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| |  Eculizumab Does Not Increase Risk of Leukaemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders: Presented at ASCO By Paula Moyer CHICAGO, IL -- June 4, 2007 -- Treatment of paroxysmal nocturnal haemoglobinuria (PNH) with eculizumab (Soliris) does not put patients at risk of leukaemia, myeloproliferative disorders, or myelodysplastic syndromes, according to multinational research. Investigators presented their findings here on June 2nd at the 43rd American Society of Clinical Oncology Annual Meeting (ASCO). "The incidence for these disorders during eculizumab treatment was the same as that previously reported for PNH patients," according to principal investigator Jörg Schubert, MD, consultant haematologist, Saarland University Medical School, Homburg/Saar, Germany. After this review of clinical trials, he said, PNH patients will continue to be followed on the Global PNH Safety Registry. He and his coinvestigators were concerned about the risks of these complications because of the increased risk of their development in some patients PNH after eculizumab treatment. PNH is a rare genetic bone marrow failure disorder. Therefore, they conducted a long-term evaluation of eculizumab treatment in 195 PNH patients who had over 250 patient-years of exposure. Patients had been involved in 2 phase 3 clinical trials for eculizumab for the treatment of PNH. The investigators obtained patients' leukocyte clone sizes that had been documented at baseline and at 26 weeks with flow cytometry. The team then calculated patients' frequency of myelodysplastic syndrome (MDS) and leukaemia as a percentage of the patients in the treatment arms across the trials. Results showed that the PNH leukocyte clone size was a median of 96.1% at baseline and 95.5% at week 26. This lack of difference suggested that inhibition of terminal complement, the mechanism by which eculizumab works, does not destroy or result in the proliferation of PNH leukocyte clones. The investigators also found 2 new cases each of MDS and chronic myelomonocytic leukaemia, respectively. This frequency was no greater than was expected for PNH patients, the investigators reported. The CMML case occurred in a patient previously diagnosed with it, and it was attributed to high-grade myelodysplasia. Therefore, the investigators concluded that treating PNH patients with eculizumab does not increase their risk for developing myeloproliferative disorders, MDS, or acute leukaemias. Soliris is manufactured by Alexion Pharmaceuticals, which funded the study. [Presentation title: Evaluation of Risk for Development of Myeloproliferative Disorders, Myelodysplastic Syndromes, or Acute Leukemias With Long-Term Eculizumab Therapy in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients. Abstract 7087]
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