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2024-11-29T13:36:40.000Z

Ibrutinib in patients with steroid-refractory cGvHD: Results from a real-world analysis

Nov 29, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in chronic graft-versus-host disease.

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A multicenter, real-world observational study assessed the safety and efficacy of ibrutinib, a BTK inhibitor, in 270 patients with SR-cGvHD from 19 centers in the US.1 Results from this analysis were published in Blood Advances by Pidala et al.1


Key learnings
Among the 131 evaluable patients, the ORR, CR, and PR rates were 45%, 3%, and 42%, respectively, with a median DOR of 15 months.
At a median follow-up of 30.5 months, the 6-month and 12-month FFS rates were 59% and 41%, respectively, and the 6-month and 12-month OS rates were 93% and 87%, respectively.
In the multivariable analysis, increased age (HR, 1.01; 95% CI, 1.0–1.02; p = 0.033), higher baseline prednisone dose (HR, 1.92; 95% CI, 1.09–3.38; p = 0.032), and lung involvement (HR, 1.58; 95% CI, 1.1–2.28; p = 0.016) were associated with worse FFS.
Results from this study confirm the safety and efficacy of ibrutinib in a real-world setting in patients with SR-GvHD and highlight the factors associated with worse outcomes. 

Abbreviations: BTK, Bruton’s tyrosine kinase; cGvHD, chronic graft-versus-host disease; CI, confidence interval; CR, complete response; DOR, duration of response; FFS, failure-free survival; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PR, partial response; SR-cGvHD, steroid-refractory cGvHD.

  1. Pidala JA, Kim J, Kalos D, et al. Ibrutinib for therapy of steroid-refractory chronic graft vs. host disease: A multicenter real-world analysis. Blood Adv. 2024. Online ahead of print. DOI: 10.1182/bloodadvances.2024014374

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