Single-dose versus low-dose rituximab in corticosteroid-resistant or relapsed ITP: A multicenter, randomized,...

Area of Science:

• Hematology
• Immunology
• Clinical Trials

Background:

• Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder.
• Rituximab (RTX) is a recommended second-line treatment for ITP, but optimal dosing is unclear.

Purpose of the Study:

• To compare the efficacy and safety of a single dose (S-RTX) versus a repeated low dose (LD-RTX) of rituximab in patients with corticosteroid-resistant or relapsed ITP.

Main Methods:

• Prospective, multicenter, open-label, randomized controlled trial.
• Patients were randomized to receive either LD-RTX (100 mg weekly for 4 weeks) or S-RTX (375 mg/m²).
• Efficacy and safety outcomes, including overall response, complete response (CR), and health-related quality of life, were assessed.

Main Results:

• Overall response rates were comparable: 64.3% for LD-RTX vs. 67.4% for S-RTX (p=0.759).
• Complete response rates were also similar: 23.8% for LD-RTX vs. 28.3% for S-RTX (p=0.635).
• S-RTX demonstrated improvements in quality of life, social activities, and work, and reduced physician visits without compromising efficacy.

Conclusions:

• Single-dose rituximab (S-RTX) is comparable in effectiveness and safety to repeated low-dose rituximab (LD-RTX) for treating corticosteroid-resistant or relapsed ITP.
• The S-RTX regimen optimizes medical resource use and cost-effectiveness.
• S-RTX represents a more convenient and promising alternative to LD-RTX for ITP management.