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

6. Observational study  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 Biologic CohortConventional cohort (anti-psoriatic therapy) vs

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 : Controls: N = 4000 ( per drug) N = 4000

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 Dermatology Team questionnaire 6 MonthlyAnnually 5 YEARS Patient questionnaire & diary LIFE LONG Year 0Year 3Year 5 Office for National Statistics (ONS) flagging 6 Monthly 3 YEARS Annually

10. Data collected at baseline 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

11. Data collected at follow up 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

12. Switching between cohorts Biologic therapy Anti-psoriatic therapy 061218243036 Drug Time (months) Time contributed to comparison cohort Time contributed to biologic cohort

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 approvals Principal 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.ukkathleen.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