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Epidemiology, outcome, and risk factors for infectious complications in myelofibrosis patients receiving ruxolitinib: A multicenter study on 446 patients
Author(s) -
Polverelli Nicola,
Palumbo Giuseppe A.,
Binotto Gianni,
Abruzzese Elisabetta,
Benevolo Giulia,
Bergamaschi Micaela,
Tieghi Alessia,
Bonifacio Massimiliano,
Breccia Massimo,
Catani Lucia,
Tiribelli Mario,
D'Adda Mariella,
Sgherza Nicola,
Isidori Alessandro,
Cavazzini Francesco,
Martino Bruno,
Latagliata Roberto,
Crugnola Monica,
Heidel Florian,
Bosi Costanza,
Ibatici Adalberto,
Soci Francesco,
Penna Domenico,
Scaffidi Luigi,
Aversa Franco,
Lemoli Roberto M.,
Vitolo Umberto,
Cuneo Antonio,
Russo Domenico,
Cavo Michele,
Vianelli Nicola,
Palandri Francesca
Publication year - 2018
Publication title -
hematological oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 44
eISSN - 1099-1069
pISSN - 0278-0232
DOI - 10.1002/hon.2509
Subject(s) - medicine , ruxolitinib , myelofibrosis , epidemiology , incidence (geometry) , etiology , hematology , bone marrow , physics , optics
Infections represent one of the major concerns regarding the utilization of ruxolitinib (RUX) in patients with myelofibrosis. With the aim to investigate epidemiology, outcome and risk factors for infections in RUX‐exposed patients, we collected clinical and laboratory data of 446 myelofibrosis patients treated with RUX between June 2011 and November 2016 in 23 European Hematology Centers. After a median RUX exposure of 23.5 months (range, 1‐56), 123 patients (28%) experienced 161 infectious events (grades 3‐4 32%, fatal 9%), for an incidence rate of 17 cases per 100 pts/y. The rate of infections tended to decrease over time: 14% of patients developed the first infection within 6 months, 5% between 6 and 12 months, 3.7% between 12 and 18 months, 3.4% between 18 and 24 months, and 7.9% thereafter ( P < .0001). Respiratory tract infections were more frequently observed (81 events, 50%), and bacteria were the most frequent etiological agents (68.9%). However, also viral (14.9%) and fungal infections (2.5%) were observed. In multivariate analysis, previous infectious event (HR 2.54; 95% CI, 1.51‐4.28; P = .0005) and high international prognostic score system category (IPSS) (HR 1.53; 95% CI, 1.07‐2.20; P = .021) significantly correlated with higher infectious risk. On the contrary, spleen reduction ≥50% from baseline after 3 months of treatment ( P = .02) was associated with better infection‐free survival. Taken together, these findings reinforce the concept of disease severity as the most important risk factor for infections, and describe, for the first time, that a positive therapeutic effect in reducing splenomegaly may also reduce subsequent infectious complications.