Long-term safety and efficacy of rituximab in 248 adults with immune thrombocytopenia: Results at 5 years from the French prospective registry ITP-ritux.
Adrenal Cortex Hormones
/ therapeutic use
Adult
Agammaglobulinemia
/ chemically induced
Aged
Aged, 80 and over
Autoimmune Diseases
/ epidemiology
Cardiovascular Diseases
/ epidemiology
Cause of Death
Disease-Free Survival
Drug Eruptions
/ epidemiology
Drug Substitution
Female
Follow-Up Studies
France
/ epidemiology
Humans
Infections
/ epidemiology
Male
Middle Aged
Neoplasms
/ epidemiology
Pregnancy
Pregnancy Complications
/ epidemiology
Pregnancy Outcome
Prospective Studies
Purpura, Thrombocytopenic, Idiopathic
/ drug therapy
Registries
Rituximab
/ adverse effects
Serum Sickness
/ chemically induced
Journal
American journal of hematology
ISSN: 1096-8652
Titre abrégé: Am J Hematol
Pays: United States
ID NLM: 7610369
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
03
07
2019
revised:
29
08
2019
accepted:
03
09
2019
pubmed:
7
9
2019
medline:
14
4
2020
entrez:
7
9
2019
Statut:
ppublish
Résumé
Rituximab is a second-line option in adults with immune thrombocytopenia (ITP), but the estimated 5-year response rate, only based on pooled retrospective data, is about 20%, and no studies have focused on long-term safety. We conducted a prospective multicenter registry of 248 adults with ITP treated with rituximab with 5 years of follow-up to assess its long-term safety and efficacy. The median follow-up was 68.4 [53.7-78.5] months. The incidence of severe infections was only 2/100 patient-years. Profound hypogammaglobulinemia (<5 g/L) developed in five patients at 15 to 31 months after the last rituximab infusion. In total, 25 patients died at a median age of 80 [69.5-83.9] years, corresponding to a mortality rate of 2.3/100 patient-years. Only three deaths related to infection that occurred 12 to 14 months after rituximab infusions could be due in part to rituximab. At 60 months of follow-up, 73 (29.4%) patients had a sustained response. On univariate and multivariate analysis, the only factor significantly associated with sustained response was a previous transient response to corticosteroids (P = .022). Overall, 24 patients with an initial response and then relapse received retreatment with rituximab, which gave a response in 92%, with a higher duration of response in 54%. As a result of its safety profile and its sustained response rate, rituximab remains an important option in the current therapeutic armamentarium for adult ITP. Retreatment could be an effective and safe option.
Substances chimiques
Adrenal Cortex Hormones
0
Rituximab
4F4X42SYQ6
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1314-1324Informations de copyright
© 2019 Wiley Periodicals, Inc.
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