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All-trans retinoic acid plus low-dose rituximab vs low-dose rituximab in corticosteroid-resistant or relapsed ITP.
- Source :
-
Blood [Blood] 2022 Jan 20; Vol. 139 (3), pp. 333-342. - Publication Year :
- 2022
-
Abstract
- The study aimed to compare the efficacy and safety of all-trans retinoic acid (ATRA) plus low-dose rituximab (LD-RTX) with LD-RTX monotherapy in corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) patients. Recruited patients were randomized at a ratio of 2:1 into 2 groups: 112 patients received LD-RTX plus ATRA, and 56 patients received LD-RTX monotherapy. Overall response (OR), defined as achieving a platelet count of ≥30 × 109/L confirmed on ≥2 separate occasions (≥7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment, and the absence of bleeding within 1 year after enrollment, was observed in more patients in the LD-RTX plus ATRA group (80%) than in the LD-RTX monotherapy group (59%) (between-group difference, 0.22; 95% CI, 0.07-0.36). Sustained response (SR), defined as maintenance of a platelet count >30 × 109/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR during 1 year following enrollment, was achieved by 68 (61%) patients in the combination group and 23 (41%) patients in the monotherapy group (between-group difference, 0.20; 95% CI, 0.04-0.35). The 2 most common adverse events (AEs) for the combination group were dry skin and headache or dizziness. Our findings demonstrated that ATRA plus LD-RTX significantly increased the overall and sustained response, indicating a promising treatment option for corticosteroid-resistant or relapsed adult ITP. This study is registered at www.clinicaltrials.gov as #NCT03304288.<br /> (© 2022 by The American Society of Hematology.)
- Subjects :
- Adrenal Cortex Hormones therapeutic use
Adult
Antineoplastic Agents administration & dosage
Drug Resistance
Drug Therapy, Combination
Female
Humans
Immunologic Factors administration & dosage
Male
Middle Aged
Recurrence
Rituximab administration & dosage
Secondary Prevention
Tretinoin administration & dosage
Antineoplastic Agents therapeutic use
Immunologic Factors therapeutic use
Purpura, Thrombocytopenic, Idiopathic drug therapy
Rituximab therapeutic use
Tretinoin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0020
- Volume :
- 139
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 34665865
- Full Text :
- https://doi.org/10.1182/blood.2021013393