Transplant immunology · 2026
Efficacy and safety of nilotinib in steroid-refractory chronic graft-versus-host disease: A systematic review and meta-analysis.
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Bahbah Eshak I, Ali Mahmoud, Elshabasy Osama, Attia Mahmoud
Аннотация
BACKGROUND: This systematic review and meta-analysis evaluated the efficacy and safety of nilotinib in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (SR/D cGVHD).
METHODS: Electronic databases and trial registries were searched from inception to June 2025. Study selection, data extraction, risk-of-bias assessment, and GRADE evaluation were performed independently. Proportions were pooled using random-effects meta-analysis.
RESULTS: Four prospective single-arm early-phase interventional studies (n = 112 patients) were included. The pooled overall response rate (ORR) was 36% (95% CI: 13% to 59%; I2 = 84.9%), but the estimate was strongly influenced by the sequential rituximab-nilotinib study by van der Wagen et al.; after omission of this study, ORR decreased to 24% (95% CI: 13% to 34%; I2 = 0%). Complete and partial response rates were 8% (95% CI: 2% to 14%) and 32% (95% CI: 10% to 54%), respectively. Treatment discontinuation due to adverse events occurred in 26% (95% CI: 9% to 43%; I2 = 82.5%). The certainty of evidence was very low for most outcomes.
CONCLUSION: Nilotinib was associated with modest and heterogeneous efficacy in SR/D cGVHD. The available evidence does not support routine salvage use after imatinib failure or intolerance; any future role is likely to be restricted to carefully selected patients, preferably within biomarker-guided or dose-optimized protocols.
METHODS: Electronic databases and trial registries were searched from inception to June 2025. Study selection, data extraction, risk-of-bias assessment, and GRADE evaluation were performed independently. Proportions were pooled using random-effects meta-analysis.
RESULTS: Four prospective single-arm early-phase interventional studies (n = 112 patients) were included. The pooled overall response rate (ORR) was 36% (95% CI: 13% to 59%; I2 = 84.9%), but the estimate was strongly influenced by the sequential rituximab-nilotinib study by van der Wagen et al.; after omission of this study, ORR decreased to 24% (95% CI: 13% to 34%; I2 = 0%). Complete and partial response rates were 8% (95% CI: 2% to 14%) and 32% (95% CI: 10% to 54%), respectively. Treatment discontinuation due to adverse events occurred in 26% (95% CI: 9% to 43%; I2 = 82.5%). The certainty of evidence was very low for most outcomes.
CONCLUSION: Nilotinib was associated with modest and heterogeneous efficacy in SR/D cGVHD. The available evidence does not support routine salvage use after imatinib failure or intolerance; any future role is likely to be restricted to carefully selected patients, preferably within biomarker-guided or dose-optimized protocols.