Epidemiology, outcome, and risk factors for infectious complications in myelofibrosis patients receiving ruxolitinib: A multicenter study on 446 patients

Nicola Polverelli, Giuseppe A. Palumbo, Gianni Binotto, Elisabetta Abruzzese, Giulia Benevolo, Micaela Bergamaschi, Alessia Tieghi, Massimiliano Bonifacio, Massimo Breccia, Lucia Catani, Mario Tiribelli, Mariella D'Adda, Nicola Sgherza, Alessandro Isidori, Francesco Cavazzini, Bruno Martino, Roberto Latagliata, Monica Crugnola, Florian Heidel, Costanza BosiAdalberto Ibatici, Francesco Soci, Domenico Penna, Luigi Scaffidi, Franco Aversa, Roberto M. Lemoli, Umberto Vitolo, Antonio Cuneo, Domenico Russo, Michele Cavo, Nicola Vianelli, Francesca Palandri

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)561-569
JournalHematological Oncology
Issue number3
Publication statusPublished - 2018


  • Infections
  • JAK inhibitors
  • Myelofibrosis
  • Ruxolitinib
  • Toxicity

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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