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Eltrombopag proven effective in chronic, persistent immune thrombocytopaenia

Stephen Padilla
21 Jun 2018

Treatment with oral thrombopoietin receptor agonist eltrombopag leads to similar platelet counts in patients with chronic immune thrombocytopaenia (cITP) and persistent (per)ITP, according to the results of phase III (EXTEND) and IV studies presented at the 23rd Congress of the European Hematology Association (EHA 2018) held in Stockholm, Sweden.

Of the 265 patients in EXTEND, seven (3 percent) had perITP and 258 (97 percent) had cITP at baseline. Median treatment duration was 2.3 years (range, 56 days to 3.7 years) and 2.5 years (10 days to 8.8 years), and mean daily dose was 32.0 (7–74) mg/day and 50.4 (1–75) mg/day, respectively. [EHA 2018, abstract PF671]

In the phase IV study, 37 patients (23 percent) had perITP and 124 (77 percent) had cITP at baseline. Median treatment duration was 2.0 years (31 days to 2.1 years) and 2.0 years (21 days to 2.2 years), and mean daily dose was 48.8 (11–75) mg/day and 48.8 (5–75) mg/day, respectively.

In both studies, median platelet counts in all subsets increased to ≥50x109/L within 2 weeks. In EXTEND, six of seven (86 percent) perITP and 230 of 258 (89 percent) cITP patients achieved a platelet count ≥50x109/L without rescue therapy. In the phase IV study, 31 of 37 (84 percent) perITP and 109 of 124 (88 percent) cITP patients achieved a platelet count ≥50x109/L without rescue therapy.

Platelets ≥50x109/L were maintained for ≥28 weeks by five (71 percent) perITP and 148 (57 percent) cITP patients in EXTEND while on treatment. This was achieved by 19 (51 percent) and 62 (50 percent) patients, respectively, in the phase IV study.

“[T]he rate of adverse events {AEs) and serious AEs were as expected for eltrombopag treatment in ITP. However, results should be interpreted with caution because of the relatively small number of perITP patients,” researchers said.

“Nonetheless, our study indicates that [eltrombopag] has the potential to be an effective treatment option for patients with perITP,” they added.

Eltrombopag was compared in perITP vs cITP by performing subanalyses of EXTEND, a phase III, open-label, extension study of long-term efficacy and safety of eltrombopag in adults with ITP ≥6 months who had participated in prior eltrombopag studies, and of a 2-year phase IV, open-label, bone marrow safety study involving adults with ITP ≥6 months (Blood 2017;130:2527-2536; Acta Haematol 2017;137:66-72; Blood 2017;130:3628]

Participants in both studies initiated eltrombopag at 50 mg/day, titrated to 25–75 mg/day or less often as required, based on a platelet count target range ≥50–200x109/L. ITP is classified as persistent between 3 and 12 months from diagnosis, and chronic if ongoing for >12 months.

“Further investigation of outcomes in perITP patients would be of interest, with larger patient numbers, to confirm responses and advance our understanding of this patient population,” researchers said. “Although not a focus of these analyses, moving forward it would also be of interest to explore outcomes in perITP patients with a 3–<6-month duration of ITP.”

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Most Read Articles
3 days ago
In advanced-stage, newly diagnosed classical, CD30-positive Hodgkin lymphoma (HL), front-line therapy has resulted in durable remission rates in up to 70–90% of patients, although approximately 25–30% of advanced stage HL patients are refractory or relapse following first-line treatment with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) chemotherapy.1–3 The standard of care for patients with relapsed or refractory (r/r) classical HL is salvage therapy using second-line high-dose chemotherapy (HDCT), followed by autologous haematopoietic stem cell transplant (ASCT) in eligible patients, which can induce a complete remission (CR) in about 50% of patients.4 Nevertheless, the prognosis of patients who relapse after the salvage HDCT/ASCT is exceedingly poor, with a median survival duration of approximately 1.2 years.5
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