PMID- 23604594
OWN - NLM
STAT- MEDLINE
DCOM- 20140318
LR  - 20211021
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Linking)
VI  - 32
IP  - 8
DP  - 2013 Aug
TI  - Safety of biologics approved for treating rheumatoid arthritis: analysis of 
      spontaneous reports of adverse events.
PG  - 1207-14
LID - 10.1007/s10067-013-2256-9 [doi]
AB  - Despite the effectiveness of biologics approved for the treatment of rheumatoid 
      arthritis, they have been associated with serious adverse events (AEs). Biologics 
      are used under close supervision of health care professionals. In Portugal, they 
      are legally required to report AEs occurring during the treatment. This study 
      aims at investigating post-marketing safety monitoring data of biologics in 
      Portugal by comparing the frequency of spontaneously reported adverse events 
      between 2009 and 2011 with the frequency of such events in the summary of the 
      product characteristics of each biologic. Sales data for biologics were obtained 
      from IMS Health and converted into defined daily doses/1,000 inhabitants/day in 
      order to estimate a proportion of the population treated. The frequency of AEs 
      was estimated as the percentage of patients in which an AE may have occurred. The 
      use of each biologic was estimated for adalimumab at 1,439 patients/year, 
      etanercept 1,944 patients/year, and infliximab 3,211 patients/year. A total of 
      992 AEs were reported: 207 for adalimumab, 199 for etanercept, and 586 for 
      infliximab. Of the 515 different spontaneously reported AEs, 194 were included 
      for comparisons with the SPCs. Of those, 31 (16 %) were similarly frequent, and 
      163 (84.0 %) occurred less frequently compared with SPCs' data. These results 
      suggest an insufficient post-marketing safety monitoring of biologics in 
      Portugal.
FAU - Mendes, Diogo
AU  - Mendes D
AD  - HTA - Health Technology Assessment Centre, AIBILI - Association for Innovation 
      and Biomedical Research on Light, Azinhaga de Santa Comba, Celas 3000-548, 
      Coimbra, Portugal. diogomendes26@gmail.com
FAU - Alves, Carlos
AU  - Alves C
FAU - Batel Marques, Francisco
AU  - Batel Marques F
LA  - eng
PT  - Journal Article
DEP - 20130421
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adalimumab
MH  - Adult
MH  - Antibodies, Monoclonal/adverse effects
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - Antirheumatic Agents/*adverse effects
MH  - Arthritis, Rheumatoid/*therapy
MH  - Biological Products/*adverse effects
MH  - Data Collection
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/adverse effects
MH  - Infliximab
MH  - Male
MH  - Middle Aged
MH  - Portugal
MH  - Product Surveillance, Postmarketing
MH  - Receptors, Tumor Necrosis Factor
MH  - Treatment Outcome
EDAT- 2013/04/23 06:00
MHDA- 2014/03/19 06:00
CRDT- 2013/04/23 06:00
PHST- 2013/01/22 00:00 [received]
PHST- 2013/04/02 00:00 [accepted]
PHST- 2013/03/21 00:00 [revised]
PHST- 2013/04/23 06:00 [entrez]
PHST- 2013/04/23 06:00 [pubmed]
PHST- 2014/03/19 06:00 [medline]
AID - 10.1007/s10067-013-2256-9 [doi]
PST - ppublish
SO  - Clin Rheumatol. 2013 Aug;32(8):1207-14. doi: 10.1007/s10067-013-2256-9. Epub 2013 
      Apr 21.