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European Biologics Registers - Methodology, selected results, and perspectives
  1. A Zink (zink{at}drfz.de)
  1. German Rheumatism Research Centre, Germany
    1. J Askling (johan.askling{at}ki.se)
    1. Clinical Epidemiology Unit, Dep. of Medicine, Karolinska University Hospital, Stockholm, Sweden
      1. W G Dixon (will.dixon{at}manchester.ac.uk)
      1. Arthritis Research Campaign Epidemiology Unit, University of Manchester, United Kingdom
        1. L Klareskog (lars.klareskog{at}ki.se)
        1. Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden
          1. A J Silman (a.silman{at}arc.org.uk)
          1. Arthritis Research Campaign, Chesterfield, United Kingdom
            1. D PM Symmons (deborah.symmons{at}manchester.ac.uk)
            1. Arthritis Research Campaign Epidemiology Unit, University of Manchester, United Kingdom

              Abstract

              With the licensing of the first TNFα 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 biologic 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.

              We summarize major results on drug safety with regard to infections, malignancies, cardiovascular events, pregnancy outcomes and deaths.

              With an increasing number of new drugs and multiple exposures of individual patients the assignment of events to specific treatments will become exceedingly difficult. We discuss this and other methodologic challenges and the approaches to cope with them.

              We anticipate 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.

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