bad biologic interventions register (badbir ) an update november 2009
TRANSCRIPT
![Page 1: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/1.jpg)
BAD Biologic Interventions Register (BADBIR )
An updateNovember 2009
![Page 2: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/2.jpg)
Presentation Overview• Project rationale • Brief history of BADBIR
• Aim and study design
• Data collection
• Conclusions
![Page 3: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/3.jpg)
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– efalizumab (recently had marketing license withdrawn) – anti-TNF agents (serious infections e.g. tuberculosis,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)
![Page 4: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/4.jpg)
How is Potential Harm of Biologic Therapy assessed?
Phase I/II– Phase III
• Spontaneous pharmacovigilance
• Observational cohortsNational 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
![Page 5: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/5.jpg)
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
![Page 6: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/6.jpg)
Brief History of BADBIR
BADBIRPilot phaseCompleted
n = 143
Dec
200
6
Au
g 2
007
Au
g 2
008
Mar
200
7
BADBIR Pilot phase started
Ap
r 20
07MREC
Approval achieved
MREC submission
BADBIR 1st patientrecruited
Jul 2
008
BADBIRMain study
Macclesfield District General
Aberdeen Royal
Infirmary
Hope Hospital, Manchester
Leigh Infirmary,
Lancs.
St Johns Institute, London
Royal Victoria
Infirmary, Newcastle
Western Infirmary,Glasgow
![Page 7: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/7.jpg)
Aim of BADBIR
To investigate the long-term outcome of psoriasis patients treated with biologic agents, with particular reference to safety
Primary endpoints of interestmalignancy infection requiring hospitalisation serious adverse eventsdeath
![Page 8: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/8.jpg)
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
![Page 9: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/9.jpg)
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 CohortStarting / switching
BIOLOGIC therapy in last 6 months
adalimumab
etanercept
infliximab
ustekinumab
![Page 10: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/10.jpg)
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 Conventional cohort(anti-psoriatic therapy)
vs.
Starting / switching BIOLOGIC therapy in
last 6 months
adalimumab etanercept
infliximab
ustekinumab
Starting* / switching CONVENTIONAL therapy
in last 6 months
acitretin ciclosporin fumaric acid esters hydroxycarbamide methotrexate PUVA
Conventional cohort additional criteria:
•Must be biologic naive
•* If starting therapy, PASI ≥10 and a DLQI >10
![Page 11: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/11.jpg)
Dermatology Team
questionnaire
6 Monthly Annually
5 YEARS
Patient questionnaire
& diary
LIFE LONG
Year 0 Year 3 Year 5
NHS Information Centre (NHSIC)
flagging
6 Monthly
5 YEARS
Annually
Study Design – Follow-up
![Page 12: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/12.jpg)
Switching between cohorts
Biologic therapy
Anti-psoriatic therapy
0 6 12 18 24 30 36
Drug
Time (months)
Time contributed to comparison
cohort
Time contributed to biologic cohort
![Page 13: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/13.jpg)
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
Conventional
N = 4000 (per drug)
N = 4000
![Page 14: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/14.jpg)
Online Data Collection Process(secure site login)
www.badbir.org
![Page 15: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/15.jpg)
BADBIR Database Security Model
![Page 16: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/16.jpg)
Data collected at baseline
Dermatology Team
diagnosis and disease characteristics
PASI
previous & current systemic therapies (only tacrolimus or pimecrolimus topically)
co-morbidities
PatientDemographics including
occupational status smoking historyHistory of alcohol intakeHistory of prior extensive sun exposure (e.g. outdoor work)
Patient Reported Outcome MeasuresDermatology Life Quality Index (DLQI)EuroQol (EQ-5D)Cut Down Angry Guilty Early Morning (CAGE)Health Assessment Questionnaire (HAQ - if co-existing inflammatory arthritis)
![Page 17: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/17.jpg)
Data collected at follow up
Dermatology Team
changes in therapyadverse event informationcurrent disease activity
Patient6 monthly summary diary (hospitalisations, new drugs, referrals)
Patient Reported Outcome MeasuresDLQIEQ-5DCAGEHAQ (if applicable)
![Page 18: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/18.jpg)
Dermatology Centre: Patient Summary Screen
![Page 19: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/19.jpg)
Extra Work InvolvedIdentify and consent patientComplete baseline questionnaire and enter onto web-based databaseComplete follow-up forms and enter onto web-based database
BADBIR Financial Assistance – 6 monthly intervals£120 per baseline questionnaire£30 per follow-up questionnaire
Collection of data Financial assistance available
Recruiting 2 patients per month 24 patients in year 1Baseline @ £120 = £2880
12 F-up @ £30 ea = £360
Total in year 1 = £3240
Recruiting 8 patients per month 96 patients in year 1Baseline @ £120 = £11520 48 F-up @ £30 ea = £1440 Total in year 1 = £12,960
![Page 20: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/20.jpg)
3 easy steps to getting involved !
Apply for R & D approvalStep 1
Step 2 Evaluate your dermatology centre infrastructureConsider how BADBIR will be integrated into standard care
The BADBIR Study Co-ordinator will visit to provide the user name and password and training on the on-line data collection process
Step 3
Contact BADBIR – we will prepare all documentation
You are now ready to register patients
www.badbir.org.uk
Consider preparing a business case for a specialist nursing service to assist in management of patients on biologic/systemic therapy
Post R & D Approval
It is essential that all relevant staff are present for this meeting
![Page 21: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/21.jpg)
BADBIR in the UK and Eire
![Page 22: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/22.jpg)
The BADBIR Team
Contact [email protected]
If you are interested in participating in BADBIR
Dr Nicki LawesBAD Biologics Manager
![Page 23: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/23.jpg)
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
![Page 24: BAD Biologic Interventions Register (BADBIR ) An update November 2009](https://reader034.vdocuments.us/reader034/viewer/2022051316/56649ed45503460f94be4c73/html5/thumbnails/24.jpg)
• The dermatology teams for their efforts in registering patients
• BAD was provided with restricted income financial support from Abbott, Wyeth and Schering Plough to set-up BADBIR
• BAD commissioned the University of Manchester to set-up BADBIR with this financial support
Acknowledgements