Transcript December 14, 2014 - The MATURA consortium

MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting
MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting
MATURA Patient Advisory Group (MPAG)
Launch meeting
Room B02/B03, Heart Centre, Charterhouse Square
Wednesday 10th December, 11am – 2pm
Costantino Pitzalis & Anne Barton (MATURA Co-Leads)
MATURA Patient Advisory Group (MPAG)
Launch meeting
• Background:
•
Why do we need stratified medicine in RA?
• MATURA Goals
• MATURA & M-PAG
Why do we need stratified medicine in the management of
rheumatoid arthritis?
To improve patient care by rationalising
therapeutic decision making through:
• Move away from trial & error treatment practice to
molecular pathology driven algorithms
• Maximise therapeutic efficacy of current drugs
• Develop novel drugs tailored to specific non-responder
patient groups
Employment: the costs of RA
Time after diagnosis people stopped working as a result of
their RA - Not employed as a result of RA
40%
failure
Methotrexate
Other DMARDs
40%
failure
Anti-TNF
Other
Biologics
time
Quality of life
Toxicity, Disability
The Impact of Rheumatoid Arthritis
Can we afford to continue using Biologics on a
“trial an error” basis?
£10K/pt/yr x 5000 new pt/yr
Problems with Biologics
Anti-TNF in MTX non-responders
A large proportion of patients still do
not optimally respond.
Huge unmet need !!!
ACR20
Response Rate
Patients (%)
ACR50
ACR70
Unmet
Clinical
Need
INF + MTX (ATTRACT): Lipsky PE et al. N Engl J Med 2000; 343: 1594–1502
ADA + MTX (DE019): Keystone EC et al. Arthritis Rheum 2004; 50: 1400–1411
ETA + MTX: Weinblatt ME et al. N Engl J Med 1999; 340: 253–925
Equivalent data for the Newer Anti-TNFs,
Abatacept, Tocilizumab and Rituximab
Anti-TNF
Tocilizumab
Methotrexate
Other DMARDs
Abatacept
Tofactitinib
Jak/STAT
Rituximab
The Impact of Rheumatoid Arthritis
The Problem
• 1% Population - 580,000 Rheumatoid Arthritis Patients in England
• Direct Medical Costs to the NHS ~ £560 million/year
• Sick leave and work-related disability costs £4.2 billion/year
The Promise of Stratified Medicine
Treat Right
First Time
Apply Algorithm
Drug Response
Algorithm
Biomarker
DRUG A
DRUG B
DRUG C
DRUG D
MATURA Patient Advisory Group (MPAG)
Launch meeting
• Background:
•
Why do we need stratified medicine in RA?
• MATURA Goals
• MATURA & M-PAG
MATURA
MAximising Therapeutic Utility in Rheumatoid Arthritis
• Nationwide consortium of academics, consultants and industry groups
• Working together to improve patient care
• Investigating blood and tissue biomarkers
to treat Rheumatoid Arthritis right, the first time.
Two work streams (WS):
• WS1 based in Queen Marys investigating synovial tissue biomarkers
within a clinical trial (STRAP).
• WS2 based in Manchester, investigating genetic biomarkers from existing
and new large nationwide blood collections.
• 2014 - 2018
MATURA
MAximising Therapeutic Utility in Rheumatoid Arthritis
GOALS
1.
Improve patient care:
• Identify tissue/blood biomarkers that predict therapeutic response and/or
toxicity
• Implement a stratified medicines approach in Rheumatoid Arthritis
• Maximise therapeutic efficacy of current drugs
2.
To engage patients in this journey to include patient perspective and help us
maximise benefits for end users
3. To work with academic and industry partners to develop new drugs & companion
diagnostics
4.
To evaluate the financial and time impact on NHS using health economics
MATURA
Workstream 1
Statistics/Health Economics
STRAP clinical trial: to
compare synovial tissue
and blood analysis from
the STRAP clinical trial
by:
Anti-TNF
Genetics/Genomics:
Large scale blood based
screening from nationwide
studies
Rituximab
Tocilizumab
Study of genes and their activity
Study of products of the cells and their activity
Pioneer new technology to examine genes and cell products
Pathobiology /Imaging data
Characteristics from blood and tissue for stratified medicine
Methotrexate
Data Analysis and model development
Pathobiology, which is the
nature of the disease:
Workstream 2
MATURA Patient Advisory Group (MPAG)
Launch meeting
• Background:
•
Why do we need stratified medicine in RA?
