Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis

Abstract

Objective To perform a meta-analysis comparing the structural progression and clinical symptom outcomes as well as adverse events experienced from intra-articular injections of sprifermin compared to a placebo treatment for patients with knee osteoarthritis (KOA). Method We systematically searched the literature for studies that compared long-term outcomes between sprifermin and placebo injections for KOA treatment. Meta-analysis was performed with RevMan5.3 using an inverse variance approach with fixed or random effects models. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results Eight studies were included. Overall, there was significantly less improvement of WOMAC total scores in patients receiving sprifermin, compared with the placebo (mean difference (MD)\u2009=\u20093.23, 95% CI 0.76–5.69; I 2 \xa0=\u20090%; P \u2009=\u20090.01). Further, sprifermin injection patients gained more, and lost less, cartilage thickness and volume in total femorotibial joint (cartilage thickness: standardized mean differences (SMD)\u2009=\u20090.55, 95% CI 0.26–0.84; I 2 \xa0=\u200978%; P \u2009=\u20090.0002; cartilage volume: SMD\u2009=\u20090.39, 95% CI 0.20–0.58; I 2 \xa0=\u200949%; P \u2009<\u20090.0001). Changes in the cartilage surface morphology of the medial tibio-femoral joint (MD\u2009=\u2009−0.30, 95% CI −0.44 to −0.16; I 2 \xa0=\u20090%; P \u2009<\u20090.0001) and patello-femoral joint (MD\u2009=\u2009−0.22; 95% CI −0.37 to −0.07; I 2 \xa0=\u20090%; P \u2009=\u20090.004) showed a significant difference between the sprifermin and placebo injections. Moreover, there were no significant differences between sprifermin and the placebo in the risk of treatment-emergent adverse events (OR\u2009=\u20091.05; 95% CI 0.52–2.14; I 2 \xa0=\u200948%; P \u2009=\u20090.89). Conclusion The data from the included studies provide strong evidence to determine the effect of intra-articular sprifermin on joint structure in individuals with KOA and show no specific adverse effects. Nevertheless, intra-articular sprifermin did not likely have any positive effect on symptom alleviation.