Efficacy and safety of a new intravenous immunoglobulin (Panzyga((R))) in chronic immune thrombocytopenia

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F19%3A00070814" target="_blank" >RIV/65269705:_____/19:00070814 - isvavai.cz</a>

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/full/10.1111/tme.12573" target="_blank" >https://onlinelibrary.wiley.com/doi/full/10.1111/tme.12573</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/tme.12573" target="_blank" >10.1111/tme.12573</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of a new intravenous immunoglobulin (Panzyga((R))) in chronic immune thrombocytopenia

Popis výsledku v původním jazyce

Objectives To assess the efficacy and safety of intravenous immunoglobulin (IVIG) 10% (Panzyga((R))), a novel human normal IVIG 10%, in patients with chronic immune thrombocytopenia (ITP). Background First-line treatment options in ITP include IVIGs. Methods In this prospective, open-label, non-controlled, multicentre, phase III study, patients received a daily dose of IVIG 10% (1 g kg(-1) body weight) for two consecutive days. The primary end point was clinical response rate; secondary end points included alternate response definitions, time to response, response duration, platelet counts, regression of bleeding and safety. Results Forty patients were enrolled (57 center dot 5% male, mean age 36 center dot 7 years); the full analysis set comprised 36 patients. A clinical response was seen for 29 of 36 patients (80 center dot 6%). Median time to response and response duration was 2 days and 14 days, respectively. IVIG 10% was well tolerated at a maximum infusion rate of 8 mg (kg min)(-1) in all but one patient; adverse events were mainly mild to moderate in severity, and the most frequent was headache (42 center dot 5%). Conclusion IVIG 10% is well tolerated even at a high infusion speed and induces a rapid platelet count increase, thus decreasing the bleeding rate and the severity of bleeding events. Trial registry: record: NCT01349790.

Název v anglickém jazyce

Efficacy and safety of a new intravenous immunoglobulin (Panzyga((R))) in chronic immune thrombocytopenia

Popis výsledku anglicky

Objectives To assess the efficacy and safety of intravenous immunoglobulin (IVIG) 10% (Panzyga((R))), a novel human normal IVIG 10%, in patients with chronic immune thrombocytopenia (ITP). Background First-line treatment options in ITP include IVIGs. Methods In this prospective, open-label, non-controlled, multicentre, phase III study, patients received a daily dose of IVIG 10% (1 g kg(-1) body weight) for two consecutive days. The primary end point was clinical response rate; secondary end points included alternate response definitions, time to response, response duration, platelet counts, regression of bleeding and safety. Results Forty patients were enrolled (57 center dot 5% male, mean age 36 center dot 7 years); the full analysis set comprised 36 patients. A clinical response was seen for 29 of 36 patients (80 center dot 6%). Median time to response and response duration was 2 days and 14 days, respectively. IVIG 10% was well tolerated at a maximum infusion rate of 8 mg (kg min)(-1) in all but one patient; adverse events were mainly mild to moderate in severity, and the most frequent was headache (42 center dot 5%). Conclusion IVIG 10% is well tolerated even at a high infusion speed and induces a rapid platelet count increase, thus decreasing the bleeding rate and the severity of bleeding events. Trial registry: record: NCT01349790.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

Transfusion Medicine

ISSN

0958-7578

e-ISSN

—

Svazek periodika

29

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

48-54

Kód UT WoS článku

000460783700009

EID výsledku v databázi Scopus

2-s2.0-85060731082