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British Association of Dermatologists’ Biologic Intervention Register (BADBIR) Update November 2007

British Association of Dermatologists’ Biologic Intervention Register (BADBIR) Update November 2007. Aim of the Register. To investigate the long-term outcome of psoriasis patients treated with biologic agents, with particular reference to safety Primary endpoints of interest

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British Association of Dermatologists’ Biologic Intervention Register (BADBIR) Update November 2007

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  1. British Association of Dermatologists’ Biologic Intervention Register (BADBIR)Update November 2007

  2. Aim of the Register • To investigate the long-term outcome of psoriasis patients treated with biologic agents, with particular reference to safety • Primary endpoints of interest • anymalignancy • any infection requiring hospitalisation • serious adverse events • death

  3. Subsidiary Aims • Long-term effectiveness data • Evaluate differences in effectiveness between agents • Assess whether sequential therapy with multiple biologic agents acts synergistically to increase the risk • Assess whether sequential therapy with conventional systemic anti-psoriatic therapy and biologic agents acts synergistically to increase the risk

  4. Study Design • Prospective observational cohort study • 5 years active follow-up • Compare rates of events in 2 cohorts of psoriasis patients

  5. Eligibility Criteria • Age ≥ 16years • Severe psoriasis(definition: PASI ≥10 and DLQI >10) • Informed consent • Under care of a UK dermatologist Recommendation from BAD and NICE All patients treated with biologic agents be registered with BADBIR

  6. Observational study vs Biologic Cohort Conventional cohort (anti-psoriatic therapy) • Commencing biologic therapy in last 6 months • infliximab • etanercept • efalizumab • Starting or switching conventional anti-psoriatic therapy • PUVA • MTX • ciclosporin • acitretin • fumaric acid esters • Biologic naïve

  7. Sample Size • Power to detect a 3-4 fold increase in skin cancer • Baseline risk in psoriasis • Non melanoma skin cancer = 100/100,000pyrs • Accounting for losses to follow-up and deaths, requires: Biologics: N = 4000 (per drug) N = 4000 Controls:

  8. Pharmocovigilance (1) Scientific epidemiological study (2) Regulatory authority purposes (on behalf of the companies) • Reporting/monitoring SAE data at specified time points

  9. Follow-up Methods 6 Monthly Annually Dermatology Team questionnaire 5 YEARS Annually 6 Monthly Patient questionnaire & diary 3 YEARS Office for National Statistics (ONS) flagging LIFE LONG Year 0 Year 3 Year 5

  10. Dermatology Team diagnosis and disease characteristics PASI DLQI EuroQol CAGE HAQ (if co-existing inflammatory arthritis) previous & current therapies co-morbidities Patient Demographics occupational status smoking history Data collected at baseline

  11. Dermatology team changes in therapy adverse event information pathology/microbiology reports current PASI Patient DLQI EuroQol ?HAQ 6 monthly diary any hospitalisation any new drugs any referrals Data collected at follow up

  12. Time contributed to comparison cohort Time contributed to biologic cohort Drug 0 6 12 18 24 30 36 Time (months) Switching between cohorts Anti-psoriatic therapy Biologic therapy

  13. Data Collection • Dermatology Team – web based transfer • Patient – paper based questionnaires • Website: www.badbir.org

  14. Website(under construction) www.badbir.org

  15. BADBIR database security model

  16. Funding • To help towards time spent collecting this data • The following payment plan is planned • Fully completed baseline form: £100 • Fully completed follow–up form: £50 • (total of 8 follow-up forms over five years) 

  17. Location of Pilot Centres • Seven centres • All have LREC approval • 5 have R & D approval • 25 patients have been registered in the pilot phase

  18. Procedure for gaining ethical approvalsPrincipal Investigator – Consultant Dermatologist

  19. If you are interested in becoming involved Contact Dr Kathy McElhone BADBIR Study Co-ordinator Telephone: 0161 603 7731 Email: kathleen.mcelhone@manchester.ac.uk

  20. In conclusion: BADBIR • Will help to answer important questions about long term safety of both biologic and systemic anti-psoriatic therapy • Enable us to provide more accurate, better quality information to patients commencing on both the biologic and the conventional treatments • Importance of Nurses involvement • Identified as key to the management of patients on biologic therapy

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