The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Pregnancy or lactation;
• Active or a history of malignancy;
• Active infection requiring systemic therapy;
• Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;
• A known diagnosis of other autoimmune diseases;
• Patients who are deemed unsuitable for the study by the investigator.