Efficacy and safety of ruxolitinib for refractory graft-versus-host disease in Chinese population: a Meta-analysis / 白血病·淋巴瘤

ABSTRACT

Objective:To systematically evaluate the efficacy and safety of ruxolitinib in the treatment of Chinese patients with refractory graft-versus-host disease(SR-GVHD) by using meta-analysis.Methods:China National Knowledge Infrastructure(CNKI), WanFang database, VIP database, China Biology Medicine disc, PubMed, Ebscore Medline, EMBASE, Web of Science Core Collection and Cochrane Library were searched by using "ruxolitinib" "Graft vs Host Disease" "graft versus host disease" "Graft-Versus-Host Disease" as key words. The retrieve time was from the establishment of the database to December 7th, 2021. The related literatures of ruxolitinib for Chinese patients with SR-GVHD were screened according to inclusion and exclusion criteria, and the characteristics of the literatures were extracted. Outcomes indexes included overall objective response rate (ORR), proportion of hormone reduction and discontinuation, survival indexes and incidence of adverse events. Meta-analysis of ORR, remission rate of affected organs, 12-month overall survival rate, overall mortality and mortality due to graft-versus-host disease (GVHD) were performed by using Stata 16.0 software or R3.6.3 software. The statistics analysis was performed on the hormone usage and adverse events.Results:A total of 19 literatures involving 775 Chinese patients with SR-GVHD treated by ruxolitinib were included. Meta analysis showed that the ORR of ruxolitinib for treatment of acute GVHD (aGVHD) was 84% (285/339), with moderate heterogeneity among studies ( I2 = 62.04%, P<0.01), and the complete remission (CR) rate, partial remission (PR) rate and non-remission (NR) rate was 56% (190/339), 28% (95/339), and 14%(47/339), respectively. The ORR of ruxolitinib for treatment of chronic GVHD (cGVHD) was 77% (332/431), with moderate heterogeneity among studies ( I2 = 50.17%, P = 0.02), and the CR rate, PR rate and NR rate was 36% (155/431), 41% (177/431) and 21% (91/431), respectively. As for hormone usage, 46.51% of aGVHD patients had steroid reduction and 34.88% patients had steroid discontinuation. Similarly, 28.2% of patients with cGVHD had steroid reduction and 36.9% had steroid discontinuation. The overall 12-month survival rate of patients with SR-GVHD after the treatment of ruxolitinib was 71% (95% CI 63%-79%, I2 = 72.70%, P<0.01). Adverse events occurred for 760 times in total, among which 287 times (36.0%) of viral infection and 269 times (34.7%) of hemocytopenia were the most common adverse events. Conclusions:Ruxolitinib is effective in the treatment of Chinese patients with SR-GVHD, and it helps reduce hormone-dependency and prolong the survival time.