bad biologic interventions register (badbir ) an update november 2010
TRANSCRIPT
BAD Biologic Interventions Register (BADBIR )
An updateNovember 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:–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– efalizumab (recently had marketing license withdrawn) – anti-TNF agents (serious infections e.g. tuberculosis,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)
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
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
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
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
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
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
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
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
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
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
Online Data Collection Process(secure site login)
www.badbir.org
BADBIR Database Security Model
Data collected at baseline
Data Collected at baseline
DemographicsOccupational Status
Smoking HistoryPatient reported outcome
measures:(DLQI, EQ-5D, CAGE
HAQ if co-existing IA)
Disease Characteristics
PASI
Current/Previous therapies
Co-morbidities
DERMATOLOGY TEAM PATIENT
Clinician register patient onto BADBIR database
Consent form faxed to BADBIR
Eligible patient signs consent form
Data Collected at baseline
DemographicsOccupational Status
Smoking HistoryPatient reported outcome
measures:(DLQI, EQ-5D, CAGE
HAQ if co-existing IA)
Disease Characteristics
PASI
Current/Previous therapies
Co-morbidities
DERMATOLOGY TEAM PATIENT
Clinician register patient onto BADBIR database
Consent form faxed to BADBIR
Eligible patient signs consent form
Data collected at follow up
Data collected at each follow-up
Patient attends follow—up visit
DERMATOLOGY TEAM PATIENT
Changes to therapy
Serious adverse events
Current disease activity
Patient Reported Outcome Measures:
(DLQI, EQ-5D, CAGE,HAQ if co-existing IA)
Patient Diary (hospitalisations, referrals,
new drugs)
Data collected at each follow-up
Patient attends follow—up visit
DERMATOLOGY TEAM PATIENT
Changes to therapy
Serious adverse events
Current disease activity
Patient Reported Outcome Measures:
(DLQI, EQ-5D, CAGE,HAQ if co-existing IA)
Patient Diary (hospitalisations, referrals,
new drugs)
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
The BADBIR Team
Contact [email protected]
If you are interested in participating in BADBIR
Dr Nicki LawesBAD Biologics Manager
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
• 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