Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials.

ABSTRACT:

Aim

To assess the 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 summarised descriptively. Analyses were done in patient subgroups (men or women; age <65, ≥65, or ≥75 years; body mass index [BMI] <25, 25 to <30, 30 to <35 or ≥35 kg/m² ; dia

SUBMITTER: Berenbaum F 

PROVIDER: S-EPMC9285028 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature