1 / 21

BAD Biologic Interventions Register (BADBIR )

BAD Biologic Interventions Register (BADBIR ). An update November 2010. Presentation Overview. Project rationale Brief history of BADBIR Aim and study design Data collection Conclusions. The advent of biologic agents. Has been met with:

randolph-tripp
Download Presentation

BAD Biologic Interventions Register (BADBIR )

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. BAD Biologic Interventions Register (BADBIR ) An updateNovember 2010

  2. Presentation Overview Project rationale Brief history of BADBIR Aim and study design Data collection Conclusions

  3. The advent of biologic agents Has been met with: Considerable enthusiasm from both clinicians and patients Concerns relatively high cost potential for serious side effects efalizumab (recently had marketing license withdrawn) anti-TNF agents (serious infections e.g. tuberculosis, certain malignancies e.g. lymphomas, demyelinating disorders, congestive heart failure)

  4. How is Potential Harm of Biologic Therapy assessed? Phase I/II– Phase III Spontaneous pharmacovigilance Observational cohorts National registers • Short-term safety of biologics has been evaluated in clinical trials Some long-term safety data on anti-TNF drugs available from use in other conditions e.g. inflammatory arthritis, Crohn’s disease

  5. Rationale for BADBIR Patients with severe psoriasis are likely to be obese smoke abuse alcohol have a high risk of cardio-vascular disease be exposed to different types of drugs, e.g. phototherapy Therefore, data on the safety of biologic use in other conditions cannot be directly extrapolated to psoriasis Recommendation from BAD All patients treated with biologic agents be registered with BADBIR

  6. Brief History of BADBIR MREC Approval achieved BADBIR Main study BADBIR 1st patient recruited BADBIR Pilot phase Completed n = 143 MREC submission BADBIR Pilot phase started Jul 2008 Aug 2008 Aug 2007 Dec 2006 Mar 2007 Apr 2007

  7. Aim of BADBIR To investigate the long-term outcome of psoriasis patients treated with biologic agents, with particular reference to safety Primary endpoints of interest malignancy infection requiring hospitalisation serious adverse events death

  8. BADBIR Study DesignObservational Cohort Study Inclusion Criteria (both biologic and conventional cohorts) • Diagnosis of psoriasis • Aged 16 years or over • Willing to provide written informed consent • Under the care of a dermatologist

  9. BADBIR Study DesignObservational Cohort Study Inclusion Criteria (both cohorts) • Diagnosis of psoriasis • Aged 16 years or over • Willing to provide written informed consent • Under the care of a dermatologist Biologic Cohort Starting / switching BIOLOGIC therapy in last 6 months • adalimumab • etanercept • infliximab • ustekinumab

  10. BADBIR Study DesignObservational Cohort Study Inclusion Criteria (both cohorts) • Diagnosis of psoriasis • Aged 16 years or over • Willing to provide written informed consent • Under the care of a dermatologist Conventional cohort Biologic Cohort (anti-psoriatic therapy) Starting / switching BIOLOGIC therapy in last 6 months Starting* / switching CONVENTIONAL therapy in last 6 months vs. • acitretin • adalimumab • ciclosporin • etanercept • fumaric acid esters • infliximab • hydroxycarbamide • ustekinumab • methotrexate • PUVA • Conventional cohort additional criteria: • Must be biologic naive • * If starting therapy, PASI ≥10 and a DLQI >10

  11. 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

  12. Study Design – Follow-up 6 Monthly Annually Dermatology Team questionnaire 5 YEARS Annually 6 Monthly Patient questionnaire & diary 5 YEARS NHS Information Centre (NHSIC) flagging LIFE LONG Year 0 Year 3 Year 5

  13. Sample Size Calculation • 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: Biologic N = 4000 (per drug) Conventional N = 4000

  14. Online Data Collection Process (secure site login) www.badbir.org

  15. BADBIR Database Security Model

  16. Data collected at baseline

  17. Data collected at follow up

  18. Collection of data Financial assistance available Extra Work Involved Identify and consent patient Complete baseline questionnaire and enter onto web-based database Complete follow-up forms and enter onto web-based database BADBIR Financial Assistance – 6 monthly intervals £120 per baseline questionnaire £30 per follow-up questionnaire Recruiting 2 patients per month 24 patients in year 1 Baseline @ £120 = £2880 12 F-up @£30 ea = £360 Total in year 1= £3240 Recruiting 8 patients per month 96 patients in year 1 Baseline @ £120 = £11520 48 F-up @£30 ea = £1440 Total in year 1 = £12,960

  19. The BADBIR Team Dr Nicki Lawes BAD Biologics Manager If you are interested in participating in BADBIR Contact badbir@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 both the biologic and the conventional treatments

  21. The dermatology teams for their efforts in registering patients BAD was provided with restricted income financial support from Abbott, Janssen Cilag, Pfizer and MSD to set-up BADBIR BAD commissioned the University of Manchester to set-up BADBIR with this financial support Acknowledgements

More Related