SAFETY AND EFFICACY OF SELF-ADMINISTERED ROMIPLOSTIM IN PATIENTS WITH IMMUNE THROMBOCYTOPENIA (ITP): RESULTS OF AN INTEGRATED ANALYSIS OF FIVE CLINICAL TRIALS
Author(s): ,
David Kuter
Affiliations:
Hematology Division,Massachusetts General Hospital,Boston,United States
,
Donald Arnold
Affiliations:
Division of Hematology & Thromboembolism, Department of Medicine, Michael G DeGroote School of Medicine,McMaster University,Hamilton,Canada
,
Francesco Rodeghiero
Affiliations:
Haematology Project Foundation, Department of Cell Therapy and Haematology,S. Bortolo Hospital,Vicenza,Italy
,
Ann Janssens
Affiliations:
Department of Hematology,University Hospitals Leuven, Campus Gasthuisberg,Leuven,Belgium
,
Dominik Selleslag
Affiliations:
Department of Hematology,AZ Sint Jan Brugge,Brugge,Belgium
,
Robert Bird
Affiliations:
Division of Cancer Services,Princess Alexandra Hospital,Brisbane,Australia
,
Adrian Newland
Affiliations:
The Pathology Clinical Academic Group,The Royal London Hospital,London,United Kingdom
,
Jiri Mayer
Affiliations:
Department of Internal Medicine, Haematology and Oncology,Masaryk University and University Hospital Brno,Brno,Czech Republic
,
Cheryl Turkington
Affiliations:
Amgen Ltd,Cambridge,United Kingdom
Nooshin Hashemi Sadraei
Affiliations:
Amgen,Thousand Oaks,United States
EHA Library. Selleslag D. Jun 14, 2019; 266495; PF696
Dominik Selleslag
Dominik Selleslag
Contributions
Abstract

Abstract: PF696

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
In chronic ITP, subcutaneous administration of romiplostim by a healthcare professional (HCP) is approved in many countries. Self-administration (SA) by patients/caregivers can offer time and cost savings to providers and is convenient for patients because the need for weekly clinic visits is eliminated. SA is available in Europe for trained patients with stable platelet count (≥50 x 109/L for ≥4 weeks [wks] without dose adjustment).

Aims
This analysis examined the safety and efficacy of romiplostim SA.

Methods
Data were pooled from 5 romiplostim clinical trials in adults (≥18 years) with ITP. In all trials, and at investigators’ discretion, patients who achieved a stable dose for ≥3 consecutive wks (≥4 wks in 3 trials; ≥3 wks in 2 trials) could self-inject romiplostim (or have it administered by a caregiver). The SA analysis group included patients who ever self-administered romiplostim in any of these 5 trials. To provide a meaningful comparator, an HCP-dosed subgroup of patients from the 5 trials were included in the analysis. Patients in this comparator subgroup were required to have received the same stable romiplostim dose for ≥5 consecutive wks (duration selected to provide a conservative comparison) with platelet response and with all doses administered by an HCP. Thus, patients in the HCP comparator group may have been eligible for SA provided they had received physician approval and adequate training. In the SA group, the analysis index date was the 1st day a patient self-injected romiplostim. In the HCP group, the index date was the date of the 5th consecutive stable dose. Safety parameters were adjusted for differences in romiplostim treatment duration in the SA and HCP groups (duration-adjusted values reported herein). Platelet response was defined as weekly platelet counts ≥50 x 109/L without any use of rescue medication within 4 wks prior to date of the platelet measurement. Statistical analyses were descriptive.

Results
At baseline, in the SA (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, median baseline platelet count was 19 vs 20 × 109/L, and 34% vs 28% had undergone splenectomy. Median romiplostim treatment duration was 89 and 52 wks for SA and HCP groups, respectively. Respective median total number of doses were 81 and 50. The median weekly romiplostim dose was 3.6µg/kg in the SA group and 3.1µg/kg in the HCP group. As shown in the table, duration-adjusted event rates were numerically lower in the SA vs HCP group for all treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious TEAEs, TEAEs leading to discontinuation and fatal TEAEs. Duration-adjusted rates of bleeding TEAEs, Grade ≥3 bleeding TEAEs and serious bleeding TEAEs were also numerically lower for the SA vs the HCP group (see Table). Following the index date, 95% of patients in the SA group and all patients (100%) in the HCP group achieved a platelet response at least once during the analysis period. The median % of wks in response in the SA vs HCP groups were 95% vs 96%, respectively. Overall, rescue medication was used in 37% vs 40% of patients in the SA vs HCP groups, respectively. Adjusting for the duration of treatment, the romiplostim dose adjustment rates/100 subject-wks were 1.24 vs 1.60 in the SA vs HCP groups, respectively.

Conclusion
Romiplostim self-administration appears well tolerated and effective in eligible patients with ITP who have stable platelet counts ≥50 × 109/L for ≥4 consecutive wks and have undergone training.

Session topic: 32. Platelets disorders

Keyword(s): Immune thrombocytopenia (ITP), Platelet count, Safety, TPO

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