PMID- 25039799 OWN - NLM STAT- MEDLINE DCOM- 20151021 LR - 20161125 IS - 1600-0609 (Electronic) IS - 0902-4441 (Linking) VI - 94 IP - 2 DP - 2015 Feb TI - Impact of self-administration of romiplostim by patients with chronic immune thrombocytopenia compared with administration by a healthcare provider. PG - 169-76 LID - 10.1111/ejh.12415 [doi] AB - OBJECTIVE: This post hoc analysis evaluated romiplostim self-administration (SA group) vs. romiplostim administration by a healthcare provider in a clinical setting (HCP group) in patients with chronic immune thrombocytopenia (ITP). METHODS: Outcomes from 3 ITP trials allowing self-administration in patients achieving a stable romiplostim dose for >/=3 consecutive weeks were compared. Evaluations were conducted for 12-wk treatment intervals. Efficacy endpoints included percentage of patients and weeks with platelets within the target range of 50-200 x 10(9) /L and safety. RESULTS: Baseline characteristics suggested less severe disease in the SA groups (n = 563) than in the HCP groups (n = 241). The SA groups had greater proportions of patients achieving the target platelet range (55-58% vs. 40-52%) and greater proportions of weeks with a platelet response (75-88% vs. 47-76%) than the HCP groups. The rate of romiplostim discontinuation was twofold to fivefold lower in the SA groups than in the HCP groups. Rates of duration-adjusted adverse events (AEs), serious AEs and treatment-related AEs were also lower in the SA groups. CONCLUSIONS: In conclusion, in adults with ITP receiving romiplostim, self-administration was comparable to healthcare provider administration in terms of efficacy and safety profiles, suggesting that self-administration of romiplostim is a feasible option for certain patients with ITP. CI - (c) 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Selleslag, Dominik AU - Selleslag D AD - AZ Sint-Jan, Brugge-Oostende, Belgium. FAU - Bird, Robert AU - Bird R FAU - Altomare, Ivy AU - Altomare I FAU - Giagounidis, Aristoteles AU - Giagounidis A FAU - Janssens, Ann AU - Janssens A FAU - Pabinger, Ingrid AU - Pabinger I FAU - Pullarkat, Vinod AU - Pullarkat V FAU - Wei, Helen AU - Wei H FAU - Kreuzbauer, Georg AU - Kreuzbauer G LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20140808 PL - England TA - Eur J Haematol JT - European journal of haematology JID - 8703985 RN - 0 (Receptors, Fc) RN - 0 (Receptors, Thrombopoietin) RN - 0 (Recombinant Fusion Proteins) RN - 9014-42-0 (Thrombopoietin) RN - GN5XU2DXKV (romiplostim) SB - IM MH - Chronic Disease MH - Clinical Trials, Phase III as Topic MH - Female MH - Humans MH - Male MH - Purpura, Thrombocytopenic, Idiopathic/*drug therapy/surgery MH - Randomized Controlled Trials as Topic MH - Receptors, Fc/administration & dosage/*therapeutic use MH - Receptors, Thrombopoietin/agonists MH - Recombinant Fusion Proteins/administration & dosage/adverse effects/*therapeutic use MH - Self Administration MH - Thrombopoietin/administration & dosage/adverse effects/*therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - diagnosis OT - primary immune thrombocytopenia OT - romiplostim OT - self-administration OT - splenectomy OT - treatment EDAT- 2014/07/22 06:00 MHDA- 2015/10/22 06:00 CRDT- 2014/07/22 06:00 PHST- 2014/07/09 00:00 [accepted] PHST- 2014/07/22 06:00 [entrez] PHST- 2014/07/22 06:00 [pubmed] PHST- 2015/10/22 06:00 [medline] AID - 10.1111/ejh.12415 [doi] PST - ppublish SO - Eur J Haematol. 2015 Feb;94(2):169-76. doi: 10.1111/ejh.12415. Epub 2014 Aug 8.