INTRODUCTION: Interferon-beta-1a (Rebif) is an established treatment for relapsing-remitting multiple sclerosis (MS) and haematological changes are commonly reported in clinical trials of this agent. The combined clinical trial and postmarketing safety database for subcutaneous interferon-beta-1a (Rebif) allows a comprehensive, retrospective assessment of both common and infrequent haematological effects associated with interferon-beta therapy. METHODS: Haematological laboratory abnormalities were analysed from six randomised, controlled clinical trials of subcutaneous interferon-beta-1a in MS, five of which were placebo-controlled. Treatment data were collected from 2482 patients for up to 6 months, 1178 patients for up to 2 years and 786 patients for up to 6 years. Total interferon-beta-1a doses ranged from 22 microg once weekly to 44 microg three times weekly. Postmarketing surveillance data were also analysed. RESULTS: Treatment with interferon-beta-1a led to asymptomatic dose-related reductions in all cell lineages under investigation, predominantly white blood cells. The greatest differences between interferon-beta-1a therapy and placebo were seen for total leucocyte and neutrophil counts. At least two-thirds of patients affected by cytopenia experienced the onset of cytopenia within the first 6 months of therapy. The majority of events were mild and generally resolved within 3--4 months, while continuing therapy. Dose reductions were uncommon and only a small proportion (6 of 727; 0.8%) of patients stopped treatment over 2 years because of haematological abnormalities when receiving the highest dose of interferon-beta-1a, 44 microg three times weekly. Postmarketing safety reports were similarly related to asymptomatic cytopenias, although one case of potentially related autoimmune haemolytic anaemia was reported. CONCLUSION: Although haematological abnormalities are common and dose-related in patients with MS receiving interferon-beta-1a, the events are mainly mild and transient, with little impact on adherence to therapy. Haematological events are rarely of clinical significance and do not adversely affect the benefit-to-risk ratio that favours high-dose interferon-beta-1a therapy.
INTRODUCTION: Interferon-beta-1a (Rebif) is an established treatment for relapsing-remitting multiple sclerosis (MS) and haematological changes are commonly reported in clinical trials of this agent. The combined clinical trial and postmarketing safety database for subcutaneous interferon-beta-1a (Rebif) allows a comprehensive, retrospective assessment of both common and infrequent haematological effects associated with interferon-beta therapy. METHODS: Haematological laboratory abnormalities were analysed from six randomised, controlled clinical trials of subcutaneous interferon-beta-1a in MS, five of which were placebo-controlled. Treatment data were collected from 2482 patients for up to 6 months, 1178 patients for up to 2 years and 786 patients for up to 6 years. Total interferon-beta-1a doses ranged from 22 microg once weekly to 44 microg three times weekly. Postmarketing surveillance data were also analysed. RESULTS: Treatment with interferon-beta-1a led to asymptomatic dose-related reductions in all cell lineages under investigation, predominantly white blood cells. The greatest differences between interferon-beta-1a therapy and placebo were seen for total leucocyte and neutrophil counts. At least two-thirds of patients affected by cytopenia experienced the onset of cytopenia within the first 6 months of therapy. The majority of events were mild and generally resolved within 3--4 months, while continuing therapy. Dose reductions were uncommon and only a small proportion (6 of 727; 0.8%) of patients stopped treatment over 2 years because of haematological abnormalities when receiving the highest dose of interferon-beta-1a, 44 microg three times weekly. Postmarketing safety reports were similarly related to asymptomatic cytopenias, although one case of potentially related autoimmune haemolytic anaemia was reported. CONCLUSION: Although haematological abnormalities are common and dose-related in patients with MS receiving interferon-beta-1a, the events are mainly mild and transient, with little impact on adherence to therapy. Haematological events are rarely of clinical significance and do not adversely affect the benefit-to-risk ratio that favours high-dose interferon-beta-1a therapy.
Authors: H Donato; R Kohan; A Picón; A Rovó; M C Rapetti; G Schvartzman; M Lavergne; A de Galvagni; A Rosso; P Rendo Journal: J Pediatr Hematol Oncol Date: 2001-12 Impact factor: 1.289
Authors: M Rotondi; G Mazziotti; B Biondi; G Manganella; A D Del Buono; P Montella; M di Cristofaro; G Di Iorio; G Amato; C Carella Journal: J Endocrinol Invest Date: 2000-05 Impact factor: 4.256
Authors: L Durelli; B Ferrero; A Oggero; E Verdun; M R Bongioanni; E Gentile; G L Isoardo; A Ricci; E Rota; B Bergamasco; M Durazzo; G Saracco; M A Biava; P C Brossa; L Giorda; R Pagni; G Aimo Journal: J Neurol Sci Date: 1999-01-01 Impact factor: 3.181
Authors: L D Jacobs; D L Cookfair; R A Rudick; R M Herndon; J R Richert; A M Salazar; J S Fischer; D E Goodkin; C V Granger; J H Simon; J J Alam; D M Bartoszak; D N Bourdette; J Braiman; C M Brownscheidle; M E Coats; S L Cohan; D S Dougherty; R P Kinkel; M K Mass; F E Munschauer; R L Priore; P M Pullicino; B J Scherokman; R H Whitham Journal: Ann Neurol Date: 1996-03 Impact factor: 10.422
Authors: Smathorn Thakolwiboon; Hannah Zhao-Fleming; Jie Pan; Jordan Knecht Scott; Eri Shoji; Gyeongmo Sohn; Mirla Avila Journal: Int J MS Care Date: 2020-05-18