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Implementation of Systematic Use of the DAS 28 in an Academic Medical Center

Implementation of Systematic Use of the DAS 28 in an Academic Medical Center. Paul P. Tak, MD, PhD Professor of Medicine Director, Div. of Clinical Immunology & Rheumatology Academic Medical Center University of Amsterdam The Netherlands. After 1 year. After 2 years. At presentation.

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Implementation of Systematic Use of the DAS 28 in an Academic Medical Center

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  1. Implementation of Systematic Use of the DAS 28 in an Academic Medical Center Paul P. Tak, MD, PhD Professor of Medicine Director, Div. of Clinical Immunology & Rheumatology Academic Medical Center University of Amsterdam The Netherlands

  2. After 1 year After 2 years At presentation

  3. RA disease progression Early RA Intermediate Late Inflammation Disability Radiographs Severity (arbitrary units) 0 5 10 15 20 25 30 Duration of Disease (years) Adapted from Kirwan J. J Rheumatol 1999;26:720-725

  4. Rheumatologic Treatment of RA • Suppression of inflammation • Protection against destruction • Reduction of co morbidity (e.g. cardiovascular disease) • Improvement of quality of life

  5. ACR20% ACR70% ACR50%

  6. Need for new approaches: how to fill the glass • Optimal use of available treatments • Early intervention • Tight control • New biologicals and targeted small molecules • Innovative combination therapy? • Personalized medicine?

  7. Need for new approaches: how to fill the glass Optimal use of available treatments Early intervention Tight control New biologicals and targeted small molecules Innovative combination therapy? Personalized medicine?

  8. Development of clinical symptoms Early RA represents chronic synovitis Early RA Longstanding RA Increased synovial tissue mass Progressive joint destruction Autoantibodies Similar cell infiltrate Initiation of immune response Asymptomatic synovitis Modified after: PP Tak. Best Practice & Research Clinical Rheumatology 2001;15:17-26

  9. Time % with Erosions Reference <3 months 26 Harrison et al. Arthritis Rheum 2000 1 year (9 months) 62 Proudman. Arthritis Rheum 2000 2 years 75 van der Heijde. Br J Rheumatol 1995 2 years (4 months) 77 Boers et al. Lancet 1997 2 years (9 months) 68 Peltomaa et al. J Rheum 2000 Erosions occur early in RA * *At 2 years, 73% ± 5% of RA patients have erosions

  10. Delaying DMARD therapy adversely affects radiographic outcomes Delayed DMARD*(median treatment lag time = 123 days; n = 109) Early DMARD* (median treatment lag time = 15 days; n = 97) 14 12 10 8 Change in Median Sharp Score 6 4 2 0 0 6 12 18 24 Months Lard LR et al. Am J Med 2001;111:446–451

  11. P =0.008 Delaying effective DMARD therapy adversely affects radiographic outcomes Damage progression (Sharp/van der Heijde) 40 SSZ: 8.6 points/year 30 COBRA: 5.4 points/year 20 10 0 0 1 2 3 4 5 Years Landewe RB et al. Arthritis Rheum 2002:46:347-356

  12. Need for new approaches: how to fill the glass Optimal use of available treatments Early intervention Tight control New biologicals and targeted small molecules Innovative combination therapy? Personalized medicine?

  13. Triple therapy in early active rheumatoid arthritis: a randomized, single-blind, controlled trial comparing step-up and parallel treatment strategies 97 RA patients, < 1 year 2 groups SSP – MTX – hydroxychloroquine step up SSP – MTX – hydroxychloroquine combination I.a. injections with corticosteroids Saunders SA et al. Arthritis Rheum. 2008;58:1310-7

  14. Triple therapy in early active rheumatoid arthritis: a randomized, single-blind, controlled trial comparing step-up and parallel treatment strategies Evaluation every month DAS 28-guided treatment Highly effective control of disease activity can be achieved using conventional DMARDs as part of an intensive disease management strategy (45% versus 33% DAS28 remission) Saunders SA et al. Arthritis Rheum. 2008;58:1310-7

  15. RA disease progression Early RA Intermediate Late Inflammation Disability Radiographs Severity (arbitrary units) 0 5 10 15 20 25 30 Duration of Disease (years) Adapted from Kirwan J. J Rheumatol 1999;26:720-725

