Abstract
BACKGROUND: Long-term clinical trials and real-world data have established a comprehensive risk-benefit profile for ibrutinib, informing adverse event (AE) management strategies to optimize safety and efficacy. METHODS: We retrospectively assessed the incidence of AEs of special interest and management strategies in all patients treated with ibrutinib for chronic lymphocytic leukemia (CLL) in Saskatchewan, Canada, since 2014. RESULTS: Among 187 patients (median age 75.7 years, 63% male), the median time from ibrutinib treatment initiation to data cutoff was 3.1 years. Approximately two-thirds of patients received ibrutinib for relapsed CLL (33.7% second-line and 32.6% third-line and beyond), with 33.7% receiving it first-line. All patients initiated ibrutinib as monotherapy at 420 mg. AEs of interest were observed in 81.3% of patients, with 42.8% experiencing ≥2 AEs. No grade 5 AEs were reported. Among the 284 first-onset AEs observed in 152 patients, 90.8% were successfully managed, allowing treatment continuation. The median time to successful management ranged from 27.0 days (range: 12.5-73.0) for infections to 84.0 days (range: 55.0-141.0) for hypertension. Both AE and discontinuation rates were comparable or favourable to previous reports. CONCLUSION: This real-world analysis suggests that ibrutinib may be safely used in the majority of CLL patients encountered in routine practice.