In a Phase III, multicentre, randomised, double-blind, parallel-group, placebo-controlled study, adult patients with chronic ITP were randomised 2:1 to Doptelet 5–40 mg once a day (n=32) or placebo (n=17). Doptelet was initiated at 20 mg once a day, and dose was titrated from days 5±1 to 28. Treatment continued until week 26, at which point eligible patients enrolled into an open-label extension phase.1
Primary endpoint: Doptelet patients (n=32) achieved a median of 12.4 weeks at or above the platelet target (≥50 × 109/L) without rescue therapy vs 0.0 weeks with placebo (p<0.0001).1
Secondary endpoint: The median platelet count was consistently higher with Doptelet vs placebo from day 8 (80.5 x 109/L vs 8 x 109/L).1
In a post-hoc subgroup analysis of the Phase III study, treatment with Doptelet was equally effective among patients with and without prior TPO-RA experience.2
Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).3
ITP, immune thrombocytopenia; TPO-RA, thrombopoietin receptor agonist.
1. Jurczak W et al. Br J Haematol. 2018; 183(3):479–490. 2. McCrae KR et al. ISTH. 2019. 3. Doptelet EMC Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/11837/smpc#gref Last accessed: April 2025.
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