Journal
AMERICAN JOURNAL OF HEMATOLOGY
Volume 95, Issue 12, Pages 1542-1552Publisher
WILEY
DOI: 10.1002/ajh.25989
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Funding
- National Natural Science Foundation of China [81770114, 81900121, 81900124, 81973994]
- Natural Science Foundation of Shandong Province [2019GSF108240]
- Taishan Scholar Foundation of Shandong Province [ts201511095]
- Young Taishan Scholar Foundation of Shandong Province [tsqn201909175]
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We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), vs HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. So, HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%,P < .001) and complete response (CR, 75.0% vs 42.7%,P < .001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs 36.5%,P= .02; sustained CR: 46.0% vs 32.3%,P= .043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P= .04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as identifier: NCT01734044.
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