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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
An approximately 46-year-old man exhibited lack of efficacy during treatment with prednisone for chronic graft-versus-host disease (GVHD).
The man, who had a history of allogeneic stem cell transplantation, was hospitalised for cough and fever at the age of 47 years. His medical history was significant for angioimmunoblastic T-cell lymphoma, and he showed complete remission under treatment with various chemotherapeutic drugs. He had undergone autologous stem cell transplantation in October 2017. In June 2018, he had relapsed and achieved a second complete clinical remission under treatment with tipifarnib. In October 2018, he underwent an allogeneic stem cell transplantation. In March 2019, after 5 months, he developed chronic GVHD with skin as well as myofascial involvement. Therefore, he was treated with prednisone [route and dosage not stated] and extracorporeal photopheresis. However, he continued to be symptomatic. His GVHD was considered to be refractory to prednisone (lack of efficacy).
Therefore, ruxolitinib was added to the man's therapy in October 2019. Prednisone was tapered following 2 months. At current hospitalisation (in 2020), he denied exposure to anyone with COVID-19. Further investigations led to a diagnosis coronavirus disease-2019. Therefore, he started receiving off-label therapy with hydroxychloroquine 400mg two times a day × 1 day followed by 200mg two times a day for 4 days. Thereafter, he remained afebrile with no need for supplemental oxygen. Following 8 days of hospitalisation, he was discharged. One week after discharge, he remained afebrile with resolving mild cough as well as clinical improvement.
Reference
- Foss FM, et al. Attenuated Novel SARS Coronavirus 2 Infection in an Allogeneic Hematopoietic Stem Cell Transplant Patient on Ruxolitinib. Clinical Lymphoma, Myeloma & Leukemia 20: 720-723, No. 11, Nov 2020. Available from: URL: 10.1016/j.clml.2020.06.014 [DOI] [PMC free article] [PubMed]
