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Rituximab-induced thrombocytopenia: a cohort study.
MedLine Citation:
PMID:  22639923     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The combined information of drug exposure and laboratory test results on an individual patient level obtained in daily clinical practice can add important information about the safety of a drug. Thrombocytopenia is a know adverse drug reaction of rituximab, which has already been identified during the pre-registration trials, but knowledge on incidence and risk factors in clinical practice is limited. We, therefore, aimed to estimate the incidence and explore risk factors for the development of rituximab-induced thrombocytopenia (a platelet count <100x10(9) platelets/ L) in clinical practice. 90 patients were eligible for inclusion of which 27 developed thrombocytopenia (cumulative incidence: 30%) within 30 days after administration of rituximab and 18 patients developed grade 3/4 thrombocytopenia (cumulative incidence: 20%). Patients with and without thrombocytopenia were compared to explore risk factors. Patients with a relatively low platelet count (217 vs. 324x10(9) /L, p=0.011) before administration of rituximab had a higher risk for the development of thrombocytopenia and although not statistically significant, patients treated with rituximab within the oncology setting (OR: 4.7 95% CI: 1.0-23.3), independent of concomitant use of cytostatics, as compared to the auto-immune diseases and patients with a high platelet distribution width (PDW) (16.1 vs. 15.8, p=0.051). In conclusion, the incidence of rituximab-induced thrombocytopenia was higher than identified during the clinical trials. Healthcare professionals should consider thrombocytopenia as a relevant reaction during treatment with rituximab. More frequent monitoring of the platelet count is especially advised in patients treated in the oncology indication and/ or with a low platelet count and high PDW. © 2012 John Wiley & Sons A/S.
Authors:
Thijs J Giezen; Aukje K Mantel-Teeuwisse; Maarten J Ten Berg; Sabine M J M Straus; Hubert G M Leufkens; Wouter W van Solinge; Toine C G Egberts
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-28
Journal Detail:
Title:  European journal of haematology     Volume:  -     ISSN:  1600-0609     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8703985     Medline TA:  Eur J Haematol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 John Wiley & Sons A/S.
Affiliation:
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands; Medicines Evaluation Board, Utrecht, the Netherlands; Department of Clinical Pharmacy, Medical Spectrum Twente, Enschede, the Netherlands.
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