| Title: |
Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia |
| Authors: |
Cines, DB; Wasser, J; Rodeghiero, F; Chong, BH; Steurer, M; Provan, D; Lyons, R; Garcia-Chavez, J; Carpenter, N; Wang, X; Eisen, M |
| Source: |
urn:ISSN:0390-6078 ; urn:ISSN:1592-8721 ; Haematologica, 102, 8, 1342-1351 |
| Publisher Information: |
Ferrata Storti Foundation (Haematologica) |
| Publication Year: |
2017 |
| Collection: |
UNSW Sydney (The University of New South Wales): UNSWorks |
| Subject Terms: |
32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; Clinical Trials and Supportive Activities; Patient Safety; Clinical Research; Hematology; 6.1 Pharmaceuticals; Cardiovascular; Female; Humans; Male; Middle Aged; Platelet Count; Purpura; Thrombocytopenic; Idiopathic; Receptors; Fc; Recombinant Fusion Proteins; Splenectomy; Thrombopoietin; Treatment Outcome; anzsrc-for: 32 Biomedical and Clinical Sciences; anzsrc-for: 3202 Clinical Sciences; anzsrc-for: 1102 Cardiorespiratory Medicine and Haematology; anzsrc-for: 3201 Cardiovascular medicine and haematology |
| Description: |
Primary immune thrombocytopenia is an autoimmune disorder characterized by increased platelet destruction and insufficient platelet production without another identified underlying disorder. Splenectomy may alter responsiveness to treatment and/or increase the risk of thrombosis, infection, and pulmonary hypertension. The analysis herein evaluated the safety and efficacy of the thrombopoietin receptor agonist romiplostim in splenectomized and nonsplenectomized adults with primary immune thrombocytopenia. Data were pooled across 13 completed clinical studies in adults with immune thrombocytopenia from 2002-2014. Adverse event rates were adjusted for time of exposure. Results were considered different when 95% confidence intervals were non-overlapping. Safety was analyzed for 1111 patients (395 splenectomized; 716 nonsplenectomized) who received romiplostim or control (placebo or standard of care). At baseline, splenectomized patients had a longer median duration of immune thrombocytopenia and a lower median platelet count, as well as a higher proportion with >3 prior immune thrombocytopenia treatments versus nonsplenectomized patients. In each treatment group, splenectomized patients used rescue medications more often than nonsplenectomized patients. Platelet response rates (≥50×10 9 /L) for romiplostim were 82% (310/376) for splenectomized and 91% (592/648) for nonsplenectomized patients (P |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| Relation: |
https://hdl.handle.net/1959.4/unsworks_53123; https://doi.org/10.3324/haematol.2016.161968 |
| DOI: |
10.3324/haematol.2016.161968 |
| Availability: |
https://hdl.handle.net/1959.4/unsworks_53123; https://doi.org/10.3324/haematol.2016.161968 |
| Rights: |
open access ; https://purl.org/coar/access_right/c_abf2 ; CC BY-NC ; https://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.B620168D |
| Database: |
BASE |