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Safety and efficacy of low-dose rituximab in steroid-refractory cGvHD

Feb 9, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in steroid refractory chronic graft-versus-host disease.

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Currently, there is no one standard of care for first-line treatment of patients with chronic graft-versus-host disease (cGvHD) who do not respond to steroids.1 There is evidence to support the use of rituximab, a chimeric anti-CD20 antibody (when administrated weekly at a dose of 375 mg/ m2), as an adequate treatment option; however, it is not cost-effective.1

Here, we summarize key findings by Colunga-Pedraza et al.1 in Transplant Immunology on the use of low-dose rituximab in steroid-refractory cGvHD (SR-cGvHD).

Study design1

  • In total, 26 patients with SR-cGvHD, who had received low-dose rituximab (100 mg weekly for 4 weeks) were included for analysis
  • cGvHD was classified as per the 2014 National Institutes of Health criteria
  • SR-cGvHD was categorized as cGvHD progression while on prednisone ≥ 1 mg/kg/day for 1–2 weeks or stable cGvHD while on ≥0.5 mg/kg/day for 1–2 months
  • Overall, 13 patients received rituximab for ≤31 days from the commencement of cGvHD therapy

Key findings1

Table 1. Overall survival in patients with and without rituximab treatment*

Overall survival, %




Among patients with cGvHD




Among patients with cGvHD following rituximab




cGvHD, chronic graft-versus-host-disease; OS, overall survival.
*Adapted from Colunga-Pedraza, et al.1

  • The overall response rate for patients treated with low-dose rituximab was 92%
  • Overall, 1-year event-free survival was achieved in 70% of patients
  • The occurrence of progression/relapse within 1-year was observed at a rate of 25%
  • By the end of the study period, 27% of patients did not have a recurrence of GvHD
  • In total, 58% of patients experienced adverse events, with Grade 1 and 2 infections being the most common (46%)
Key learnings1
  • Low-dose rituximab was found to be as safe and effective as using the more commonly used, higher dose, for the treatment of SR-cGvHD.
  • Using a lower dose of rituximab is a cost-effective alternative for the treatment of patients with SR-cGvHD.

  1. Colunga-Pedraza PR, Barbosa-Castillo LM, Coronado-Alejandro EU, et al. Low-dose rituximab in steroid-refractory chronic graft-versus-host disease. Transplant Immunol. 2023;81:10195 DOI:10.1016/j.trim.2023.101959


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