Haematological Effects of Interferon-??-1a (Rebif??) Therapy in Multiple Sclerosis
- 1 January 2004
- journal article
- Published by Springer Science and Business Media LLC in Drug Safety
- Vol. 27 (10), 745-756
- https://doi.org/10.2165/00002018-200427100-00005
Abstract
Introduction: Interferon-β-Abstract-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-β-1a (Rebif®) allows a comprehensive, retrospective assessment of both common and infrequent haematological effects associated with interferon-β therapy. Methods: Haematological laboratory abnormalities were analysed from six randomised, controlled clinical trials of subcutaneous interferon-β-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-β-1a doses ranged from 22μg once weekly to 44μg three times weekly. Postmarketing surveillance data were also analysed. Results: Treatment with interferon-β-1a led to asymptomatic dose-related reductions in all cell lineages under investigation, predominantly white blood cells. The greatest differences between interferon-β-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-β-1a, 44μg 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-β-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-β-1a therapy.Keywords
This publication has 34 references indexed in Scilit:
- Hepatic Reactions During Treatment of Multiple Sclerosis with Interferon-??-1aDrug Safety, 2003
- Aplastic Anemia Associated With Interferon ??-1aClinical Journal of Sport Medicine, 2002
- Recombinant Human Interferon α-2a Therapy in Children With Chronic Immune Thrombocytopenic PurpuraJournal of Pediatric Hematology/Oncology, 2002
- α-Interferon Therapy Induces Improvement of Platelet Counts in Children With Chronic Idiopathic Thrombocytopenic PurpuraJournal of Pediatric Hematology/Oncology, 2001
- PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MSNeurology, 2001
- Interferon-ɑ-induced pure red cell aplasia following chronic myelogenous leukemiaAnti-Cancer Drugs, 2001
- Managing the Adverse Effects of Interferon-?? Therapy in Multiple SclerosisDrug Safety, 2000
- Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosisAnnals of Neurology, 1996
- Clinical Toxicity of the InterferonsDrug Safety, 1994
- In vivo and in vitro inhibitory effect of α‐interferon on megakaryocyte colony growth in essential thrombocythaemiaBritish Journal of Haematology, 1989