Transcript British Society for Rheumatology Biologics Register

British Association of Dermatologists’
Biologic Intervention Register
(BADBIR)
Update November 2007
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
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
Study Design
 Prospective observational cohort study
 5 years active follow-up
 Compare rates of events in 2 cohorts of
psoriasis patients
Eligibility Criteria
 Age ≥ 16years
 Severe psoriasis (definition: PASI ≥10 and DLQI >10)
 Informed consent
Under care of a UK dermatologist
Recommendation from BAD and NICE
All patients treated with biologic agents be registered with BADBIR
Observational study
Biologic Cohort
vs
Conventional cohort
(anti-psoriatic therapy)
Commencing biologic
therapy in last 6 months
 infliximab
Starting or switching
conventional anti-psoriatic
therapy
etanercept
 PUVA
efalizumab
 MTX
 ciclosporin
 acitretin
 fumaric acid esters
 Biologic naïve
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
Pharmocovigilance
(1) Scientific epidemiological study
(2) Regulatory authority purposes
(on behalf of the companies)
 Reporting/monitoring SAE data at specified time
points
Follow-up Methods
6 Monthly
Dermatology
Team
questionnaire
Annually
5 YEARS
Annually
6 Monthly
Patient
questionnaire
& diary
Office for
National
Statistics (ONS)
flagging
Year 0
3 YEARS
LIFE LONG
Year 3
Year 5
Data collected at baseline
Dermatology Team
Patient
 diagnosis and disease characteristics
 Demographics
 PASI
 occupational status
 DLQI
 EuroQol
 CAGE
 HAQ (if co-existing inflammatory arthritis)
 previous & current therapies
 co-morbidities
 smoking history
Data collected at follow up
Dermatology team
Patient
 changes in therapy
 DLQI
 adverse event information
 pathology/microbiology reports
 current PASI
 EuroQol
 ?HAQ
 6 monthly diary



any hospitalisation
any new drugs
any referrals
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
Data Collection
• Dermatology Team – web based transfer
• Patient – paper based questionnaires
• Website:
www.badbir.org
Website
(under construction)
•
www.badbir.org
BADBIR database security model
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)
Location of Pilot Centres
 Seven centres
Aberdeen
Royal
Infirmary
Western
Infirmary,
Glasgow
Leigh
Infirmary,
Lancs.
Hope Hospital,
Manchester
 All have LREC approval
Royal
Victoria
Infirmary,
Newcastle
 5 have R & D approval
 25 patients have been
registered in the pilot
phase
Macclesfield
District
General
St Johns
Institute,
London
Procedure for gaining ethical approvals
Principal Investigator – Consultant Dermatologist
STEP 1: Create account with NRES
Once registered contact BADBIR to provide email address
BADBIR will electronically transfer SSI form to you
STEP 2: When SSI completed, lock and print. Submit both SSI
and CV signed by (PI) with locally adapted Patient Information
Sheet and Consent Form to LREC
STEP 3: On receipt of Ethics approval submit SSI to R&D
When both (Ethics and R & D) approvals are in
place contact BADBIR for Log in passwords
You are now ready to enter patients into the register
If you are interested in becoming
involved
Contact Dr Kathy McElhone
BADBIR Study Co-ordinator
Telephone: 0161 603 7731
Email: [email protected]
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