yusuf yazıcı, md nyu hospital for joint diseases, new york

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Remission In Rheumatoid Arthritis (RA): How Will The New Criteria Change Our Approach To RA Treatment?. Yusuf Yazıcı, MD NYU Hospital for Joint Diseases, New York. Disclosures. Abbott BMS Celgene Centocor Genentech Janssen Merck Pfizer Roche Takeda UCB. Background. - PowerPoint PPT Presentation

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  • Remission In Rheumatoid Arthritis (RA):How Will The New Criteria Change Our Approach To RA Treatment? Yusuf Yazc, MDNYU Hospital for Joint Diseases, New York

  • DisclosuresAbbottBMSCelgeneCentocorGenentechJanssenMerckPfizerRocheTakedaUCB

  • BackgroundEarly, aggressive treatmentMeasurement toolsTreat to targetRoutine monitoring

  • Why Do We Need to Measure?102 patients with RA on conventional treatment, judged by their rheumatologist to be in remissionBrown AK et al. Arthritis Rheum. 2008;58:2958-2967. Association between baseline findings and radiographic progression over 12 months

    % Meeting remission criteria54DAS28 remission criteriaMean score2.53% Remission, 5.11

    Baseline variableNo radiographic progression, n=73Radiographic progression, n=17Odds ratio (95% CI)PRF + (n)28112.95 (0.98, 8.86)0.054ESR, median, mm/h10131.01 (0.96. 1.06)0.667CRP, median, mg/L501.01 (0.93, 1.10)0.765Met ACR remission (n)4150.33 (0.10, 1.02)0.054Met DAS28 remission (n)4460.36 (0.12, 1.08)0.068DAS28 score, mean2.482.891.54 (0.89, 2.65)0.122Total US PD score, median111.36 (1.02, 1.81)0.038Dominant hand US PD score, median001.64 (1.03, 2.61)0.036

  • ACR Core Data SetSwollen joint countTender joint countPhysician Global Assessment

    ESR or CRP

    Physical Function (HAQ, MHAQ, MDHAQ)PainPatient Global Assessment

    Radiographs

  • Clinical Measurement ToolsSDAI=Simplified Disease Activity Index; CDAI=Clinical Disease Activity Index; GAS=Global Arthritis Score, ERAM=Easy Rheumatoid Arthritis Measure; RADAI=Rheumatoid Arthritis Disease Activity Index; RADARA=Real-Time Assessment of Disease Activity in Rheumatoid Arthritis; RAPID=Routine Assessment of Patient Index Data.

    Cush JJ. Presented at: 2005 ACR Annual Scientific Meeting. November 12-17, 2005. San Diego, CA. Abstract 1854; Sesin CA et al. Semin Arthritis Rheum. 2005;35:185-196; Makinen H et al. Clin Exp Rheumatol. 2006;24:22-28; Yazici Y. Bull NYU Hosp Jt Dis. 2007;65(suppl 1):25-28; Call S et al. Presented at : 2007 ACR Annual Scientific Meeting. Boston, MA. Abstract 425. Fransen J et al; Rheumatol. 2000;39:321-327.+ACR20DAS28SDAICDAIGASERAMRADAIRADARARAPID3Outcome Measures in RAPatient functionPatient pain Patient globalMD global# Tender joints# Swollen jointsESR or CRP++++++++++++++++++++++++++++++++++

  • New ACR/EULAR RA remission criteriaDeveloped by committee using data from clinical trialsAssessed ability of candidate measures to predict: damage (change 0 in vdH/S score) and function (change in HAQ 0; HAQ 0.5) over 2 ysBest results obtained by 2 proposed definitions: TJC and SJC and CRP and Pt Global all 1 ORSDAI 3.3 [SDAI = TJC (28) + SJC (28) + Phys global (010 cm VAS) + Pt global (010 cm VAS) + CRP (mg/dL)

    Felson DT, et al. Ann Rheum Dis 2011

  • New remission criteriaNew remission criteria for RA more stringent than DAS28, CDAI or RAPID3 remission

    Little information regarding Feasibility of use in routine clinical care If it is better than RAPID3 remission a very simple, patient friendly tool and easily implemented in everyday patient care.

