Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation. A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
oral iguratimod at 25mg twice daily for 26 weeks
rituximab 100mg once weekly for 6 weeks
Peking University Insititute of Hematology
Beijing, China
overall response
The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
sustained response
The number of participants that can maintain the platelet count \> 30 x 109/L, an absence of bleeding events, and without requirement for any other ITP-specific treatment for 6 consecutive months after achievement of response.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
complete response
The number of participants (responders) with platelet count\>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
time to response
Time to response was defined as the time from starting treatment to the time to achieve the response.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
duration of response
Duration of response was measured from the achievement of response to the loss of response.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
incidence of adverse events
From the start of study treatment (Day 1) up to the end of Year 1
Time frame: All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0
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Bleeding events
Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
Health-related quality of life (HRQoL)
ITP-PAQ is used to assess the Health Related Quality of Life (HRQoL) before and after treatment.
Time frame: From the start of study treatment (Day 1) up to the end of Year 1