Safety and efficacy of self-administered romiplostim in
patients with immune thrombocytopenia: Results of an integrated
database of five clinical trials

J 2020

Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials

KUTER, D. J., D. M. ARNOLD, F. RODEGHIERO, A. JANSSENS, D. SELLESLAG et. al.

Základní údaje

Originální název

Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials

Autoři

KUTER, D. J. (840 Spojené státy, garant), D. M. ARNOLD (124 Kanada), F. RODEGHIERO (56 Belgie), A. JANSSENS (56 Belgie), D. SELLESLAG (56 Belgie), R. BIRD (36 Austrálie), A. NEWLAND (826 Velká Británie a Severní Irsko), Jiří MAYER (203 Česká republika, domácí), K. J. WANG (840 Spojené státy) a R. OLIE (756 Švýcarsko)

Vydání

American Journal of Hematology, Hoboken, John Wiley & Sons, 2020, 0361-8609

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 10.047

Kód RIV

RIV/00216224:14110/20:00116538

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1002/ajh.25776

UT WoS

000522675000001

Klíčová slova anglicky

immune thrombocytopenia; romiplostim

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 30. 9. 2020 14:03, Mgr. Tereza Miškechová

Anotace

V originále

Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for >= 3 weeks (HCP group >= 5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts >= 50 x 10(9)/L were eligible. In the self-administration (n = 621) vs HCP (n = 133) groups, respectively, median age was 53 vs 58 years, median time since primary ITP diagnosis was 3.7 vs 2.5 years, and median baseline platelet count at ITP diagnosis was 19.0 vs 20.0 x 10(9)/L. In the self-administration and HCP-dosed groups, median romiplostim treatment duration was 89 vs 52 weeks and median total number of doses was 81 vs 50, respectively. In the self-administration and HCP groups, respectively: 95.0% and 100.0% of patients achieved >= 1 platelet response (defined as weekly platelet count >= 50 x 10(9)/L without rescue medication in previous 4 weeks); the median percentage of weeks with a response was 94.5% and 95.9%; and rescue medication was used in 36.7% and 39.8% of patients. Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.

Citovat

KUTER, D. J., D. M. ARNOLD, F. RODEGHIERO, A. JANSSENS, D. SELLESLAG, R. BIRD, A. NEWLAND, Jiří MAYER, K. J. WANG a R. OLIE. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. American Journal of Hematology. Hoboken: John Wiley & Sons, 2020, roč. 95, č. 6, s. 643-651. ISSN 0361-8609. Dostupné z: https://dx.doi.org/10.1002/ajh.25776.

@article{1681899,
   author = {Kuter, D. J. and Arnold, D. M. and Rodeghiero, F. and Janssens, A. and Selleslag, D. and Bird, R. and Newland, A. and Mayer, Jiří and Wang, K. J. and Olie, R.},
   article_location = {Hoboken},
   article_number = {6},
   doi = {http://dx.doi.org/10.1002/ajh.25776},
   keywords = {immune thrombocytopenia; romiplostim},
   language = {eng},
   issn = {0361-8609},
   journal = {American Journal of Hematology},
   title = {Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials},
   url = {https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ajh.25776},
   volume = {95},
   year = {2020}
}

TY  - JOUR
ID  - 1681899
AU  - Kuter, D. J. - Arnold, D. M. - Rodeghiero, F. - Janssens, A. - Selleslag, D. - Bird, R. - Newland, A. - Mayer, Jiří - Wang, K. J. - Olie, R.
PY  - 2020
TI  - Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials
JF  - American Journal of Hematology
VL  - 95
IS  - 6
SP  - 643-651
EP  - 643-651
PB  - John Wiley & Sons
SN  - 03618609
KW  - immune thrombocytopenia
KW  - romiplostim
UR  - https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ajh.25776
L2  - https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ajh.25776
N2  - Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for >= 3 weeks (HCP group >= 5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts >= 50 x 10(9)/L were eligible. In the self-administration (n = 621) vs HCP (n = 133) groups, respectively, median age was 53 vs 58 years, median time since primary ITP diagnosis was 3.7 vs 2.5 years, and median baseline platelet count at ITP diagnosis was 19.0 vs 20.0 x 10(9)/L. In the self-administration and HCP-dosed groups, median romiplostim treatment duration was 89 vs 52 weeks and median total number of doses was 81 vs 50, respectively. In the self-administration and HCP groups, respectively: 95.0% and 100.0% of patients achieved >= 1 platelet response (defined as weekly platelet count >= 50 x 10(9)/L without rescue medication in previous 4 weeks); the median percentage of weeks with a response was 94.5% and 95.9%; and rescue medication was used in 36.7% and 39.8% of patients. Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.
ER  -

KUTER, D. J., D. M. ARNOLD, F. RODEGHIERO, A. JANSSENS, D. SELLESLAG, R. BIRD, A. NEWLAND, Jiří MAYER, K. J. WANG a R. OLIE. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. \textit{American Journal of Hematology}. Hoboken: John Wiley \&{} Sons, 2020, roč.~95, č.~6, s.~643-651. ISSN~0361-8609. Dostupné z: https://dx.doi.org/10.1002/ajh.25776.

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