A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Patients aged ≥18 years;
Newly diagnosed, treatment naïve ITP patients;
Patients with a platelet count <30 x10^9/L or a platelet count <50 x10^9/L with bleeding manifestations at the enrollment;
Willing and able to sign written informed consent.
Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);
Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);
Severe cardiac, renal, hepatic, or respiratory insufficiency;
Severe immunodeficiency;
Parallel
Teriflunomide
DrugTeriflunomide 14 mg orally once daily for 24 weeks.
Dexamethasone
DrugDexamethasone 40 mg orally once daily for four consecutive days.
Sustained response
Sustained response was defined as a platelet count ≥ 30 x10\^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.
Initial response
The number of participants with achievement of CR or R at 4 weeks. Complete response (CR) was defined as a platelet count ≥ 100 x10\^9/L and absence of bleeding. Response (R) was defined as a platelet count ≥ 30 x10\^9/L and at least a 2-fold increase of the baseline count and absence of bleeding. No response was defined as a platelet count of less than 30 x10\^9/L, or less than two times increase from baseline platelet count, or bleeding.
Time to response
The time from treatment initiation to time of achievement of CR or R.
Duration of response
The time from the achievement of a CR or R to the loss of CR or R.
Bleeding events
Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.
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Peking University People's Hospital
Lead sponsor
Peking University Health Science Center
Collaborator
Cisen Pharmaceutical CO., LTD.
Collaborator
