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.

Basic information

Original name

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

Authors

KUTER, D. J. (840 United States of America, guarantor), D. M. ARNOLD (124 Canada), F. RODEGHIERO (56 Belgium), A. JANSSENS (56 Belgium), D. SELLESLAG (56 Belgium), R. BIRD (36 Australia), A. NEWLAND (826 United Kingdom of Great Britain and Northern Ireland), Jiří MAYER (203 Czech Republic, belonging to the institution), K. J. WANG (840 United States of America) and R. OLIE (756 Switzerland)

Edition

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

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 10.047

RIV identification code

RIV/00216224:14110/20:00116538

Organization unit

Faculty of Medicine

DOI

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

UT WoS

000522675000001

Keywords in English

immune thrombocytopenia; romiplostim

Abstract

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 and 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, vol. 95, No 6, p. 643-651. ISSN 0361-8609. Available from: 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 and 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, vol.~95, No~6, p.~643-651. ISSN~0361-8609. Available from: https://dx.doi.org/10.1002/ajh.25776.

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