Effectiveness and Safety of Romiplostim Among Patients with Newly Diagnosed, Persistent and Chronic Immune Thrombocytopenia in European Clinical Practice
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F21%3A43923887" target="_blank" >RIV/00216208:11120/21:43923887 - isvavai.cz</a>
Result on the web
<a href="https://doi.org/10.1007/s12325-021-01727-5" target="_blank" >https://doi.org/10.1007/s12325-021-01727-5</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s12325-021-01727-5" target="_blank" >10.1007/s12325-021-01727-5</a>
Alternative languages
Result language
angličtina
Original language name
Effectiveness and Safety of Romiplostim Among Patients with Newly Diagnosed, Persistent and Chronic Immune Thrombocytopenia in European Clinical Practice
Original language description
Introduction Romiplostim has been approved in Europe since 2009 to treat patients with chronic primary immune thrombocytopenia (ITP). Using real-world data from seven European countries, we measured the effectiveness and safety outcomes within 24 weeks following romiplostim initiation by duration of ITP: less than 3 months ("newly diagnosed"), 3-12 months ("persistent"), and more than 12 months ("chronic"). Methods Adults with ITP and >= 1 romiplostim administration between 2009 and 2012 were included. Endpoints included durable platelet response, median platelet count, rescue therapy, bleeding and adverse events. We used inverse probability of censoring weighted estimators to estimate cumulative risk of each outcome. There were 64 newly diagnosed, 50 persistent, and 226 chronic ITP patients at romiplostim initiation. Results Durable platelet response at 24 weeks ranged from 32% [confidence interval (CI): 18-46%] in newly diagnosed patients to 53% (CI 37-68%) in persistent patients. Median platelet count during follow-up ranged from 88 (CI 80-96) x 10(9)/L in chronic patients to 131 (CI 102-160) x 10(9)/L in newly diagnosed patients. Conclusion Regardless of ITP duration, over half of patients discontinued concomitant ITP medications. Few adverse events were observed. Although only approved for chronic patients, estimates of the romiplostim treatment effect were similar across patients being managed in European clinical practice, regardless of ITP duration at romiplostim initiation.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30205 - Hematology
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Advances in Therapy
ISSN
0741-238X
e-ISSN
1865-8652
Volume of the periodical
38
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
16
Pages from-to
2673-2688
UT code for WoS article
000640960400001
EID of the result in the Scopus database
2-s2.0-85104822417