Adult Patients Clinical Trial
Official title:
Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.
Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet
destruction and inadequate platelet production. Its incidence is of three cases per 100,000
people a year, with a prevalence in women in young and older adults.
Splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a
long term response (around 60+70%). Nevertheless, splenectomy may be accompanied by
peri-operative complications in almost 10% of patients, which in rare cases may be fatal.
These are normally hemorrhagic complications due to low platelet count. Thus, a previous
therapy to increase platelets is advisable before any splenectomy.
In patients who are refractory to corticosteroids and immunoglobulins or when its use is not
indicated, splenectomy has a potential risk of more complications. Since the last few years,
we count with TPO-mimetic drugs, specific for c-MPL receptor, able to stimulate platelet
production, such as romiplostim and eltrombopag.
Nowadays, TPO-mimetics are allowed in Italy when patients refuse splenectomy or when
splenectomy is not contraindicated, but being ITP with a low platelet count (< 20-50.000/mmc)
a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be
considered. Nevertheless, there are no data on therapeutic risks and safety of these agents
when used for this indication. The aim of the present study is to verify, on an Italian
national scale, the frequency of use, its impact and the safety profile.
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