• MATURA Goals
• MATURA & M-PAG
MPAG:
MATURA Patient Advisory Group
Public and patient involvement:
• The mission of MPAG is active consultation, listening to
and involving patients and members of the public about
their views on the MATURA strategy to ensure that we
take on patients perspective to make our work
meaningful
• Advising on PPI plans as they progress, e.g. qualitative
research project
• Feedback on dissemination methods, e.g. newsletters,
website, reports, lay summaries.
MATURA TIMELINE FOR MPAG
Review MATURA Website
1/2015
GRANT
START
STRAP
OPENS
3/3/2014
GRANT
END
2/3/2018
2014
2015
2016
2017
2018
Today
Recruit
Staff
Study set up
Clinical Trial Initiation &
Recruitment/Blood
Collections
Initial Data Generation
MATURA strategy review &
recruitment update
KEY
MPAG Meetings
MATURA ongoing
Feedback Interim Analysis
Progress updates
Review of
economic savings
Newsletter
MPAG Specific time points
Stratification of Biologic Therapies for RA by Pathobiology
(STRAP trial)
A randomised, open-label biopsy-driven stratification trial in DMARD inadequate responder patients
randomised to Etanercept, Tocilizumab or Rituximab
Funder
• MRC (WS1 of the MATURA Consortium)
Sponsor
• Queen Mary University of London
Recruitment
• 207 patients (DMARD ir)
Trial Design
• Open label randomised control trial
• Mandatory baseline synovial biopsy for stratification
Follow-up Duration
Investigation Medicinal
Products
• 48 weeks
• Rituximab (iv), Tocilizumab (sc) - Roche
• Etanercept (sc) - Pfizer
19
Programme of work
Blood based sampling
Genetics
Epigenetics (partial funding)
Methotrexate samples
Transcriptomics (unfunded)
Rituximab samples
Proteomics (pilot funding)
Integrated
Analysis
Anti TNF samples
Existing/new WS1 and WS2
blood sample cohorts
Anti TNF Cohort
Early Arthritis
n=500 - collected
RTX Cohort
n=1200
collection started
RNA-sequencing
Selecting
patients
Proteomic
analysis
Deep
immunological
phenotyping on
going at QMUL
Integrated
Analysis
Genetic/genomic
analysis to be
carried out in
Manchester
MTX Cohort
Early Arthritis
n=500 – collected
Summary
• MATURA: Tackling a major unmet need in RA
• MATURA: Opportunity to transform patients care
• MPAG: Opportunity to meaningfully engage
• MPAG: Opportunity to help inform strategy to make
MATURA achievable
MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting
MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting
MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting
Qualitative Research Background
MATURA aims – stratified medicine
Patient views:
• Stratified medicine
• Diagnostic techniques
• Risk/Benefit ratio
Qualitative research – asking the right questions,
ultimately to inform a patient survey on
acceptable risk/benefit ratios.
Focus group interviews
• We aim to conduct interviews with patients to
obtain their views on their;
• Willingness to accept predictive testing
• Preference to different tests
• Information desired by patients at the time of
undergoing the tests
• Development of an interview topic guide
Your valuable support
•
•
•
•
Development of an interview topic guide
We are seeking 2-3 MPAG members
Help inform the interview topic guide
This topic guide will contain questions that will
assist us on having an open discussion around
patients’ views about predictive testing
• The agreed topic guide will be used during the
interview
Working team
• You will work closely with one of our experienced
research team member: Kanta Kumar – Nurse
Specialist and a Lecturer
• She will hold approximately two meetings to talk to
you about the interview guide and sort of questions
that will be included
If you are interested…
• Please contact us on
• Kanta Kumar: [email protected]
Tel: 07904 507 726
• Debbie Maskell:
[email protected]
Tel: 0161 275 5046
MATURA Patient Advisory Group (MPAG)
Launch meeting
11.00am – 11.20am: Welcome & Introductions led by Chair, Zoe Ide
11.20 – 11.50am: MATURA introduction: Prof Cos Pitzalis and Prof Anne Barton
11.50 – 12.10am: MATURA Patient Advisory Group (MPAG): Zoe Ide
12.10 – 12.30pm: Introduction to clinical trial (STRAP): Dr Frances Humby
Ask the Clinician
12.30 – 12.50pm: Patient and Public Involvement and Engagement for MATURA:
Debbie Maskell (on behalf of Kanta Kumar)
How to engage / involvement
12.50 – 1.30pm: Any other business
Q&A
Next meeting date
Lunch provided during the meeting