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Eltrombopag safety and efficacy for primary chronic immune thrombocytopenia in clinical practice
Author(s) -
GonzálezLópez Tomás José,
AlvarezRomán María Teresa,
Pascual Cristina,
SánchezGonzález Blanca,
FernándezFuentes Fernando,
Jarque Isidro,
PérezRus Gloria,
PérezCrespo Susana,
Bernat Silvia,
HernándezRivas José Angel,
Andrade Marcio M.,
Cortés Montserrat,
GómezNuñez Marta,
Olivera Pavel,
MartínezRobles Violeta,
FernándezRodríguez Angeles,
FuertesPalacio Miguel Angel,
FernándezMiñano Carmen,
Cabo Erik,
Fisac Rosa,
Aguilar Carlos,
Bárez Abelardo,
Peñarrubia María Jesús,
GarcíaFrade Luis Javier,
GonzálezPorras José Ramón
Publication year - 2016
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12725
Subject(s) - eltrombopag , medicine , immune thrombocytopenia , interquartile range , adverse effect , concomitant , cohort , platelet , clinical endpoint , surgery , gastroenterology , clinical trial
Background Eltrombopag is effective and safe in chronic immune thrombocytopenia ( ITP ). However, clinical trials may not accurately reflect what happens in clinical practice. We evaluated the efficacy and safety of eltrombopag in primary chronic ITP in a real‐world setting. Methods A total of 164 primary patients with chronic ITP from 40 Spanish centers, who had been treated with eltrombopag, were retrospectively evaluated. Results The median age of our cohort (72% women) was 63 yr (interquartile range, IQR , 45–75 yr). The median time with ITP diagnosis was 81 months ( IQR , 30–192 months). The median number of therapies prior to eltrombopag was 3 ( IQR , 2–4). At the time of eltrombopag start, 45 patients (30%) were receiving concomitant treatment for ITP . Forty‐six patients (30%) had bleeding signs/symptoms the month before the treatment started. The median platelet count at eltrombopag initiation was 22 × 10 9 /L ( IQR , 8–39 × 10 9 /L). A total of 135 patients (88.8%) achieved a platelet response. The median time to platelet response was 12 d (95% CI , 9–13 d). Maintained platelet response rate during the 15‐month period under examination was 75.2%. Twenty‐eight patients (18.4%) experienced adverse events, mainly grades 1–2. Conclusion Eltrombopag is highly effective and well tolerated in unselected patients with primary chronic ITP .