A pharmacokinetic evaluation of ropeginterferon alfa-2b in the treatment of polycythemia vera

References

• Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127:2375–2390.
   PubMed Web of Science ®Google Scholar
• McLornan D, Percy M, McMullin MF. JAK2 V617F: a single mutation in the myeloproliferative group of disorders. Ulster Med J. 2006;75:112–119.
   PubMedGoogle Scholar
• Cario H, Schwarz K, Herter JM, et al. Clinical and molecular characterisation of a prospectively collected cohort of children and adolescents with polycythemia vera. Br J Haematol. 2008;142:622–626.
   PubMed Web of Science ®Google Scholar
• Passamonti F, Rumi E, Pietra D, et al. A prospective study of 338 patients with polycythemia vera: the impact of JAK2 (V617F) allele burden and leukocytosis on fibrotic or leukemic disease transformation and vascular complications. Leukemia. 2010;24:1574–1579.
   PubMed Web of Science ®Google Scholar
• Hjelmgren J, Nilsson K, Birgegård G. JAK2 V617F as a marker for long-term disease progression and mortality in polycythemia vera and its role in economic modeling. J Heal Econ Outcomes Res. 2020;7:61–70.
   PubMedGoogle Scholar
• Messinezy M, Westwood NB, Woodcock SP, et al. Low serum erythropoietin - A strong diagnostic criterion of primary polycythaemia even at normal haemoglobin levels. Clin Lab Haematol. 1995;17:217–220.
   PubMedGoogle Scholar
• Masciulli A, Barbui T, Marfisi RM, et al. How epidemiology of polycythemia vera has changed in the last 10 years: results from the whole prospective cohort of patients in Cyto-PV trial as compared with eclap prospective cohort. Blood. 2012;120:1748.
   Web of Science ®Google Scholar
• Chievitz E, Thiede T. Complications and causes of death in polycythaemia vera. Acta Med Scand. 1962;172:513–523.
   PubMed Web of Science ®Google Scholar
• Barbui T, Finazzi G, De Gaetano G, et al. Polycythemia vera: the natural history of 1213 patients followed for 20 years. Ann Intern Med. 1995;123:656–664.
   PubMed Web of Science ®Google Scholar
• Spivak JL. Myeloproliferative neoplasms. N Engl J Med. Massachussetts Medical Society. 2017;376:2168–2181.
   PubMed Web of Science ®Google Scholar
• Griesshammer M, Kiladjian JJ, Besses C. Thromboembolic events in polycythemia vera. Ann Hematol. 2019;98:1071.
   PubMed Web of Science ®Google Scholar
• Tefferi A, Rumi E, Finazzi G, et al. Survival and prognosis among 1545 patients with contemporary polycythemia vera: an international study. Leukemia. 2013;27:1874–1881.
   PubMed Web of Science ®Google Scholar
• Tefferi A, Guglielmelli P, Larson DR, et al. Long-term survival and blast transformation in molecularly annotated essential thrombocythemia, polycythemia vera, and myelofibrosis. Blood. 2014;124:2507–2513.
   PubMed Web of Science ®Google Scholar
• Mesa R, Verstovsek S, Kiladjian JJ, et al. Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy. Eur J Haematol. 2016;97:192–200.
   PubMed Web of Science ®Google Scholar
• Mascarenhas J, Kosiorek HE, Prchal JT, et al. Results of the myeloproliferative neoplasms - research consortium (MPN-RC) 112 randomized trial of pegylated interferon Alfa-2a (PEG) versus hydroxyurea (HU) therapy for the treatment of high risk polycythemia vera (PV) and high risk essential thrombocythemia (ET). Blood. 2018;132:577.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Besremi assessment report. European Medicines Agency website; 2020 [cited 2020 Jul 31]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/besremi
   Google Scholar
• Verger E, Soret-Dulphy J, Maslah N, et al. Ropeginterferon alpha-2b targets JAK2V617F-positive polycythemia vera cells in vitro and in vivo. Blood Cancer J. 2018;8:94.
   PubMed Web of Science ®Google Scholar
• Kiladjian JJ, Cassinat B, Turlure P, et al. High molecular response rate of polycythemia vera patients treated with pegylated interferon α-2a. Blood. 2006;108:2037–2040.
   PubMed Web of Science ®Google Scholar
• Quintás-Cardama A, Kantarjian H, Manshouri T, et al. Pegylated interferon alfa-2a yields high rates of hematologic and molecular response in patients with advanced essential thrombocythemia and polycythemia vera. J Clin Oncol. 2009;27:5418–5424.
   PubMed Web of Science ®Google Scholar
• Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol. 2020;7:e196–e208.
   PubMed Web of Science ®Google Scholar
• George PM, Badiger R, Alazawi W, et al. Pharmacology and therapeutic potential of interferons. Pharmacol Ther. 2012;135:44–53.
   PubMed Web of Science ®Google Scholar
• Lane SW, Mullally A. Jak2V617F myeloproliferative neoplasm stem cells and interferon-alpha. Oncotarget. 2013;4:500–501.
   PubMedGoogle Scholar
• Elliott MA, Tefferi A. Interferon-α therapy in polycythemia vera and essential thrombocythemia. Semin Thromb Hemost. 1997;23:463–472.
   PubMed Web of Science ®Google Scholar
• Osborn BL, Olsen HS, Nardelli B, et al. Pharmacokinetic and pharmacodynamic studies of a human serum albumin-interferon-α fusion protein in cynomolgus monkeys. J Pharmacol Exp Ther. 2002;303:540–548.
   PubMed Web of Science ®Google Scholar
• Gisslinger H, Zagrijtschuk O, Buxhofer-Ausch V, et al. Ropeginterferon alfa-2b, a novel IFNα-2b, induces high response rates with low toxicity in patients with polycythemia vera. Blood. 2015;126:1762–1769.
   PubMed Web of Science ®Google Scholar
• Wagner SM, Melchardt T, Greil R. Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera. Drugs Today. 2020;56:195–202.
   PubMed Web of Science ®Google Scholar