Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F15%3A43910355" target="_blank" >RIV/00216208:11120/15:43910355 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/15:#0000474

Výsledek na webu

<a href="http://dx.doi.org/10.1159/000381657" target="_blank" >http://dx.doi.org/10.1159/000381657</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1159/000381657" target="_blank" >10.1159/000381657</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity

Popis výsledku v původním jazyce

Romiplostim is recommended for the second- and third-line treatment of primary immune thrombocytopenia (ITP). We conducted a large, single-arm study (clinicaltrials.gov; NCT00508820) with broad entry criteria to evaluate the safety of romiplostim in adult ITP. Patients (n = 407) with ITP lasting 0.03-57.14 years and low platelet counts (median 14.0 x 10(9)/l) or uncontrolled bleeding received romiplostim for up to 4 years. The rates of treatment-related, serious adverse events, serious hemorrhage events, thromboembolic events and fatal events were similar to those reported in previous romiplostim trials (0.2, 0.4, 0.2 and 0.1/100 patient-weeks, respectively). Bone marrow reticulin was observed in 4 patients, but biopsies were not routinely performed sothe true incidence of this event cannot be determined. Type I collagen (nonserious, unrelated) was reported in 1 patient who likely had myelodysplastic syndrome. No new class of adverse events was reported. Platelet responses were achiev

Název v anglickém jazyce

Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity

Popis výsledku anglicky

Romiplostim is recommended for the second- and third-line treatment of primary immune thrombocytopenia (ITP). We conducted a large, single-arm study (clinicaltrials.gov; NCT00508820) with broad entry criteria to evaluate the safety of romiplostim in adult ITP. Patients (n = 407) with ITP lasting 0.03-57.14 years and low platelet counts (median 14.0 x 10(9)/l) or uncontrolled bleeding received romiplostim for up to 4 years. The rates of treatment-related, serious adverse events, serious hemorrhage events, thromboembolic events and fatal events were similar to those reported in previous romiplostim trials (0.2, 0.4, 0.2 and 0.1/100 patient-weeks, respectively). Bone marrow reticulin was observed in 4 patients, but biopsies were not routinely performed sothe true incidence of this event cannot be determined. Type I collagen (nonserious, unrelated) was reported in 1 patient who likely had myelodysplastic syndrome. No new class of adverse events was reported. Platelet responses were achiev

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Acta Haematologica

ISSN

0001-5792

e-ISSN

—

Svazek periodika

134

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

14

Strana od-do

215-228

Kód UT WoS článku

000362731500003

EID výsledku v databázi Scopus

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