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Yusuf Yazıcı, MD NYU Hospital for Joint Diseases, New York

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.

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Yusuf Yazıcı, MD NYU Hospital for Joint Diseases, New York

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  1. 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

  2. Disclosures • Abbott • BMS • Celgene • Centocor • Genentech • Janssen • Merck • Pfizer • Roche • Takeda • UCB

  3. Background • Early, aggressive treatment • Measurement tools • Treat to target • Routine monitoring

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

  5. ACR Core Data Set • Swollen joint count • Tender joint count • Physician Global Assessment • ESR or CRP • Physical Function (HAQ, MHAQ, MDHAQ) • Pain • Patient Global Assessment • Radiographs

  6. Clinical Measurement Tools Outcome Measures in RA ACR20 DAS28 SDAI CDAI GAS ERAM RADAI RADARA RAPID3 Patient function + + + + Patient pain + + + + Patient global + + + + + + + MD global + + + + # Tender joints + + + + + + + # Swollen joints + + + + + + ESR or CRP + + + SDAI=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.

  7. New ACR/EULAR RA remission criteria • Developed by committee using data from clinical trials • Assessed ability of candidate measures to predict: damage (change 0 in vdH/S score) and function (change in HAQ 0; HAQ 0.5) over 2 ys • Best results obtained by 2 proposed definitions: • TJC and SJC and CRP and Pt Global all 1 OR • SDAI 3.3 • [SDAI = TJC (28) + SJC (28) + Phys global (0–10 cm VAS) + Pt global (0–10 cm VAS) + CRP (mg/dL) Felson DT, et al. Ann Rheum Dis 2011

  8. New remission criteria • New 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.

  9. Pain (VAS) HAQ (mean) HAQ DI ESR CRP Phys Global Pt Global SJC TJC Patient-Reported Outcomes:Placebo Response at 6 Months % Change from Baseline Improvement Physician-derived Patient-derived Laboratory Strand V et al. Rheumatol. 2004;43:640-647.

  10. PBO + DMARDs TCZ 8 mg/kg + DMARDs TCZ in DMARD-IR RA (ROSE) • TCZ 8 mg/kg (n=412) vs PBO (n=207), 1° EP: ACR50 Week 24 • 62 patients, subset analysis for 1-week results • DAS28, CRP, pain, PGA improved at 1 week; not joints or MDGA P=0.007 P=0.001 MDGA MDHAQ-PF TJC SJC (P=0.0502) Pt Pain PGA DAS28 P=0.005 Pt Pain VAS MD Global VAS NS NS NS P=0.007 P=0.01 P=0.005 Patient, not physician, measures show improvement at 1 week Yazici Y, et al. ACR 2010, Atlanta, #1808

  11. CATCH: Remission prevalence in early RA new criteria vs other criteria • ACR-EULAR criteria agrees w/ SDAI (k=0.77) & CDAI (k=0.75) • Fair agreement w/ DAS28<2.6 (k=0.40) & DAS28<2.0 (k=0.40) All remission is not the same1,2 1. Kuriya B, et al. EULAR 2011, London, #SAT0405; 2. Bernard M, et al. Ibid, #OP0027

  12. Utility of 2011 ACR/EULAR 2011 remission criteria • US VA and community practice cohort study1 • 1341 VA patients / 9700 visits (91% men) • 1168 community practice patients / 6362 visits (28% men) • Remission: • Cross sectional: 8.9% / 8.3% • Cumulative: 24.4% / 19.0% over 2.2 y • 1.9–4.6% patients met remission at ≥ 2 visits • Among all patients, <3% had remission lasting 2 y • DREAM: ↑ PtG most common reason for failure to meet remission2 • Non-inclusion of feet may overestimate remission3 • Patients in ACR/EULAR remission have function capacity = to normal4 Remission is uncommon in the clinic, especially long term 1. Michaud K, et al. EULAR 2011, London, #FRI0333; 2. Vermeer M, et al. Ibid, #OP0311;3. Bakker MF, et al. Ibid, #SAT0376; 4. Listing J, et al. Ibid, #THU0351

  13. HAQ improvement and time in remission in RA patients using various criteria • BRASS Registry: pts with >2 y F/U; more time in remission  better HAQ  with respect to F/U visits 0 1 2 3 4 0  mdHAQ according to dd by DAS28-CRP <2.6 rem DAS28 <2.6 0.2 –0.05 DAS28 <2.3 SDAI 0 CDAI 0 1 2 3 4 –0.1 ACR/EULAR mdHAQ mdHAQ –0.2 dd –0.15 –0.4 4 –0.2 4–11 –0.6 11–22 No. of yearly visits in remission >22 No. of yearly visits in remission –0.25 Duration of time in remission regardless of measure correlates with HAQ improvement; patients with early RA do better Prince FHM, et al. ACR 2011, Chicago, #333

  14. Impact of different remission criteria on functional ability • 5788 RA pts from NOR-DMARD registry: starting DMARDs (n=3875) or biologics (n=1913) Different numbers of patients achieve remission, but no difference in predicting physical function Uhlig T, et al. ACR 2011, Chicago, #1229

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

  16. NYU Arthritis Registry Monitoring Database (NYU ARMD) • Established in 2005 • All consecutive patients • ~800 RA patients, • ~6500 all dx patients • MDHAQ completed at each and every visit by all patients as part of routine care and part of the medical record • “if there is a reason to visit the doctor, there is a reason to complete a questionnaire” Ted Pincus, MD

  17. MDHAQ page 1

  18. MDHAQ page 2

  19. RAPID3 (Routine Assessment of Patient Index Data 3)

  20. RAPID3 (Routine Assessment of Patient Index Data 3) RAPID3 MDHAQ functional score(0-10) Pain VAS (0-10) Patient Global Assessment VAS (0-10) RAPID4 and RAPID5 RADAI - Patient Reported Joint Count (0-10) Physician Global Assessment (0-10)

  21. DAS28 and RAPID3 RA Categories DAS28 Categories <2.6 = Remission 2.6-3.19 = Low DAS 3.2-5.1 = Moderate DAS >5.1 = High DAS RAPID3 Categories < 3.0 = Near Remission 3.01-6 = Low Severity 6.01-12.0 = Moderate Severity >12.0 = High Severity

  22. RAPID3 vs DAS28 in 285 RA Patients Spearman correlation rho = 0.657 Pincus T, et al. J Rheumatol. 2008;35:2136-2147.

  23. RAPID3 & DAS28 Categories are Correlated Significantly in 285 Patients at 3 Sites Pincus T, et al. J Rheumatol. 2010

  24. Time Needed to Score Various RA Measures Yazici Y, et al. J Rheumatol. 2008;35:603.

  25. Methods • NYU Arthritis Registry Monitoring Database (ARMD) • Prospective, consecutive patient data since 2005 • all patients seen in routine care • Each 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 function • pain • patient global estimate • fatigue • self-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

  26. NYU ARMD Registry

  27. Results • 704 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).

  28. RAPID3 components

  29. ACR Core Dataset by Remission

  30. Conclusion • RAPID3 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

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