  16. Radiological progression is related to disease activity NO RX PROGRESSION RX PROGRESSION NON RESPONDERS Svensson B et al. Rheumatology 2000;39: 1031-1036

  17. Active RA: Early DMARD therapy MTX dose20–25 mg/week (within 2 months) (+ steroids) Remission continue Active RA DMARD combination (+ steroids) Low disease activity Optimize and continue Active RA DMARD (combination) (+ steroids) + Biological Low disease activity Optimize and continue Algorithm for achieving therapeutic success in RA in 2009

  18. Components of DAS 28 scoreJOINTS • SJC Number of Swollen Joints out of 28 joints: shoulders, elbows, wrists, MCP joints, PIP joints and knees • TJC Number of Tender Joints out of 28 joints Source: Eular handbook of clinical assessments in RA – Third edition

  19. Components of DAS 28 scoreJoint ASSESSMENT TECHNIQUE • Swelling (SJC): • Soft tissue swelling, detectable along the joint margin • Synovial effusion invariably means the joint is swollen • Bony swelling or deformity, or oedema surrounding the joints do not constitute joint swelling • Fluctuation is a characteristic feature of swollen joints • Joint swelling may influence the range of joint movement (for example decreased dorsiflexion of the wrist, or decreased elbow extension). This can be useful in determining the presence of swelling Source: Eular handbook of clinical assessments in RA – Third edition

  20. Components of DAS 28 scoreJoint ASSESSMENT TECHNIQUE • Tenderness (TJC): • Pain in a joint under defined circumstances, including: • Pain at rest with pressure (for example MCP and wrist joints) • Pain on movement (for example shoulders) • From questioning about joint pain • Pressure to elicit tenderness should be exerted by the examiner's thumb and index finger, sufficient to cause 'whitening' of the examiner's nail beds Source: Eular handbook of clinical assessments in RA – Third edition

  21. Components of DAS 28 scoreESR or CRP • ESR (erythrocyte sedimentation rate) in mm/h • Unspecific marker of inflammatory processes • Normal range: 1-15 mm/h (slightly higher in women) • Also increased in AID, like RA, or in case of malignancy • Reflects disease activity of the past few weeks • CRP (C-reactive protein) in mg/L • Sensitive marker of inflammatory processes • Normal range: below 3 mg/L • Less susceptible to disturbing factors than ESR • Better reflects short-term changes • Shorter waiting time for lab result Source: Eular handbook of clinical assessments in RA – Third edition

  22. Components of DAS 28 scoreVisual Analogue Scale (VAS) • Scale of 100 mm • Range: 0-100 • Reflects perception by the patient of global disease activity Source: Eular handbook of clinical assessments in RA – Third edition

  23. Validated formula's depending on availability of data • DAS 28 ESR 4 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*Ln(ESR) + 0.014*VAS • DAS 28 ESR 3 (no VAS) [0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*Ln(ESR)]*1.08 + 0.16 • DAS 28 CRP 4 (CRP) 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*VAS + 0.96 • DAS 28 CRP 3 (CRP, no VAS) [0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1)]*1.10 + 1.15 Note: VAS in mm ! (0-100) CRP in mg/L (lab values mostly given in mg/dL)

  24. Validated DAS 28 segments according to disease activity Therapeutic goal Source: www.das-score.nl

  25. EULAR response criteria Source: Eular handbook of clinical assessments in RA – Third edition

  26. DAS 28 in current clinical practice

  27. Algorithm for achieving therapeutic success in RA in 2009 Active RA: Early DMARD therapy MTX dose20–25 mg/week (within 2 months) (+ steroids) DAS28<2.6 continue Active RA (DAS28≥2.6): DMARD combination (+ steroids) DAS28<3.2 Optimize and continue Active RA (DAS28≥3.2): DMARD (combination) (+ steroids) + TNF blocker DAS28<3.2 Optimize and continue Related to Dutch reimbursement regulations

