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Biologics in inflammatory disease
- a novel European network for pharmacovigilance
Biologics in inflammatory disease - a novel European network for - - PowerPoint PPT Presentation
Biologics in inflammatory disease - a novel European network for - - PowerPoint PPT Presentation
Biologics in inflammatory disease - a novel European network for pharmacovigilance and pharmacoepidemiology Johan Askling, MD PhD Dept of Medicine, Karolinska Institutet, Stockholm, Sweden Biologics in inflammatory diseases As a
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Drug safety in chronic disease
Time-course of the chronic disease
Disease activity Destruction, loss of function Co-morbidity
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Co-morbidity as an indirect treatment outcome
Disease activity Destruction, loss of function Co-morbidity Therapy
Safety of biologics: challenges
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Co-morbidity as a direct treatment outcome
Disease activity Destruction, loss of function Co-morbidity Therapy
Safety of biologics: challenges
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Co-morbidity as a safety endpoint
Disease activity Destruction, loss of function Co-morbidity Therapy
Safety of biologics: challenges
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Attribution of an observed risk
Risk directly related to treatment Risk due to disease (control) Baseline risk in humans risk
Safety of biologics: challenges
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European Biologics Registers
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annually >2,000 patients DMARD patients start of treatment with biologic agent routine registration University of Geneva 1996 Swiss Clinical Quality Management Database Baseline, 3,6,9,12,18,24,30, 36 etc. months >1,000 early RA cohort start of treatment with biologic agent epidemiologic cohort study Radboud University Nijmegen Medical Centre 2003 Dutch Rheumatoid Arthritis Monitoring Register DREAM Baseline, 3, 6, 12, 24, 36, etc. months > 2000 DMARDs treatment start with DMARD
- r biologic
agent routine registration of all DMARDs and biologics Diakonhjemmet Hospital, Oslo 2000 Norwegian DMARD register NOR- DMARD regular visits as long as patients is seen in department > 3,500 RA new prescriptions routine registration in 26 rheumatologic departments Hvidovre Hospital 2000 Danish Rheumatologic database DANBIO registration at inception of adverse event >8,000 patients EMECAR cohort new prescription of biologic routine registration Research Unit of Spanish Society of Rheumatology 2000 Spanish BIOBADASER register baseline, 3,6,12,18,24 months etc. 18,000 treatments national register data new prescription of biologic routine registration Karolinska Institute, Stockholm 1999 Swedish Biologics Register ARTIS baseline, 3,6,12,18,24,30, 36,48,60,72,84,96 , 108,120 months >3,500 controls: 1,800 internal control group: DMARD failures new prescription of biologic; 1,000 per drug epidemiologic cohort study Epidemiology Unit, German Rheumatism Research Centre 2001 German Biologics Register RABBIT baseline, 3,6,12,18,24,30, 36,48,60 months >14,000 controls: > 3,000 control group collected at defined sites new prescription of biologic; 4,000 per drug epidemiologic cohort study arc Epidemiology Unit Manchester 2001 British Society for Rheumatology Biologics Register (BSRBR) follow-up current size controls inclusion type coordination started name
European Biologics Registers
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European Biologics Registers
Specific features 1.Initiated by the profession 2.Disease registers, not drug-specific
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MI cancer pneumonia Patient 1 Patient 2 Patient 3 Patient 4 Patient 5
In reality, and as seen from a disease-register
= infliximab = etanercept = rituximab
Drug- or Disease-registers?
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European Biologics Registers
Specific features 1.Initiated by the profession 2.Disease registers, not drug-specific 3.From treatment start, and onwards 4.Use of comparators
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comparator cohort Anti-TNF starters
“project-based” biologics registers
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external comparator RA cohort (EMECAR) Anti-TNF starters
“project-based” biologics registers
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Baseline data Follow-up data
Swedish Rheumatology Registers
“integrated” biologics registers
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Other National Swedish Registers
National health-related registers Hospital Discharge Register Non-GP Outpatients Register Prescription Register Cancer Register Cause of Death Register Medical Birth Register TB register
“integrated” biologics registers
Demographics registers Population Register Emigrations Register
- Generation Register
- Census Surveys Data
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Biologics exposure Non-exposed subjects with the disease General population comparator
“integrated” biologics registers
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European Biologics Registers
Specific features 1.Initiated by the profession 2.Disease registers, not drug-specific 3.From treatment start, and onwards 4.Use of comparators 5.Supported by joint grants from all companies 6.Standardised reporting of data for PSURs 7.Inter-register collaboration
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Stake-holders in disease registers
Health authorities Company X Medical academia Clinicial care Patients Register Company Y Company Z Regulators
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European Biologics Registers
Specific features 1.Initiated by the profession 2.Disease registers, not drug-specific 3.Designed for ”indefinite” follow-up 4.Use of comparators 5.Supported by joint grants from all companies 6.Standardised reporting of data for PSURs 7.Inter-register collaboration
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Conclusions
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