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With the licensing of the first tumour necrosis factor (TNF)alpha inhibitors, independent academia-initiated but industry-sponsored drug registers were set up by the national rheumatology societies in several European countries in order to monitor the long-term safety and effectiveness of this new generation of drugs. Even though different in some respects of study design and monitoring, the registers share a number of common features: they include all licensed biological agents, they observe the patients for a defined period of time or indefinitely irrespective of the drug given and they use comparator cohorts or national registers in order to put the results into perspective. The registers have been collaborating closely since inception. Three of them (the British, Swedish and German registers) have agreed on a standardised reporting system of adverse events which ensures a high and uniform quality of data submitted to the companies, who subsequently report to the drug regulatory authorities, enabling regulatory requirements on safety surveillance to be fulfilled. In the present work, major results on drug safety with regard to infections, malignancies, cardiovascular events, pregnancy outcomes and deaths are summarised. With an increasing number of new drugs and multiple exposures of individual patients the assignment of events to specific treatments will become exceedingly difficult. This and other methodological challenges and the approaches to cope with them are discussed. A growing dialogue between drug regulatory authorities, academic medicine and companies in order to make best use of the potentials of academia-driven drug registers as new tools for pharmacovigilance with currently described rheumatology registers as prototypes is anticipated.

Original publication

DOI

10.1136/ard.2008.091926

Type

Journal article

Journal

Annals of the rheumatic diseases

Publication Date

08/2009

Volume

68

Pages

1240 - 1246

Addresses

German Rheumatism Research Centre, Epidemiology Unit, Chariteplatz 1, 10117 Berlin, Germany. zink@drfz.de

Keywords

Humans, Opportunistic Infections, Neoplasms, Cardiovascular Diseases, Antirheumatic Agents, Registries, Product Surveillance, Postmarketing, Adverse Drug Reaction Reporting Systems, International Cooperation, Europe, Biological Agents