Biological treatment in rheumatic diseases: results from a longitudinal surveillance : adverse events

Biological treatment in rheumatic diseases: results from a longitudinal surveillance : adverse events

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 v...

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Published in:Rheumatology international Vol. 26; no. 10; pp. 916 - 922
Main Authors: KONTTINEN, L, HONKANEN, V, NORDSTROM, D. C, UOTILA, T, PÖLLÄNEN, J, WAAHTERA, M, ROMU, M, PUOLAKKA, K, VASALA, M, KARJALAINEN, A, LUUKKAINEN, R
Format: Journal Article
Language:English
Published: Berlin Springer 01-08-2006
Springer Nature B.V
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Antirheumatic Agents - adverse effects
Antirheumatic Agents - immunology
Antirheumatic Agents - therapeutic use
Biological and medical sciences
Cohort Studies
Diseases of the osteoarticular system
Drug Therapy, Combination
Female
Finland - epidemiology
Humans
Longitudinal Studies
Male
Medical sciences
Medical treatment
Middle Aged
Miscellaneous. Osteoarticular involvement in other diseases
Pharmaceutical industry
Population Surveillance
Registries
Retrospective Studies
Rheumatic diseases
Rheumatic Diseases - drug therapy
Finland
Treatment
Surveillance
Adverse events
Diseases of the osteoarticular system
Rheumatology
Rheumatism
Biologicals
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Summary: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.
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ISSN:0172-8172
1437-160X
DOI:10.1007/s00296-005-0097-9