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The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-1a: analysis of data from clinical trial and post-marketing surveillance settings.

Sandberg Wollheim, Magnhild LU ; Kornmann, Gabrielle; Bischof, Dorina; Moraga, Margaretha Stam; Hennessy, Brian and Alteri, Enrica (2011) In Multiple Sclerosis 17(4). p.431-440
Abstract
Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query "malignancies" was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales... (More)
Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query "malignancies" was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population. Results: Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9-5.5) compared with placebo (6.4; 95% CI: 3.3-11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours. Conclusion: Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Multiple Sclerosis
volume
17
issue
4
pages
431 - 440
publisher
Arnold, Hodder Headline PLC
external identifiers
  • wos:000290969600008
  • pmid:21486902
  • scopus:79954622175
ISSN
1477-0970
DOI
10.1177/1352458511403642
language
English
LU publication?
yes
id
227663b3-917e-4158-8ea4-29cf9521aa0e (old id 1937221)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/21486902?dopt=Abstract
date added to LUP
2011-05-02 12:08:28
date last changed
2017-11-05 03:25:53
@article{227663b3-917e-4158-8ea4-29cf9521aa0e,
  abstract     = {Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query "malignancies" was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population. Results: Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9-5.5) compared with placebo (6.4; 95% CI: 3.3-11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours. Conclusion: Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS.},
  author       = {Sandberg Wollheim, Magnhild and Kornmann, Gabrielle and Bischof, Dorina and Moraga, Margaretha Stam and Hennessy, Brian and Alteri, Enrica},
  issn         = {1477-0970},
  language     = {eng},
  number       = {4},
  pages        = {431--440},
  publisher    = {Arnold, Hodder Headline PLC},
  series       = {Multiple Sclerosis},
  title        = {The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-1a: analysis of data from clinical trial and post-marketing surveillance settings.},
  url          = {http://dx.doi.org/10.1177/1352458511403642},
  volume       = {17},
  year         = {2011},
}