title: 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.
abstract: Rituximab is an effective treatment for CD20 + 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%) (p < .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.
authors.affiliation: a Hematology and Stem Cell Transplantation Unit , IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
authors.forename: Giovanni
authors.identifier: 0000-0002-3807-7287
authors.initials: G
authors.lastname: D'Arena
authors.affiliation: b Laboratory of Preclinical and Translational Research, IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Simeon
authors.affiliation: c Hematology and Stem Cell Transplantation Unit , Catholic University of 'Sacred Hearth' , Rome , Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Laurenti
authors.affiliation: d Hematology and Stem Cell Transplantation Unit , ' S. Carlo' Hospital , Potenza , Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Cimminiello
authors.affiliation: c Hematology and Stem Cell Transplantation Unit , Catholic University of 'Sacred Hearth' , Rome , Italy.
authors.forename: Idanna
authors.initials: I
authors.lastname: Innocenti
authors.affiliation: e Rheumatology Department , ' S. Carlo' Hospital , Potenza , Italy.|f Department of Health Sciences , University of Catanzaro 'Magna Graecia' , Catanzaro , Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Gilio
authors.affiliation: e Rheumatology Department , ' S. Carlo' Hospital , Potenza , Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Padula
authors.affiliation: g Hematology Unit , ' S. Sebastiano' Hospital , Caserta , Italy.
authors.forename: Maria Luigia
authors.initials: ML
authors.lastname: Vigliotti
authors.affiliation: h Hematology and Stem Cell Transplantation Unit , ' A. Tortora' Hospital , Pagani , Italy.
authors.forename: Sonya
authors.initials: S
authors.lastname: De Lorenzo
authors.affiliation: i Hematology Unit , IRCCS National Cancer Research Institute 'Giovanni Paolo II' , Bari , Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Loseto
authors.affiliation: j Department of Biomedical Sciences and Human Oncology , ' Aldo Moro' University , Bari , Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Passarelli
authors.affiliation: k Department of Clinical Medicine and Surgery , Regional Service Centre of Coagulation Disorders, 'Federico II' University , Naples , Italy.|l Unit of Cell and Molecular Biology in Cardiovascular Diseases , IRCCS Monzino Cardiology Center , Milan , Italy.
authors.forename: Matteo Nicola Dario
authors.identifier: 0000-0001-8059-3819
authors.initials: MND
authors.lastname: Di Minno
authors.affiliation: j Department of Biomedical Sciences and Human Oncology , ' Aldo Moro' University , Bari , Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Tucci
authors.affiliation: m Department of Pharmacology , University of Salerno , Salerno , Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: De Feo
authors.affiliation: n Laboratory of Clinical and Advanced Diagnostics, IRCCS-CROB, Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
authors.forename: Fiorella
authors.initials: F
authors.lastname: D'Auria
authors.affiliation: j Department of Biomedical Sciences and Human Oncology , ' Aldo Moro' University , Bari , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Silvestris
authors.affiliation: k Department of Clinical Medicine and Surgery , Regional Service Centre of Coagulation Disorders, 'Federico II' University , Naples , Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Di Minno
authors.affiliation: o Scientific Direction, IRCCS-CROB , Referral Cancer Center of Basilicata , Rionero in Vulture , Italy.
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000074322:Antineoplastic Agents, Immunological / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001327:Autoimmune Diseases / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000097:blood / Q000209:etiology; D005260:Female; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000074322:Antineoplastic Agents, Immunological; D000069283:Rituximab
keywords: Rituximab; adverse drug reaction; autoimmune diseases; lymphoma; pharmacovigilance; rheumatoid arthritis