What question did this study set out to answer?

To evaluate the safety and efficacy of ibrutinib in patients with active chronic graft-versus-host disease who had an inadequate response to corticosteroid therapies.

September 19, 2017BloodOpen Access

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

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To evaluate the safety and efficacy of ibrutinib in patients with active chronic graft-versus-host disease who had an inadequate response to corticosteroid therapies.
Multicenter, open-label trial (NCT02195869) enrolled 42 patients with active chronic graft-versus-host disease who failed 1 to 3 prior systemic treatments.
Patients received oral ibrutinib at 420 mg daily until disease progression or unacceptable toxicity.
The primary efficacy endpoint was chronic graft-versus-host disease response determined by 2005 National Institutes of Health consensus criteria.
At a median follow-up of 13.9 months, the best overall response rate was 67%, with 71% of responders sustaining their response for ≥20 weeks.
Median corticosteroid dose in responders dropped from 0.29 mg/kg per day at baseline to 0.12 mg/kg per day at week 49, and 5 responders completely discontinued corticosteroids.
Common adverse events included fatigue, diarrhea, muscle spasms, nausea, and bruising, alongside significant reductions in circulating inflammatory and fibrotic plasma markers.

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Implication

Randomized trial demonstrates high response rates with ibrutinib in steroid-refractory chronic graft-versus-host disease, suggesting an effective therapeutic option after prior treatment failure.

Cite This Study

Miklos et al. (2017) studied this question.

synapsesocial.com/papers/69dd531b27c48be1bb40cf4b https://doi.org/10.1182/blood-2017-07-793786

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Implication

Randomized trial demonstrates high response rates with ibrutinib in steroid-refractory chronic graft-versus-host disease, suggesting an effective therapeutic option after prior treatment failure.

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

Key Points

Discussion

Implication

Cite This Study

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

Key Points

Discussion

Implication

Cite This Study

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