PMID- 21486902
OWN - NLM
STAT- MEDLINE
DCOM- 20110815
LR  - 20151119
IS  - 1477-0970 (Electronic)
IS  - 1352-4585 (Linking)
VI  - 17
IP  - 4
DP  - 2011 Apr
TI  - The risk of malignancy is not increased in patients with multiple sclerosis 
      treated with subcutaneous interferon beta-la: analysis of data from clinical 
      trial and post-marketing surveillance settings.
PG  - 431-40
LID - 10.1177/1352458511403642 [doi]
AB  - 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.
FAU - Sandberg-Wollheim, Magnhild
AU  - Sandberg-Wollheim M
AD  - Department of Neurology, University Hospital, University of Lund, Sweden. 
      magnhild.sandberg_wollheim@med.lu.se
FAU - Kornmann, Gabrielle
AU  - Kornmann G
FAU - Bischof, Dorina
AU  - Bischof D
FAU - Moraga, Margaretha Stam
AU  - Moraga MS
FAU - Hennessy, Brian
AU  - Hennessy B
FAU - Alteri, Enrica
AU  - Alteri E
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Mult Scler
JT  - Multiple sclerosis (Houndmills, Basingstoke, England)
JID - 9509185
RN  - 0 (Adjuvants, Immunologic)
RN  - 77238-31-4 (Interferon-beta)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adjuvants, Immunologic/*adverse effects/therapeutic use
MH  - Clinical Trials as Topic
MH  - Databases, Factual
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interferon beta-1a
MH  - Interferon-beta/*adverse effects
MH  - Multiple Sclerosis/*drug therapy
MH  - Neoplasms/*etiology
MH  - Product Surveillance, Postmarketing
EDAT- 2011/04/14 06:00
MHDA- 2011/08/16 06:00
CRDT- 2011/04/14 06:00
PHST- 2011/04/14 06:00 [entrez]
PHST- 2011/04/14 06:00 [pubmed]
PHST- 2011/08/16 06:00 [medline]
AID - 17/4/431 [pii]
AID - 10.1177/1352458511403642 [doi]
PST - ppublish
SO  - Mult Scler. 2011 Apr;17(4):431-40. doi: 10.1177/1352458511403642.