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Annals of the Rheumatic Diseases 2005;64:246-252
© 2005 by BMJ Publishing Group Ltd & European League Against Rheumatism

EXTENDED REPORT

Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept

N Feltelius 1, C M Fored 3, P Blomqvist 3, L Bertilsson 4, P Geborek 5, L T Jacobsson 6, S Lindblad 2, J Lysholm 7, S Rantapää-Dahlqvist 8, T Saxne 5, L Klareskog 2 for the ARTIS group*

1 The Swedish Medical Products Agency, Uppsala, Sweden
2 Rheumatology Unit, Karolinska University Hospital, Stockholm, Sweden
3 Clinical Epidemiology Unit, Karolinska University Hospital
4 Rheumatology Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden
5 Department of Rheumatology, Lund University Hospital, Lund, Sweden
6 Department of Rheumatology, Malmö University Hospital, Malmö, Sweden
7 Department of Rheumatology, Falun County Council Hospital, Falun, Sweden
8 Department of Rheumatology, Umeå University Hospital, Umeå, Sweden

Correspondence to:
Correspondence to:
Dr Nils Feltelius
The Swedish Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden; nils.feltelius{at}mpa.se

Objectives: To describe a nationwide system for postmarketing follow up of new antirheumatic drugs in Sweden, and to analyse safety and effectiveness in an etanercept treated patient cohort.

Methods: Etanercept became available in Sweden for prescribing on a named patient basis in 1999. All patients treated were included in a follow up of intensified adverse event reporting and recording of clinical outcome during 24 months, according to the EULAR core set.

Results: The mean (SD) disease activity score (DAS 28) value at inclusion among 820 patients recruited on a named patient basis during year 1 was 5.99 (1.19). After two years, 21% (n = 172) of these patients had discontinued the treatment. Of the remaining 648 patients, 68% (n = 442) responded to the treatment. However, in 55% of the responders, the disease activity was intermediate or high (mean DAS 28, 3.37 (1.20)). In all, 540 adverse events were reported in 421 adverse drug reaction (ADR) reports, in 294 patients. The events in 80 reports (19%) were serious. Twenty two per cent of the events were infections, of which 24% (n = 29) were serious. The incidence of serious adverse events remained constant over time.

Conclusions: At start of etanercept treatment, patients had high disease activity. Activity remained high in a large proportion of the responding patients. Although serious ADRs occurred during late phases of treatment, no unexpected safety problems arose. No specific indicators of ADR risk were found. The monitoring system that was established may be useful in future postmarketing surveillance.

Abbreviations: ADR, adverse drug reaction; CPMP, Committee for Propriety Medicinal Products; DAS, disease activity score; DMARD, disease modifying antirheumatic drug; EMEA, European Agency for the Evaluation of Medicinal Products; EULAR, European League Against Rheumatism; HAQ, health assessment questionnaire; ICH, International Conference on Harmonisation; MPA, Swedish Medical Products Agency

Keywords: rheumatoid arthritis; etanercept; cohort study; national database




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