Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials
Authors' conclusion
Baseline medial JSWs were heterogeneous across trials despite KL inclusion criteria. LOR demonstrated greater symptomatic improvements in patients with less structurally advanced disease, indicative of an association between OA structural damage and pain.
Study context
- Population
- Knee osteoarthritis (OA) patients with Kellgren-Lawrence (KL) grades 2–3 and Pain NRS (0–10) ≥ 4 to ≤8 in the target knee, two phase 2 and two phase 3 trials4 trials
- Comparison
- Lorecivivint 0.07 mg intra-articular vs placebo, by baseline structural severity (KL grade, medial JSW)
- Primary endpoint
- Impact of baseline joint structure on OA pain response (Pain NRS change, baseline-adjusted ANCOVA)
Methodological detailspooled review of four trials, cumulative frequency distribution plots, baseline-adjusted ANCOVA
- Pooled review of four trials
- Cumulative frequency distribution plots
- Baseline-adjusted ANCOVA
Primary result
As reported in the abstract
Pain response by baseline structural severity
- Lorecivivint (LOR) showed beneficial treatment effects vs placebo in KL 2 subgroups (higher proportions of baseline medial JSW >3 mm), apart from one phase 3 trial with advanced structural knee OA
Further findings
- Phase 3 trials had an increased proportion of patients with baseline medial JSW <3 mm vs phase 2 trials
Original publication
Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology (Oxford). Published 4 November 2024. doi:10.
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