Zusammenfassung der Studie

Eight randomized controlled trials containing a total of 2671 patients suffering from symptomatic knee osteoarthritis (OA) were included in this meta-analysis comparing injections of sprifermin to placebo. Pooled outcomes of interest include the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and its subscores (i.e., pain, function, and stiffness), changes in cartilage (i.e., thickness, volume, and morphology), change in joint space width (JSW), change in bone marrow legions (BMLs), the incidence of treatment-emergent adverse events (TEAEs), and the incidence of acute inflammatory reactions (AIRs). Outcomes were measured as changes from baseline values. Meta-analysis results revealed significantly favorable improvements in pooled WOMAC total, pain, function, and stiffness scores in the placebo group vs. sprifermin group (p<0.05 for all). However, pooled change in scores for total cartilage thickness and volume were significantly improved in the sprifermin group vs placebo. Moreover, pooled change in cartilage morphology in specific subregions of the knee were significantly improved in the sprifermin group vs. placebo, but not for the entire knee (p=0.06). Overall, no significant differences in pooled risk of TEAEs and AIRs were observed between the 2 groups (p>0.05 for both).