Transcript www.badbir.org

BAD Biologic Interventions Register
(BADBIR )
An update
November 2009
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– efalizumab (recently had marketing license withdrawn)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?
Short-term safety of biologics has been evaluated in clinical trials
Phase I/II– Phase III
• Spontaneous pharmacovigilance
• Observational cohorts
National registers
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
MREC
Approval
achieved
MREC
submission
Aberdeen
Royal
Infirmary
Western
Infirmary,
Glasgow
Leigh
Infirmary,
Lancs.
Hope Hospital,
Manchester
BADBIR
1st patient
recruited
Royal
Victoria
Infirmary,
Newcastle
Macclesfield
District
General
St Johns
Institute,
London
BADBIR
Pilot phase
Completed
n = 143
BADBIR
Main study
Aug 2008
Jul 2008
Aug 2007
Apr 2007
Mar 2007
Dec 2006
BADBIR Pilot phase started
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
BADBIR Study Design
Observational 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 Design
Observational 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
BADBIR Study Design
Observational 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
Starting / switching
BIOLOGIC therapy in
last 6 months
Starting* / switching
CONVENTIONAL therapy
in last 6 months
 adalimumab
 etanercept
 infliximab
 ustekinumab
(anti-psoriatic therapy)
vs.
 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
Study Design – Follow-up
6 Monthly
Dermatology
Team
questionnaire
Annually
5 YEARS
Annually
6 Monthly
Patient
questionnaire
& diary
NHS Information
Centre (NHSIC)
flagging
Year 0
5 YEARS
LIFE LONG
Year 3
Year 5
Switching between cohorts
Time contributed
to comparison
cohort
Anti-psoriatic
therapy
Time contributed to
biologic cohort
Biologic
therapy
Drug
0
6
12
18
24
30
Time (months)
36
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
Online Data Collection Process
(secure site login)
www.badbir.org
BADBIR Database Security Model
Data collected at baseline
Dermatology Team
diagnosis and disease
characteristics
PASI
previous & current
systemic therapies (only
tacrolimus or pimecrolimus
topically)
co-morbidities
Patient
Demographics including
occupational status
smoking history
History of alcohol intake
History of prior extensive sun
exposure (e.g. outdoor work)
Patient Reported Outcome Measures
Dermatology Life Quality Index (DLQI)
EuroQol (EQ-5D)
Cut Down Angry Guilty Early Morning
(CAGE)
Health Assessment Questionnaire
(HAQ - if co-existing inflammatory
arthritis)
Data collected at follow up
Dermatology Team
changes in therapy
adverse event information
current disease activity
Patient
6 monthly summary diary
(hospitalisations, new drugs, referrals)
Patient Reported Outcome Measures
DLQI
EQ-5D
CAGE
HAQ (if applicable)
Dermatology Centre:
Patient Summary Screen
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
3 easy steps to getting involved !
Step 1
Apply for R & D approval
Contact BADBIR – we will prepare all documentation
Step 2
Evaluate your dermatology centre infrastructure
Consider how BADBIR will be integrated into standard care
Consider preparing a business case for a specialist nursing service to
assist in management of patients on biologic/systemic therapy
Step 3
Post R & D Approval
The BADBIR Study Co-ordinator will visit to provide the user name and
password and training on the on-line data collection process
It is essential that all relevant staff are present for this meeting
You are now ready to register patients
www.badbir.org.uk
BADBIR in the UK and Eire
The BADBIR Team
Dr Nicki Lawes
BAD Biologics Manager
If you are interested in participating in
BADBIR
Contact [email protected]
In conclusion: BADBIR
• Will help to answer important
questions about long-term safety of
both biologic and systemic antipsoriatic therapy
• Enable us to provide more accurate,
better quality information to patients
commencing both the biologic and the
conventional treatments
Acknowledgements
• 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