P195 | INFECTIOUS COMPLICATIONS IN PATIENTS WITH POLYCYTHEMIA VERA TREATED WITH RUXOLITINIB: A REAL-LIFE MULTICENTRE RETROSPECTIVE COHORT STUDY

Introduction. Ruxolinitib (RUX) therapy in patients (pts) with Myelofibrosis is burdened by an increase in infectious events. However, real-life data on infectious complications during RUX in pts with PV are scarce. Aim. To describe the infectious events in pts with PV treated with RUX in a real-life setting. Methods. We retrospectively studied 119 PV pts treated with RUX from 15 centres in the Triveneto area. We collected by medical records data regarding demographics, comorbidities, PV diagnosis, PV therapies and infectious events with CTCAE grade ≥2. Results. We analysed 119 pts (63 male and 56 female) with a median RUX exposure of 27 months (1-95). The median age at PV diagnosis was 57 years while the median age at RUX start was 69 years. Only 5 pts had a previous history of multiple infectious events. 115 pts (96%) had a previous therapy with Hydroxycarbamide (HU) before RUX with a predominance of HU resistance as reason for the switch (60.5% of cases). Median duration of HU therapy before RUX was 5 years. Overall, 36 pts (30%) experienced 58 infectious events with a median severity grade of 2 (range 2-4) for an incidence rate of 16.2% per patient-year. 11 pts (9%) reported multiple events (max 5). Median time from RUX start to the first event was 11 months (0-44). Most frequent events were urinary infections (24%) and herpes zoster reactivation (24%), follow by respiratory infections (12%) and SARS-CoV2 infection (12%). The median RUX dose at the infectious event was 10 mg BID. In 8 events (13.8%) RUX was suspended and resumed later and in no case RUX was permanently discontinued. No HBV/HCV reactivation, TBC case, atypical infections or fatal event were reported. We also compared patients who experienced infections with those without events (Table 1). No parameter was found to be significant between the two groups except for thrombotic history, the correlation of which with infectious events is however not clear. Conclusions. A significant proportion of patients reported one or more significant infectious events with urinary infections, HZ reactivation and respiratory infections as the most common events. The events were manageable with the reduction/temporally suspension of RUX. No clear predictors of infectious risk have emerged during RUX therapy. Based on these data it is reasonable to propose vaccination for HZ, seasonal influenza, SARS-CoV2 and pneumococcus in pts with PV treated with RUX.