title: Low-dose rituximab in adult patients with idiopathic autoimmune hemolytic anemia: clinical efficacy and biologic studies.
abstract: This prospective study investigated the efficacy, safety, and response duration of low-dose rituximab (100 mg fixed dose for 4 weekly infusions) together with a short course of steroids as first- or second-line therapy in 23 patients with primary autoimmune hemolytic anemia (AIHA). The overall response was 82.6% at month +2, and subsequently stabilized to ∼ 90% at months +6 and +12; the response was better in warm autoimmune hemolytic anemia (WAIHA; overall response, 100% at all time points) than in cold hemagglutinin disease (CHD; average, 60%); the relapse-free survival was 100% for WAIHA at +6 and +12 months versus 89% and 59% in CHD, respectively, and the estimated relapse-free survival at 2 years was 81% and 40% for the warm and cold forms, respectively. The risk of relapse was higher in CHD and in patients with a longer interval between diagnosis and enrollment. Steroid administration was reduced both as cumulative dose (∼ 50%) and duration compared with the patient's past history. Treatment was well tolerated and no adverse events or infections were recorded; retreatment was also effective. The clinical response was correlated with amelioration biologic markers such as cytokine production (IFN-γ, IL-12, TNF-α, and IL-17), suggesting that low-dose rituximab exerts an immunomodulating activity. This study is registered at www.clinicaltrials.gov as NCT01345708.
authors.affiliation: Unità Operativa Ematologia, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. wbarcel@policlinico.mi.it
authors.forename: Wilma
authors.initials: W
authors.lastname: Barcellini
authors.forename: Francesco
authors.initials: F
authors.lastname: Zaja
authors.forename: Anna
authors.initials: A
authors.lastname: Zaninoni
authors.forename: Francesca Guia
authors.initials: FG
authors.lastname: Imperiali
authors.forename: Marta Lisa
authors.initials: ML
authors.lastname: Battista
authors.forename: Eros
authors.initials: E
authors.lastname: Di Bona
authors.forename: Bruno
authors.initials: B
authors.lastname: Fattizzo
authors.forename: Dario
authors.initials: D
authors.lastname: Consonni
authors.forename: Agostino
authors.initials: A
authors.lastname: Cortelezzi
authors.forename: Renato
authors.initials: R
authors.lastname: Fanin
authors.forename: Alberto
authors.initials: A
authors.lastname: Zanella
mesh_terms: D000328:Adult; D000368:Aged; D000744:Anemia, Hemolytic, Autoimmune / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D016207:Cytokines / Q000097:blood / Q000276:immunology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D000069283:Rituximab; D055502:Secondary Prevention; D013256:Steroids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D016207:Cytokines; D007155:Immunologic Factors; D013256:Steroids; D000069283:Rituximab