GRAPPA Committee Reports and Outcome measures Dafna D. Gladman, MD, FRCPC Professor of Medicine, University of Toronto Director, PsA Program, University.

Slides:

Advertisements

Similar presentations

Responding to the Patient’s Voice: the importance of Patient Reported Outcomes Dr. Kirstie Haywood Senior Research Fellow RCN Research Institute, School.

Advertisements

ASSESSING RESPONSIVENESS OF HEALTH MEASUREMENTS. Link validity & reliability testing to purpose of the measure Some examples: In a diagnostic instrument,

Efficacy of Methotrexate and/or Etanercept for treatment of RA Rheumatoid Arthritis:

Psoriatic Arthritis: Creating a Model for Cost- Effectiveness Analysis GRAPPA meeting San Antonio, TX October 15, 2004 Supported by Schering Participants:

Guidelines Mission Statement “To develop guidelines, based upon the best scientific evidence, for the optimal treatment of patients with psoriatic arthritis.

Identifying Domains of Inquiry in Psoriatic Arthritis Dafna D. Gladman, Professor of Medicine, University of Toronto, Director, Psoriatic Arthritis Program.

First International Psoriatic Arthritis Working Group Meeting: 8/15-17/03 NYC Philip Mease MD.

How Much Improvement in Functional Status Is Considered Important by Patients With Active Psoriatic Arthritis: Applying the Outcome Measures in Rheumatoid.

Fibromyalgia: Creating a Claim James Witter MD, PhD Arthritis Advisory Committee June 23, 2003.

The Impact of IMMPACT Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia and Rheumatology Products Center for Drug Evaluation and Research.

GRAPPA Guidelines for PsA: Considerations

GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis Philip Mease MD.

GRAPPA Examples of Work Projects Philip Mease. Examples of GRAPPA Work Projects Classification and diagnosis of PsA (CASPAR) Evaluation of PsA composite.

A history of GRAPPA from inception through the constitution to voting for the committees Philip Helliwell On behalf of the Constitution Committee.

An assessment tool for dactylitis Philip Helliwell.

Non-Radiographic Spondyloarthritis Has Greater Work Instability than Other Spondyloarthritis Subtypes in a National Database Sherry Rohekar 1, Robert D.

Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences Outcome measures in psoriatic arthritis Preliminary identification.

PsA: Review of Available Assessment Instruments and Lessons from Trial Results Part II Christian Antoni Friedrich Alexander University Erlangen-Nürnberg.

Gerald G Krueger MD Professor, Benning Presidential Endowed Chair

OUTCOME MEASURES IN PsA: TISSUE ANALYSIS Oliver FitzGerald.

Group for Research and Assessment in Psoriasis and Psoriatic Artritis PGA/VAS Patient and Physician Perception of disease in Psoriatic Arthritis (3PPsA)

GRAPPA research committee Philip Helliwell. History Steering committee in March 2005 received an application for funds to support a research project No.

Lecture 6: Reliability and validity of scales (cont) 1. In relation to scales, define the following terms: - Content validity - Criterion validity (concurrent.

OMERACT 8 PsA Module Co-Chairs Dafna Gladman and Philip Mease Steering Committee Alice Gottlieb, Philip Helliwell, Arthur Kavanaugh, Gerry Krueger, Peter.

Psoriatic Arthritis Workshop OMERACT May 14 th, 2004 Steering Committee Dafna Gladman, Philip Mease, Gerald Krueger, Désirée van der Heijde, Christian.

INternational Spondyloarthritis Inter- observer Reliability Exercise – the INSPIRE study. Gladman DD, Inman RD, Cook R, Maksymowych W, van der Heijde D,

Assessment of enthesitis in psoriatic arthritis

OMERACT 8 PsA Module Co-Chairs Dafna Gladman and Philip Mease Steering Committee Alice Gottlieb, Oliver FitzGerald, Philip Helliwell, Arthur Kavanaugh,

Axial Spondyloarthritis (SpA): Representative Values of Sensitivity and Specificity for Several Tests with the Resulting LRs *LR+ = sensitivity/(1 – specificity);

1 Assessing Disease Activity Janice Booth Rheumatology Nurse Practitioner January 2012.

GRAPPA Meeting, Oct. 16, 2004 San Antonio, Texas Patient Global Question Alberto Cauli Rheumatology Division University of Cagliari, Italy Director Prof.

