Ibrutinib as a Secondary Treatment for Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease: A Case Series of 11 Patients During the COVID-19 Era.

Introduction: Ibrutinib, a Bruton's tyrosine kinase inhibitor, has recently become available for treating chronic graft-versus-host disease (cGVHD). Because the pivotal clinical trials for this approach were conducted before the COVID-19 pandemic, evidence regarding ibrutinib treatment for cGVHD in the COVID-19 era is insufficient.

Methods: We assessed the safety and efficacy of ibrutinib treatment in a real-world setting by retrospectively analyzing the outcomes of 11 patients with steroid-refractory and steroid-dependent cGVHD who were treated with ibrutinib between November 2021 and April 2024 at our hospital.

Results: The best overall response rate was 63.6%, and the steroid dose was successfully reduced in seven of the patients. Ibrutinib improved hemolytic anemia and serositis in some of the patients. The most common adverse events were infections and bleeding. Four of the patients contracted COVID-19 during the study period, of whom one discontinued the treatment because of severe COVID-19 pneumonia.

Conclusions: Ibrutinib was effective for treating cGVHD, particularly when B cells were involved in its pathogenesis, and decreased the steroid dose needed for treatment in a real-world setting. Patients should be carefully monitored and treated for adverse events during this treatment, particularly bleeding and any complications associated with COVID-19 infection.