Page 265 - Haematologica Vol. 109 - July 2024

LETTER TO THE EDITOR
lated, 3.4%). Pneumonia (8.2%) was the only serious TEAE in ≥5% of patients. In summary, these findings were consistent with those for the prior pooled safety analysis,1 even with a median treatment duration ≈9 months longer.
Select TEAE preferred terms were grouped as AESI (“op- portunistic infections” included preferred terms under the narrow standardized MedDRA query “opportunistic infections”; for all other AESI preferred terms, see Tam et al.1). In order to account for differing treatment expo- sures across the trials, exposure-adjusted incidence rates (EAIR) of these AESI were determined for the total pooled zanubrutinib population (Figure 1B; see legend for EAIR calculation and assumption) and comparative analysis populations (Figure 1C).
Infections, hemorrhage, and neutropenia were the most
A
frequently reported AESI in the total pooled zanubrutinib population, even after adjusting for dose exposure (Figure 1B). Despite a longer median treatment duration, the EAIR of the cardiovascular AESI were comparable to those of the earlier analysis (hypertension, 6.81 in the present analysis vs. 6.87 persons per 100 person-years [PY] in Tam et al.;1 afib/flutter, 1.74 vs. 1.45 persons per 100 PY, respectively). ALPINE had a greater hypertension EAIR than SEQUOIA and ASPEN; exclusion of data from ALPINE decreased the hypertension EAIR to 5.73 persons per 100 PY. In ALPINE, the hypertension rate was similar between the zanubrutinib and ibrutinib arms; however, the incidence of cardiac dis- orders such as afib/flutter was higher in the ibrutinib arm,3 whereas incidence in the zanubrutinib arm remained low and comparable to that observed in SEQUOIA and ASPEN.
1;
B
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