Research Techniques Made Simple: Validation of Outcome Measures in Dermatology Kate V. Viola, MD, MHS 1 Tamar Nijsten, MD, PhD 2 Karthik Krishnamurthy,

Group for Research and Assessment in Psoriasis and Psoriatic Artritis PGA/VAS Patient and Physician Perception of disease in Psoriatic Arthritis (3PPsA)

OMERACT Workshop Outcome Measures in Psoriatic Arthritis

Guideline Development Societal needs have driven guideline development to the forefront: – Aid physician education on new clinical information – Set research.

OUTCOME MEASURES IN PsA: IMMUNOHISTOLOGY Oliver FitzGerald.

Outcome Measures in PsA Philip Mease MD Seattle, WA.

Radiological scoring in Psoriatic Arthritis

Psoriatic Arthritis Workshop Part 2 OMERACT May 15 th, 2004 Steering Committee Dafna Gladman, Philip Mease, Gerald Krueger, Désirée van der Heidje, Christian.

GRAPPA Guidelines for PsA: Considerations GRAPPA Guidelines Mission Statement: “To develop guidelines, based upon the best scientific evidence, for the.

1 Agenda  Overview –Burt Adelman MD  Efficacy and Pharmacodynamics –Akshay Vaishnaw MD, PhD  Safety –Gloria Vigliani MD  Alefacept Risk Benefit Profile.

OMERACT 8 PsA Module Proposal Submitted by: Dafna Gladman and Philip Mease.

The Value of Reference Case Methods for Resource Allocation Decision Making Mark Sculpher, PhD Professor of Health Economics Centre for Health Economics.

Psoriatic Arthritis Workshop OMERACT 7 Steering Committee Dafna Gladman, Philip Mease, Gerald Krueger, Désirée van der Heijde, Christian Antoni, Philip.

Long-Term Outcomes after Acute Stroke Treatment Larry B. Goldstein, M.D. Professor of Medicine (Neurology) Center for Cerebrovascular Disease Center for.

Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis R1 신가영 / Modulator Prof. 이연아 N Engl J Med 2015; 373: Philip J.

Professor, Rheumatology Division, Ankara University Medical Faculty

Patients were considered not in MDA (MDA−) with a score of 0, 1, 2, 3 or 4 points and in MDA (MDA+) with a score of 5, 6 or 7 points.

Training on the Modular Approach on the assessment and management of psoriatic arthritis (PsA) for dermatology units This PsA Assessment initiative is.

Psoriatic Arthritis.

PASI responder rates (A, B) and total resolution in (C) nail psoriasis, (D) enthesitis and (E) dactylitis in affected patients receiving CZP from Week.

Effective Management of Psoriatic Arthritis: Tailoring Treatments

IL-17 Inhibitors in the Management of Psoriatic Disease

Figure 2 Simplified EULAR and GRAPPA

Percentage of patients achieving minimal disease activity (MDA): A

Updated 2016 PsA Core Domain Set.

Efficacy end points: the percentage of patients achieving an improvement in American College of Rheumatology (ACR) of (A) 20% (ACR20), (B) 50% (ACR50)

Improvement in PROs, TJC, SJC and PGA at month 6 in patients achieving (A) ACR50, (B) CDAI LDA and (C) HAQ-DI

Clinical and patient-reported outcomes for patients randomised to CZP 200 mg Q2W and CZP 400 mg Q4W to week 96. Clinical and patient-reported outcomes.

Correlations between observed patient-reported outcomes and disease activity scores at week 24. Correlations between observed patient-reported outcomes.

Exercise / Physical Activity as Medicine Special interest group

OR for baseline predictors of MDA at weeks 12, 24, 48, 96 and 144 by univariate analysis of observed data. OR for baseline predictors of MDA at weeks 12,

OR for selected baseline predictors of MDA at weeks 12, 24, 48, 96 and 144 by multivariate analysis of observed data. OR for selected baseline predictors.

