RAISE & MAINTAIN PLATELET COUNTS1

Doptelet® (avatrombopag) is a fast-acting, long-lasting TPO-RA for chronic ITP.1,2*

Four Hot Air Balloons in the Sky Carrying Three Doptelet Platelet Characters

Doptelet provided a rapid and durable platelet response over time1†

Patients on Doptelet reached target platelet counts of 50,000/μL for a median of 12.4 cumulative weeks.1

Median Platelet Count (Q1, Q3)2,3
P<0.0001 vs placebo

In as few as 8 days, 66% of Doptelet patients reached 50,000 platelets/μL1

Core Study: Efficacy was evaluated in a 6-month, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. Patients had received one or more prior chronic ITP therapies and had average screening and baseline platelet counts of <30×109/L. Forty-nine patients were randomized (2:1) to receive either Doptelet (n=32) or placebo (n=17).1

  • The primary efficacy endpoint was the cumulative number of weeks of platelet response, defined as a platelet count ≥50×109/L in the absence of rescue therapy, over 6 months of once-daily treatment in adults with chronic ITP. Doptelet-treated patients had a median duration of 12.4 cumulative weeks vs 0 weeks for placebo1
  • A secondary efficacy endpoint was the proportion of patients with a platelet response (platelet counts ≥50×109/L) at Day 8. 66% (n=21/32) of Doptelet-treated patients had platelet counts of ≥50,000/μL at Day 8 compared to placebo (n=0/17)1

Open-label extension: Patients could enter the open-label extension phase if they completed the 6-month core study, or if they experienced a lack of efficacy during that period. In the extension phase, all patients received titrated Doptelet once daily. Thirty-nine patients (24 Doptelet and 15 placebo) entered the 90-week maintenance period of the extension phase, in which Doptelet dose titration and downward titration of concomitant ITP medications were allowed. At the end of the extension phase, a 4-week, dose-tapering period was followed by a 30-day follow-up after the last dose of Doptelet.2,4

  • The primary endpoint of the extension study was to assess the long-term safety and efficacy of treatment with Doptelet by measuring platelet response rate, bleeding, and the use of rescue therapy2
  • Exploratory endpoints included the percentage of patients who achieved platelet counts ≥50,000/μL or ≥100,000/μL at any time during the core study and its extension phase. These endpoints were reported in an integrated analysis of the Phase 3 core study and extension phase data. In an integrated analysis of the core study and its extension phase, 93.8% of patients initially randomized to Doptelet and who continued to be treated with Doptelet during the extension phase achieved a platelet count of ≥50,000/μL at any time, compared to 64.7% of placebo patients who rolled over to Doptelet4,5

*Throughout the core study and extension phase, 72.3% of patients were exposed to avatrombopag for at least 32 weeks. In the open-label extension phase for those patients continuing Doptelet treatment, a response was achieved at 44.2% of visits.2,4

†ASH guidelines define a durable response as platelet count ≥30x109/L and at least doubling of the baseline count at 6 months.2,6

‡Target platelet count window in pivotal trial was ≥50x109/L to ≤150x109/L.2

Learn About The Doptelet Clinical Trial Results

Dop•Tell•Us The Data: Doptelet Clinical Trial Results

Visit the video library to view more.

Watch Video

Dop•Tell•Us The Data
Curious Safety

Curious about Doptelet’s safety profile?

Learn more about Doptelet’s adverse reactions from clinical trials.

View Safety

  1. DOPTELET (avatrombopag) [prescribing information]. Durham, NC: AkaRx, Inc; 2021.
  2. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490. 
  3. Data on File. Summary of Local Platelet Count. 2014: Sobi, Inc.
  4. Al-Samkari H, Aggarwal K, Vredenburg M, Tian W, Allen LF. Long-term response rates in patients with chronic immune thrombocytopenia treated with avatrombopag: additional analyses from a phase 3 study and its extension phase. Blood. 2019;134(suppl 1):2356.
  5. Nagalla S, Vredenburg M, Tian W, Allen LF. Platelet response to avatrombopag in patients with chronic immune thrombocytopenia: additional analyses from a phase 3 study and its extension. Blood. 2019;134(suppl 1):1071.
  6. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866.