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Leuk Lymphoma. 2017 Nov;58(11):2633-2641. doi: 10.1080/10428194.2017.1306648. Epub 2017 Apr 3.

Adverse drug reactions after intravenous rituximab infusion are more common in hematologic malignancies than in autoimmune disorders and can be predicted by the combination of few clinical and laboratory parameters: results from a retrospective, multicenter study of 374 patients.

Author information

1
a Hematology and Stem Cell Transplantation Unit , IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
2
b Laboratory of Preclinical and Translational Research, IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
3
c Hematology and Stem Cell Transplantation Unit , Catholic University of 'Sacred Hearth' , Rome , Italy.
4
d Hematology and Stem Cell Transplantation Unit , ' S. Carlo' Hospital , Potenza , Italy.
5
e Rheumatology Department , ' S. Carlo' Hospital , Potenza , Italy.
6
f Department of Health Sciences , University of Catanzaro 'Magna Graecia' , Catanzaro , Italy.
7
g Hematology Unit , ' S. Sebastiano' Hospital , Caserta , Italy.
8
h Hematology and Stem Cell Transplantation Unit , ' A. Tortora' Hospital , Pagani , Italy.
9
i Hematology Unit , IRCCS National Cancer Research Institute 'Giovanni Paolo II' , Bari , Italy.
10
j Department of Biomedical Sciences and Human Oncology , ' Aldo Moro' University , Bari , Italy.
11
k Department of Clinical Medicine and Surgery , Regional Service Centre of Coagulation Disorders, 'Federico II' University , Naples , Italy.
12
l Unit of Cell and Molecular Biology in Cardiovascular Diseases , IRCCS Monzino Cardiology Center , Milan , Italy.
13
m Department of Pharmacology , University of Salerno , Salerno , Italy.
14
n Laboratory of Clinical and Advanced Diagnostics, IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
15
o Scientific Direction, IRCCS-CROB , Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.

Abstract

Rituximab is an effective treatment for CD20ā€‰+ā€‰B-cell malignancies and autoimmune disorders. However, adverse drug reactions (ADRs) may occur after rituximab infusion, causing, in rare cases, its discontinuation. In this multicenter, retrospective study, among 374 patients treated with rituximab i.v., 23.5% experienced ADRs. Mean follow-up was 20.6 months (range 8-135). Overall, ADRs were significantly more frequent in non-Hodgkin lymphomas (NHL) and chronic lymphocytic leukemias (25-35.9%), than in autoimmune diseases (9.4-17.5%) (pā€‰<ā€‰.0001). Grade 3-4 toxicity was observed in eight patients (2.1%), and in four of them (1% of all patients) definitive drug discontinuation was necessary. Interestingly, three groups of patients with different risk of developing ADR were identified, according to a predictive heat-map developed combining four parameters (splenomegaly, history of allergy, hemoglobin levels and gender) selected by multivariate analysis. This model may be useful in identifying patients at higher risk of ADRs, needing appropriate preventing therapies.

KEYWORDS:

Rituximab; adverse drug reaction; autoimmune diseases; lymphoma; pharmacovigilance; rheumatoid arthritis

PMID:
28367662
DOI:
10.1080/10428194.2017.1306648
[Indexed for MEDLINE]

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