Romiplostim or standard of care in patients with immune thrombocytopenia.

@article{Kuter2010RomiplostimOS,
  title={Romiplostim or standard of care in patients with immune thrombocytopenia.},
  author={David J Kuter and Mathias J. Rummel and Ralph V. Boccia and Barbara Gail Macik and Ingrid Pabinger and Dominik Selleslag and Francesco Rodeghiero and Beng H. Chong and Xuena Wang and Dietmar P Berger},
  journal={The New England journal of medicine},
  year={2010},
  volume={363 20},
  pages={
          1889-99
        }
}
BACKGROUND Romiplostim, a thrombopoietin mimetic, increases platelet counts in patients with immune thrombocytopenia, with few adverse effects. METHODS In this open-label, 52-week study, we randomly assigned 234 adult patients with immune thrombocytopenia, who had not undergone splenectomy, to receive the standard of care (77 patients) or weekly subcutaneous injections of romiplostim (157 patients). Primary end points were incidences of treatment failure and splenectomy. Secondary end points… 
View on PubMed
phdres.caregate.net
345 Citations
Highly Influential Citations
16
Background Citations
99
Methods Citations
22
Results Citations
15

Figures and Tables from this paper

345 Citations

Citation Type

Citation Type

Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity
TLDR
This study confirms and extends the tolerability/efficacy findings of previous romiplostim clinical studies and was performed on a large ITP population, which is likely more representative of clinical practice.
Use of Romiplostim for Primary Immune Thrombocytopenia in Children
TLDR
Results show that romiplostim could be considered an alternative to immunosuppressive therapies, such as rituximab, or splenectomy in refractory chronic ITP.
Romiplostim: a review of its use in immune thrombocytopenia.
TLDR
Subcutaneous romiplostim was generally well tolerated in patients with ITP; in short-term trials, the majority of adverse events were of mild to moderate severity and appeared to be related to the underlying thrombocytopenia.
Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trial
TLDR
In conclusion, romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP.
Long‐term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy
TLDR
It is demonstrated that romiplostim was safe and well‐tolerated over 614 patient‐years of exposure in ITP patients, and that efficacy was maintained with stable dosing for up to 5 years of continuous treatment.
Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program.
TLDR
The results confirmed that romiplostim use in clinical practice is effective and safe for severe chronic ITP.
Evaluation of bleeding-related episodes in patients with immune thrombocytopenia (ITP) receiving romiplostim or medical standard of care
TLDR
Romiplostim treatment provided greater reductions in all BREs, as well as BREs involving Ig rescue medications, than did SOC, and Bleeding-related hospitalizations were rare in both groups.
Romiplostim and Eltrombopag in Immune Thrombocytopenia as a Second-Line Treatment
TLDR
More detailed studies are needed to determine which of these drugs should be considered the first choice, to report long term efficacy and adverse effects, and to determine if treatment guidelines can change regarding the use of TRAs as first-line treatment.
Health‐related quality of life in nonsplenectomized immune thrombocytopenia patients receiving romiplostim or medical standard of care
TLDR
Overall, treatment of ITP was associated with improvement inHRQOL, and patients receiving romiplostim had greater HRQOL improvements than those receiving SOC, but the magnitude of the difference is of uncertain clinical benefit.
Efficacy of romiplostim in treatment of thrombocytopenia in children with Wiskott–Aldrich syndrome
TLDR
It is demonstrated that romiplostim can be used to increase platelet counts and reduce the risks of life‐threatening bleeding in WAS patients awaiting haematopoietic stem cell transplantation or forgoing the procedure for various reasons.
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 28 REFERENCES
Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP.
TLDR
In conclusion, romiplostim increased platelet counts in most patients for up to 156 weeks without tachyphylaxis and had an acceptable safety profile.
Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial
Evaluation of bleeding and thrombotic events during long‐term use of romiplostim in patients with chronic immune thrombocytopenia (ITP)
TLDR
The incidence and severity of bleeding was decreased in chronic ITP patients treated with romiplostim compared with placebo, and the incidence of thrombotic events was not different between the two groups.
Long-Term Efficacy and Safety of Romiplostim for the Treatment of Patients with Chronic Immune Thrombocytopenia (ITP): 5-Year Update From An Open-Label Extension Study.
TLDR
Romiplostim was well-tolerated and adverse events did not increase with longer duration of treatment, and patients with chronic ITP-treated patients were able to maintain platelet counts within the target range, with minimal dose adjustments for up to almost 5 years.
Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial
Treatment options for chronic idiopathic (immune) thrombocytopenic purpura.
Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study.
Whether rituximab could effectively and safely avoid splenectomy for adults with chronic immune thrombocytopenic purpura (ITP) remains unresolved. A multicenter, prospective, open-label, single-arm,…
Improved quality of life for romiplostim‐treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo‐controlled trials
TLDR
It is suggested that adult patients with chronic ITP have improved HRQoL following romiplostim therapy.
Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim.
TLDR
It is suggested that romiplostim produces reversible, dose-dependent bone marrow changes in rats and produces modest increases in bone marrow reticulin in some ITP patients that decrease when therapy is discontinued.
Splenectomy for adult patients with idiopathic thrombocytopenic purpura: a systematic review to assess long-term platelet count responses, prediction of response, and surgical complications.
TLDR
Although the risk of surgery is an important consideration, splenectomy provides a high frequency of durable responses for adult patients with ITP and the ability to predict who will respond, and the frequency of surgical complications all remain uncertain.
...
1
2
3
...