Yazarlar : Rodeghiero F, Stasi R, Giagounidis A, Viallard JF, Godeau B, Pabinger I, Cines D, Liebman H, Wang X, Woodard P.

Yayın : Eur J Haematol

Yayın Yılı : 2013

Konu : Diğer

Literatür İçeriği :

BACKGROUND AND OBJECTIVES:

Thrombopoietin-receptor agonists (TPOra) are the only treatments for immune thrombocytopenia (ITP) for which evidence of efficacy and safety from randomized, placebo-controlled trials is available. We sought to determine the long-term tolerability of the TPOra romiplostim, with a particular focus on thrombosis, bleeding, bone marrow reticulin, neoplasms/haematological malignancies and fatal events.

METHODS:

Data from 13 romiplostim clinical trials in which 653 ITP patients received romiplostim for up to 5 years (921.5 patient-years) were pooled; subject incidence rates and exposure adjusted event rates (per 100 patient-years) were calculated.

RESULTS:

The rate of thrombotic events (6% of patients; 7.5 events/100 patient-years) did not appear to increase over time; 7 events were associated with platelet counts >400 x 10⁹ /L and 10 with romiplostim doses exceeding current recommendations. Serious and grade ≥3 bleeding each occurred in approximately 8% of patients (~11 events/100 patient-years). Adverse events of bone marrow reticulin were recorded for 12 patients (1.8%; 1.3 events/100 patient-years; confirmed by bone biopsy in 10 patients), and bone marrow collagen for 1 patient (0.2%; 0.1 events/100 patient-years; confirmed by trichrome staining). Neoplasms and haematological malignancies occurred in 2.1% and 0.8% of patients, respectively (2.2 and 0.7 events/100 patient-years). Fatal events occurred in 3.7% of patients (2.6 events/100 patient-years; 4 events treatment-related).

CONCLUSIONS:

Romiplostim is the TPOra for which the longest duration of safety data is available. Our data demonstrate that long-term romiplostim treatment is well tolerated, with no new safety signals, even in patients treated for up to 5 years.

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