Rilzabrutinib, an oral Bruton tyrosine kinase inhibitor, in patients with warm autoimmune haemolytic anaemia: a prospective, single-arm, multicentre, phase 2b safety and clinical activity study (LUMINA 2).
Lancet HaematolOct 1, 2026
Clinical ResearchHematology
Nichola Cooper, David J Kuter, Henrik Frederiksen et al.
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In 30 seconds
The LUMINA 2 study evaluated the safety and clinical activity of rilzabrutinib, a Bruton tyrosine kinase inhibitor, in adults with warm autoimmune haemolytic anaemia. This multicentre, single-arm, phase 2b trial included patients who were relapsed or refractory to corticosteroids. At the 50-week data cutoff, 14 of 22 patients (64%) in part A achieved an overall haemoglobin response.
Key findings
- 14 (64%; 95% CI 41-83) of 22 patients in part A had an overall haemoglobin response.
- 12 (80%) of 15 patients in part B achieved a durable haemoglobin response.
- Treatment-related adverse events occurred in 10 (45%) of 22 patients in part A.
Why it matters
This study highlights the potential of rilzabrutinib to improve haemoglobin levels in patients with warm autoimmune haemolytic anaemia, a condition often challenging to manage. Its favorable safety profile may offer an alternative to corticosteroid therapy.