(404) Concordance of Baseline Pain Measures Influences Treatment Effect: Post-Hoc Analysis of 3 Randomized Controlled Trials of Triamcinolone Acetonide Extended-Release in Patients with Knee Osteoarthritis

Abstract

Knee osteoarthritis (OA) is a painful condition and intra-articular corticosteroids (IACS) are often used to manage OA pain. In Phase 2/3 clinical studies, triamcinolone acetonide extended-release (TA-ER) demonstrated sustained, clinically meaningful pain relief compared with saline-placebo using general Average Daily Pain (ADP)-intensity scores, and compared with saline-placebo and TA crystalline solution (TAcs) using disease-specific Western Ontario and McMaster Universities OA Index (WOMAC-A) measures. As patients may report baseline pain differently using ADP and WOMAC-A measures, we evaluated whether discordant baseline pain reporting influenced measured outcomes. A post hoc analysis of pooled data from 3 Phase 2/3 studies (NCT01487161, NCT02116972, NCT02357459) was conducted to assess treatment effects for patients who reported moderate-to-severe pain at baseline on both pain measures (concordant pain reporters; ADP ≥5 to ≤9 & WOMAC-A ≥2) versus those that reported it only on ADP (discordant pain reporters; ADP ≥5 to ≤9 & WOMAC-A