Real‐world non‐interventional long‐term post‐authorisation safety study of ruxolitinib in myelofibrosis
Autor: | Raoul Herbrecht, Robert Pack, Monika Wroclawska, Rüdiger Liersch, Burkhard Schmidt, Fiorenza Barraco, Heinz Gisslinger, Reinier Raymakers, Andreas Reiter, Richard Greil, Divyadeep Karumanchi, Wolfgang Willenbacher, Karin Burock |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male Ruxolitinib medicine.medical_specialty Sepsis 03 medical and health sciences 0302 clinical medicine Internal medicine Nitriles Humans Medicine Prospective Studies Adverse effect Myelofibrosis Aged Aged 80 and over business.industry Incidence (epidemiology) Hematology Middle Aged medicine.disease Pneumonia Pyrimidines Primary Myelofibrosis 030220 oncology & carcinogenesis Cohort Pyrazoles Female business Adverse drug reaction 030215 immunology medicine.drug |
Zdroj: | British Journal of Haematology. 191:764-774 |
ISSN: | 1365-2141 0007-1048 |
Popis: | Primary objective of this non-interventional, post-authorisation safety study was to provide real-world safety data [incidence of adverse drug reactions (ADRs)/serious adverse events (SAEs)] on adult patients with myelofibrosis exposed/or not exposed to ruxolitinib. Key secondary objectives included the incidence/outcome of events of special interest (bleeding events, serious/opportunistic infections, second primary malignancies, and deaths). Overall, 462 patients were included [prevalent users = 260, new users = 32, non-exposed = 170 (inclusive of ruxolitinib-switch, n = 57)]. The exposure-adjusted incidence rates (per 100 patient-years) of ADRs (19·3 vs. 19·6) and SAEs (25·2 vs. 25·0) were comparable amongst new-users versus prevalent-users cohorts, respectively; most frequent ADRs across all cohorts included thrombocytopenia, anaemia, epistaxis, urinary tract infection, and herpes zoster. Anaemia, pneumonia, general physical health deterioration, sepsis, and death were the most frequent SAEs across all cohorts. Incidence rates of bleeding events (21·6) and serious/opportunistic infections (34·5) were higher in ruxolitinib-switch cohort versus other cohorts. The incidence rate of second primary malignancies was higher in the prevalent-users cohort (10·1) versus other cohorts. The observed safety profile of ruxolitinib in the present study along with the safety findings from the COMFORT/JUMP/EXPAND studies support the use of ruxolitinib for long-term treatment of patients with myelofibrosis. |
Databáze: | OpenAIRE |
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