Thrombopoietin receptor agonists (TPO-RAs) represent a highly effective and well-tolerated second-line ITP treatment that provides excellent responses.If there is cross-resistance between 2 drugs for the treatment of adult ITP is still unkonwn.The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.
Thrombopoietin Receptor Agonists (TPO-RAs) are novel treatments for patients with chronic Primary Immune Thrombocytopenia (ITP). According to the findings of mechanism-based studies, rhTPO competes with endogenous TPO for binding to TPO-R while avatrombopag has an additive effect with endogenous TPO, indicating that the treatment mechanism and side-effect profiles could be somewhat different between these drugs. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.This is a non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to avatrombopag or vice versa will be enrolled. The reason for switch will be recorded. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.
Study Type
OBSERVATIONAL
Enrollment
100
Initial response after switching
Rate of response at 4 weeks after switching from rhTPO to avatrombopag or vise versa
Time frame: 4 weeks
Response rate at 12 weeks after switching
Rate of response at 12 weeks after switching from rhTPO to avatrombopag or vise versa
Time frame: 12 weeks
Initial response after switching according to the reasons of switching
Rate of response at 1 month after switching according to the reasons of switching,such as lack of efficacy, Platelet count fluctuations, development of adverse events,patient's or doctor's preference
Time frame: 4 weeks
Rate of response at 12 weeks after switching according to the reasons of switching
Rate of response at 12 weeks after switching according to the reasons of switching,such as lack of efficacy, Platelet count fluctuations, development of adverse events,patient's or doctor's preference
Time frame: 12 weeks
Time to response
Time to CR or R from switching
Time frame: 4 weeks
Durable response
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 24 weeks follow-up.
Time frame: 24 weeks
Incidence of bleeding events
Incidence of clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
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Time frame: 24 weeks
Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)
In all participants ,use ITP-PAQ to assess the Health Related Quality of Life(HRQoL) before and after treatment.
Time frame: 24 weeks
Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
In all participants ,use FACIT-F to assess the Health Related Quality of Life(HRQoL) before and after treatment.
Time frame: 24 weeks
Safety assessment
Number of Participants with side effects of the drugs
Time frame: 24 weeks