  28. Algorithm for achieving therapeutic success in RA in 2009 Active RA: Early DMARD therapy MTX dose20–25 mg/week (within 2 months) (+ steroids) DAS28<2.6 continue Active RA (DAS28≥2.6): DMARD combination (+ steroids) DAS28<3.2 Optimize and continue Active RA (DAS28≥3.2): DMARD (combination) (+ steroids) + TNF blocker DAS28<3.2 Optimize and continue Within 1 year after first symptoms of arthritis

  29. Algorithm for achieving therapeutic success in RA in 2009 Active RA: Early DMARD therapy MTX dose20–25 mg/week (within 2 months) (+ steroids) DAS28<2.6 continue Active RA (DAS28≥2.6): DMARD combination (+ steroids) DAS28<3.2 Optimize and continue Active RA (DAS28≥3.2): DMARD (combination) (+ steroids) + TNF blocker Inadequate response: Other TNF blocker Or rituximab Or abatacept Or tocilizumab DAS28<3.2 Optimize and continue

  30. Algorithm for achieving therapeutic success in RA in 2009 Major objective: systematic approach to induce remission Clinical insight comes first, CAVE: High DAS 28 due to high VAS in fibromyalgia Low DAS 28 but active arthritis in ankle joint: treatment (or use of e.g. DAS 44) Radiological progression: more intense treatment required

  31. Median DAS 28 score in RA patients per COUNTRY (2005-2006) Assessment period: Jan 2005-Oct 2006 Sokka et al. Ann Rheum Dis 2007;66:407-409

  32. Interpretation median DAS 28 scores • Median DAS 28 score > 3.2 means… • PROBABLY MORE THAN 50% OF PATIENTS HAVING DAS28 SCORES OF > 3.2 !!!

  33. Project: Innovation of care • ‘Zorgvernieuwingsproject’

  34. Activities rheumatology nurse before the project • Inventory of health problems • Psychological and emotional problems • Social problems

  35. Activities rheumatology nurse after the project • Inventory of health problems • Psychological and emotional problems • Social problems • Medical problems • Monitoring of disease activity • Medical care as directed by rheumatologist

  36. VRC VRC VRC Before the project Implementation After the project MD MD MD months

  37. VRC VRC VRC MD MD + + + Monitoring + + Formulate medical objective Medical examination + + + After implementation of the project

  38. Improvement of quality of care • More effective treatment • Continuity in measurement of disease activity • Rapid feed-back loop nurse - rheumatologist • Improved psychosocial care • Information obtained during consult • Easier access to the nurse • Better continuity of psychosocial support

  39. Improvement of quality of care • Improved access to information • Nurse checks which information has been received • Booklets and flyers • Improved logistics • One-stop visit to the nurse, including blood tests • Better monitoring of the administrative process related to reimbursement for biologicals • Easier access to the rheumatologist when necessary • Cost effective

  40. Implementation Administrative procedures Reservation of space at the outpatient clinic Lab: one stop visit Clarification of responsiblities Protocol development Implementation in the outpatient clinic Recruitment of specialized nurses Training of nurses and rheumatologists

  41. Do we reach our goals? Care: • Systematic DAS-guided treatment • Improved psychosocial care • Easier access to information • Improved logistics Research: • Structured follow-up of cohorts, e.g. genetics, genomics Training: • Improved supervision • Development of management skills for residents/fellows VAS patient satisfaction: 95/100

  42. DAS28-guided rituximab re-treatment in rheumatoid arthritis

  43. Rituximab • Rituximab is an anti-CD20 monoclonal antibody

  44. Median CD19+ B cells per mm3 200 150 CON +R 100 +R+CTX +R+MTX 50 0 0 4 8 12 16 20 24 Weeks Circulating B cell count after anti-CD20 therapy Edwards et al. N Engl J Med. 2004;17;350:2572-81

  45. Change in CD22+ B cells of individual patients before and 4 weeks after treatment Values for number of CD22+ B cells /mm2 in serial synovial tissue samples are shown for individual patients Vos K et al. Arthritis Rheum 2007;56:772-8

  46. 60 51 50 40 % patients 27 30 18 20 12 10 5 1 0 ACR20 ACR50 ACR70 Placebo (N=201) Rituximab (N=298) REFLEX - ACR Responses at Week 24Patients who initially failed TNF blockade p < 0.0001 p < 0.0001 p < 0.0001 Cohen SB et al. Arthritis Rheum 2006;54:2793-806

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