Different treatment strategies in rheumatoid arthritis in relation to radiographic progression (A) number of swollen joints (B) and fatigue severity over.

Improvement in PROs, TJC, SJC and PGA at month 6 in patients achieving (A) ACR70, (B) CDAI REM and (C) SDAI REM. For tofacitinib 5 and 10 mg BID treatment.

Percentages of patients reporting improvements from baseline ≥minimum clinically important difference (MCID) and number needed to treat (NNT) in (A) patient-reported.

A. A. Percentages of patients with active dactylitis in ≥ 4 digits (fingers or toes) at baseline and Week 12. *p < versus baseline. Data are observed.

Effect sizes (95% CI) of clinical variables per treatment group of studies directly comparing different dosages/routes. Effect sizes (95% CI) of clinical.

Multivariable model of adjusted

Psoriatic Arthritis.

Presentation transcript:

GRAPPA Committee Reports and Outcome measures Dafna D. Gladman, MD, FRCPC Professor of Medicine, University of Toronto Director, PsA Program, University Health network

OMERACT 7 PsA Workshop Research Agenda u Identify optimal joint count. u Develop instrument for patient global to incorporate skin and joint question. u Identify optimal Skin assessment. u Develop tools to define structural damage. u Develop instruments for Axial assessment. u Develop a tool for the assessment of participation. u Develop instruments for the assessment of Enthesitis. u Develop tools for the assessment Dactylitis. u Imaging modalities to assess inflammation and damage. u Develop Composite responder indices. u Differential tissue response to therapies. u Study methods to evaluate Fatigue in PsA.

GRAPPA research committees TopicResponsible members Peripheral joint assessment Global Assessment Dactylitis and Enthesitis Quality of life, participation Spinal Assessment Treatment Guidelines for PsA Immunohistology and biomarkers Imaging Economic Impact Gladman, Mease, Antoni Cauli Helliwell Mease, Taylor, Veale Olivieri, Helliwell Kavanaugh, Ritchlin Fitzgerald, Ritchlin Van der Heijde Gladman

OMERACT Outcome MEasures in RheumAtology Clinical Trials u OMERACT was established at a conference in Maastricht, The Netherlands, in u An informal international network of clinicians and investigators in the field of rheumatology. u The OMERACT process involves achieving consensus on outcome measures and is based on the “OMERACT filter”.

OMERACT Filter u 3 concepts: –Truth: face, content, construct and criterion validity »does the measure address what it was meant to in an unbiased and relevant way. –Discrimination: reliability and sensitivity to change »does the measure discriminate between situations of interest. –Feasibility: »can a measure be applied pragmatically, given financial and interpretation constraints, in longitudinal observational studies and randomized controlled trials.

Psoriatic Arthritis u Peripheral joint assessment –68 tender/66 swollen for entry –68 tender/66 swollen for calculation of ACR20/50/70 and PsARCC »Both include joint counts, patient and physician global assessment »ACR includes ESR/CRP –Should ACR or PsARC be considered primary outcome measures? –Should we develop a new response measure? What Measurements?

New Therapies in PsA *12 weeks; + 16 weeks; X 24 weeks Mease et al. Lancet 2000;356:385-90; Antoni et al, A8R 2005; Mease et al. A&R 2004;50: ; Kaltwasser et al. A&R 2004; 50: ; Serono Website; Kavanaugh et al. ARD 2005; Xoma website; Mease et al A&R 2004; Mease et al, ARD 2005 Effect on Joint Disease

Proposed Measurements for Clinical Trials u Peripheral Joint Count –Tender –Swollen u Dactylitis –No. digits –Level of tenderness/swelling u Enthesitis (4 vs 13 sites) u Spinal assessment (Study to be done) u Skin assessment (PASI, Target) u Patient and Physician Global u HAQ, SF-36 u Fatigue Scale (FSS, FACIT)

Committee Reports u Research Committee (P. Helliwell) u QOL/Participation (P. Mease/W. Taylor) u PGA/VAS (A. Cauli) u Tissue Histology (D. Baeten) u World Congress (PsO/PsA) in Stockholm May 31-Jun 2, 2006 (P. Mease) u Reporting from Dermatology (W. Henning) u Publications Committee (P. Mease)