Risk factors for infections and secondary malignancies in patients with a myeloproliferative neoplasm treated with ruxolitinib: a dual-center, propensity score-matched analysis

Abstract

Ruxolitinib is a JAK1/2 inhibitor approved for the treatment of myelofibrosis (MF) and polycythemia vera (PV). Recent data have suggested the possibility of increased infectious and secondary malignancy rates in patients treated with ruxolitinib. We conducted a dual-center, retrospective study of 202 myeloproliferative neoplasm (MPN) patients receiving ruxolitinib and a control cohort of 73 ruxolitinib-naïve MPN patients. We utilized propensity score matching to analyze the primary outcome of development of any grade infection. Infections occurred in 38.4% of ruxolitinib-naïve patients and 42.6% of ruxolitinib-treated patients and were primarily grade 1/2. After propensity score weighting, there was no difference in risk of infection between ruxolitinib-treated and -naïve patients with MF (HR 1.15 [95% CI 0.80–1.65], p = .466) and non-MF MPNs (HR = 0.52 [95% CI 0.21–1.28, p = .152). These results suggest that there is not an increased risk of infection with ruxolitinib therapy.

Keywords:

• Ruxolitinib
• JAK inhibitor
• infection
• myeloproliferative

Author contributions

D. T. and A. K. developed the project, collected and analyzed data, and wrote the manuscript. L. L. and E. M. performed statistical analysis. A. C. and A. K. collected data. M. K., R. H., M. J. M., R. K. R., and J. M. developed the project and wrote the manuscript. All authors reviewed the data and the manuscript.

Disclosure statement

M. K. has received research funding from Incyte, Celgene, Constellation, and Blueprint Medicines, and consulting fees from La Jolla Pharmaceutical. M. J. M. has served as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, and Takeda and has received research support to his institution from Bristol-Myers Squibb and SPARC/Sun Pharma. R. H. serves on the advisory board Novartis and La Jolla Pharmaceuticals. R. K. R. has received consulting fees from Incyte, Celgene, Agios Pharmaceuticals, Apexx Oncology, and Jazz Pharmaceuticals and has received research funding from Constellation Pharmaceuticals, Incyte, and Stemline Therapeutics. J. M. has received clinical research funding to the institution from Incyte, CTI Biopharma, Janssen, Merck, Roche, Promedior, and Celgene. Clinical trials steering committee membership for Incyte, CTI Biopharma, Roche, Celgene, and Pharmaessentia.