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Media type:
E-Article
Title:
Romiplostim for Primary Immune Thrombocytopenia in Routine Clinical Practice: Results from a Multicentre Observational Study in Germany
Contributor:
Reiser, Marcel;
Josten, Klaus M.;
Dietzfelbinger, Hermann;
Seesaghur, Anouchka;
Schill, Markus;
Hippenmeyer, Jane;
Welslau, Manfred
Published:
S. Karger AG, 2022
Published in:
Acta Haematologica, 145 (2022) 4, Seite 394-403
Language:
English
DOI:
10.1159/000521689
ISSN:
0001-5792;
1421-9662
Origination:
Footnote:
Description:
<b><i>Introduction:</i></b> The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/persistent/chronic) at romiplostim initiation. <b><i>Methods:</i></b> This is a post hoc analysis of a prospective, German, multicentre, observational study in adults with ITP who received ≥1 dose of romiplostim. Follow-up data were collected for ≤2 years. Outcomes included overall platelet response (≥1 platelet count ≥50 × 10<sup>9</sup>/L at 2–24 weeks after romiplostim initiation) or durable platelet response (≥75% of measurements ≥50 × 10<sup>9</sup>/L at 14–24 weeks) and adverse drug reactions (ADRs), evaluated by ITP phase. <b><i>Results:</i></b> Data from 96 patients were analysed (newly diagnosed, <i>n</i> = 18; persistent, <i>n</i> = 25; chronic, <i>n</i> = 53). During the 2- to 24-week follow-up, overall platelet response was achieved in 100% (95% confidence interval: 81.5–100), 100% (86.3–100), and 96.2% (87.0–99.5) of patients with newly diagnosed, persistent, or chronic ITP, respectively, and platelet responses were durable in 88.2% (63.6–98.5), 65.0% (40.8–84.6), and 69.4% (54.6–81.7) of patients. During the 2-year follow-up, ADRs occurred in 24.0–35.8% of patients across phases. Two patients with chronic ITP experienced bone marrow ADRs; no thrombotic ADRs occurred. <b><i>Conclusion:</i></b> Romiplostim was effective and well tolerated in patients with newly diagnosed, persistent, or chronic ITP in routine clinical practice.