All-trans retinoic acid plus low-dose rituximab vs low-dose rituximab in corticosteroid-resistant or relapsed ITP
Autor: | Ying-Jun Chang, Qiao-Zhu Zeng, Ye-Jun Wu, Lan-Ping Xu, Qian Jiang, Yun He, Xiao-Hui Zhang, Yi Liu, He-Bing Zhou, Jing-Wen Wang, Hao Jiang, Qiu-Sha Huang, Hui Liu, Jia Feng, Wen-Sheng Wang, Xiao-Jun Huang, Xiao-Lu Zhu, Hai-Xia Fu |
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Rok vydání: | 2021 |
Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class Immunology Retinoic acid Drug Resistance Antineoplastic Agents Tretinoin Biochemistry Gastroenterology chemistry.chemical_compound Adrenal Cortex Hormones Recurrence Internal medicine Dry skin medicine Secondary Prevention Humans Immunologic Factors Platelet Purpura Thrombocytopenic Idiopathic business.industry Low dose All trans Cell Biology Hematology Middle Aged Immune thrombocytopenia chemistry Corticosteroid Rituximab Drug Therapy Combination Female medicine.symptom business medicine.drug |
Zdroj: | Blood. 139(3) |
ISSN: | 1528-0020 |
Popis: | 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. |
Databáze: | OpenAIRE |
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