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Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.

Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients.

Author information

1
Service de Médecine Interne, Centre de Référence Labellisé des Cytopénies Auto-Immunes de l'Adulte and.
2
Unité de Recherche Clinique, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France;
3
Service de Médecine Interne, Hôpital Jean-Verdier, Assistance Publique-Hôpitaux de Paris, Université Paris XIII, Bondy, France;
4
Service de Médecine Interne, Centre Hospitalier Régional Universitaire de Lille, Lille, France;
5
Département de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Universitaire Haut Lévêque, Université de Bordeaux, Pessac, France;
6
Service d'Hématologie Clinique, Centre Hospitalier Universitaire de la Côte de Nacre, Caen, France;
7
Service de Médecine Interne, Centre Hospitalier Universitaire de Nantes, Nantes, France;
8
Service d'Hématologie, Centre Hospitalier d'Avignon, Avignon, France;
9
Service de Médecine Interne, Hôpital Le Bocage, Dijon, France;
10
Service de Médecine Interne, Hôpital de La Conception, Assistance Publique-Hôpitaux de Marseille, Université Aix-Marseille, Marseille, France;
11
Service de Médecine Interne, Centre Hospitalier Universitaire Estaing, Clermont Ferrand, France;
12
Département d'Hématologie, Groupe Hospitalier de l'Institut Catholique de Lille, Lille, France;
13
Service d'Hématologie, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre-Bénite, University Claude Bernard Lyon 1, Lyon, France;
14
Service d'Hématologie, Centre Hospitalier Universitaire de Nancy, Nancy, France;
15
Département d'Immuno-Hématologie, Centre Hospitalier Universitaire Louis Mourrier, Assistance Publique-Hôpitaux de Paris, Colombes, France;
16
Service d'Immuno-Pathologie, Centre Hospitalier Universitaire Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France;
17
Service de Médecine Interne, Groupement Hospitalier Edouard Herriot, Lyon, France;
18
Service de Médecine Interne, Centre Hospitalier Universitaire Bicêtre, Assistance Publique-Hôpitaux de Paris, Paris, France;
19
Service d'Hématologie, Centre Hospitalier Universitaire Necker, Assistance Publique-Hôpitaux de Paris, Paris, France;
20
Service de Médecine Interne, Centre de Référence Labellisé des Cytopénies Auto-Immunes de l'Adulte and Etablissement Français du Sang, Henri-Mondor, Creteil, France; and.
21
Service de Santé Publique, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France.

Abstract

We conducted a prospective multicenter registry of 248 adult patients with immune thrombocytopenia (ITP) treated with rituximab to assess safety. We also assessed response and predictive factors of sustained response. In total, 173 patients received 4 infusions of 375 mg/m(2) and 72 received 2 fixed 1-g infusions 2 weeks apart. The choice of the rituximab regimen was based on the physician's preference and not patient characteristics. Overall, 38 patients showed minor intolerance to rituximab infusions; infusions had to be stopped for only 3 patients. Seven showed infection (n = 11 cases), with an incidence of 2.3 infections/100 patient-years. Three patients died of infection 12 to 14 months after rituximab infusions, but the role of rituximab was questionable. In total, 152 patients (61%) showed an overall initial response (platelet count ≥30 × 10(9)/L and ≥2 baseline value). At a median follow-up of 24 months, 96 patients (39%) showed a lasting response. On multivariate analysis, the probability of sustained response at 1 year was significantly associated with ITP duration <1 year (P = .02) and previous transient complete response to corticosteroids (P = .05). The pattern of response was similar with the 2 rituximab regimens. With its benefit/risk ratio, rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. This trial was registered at www.clinicaltrials.gov as #NC1101295.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01101295.

PMID:
25293768
DOI:
10.1182/blood-2014-06-582346
[Indexed for MEDLINE]
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