PowerPointPrsentation

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Why do we need a long-term prospective
observation of AS patients treated with biologics?
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Randomised controlled trials have shown a high
efficacy of infliximab or etanercept in AS

• but
• sample sizes were rather small
• adverse events are insufficiently observed
• lack of experience with long term application
• study participants are not representative
• no information on off-label combinations

3
Prospective cohort studies allow to investigate

• (rare) adverse events
• adverse events with longer latency
• long-term effectiveness
• interactions with co-medication
• cost effectiveness

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• German long-term observation of biologics in RA
• Rheumatoide Arthritis Beobachtung
• der Biologika-Therapie
• Study coordination Angela Zink, Joachim Listing
• German Rheumatism Research Center, Berlin
• Under the umbrella of the German Society of
  Rheumatology
• and the Competence Network Rheumatology

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Study protocol
Consecutive inclusion of RA patients (ACR
criteria), age 18 to 75 years as cases
with start of a cytokine inhibitor
treatment as controls with switch from one
DMARD therapy to another follow up over 5
years fixed time intervals (3), 6 months Planned
? 1000 cases each under Enbrel,
Remicade, Humira or Kineret ? 2000
controls
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Planned study Long-term observation biologics in
AS
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Aims

• long-term effectivness of biologics
• description of clinical outcomes
• adverse outcomes
• consequences (direct and indirect costs)

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Aims

• long-term effectivness of biologics
• time under therapy, reasons for treatment
  termination
• description of clinical outcomes
• physician enthesitis, arthritis, global
  assessment
• patient BASDAI,BASFI, pain, SF-12, EQ 5D,
• adverse outcomes
• adverse events, new co-morbidity
• consequences (direct and indirect costs)
• physician visits, drugs, days in hospital,
  sick leave days, early retirement

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Which parameters should be observed?
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Data set

• age
• gender
• disease duration
• B27
• co-morbidity
• therapy (biologics, DMARD with month/yr. of
  start and end, reasons for terminations)
• therapy with NSAIDs, glucocorticoids

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Data set

• BASDAI
• pain
• ESR, CRP
• physician global
• BASFI
• periph. arthritis, enthesitis
• quality of live (SF-12, EQ 5D)
• adverse events (coding with MedDRA)
• mortality
• days in hospital, on sick leave, job situation

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Requirements on conducting the study

• study protocol
• control group
• professional monitoring system
• reminder to physicians on next visits
• check of possible dropouts
• check of missing data
• performing queries as soon as possible
• coding of adverse events according to MedDRA

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Requirements on conducting the study

• conduct of the study under the umbrella of the
  German Society of Rheumatology
• unrestricted grant from the companies
• register is the owner of the data
• regular reporting system to companies / EMEA
• regulary meetings with advisory board,
  companies, ASAS, other registers

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3rd. Meeting of Biologics Registers in RA
21./22. 01. 2004 German Rheumatism Resarch
Center Berlin