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

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

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

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: kathleen.mcelhone@manchester.ac.uk

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