PMID- 16402217
OWN - NLM
STAT- MEDLINE
DCOM- 20061213
LR  - 20181113
IS  - 0172-8172 (Print)
IS  - 0172-8172 (Linking)
VI  - 26
IP  - 10
DP  - 2006 Aug
TI  - Biological treatment in rheumatic diseases: results from a longitudinal 
      surveillance: adverse events.
PG  - 916-22
AB  - The objective of this study was to assess the long-term safety and tolerability 
      of biologicals in a clinical setting. Data on adverse events (AEs) have been 
      collected over a 5-year period by means of detailed reports sent in to the 
      National Register of Biological Treatment in Finland (ROB-FIN) and validated by 
      information collected by the National Agency for Medicines. Three hundred and 
      eight reports on AEs were filed, concerning a total of 248 patients; this 
      corresponds to 17% of all patients in the ROB-FIN register who started biological 
      treatments. Skin reactions and infections comprised 35 and 28% of the AEs, 
      respectively. Some cases of tuberculosis and other infections, heart failure and 
      demyelinating conditions were seen. Our work demonstrates no unexpected AEs in a 
      Finnish patient cohort consisting of rheumatoid arthritis and spondylarthropathy 
      patients, although many of them were treated with combination treatments in 
      common use in Finland. Biological treatment appears safe in the hands of the 
      Finnish rheumatologists.
FAU - Konttinen, L
AU  - Konttinen L
AD  - Department of Medicine, University of Helsinki, Helsinki, Finland.
FAU - Honkanen, V
AU  - Honkanen V
FAU - Uotila, T
AU  - Uotila T
FAU - Pollanen, J
AU  - Pollanen J
FAU - Waahtera, M
AU  - Waahtera M
FAU - Romu, M
AU  - Romu M
FAU - Puolakka, K
AU  - Puolakka K
FAU - Vasala, M
AU  - Vasala M
FAU - Karjalainen, A
AU  - Karjalainen A
FAU - Luukkainen, R
AU  - Luukkainen R
FAU - Nordstrom, D C
AU  - Nordstrom DC
CN  - ROB-FIN study group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20060110
PL  - Germany
TA  - Rheumatol Int
JT  - Rheumatology international
JID - 8206885
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antirheumatic Agents/*adverse effects/immunology/therapeutic use
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Female
MH  - Finland/epidemiology
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - *Population Surveillance
MH  - Registries
MH  - Retrospective Studies
MH  - Rheumatic Diseases/*drug therapy
EDAT- 2006/01/13 09:00
MHDA- 2006/12/14 09:00
CRDT- 2006/01/13 09:00
PHST- 2005/11/24 00:00 [received]
PHST- 2005/12/18 00:00 [accepted]
PHST- 2006/01/13 09:00 [pubmed]
PHST- 2006/12/14 09:00 [medline]
PHST- 2006/01/13 09:00 [entrez]
AID - 10.1007/s00296-005-0097-9 [doi]
PST - ppublish
SO  - Rheumatol Int. 2006 Aug;26(10):916-22. doi: 10.1007/s00296-005-0097-9. Epub 2006 
      Jan 10.