  • Patient-Reported Outcomes:Placebo Response at 6 MonthsStrand V et al. Rheumatol. 2004;43:640-647.Physician-derivedPatient-derivedLaboratory% Change from BaselineImprovement

    Copyright 2010, TREG Consultants LLC

    TCZ in DMARD-IR RA (ROSE)TCZ 8 mg/kg (n=412) vs PBO (n=207), 1 EP: ACR50 Week 2462 patients, subset analysis for 1-week resultsDAS28, CRP, pain, PGA improved at 1 week; not joints or MDGA

    Yazici Y, et al. ACR 2010, Atlanta, #1808Patient, not physician, measures show improvement at 1 weekP=0.007P=0.01P=0.005 (P=0.0502)NSNSNS

    Copyright 2011, TREG Consultants LLC

    CATCH: Remission prevalence in early RA new criteria vs other criteria1. Kuriya B, et al. EULAR 2011, London, #SAT0405; 2. Bernard M, et al. Ibid, #OP0027All remission is not the same1,2ACR-EULAR criteria agrees w/ SDAI (k=0.77) & CDAI (k=0.75) Fair agreement w/ DAS28

  • BRASS: Radiological progression in remission by new ACR/EULAR criteria vs other criteriawww.TREGdocs.com

  • NYU Arthritis Registry Monitoring Database (NYU ARMD)Established in 2005All consecutive patients~800 RA patients,~6500 all dx patientsMDHAQ completed at each and every visit by all patients as part of routine care and part of the medical recordif there is a reason to visit the doctor, there is a reason to complete a questionnaireTed Pincus, MD

  • MDHAQ page 1

  • MDHAQ page 2

  • RAPID3 (Routine Assessment of Patient Index Data 3)

  • RAPID3 (Routine Assessment of Patient Index Data 3)RAPID3MDHAQ functional score(0-10)Pain VAS (0-10)Patient Global Assessment VAS (0-10)RAPID4 and RAPID5RADAI - Patient Reported Joint Count (0-10)Physician Global Assessment (0-10)

  • DAS28 and RAPID3 RA CategoriesDAS28 Categories

    5.1=High DAS

    RAPID3 Categories

    < 3.0=Near Remission3.01-6=Low Severity6.01-12.0=Moderate Severity>12.0=High Severity

  • *RAPID3 vs DAS28 in 285 RA PatientsSpearmancorrelation rho = 0.657Pincus T, et al. J Rheumatol. 2008;35:2136-2147.

  • *RAPID3 & DAS28 Categories are Correlated Significantly in 285 Patients at 3 SitesPincus T, et al. J Rheumatol. 2010

    DAS28RAPID3 Scores> 6.1 = High or moderate severity< 6.0 = Low severity or remissionTotal> 3.2 = Moderate or high activity114 (81%)26 (19%)140 (49%) < 2.6 = Low activity or remission47 (32%)98 (68%)145 (51%) Total161 (56%)124 (44%)285

  • *Time Needed to Score Various RA MeasuresYazici Y, et al. J Rheumatol. 2008;35:603.

  • MethodsNYU Arthritis Registry Monitoring Database (ARMD) Prospective, consecutive patient data since 2005 all patients seen in routine careEach patient with any diagnosis completes a 2-sided, 1-page MDHAQ at every visit as part of routine clinical care

    MDHAQ includes scales for physical functionpainpatient global estimatefatigueself-report RADAI painful joint count

    Last visits of RA patients seen between July 2005 and April 2011 were studied. Differences in self-report MDHAQ scores, RAPID3 and the new ACR remission criteria were analyzed

  • RAPID3 Disease State at Last Visit

  • NYU ARMD Registry

  • Results704 RA patients (mean age 53.9, disease duration 5.5 years, 80% female)

    16% (116) were in remission as defined by RAPID3 9% low, 27% moderate, and 48% were high disease activity

    17% (118) were in remission by the new ACR/EULAR criteria

    Percent agreement between remission by RAPID3 and new ACR criteria was 96% with a very strong agreement beyond chance (kappa = 0.86, p < 0.001).

