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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
Recommendation from BAD and NICE
All patients treated with biologic agents be registered with BADBIR
Age ≥ 16years
Severe psoriasis (definition: PASI ≥10 and DLQI >10)
Informed consent
Under care of a UK dermatologist
Observational study
Commencing biologic therapy in last 6 months
infliximab
etanercept
efalizumab
Starting or switching conventional anti-psoriatic therapy
PUVA
MTX
ciclosporin
acitretin
fumaric acid esters
Biologic naïve
Biologic Cohort Conventional cohort
(anti-psoriatic therapy)
vs
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 MethodsFollow-up Methods
Dermatology Team
questionnaire
6 Monthly Annually
5 YEARS
Patient questionnaire
& diary
LIFE LONG
Year 0 Year 3 Year 5
Office for National
Statistics (ONS) flagging
6 Monthly
3 YEARS
Annually
Data collected at baseline
Dermatology Team
diagnosis and disease characteristics
PASI
DLQI
EuroQol
CAGE
HAQ (if co-existing inflammatory arthritis)
previous & current therapies
co-morbidities
Patient
Demographics
occupational status
smoking history
Data collected at follow up
Dermatology team
changes in therapy
adverse event information pathology/microbiology reports
current PASI
Patient
DLQI
EuroQol
?HAQ
6 monthly diary
any hospitalisation
any new drugs any referrals
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
Data Collection
• Dermatology Team – web based transfer
• Patient – paper based questionnaires
• Website: www.badbir.org
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
Macclesfield District General
Aberdeen Royal
Infirmary
Hope Hospital, Manchester
Leigh Infirmary,
Lancs.
St Johns Institute, London
Royal Victoria
Infirmary, Newcastle
Western Infirmary,Glasgow
Seven centres
All have LREC approval
5 have R & D approval
25 patients have been registered in the pilot phase
Procedure for gaining ethical approvalsPrincipal Investigator – Consultant Dermatologist
STEP 3: On receipt of Ethics approval submit SSI to R&DSTEP 3: On receipt of Ethics approval submit SSI to R&D
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 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
When both (Ethics and R & D) approvals are in
place contact BADBIR for Log in passwords
BADBIR will electronically transfer SSI form to youBADBIR will electronically transfer SSI form to you
STEP 1: Create account with NRESSTEP 1: Create account with NRES
Once registered contact BADBIR to provide email addressOnce registered contact BADBIR to provide email address
You are now ready to enter patients into the registerYou are now ready to enter patients into the register
STEP 3: On receipt of Ethics approval submit SSI to R&DSTEP 3: On receipt of Ethics approval submit SSI to R&D
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 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
When both (Ethics and R & D) approvals are in
place contact BADBIR for Log in passwords
BADBIR will electronically transfer SSI form to youBADBIR will electronically transfer SSI form to you
STEP 1: Create account with NRESSTEP 1: Create account with NRES
Once registered contact BADBIR to provide email addressOnce registered contact BADBIR to provide email address
You are now ready to enter patients into the registerYou are now ready to enter patients into the register
If you are interested in becoming involved
Contact Dr Kathy McElhoneBADBIR Study Co-ordinatorTelephone: 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