacy; N = 1545) or three (safety; N = 1754) phase 3 placebo-controlled trials. Change from baseline to week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Physical Function, and patient global assessment of OA (PGA-OA) scores was compared between tanezumab (2.5 and 5 mg) and placebo groups via analysis of covariance. Treatment-emergent adverse events (TEAEs) were summarized descriptively. Analyses were done in patient subgroups (male or female; age <65, ≥65, or ≥75 years; body mass index [BMI] <25, 25 to <30, 30 to <35, or ≥35 kg/m2; diabetes or no diabetes; baseline WOMAC Pain score <7 or ≥7; and Kellgren-Lawrence [KL] grade 2, 3, or 4 in the index joint) and the overall population).
Results
In all subgroups, improvements in WOMAC Pain were numerically greater and often statistically significant (P < .05) for both tanezumab groups compared with placebo. Results were similar for WOMAC Function and PGA-OA. TEAE profiles were generally consistent across subgroups and similar to the overall population (i.e., slightly higher rates of TEAEs, serious TEAEs, and severe TEAEs with tanezumab relative to placebo) with a few exceptions. Exceptions included females reporting slightly more TEAEs with tanezumab than males, and patients with diabetes reporting slightly more severe TEAEs with tanezumab than patients without diabetes. Additionally, TEAEs were more frequent with tanezumab than placebo in the age ≥65 and ≥75 years, but not the age <65 years, subgroups.
Conclusions
Efficacy and safety/tolerability of tanezumab may not be meaningfully impacted by gender, age, BMI, diabetes status, baseline pain severity or KL grade in the index joint. Conclusions are limited by low patient number in some subgroups.
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Berenbaum et al. - Gender, age, disease severity, body mass index, an.pdf (1.18 Mo)
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