  • ACR Core Dataset by RAPID3 Remission

    RemissionActiveTotalN113565678Age (Years)53.3 (15.1)54.8 (15.3)54.6 (15.3)Duration (Years)5.1 (6.4)5.5 (6.9)5.4 (6.8)Female (%)91 (81.3%)466 (84.6%)557 (84.0%)Function [0-10]0.8 (0.6)3.4 (2.1)3.2 (2.1)Pain [0-10]1.0 (0.5)5.7 (2.7)5.2 (2.9)Global [0-10]1.0 (0.6)5.4 (2.6)5.1 (2.7)MD Global [0-10]1.5 (1.0)2.6 (1.5)2.5 (1.5)Swollen [0-28]0.1 (0.3)2.0 (3.4)1.6 (3.1)Tender [0-28]0.6 (1.9)4.0 (4.4)3.4 (4.3)ESR (mm/hr)19.3 (17.4)28.1 (24.2)26.0 (23.0)

  • RAPID3 components

  • ACR Core Dataset by Remission

    Remission CriteriaRAPID3ACR/EULARAge (Years)52.7 (15.6)56.1 (8.1)Duration (Years)4.8 (6.2)3.9 (2.6)Function [0-10]0.3 (0.5)0.5 (0.6)Pain [0-10]0.6 (0.6)0.6 (0.6)Global [0-10]0.4 (0.6)0.3 (0.4)MD Global [0-10]1.0 (1.1)0.6 (0.6)Swollen [0-28]0.1 (0.4)0.2 (0.4)Tender [0-28]0.7 (2.0)0.2 (0.4)ESR (mm/hr)17.5 (15.6)22.0 (16.1)CRP (mg/dL)2.4 (4.5)0.3 (0.2)

  • ConclusionRAPID3 definition of remission performs similarly to the new ACR remission criteria and can likely be used in routine care with similar benefits as part of treat to target strategy

    The ease of use of RAPID3 compared to the new criteria may make it a good option for busy clinics and clinicians

    More important to use an outcome measure and target remission/low disease activity accordingly

    **Repeated studies, and now BeSt have shown that close supervision and monitoring of responses to drive treatment results in better patient outcome measures. However, very few physicians (12%) are obtaining and/or using these measures. Some of the reasons given include: they are too difficult to do outside of a clinical trial, they take too much time (although my poster shows that the method proposed by Ted Pincus takes 20 seconds---shameless plug--), or require labs and formulae that are not available or difficult to calculate. To make these calculations more user friendly, many have proposed alternatives to the ACR criteria or DAS28. Smolen has been using SDAI and now CDAI (which eliminates the CRP), Pincus is using the MD-HAQ and RAPID and now Dr. Cush has proposed another, simple measure that can be readily calculated by anyone, at the time of the office visit.

    Global Arthritis Score: A Rapid Practice Tool for Rheumatoid Arthritis (RA) AssessmentPURPOSE: Validated outcome measures have been promoted to assess outcomes in RA clinical trials. However, such tools (ACR20, DAS, DAS28, HAQ-DI, MD-HAQ, SF-36, SDAI, mSDAI, etc) are seldom used in practice or clinical decision making. Reasons for their neglect include time constraints, uncommon measurements (global scores, long surveys), lab delays and complicated calculations. A recent survey of 1130 US rheumatologists revealed that only 12.2% used the HAQ and 6% calculated the disease activity score (DAS) when assessing RA. Half of US Rheums make treatment changes based on MD preferences, yet few use objective measures. This study will demonstrate the value and validity of a novel practice tool, the Global Arthritis Score (GAS), in the assessment and management of RA patients. The GAS is the sum of 3 measures: 1)

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