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DAS 28 in Belgium

DAS 28 in Belgium. Prof. F. De Keyser. Introduction of DAS 28 in Belgian rheumatology. Background RTX reimbursement since June 2007 K55 nomenclature since Feb. 2009 1) Why the DAS 28 ? 2) Which cut-off should alert for a change in therapy? 3) Rituximab and DAS 28. 1) Why DAS 28 ?.

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DAS 28 in Belgium

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  1. DAS 28 in Belgium Prof. F. De Keyser

  2. Introduction of DAS 28 in Belgian rheumatology • Background • RTX reimbursement since June 2007 • K55 nomenclature since Feb. 2009 1) Why the DAS 28 ? 2) Which cut-off should alert for a change in therapy? 3) Rituximab and DAS 28

  3. 1) Why DAS 28 ? • Because DAS 28 best correlates with the expert’s satisfaction about control of disease activity • Belgian EAP of IFX in RA (2000-2001) • 511 Belgian RA patients were included • IFX 3mg/kg at w 0,2,6 and every 8 w thereafter (+ MTX) • IFX dose increase in case of insufficient control of disease activity • decided at w22 by treating rheumatologist • 102 patients received a dose increase • Which parameter/test (single or composite) corresponds best with decision for dose increase? • The performance of a diagnostic test can be measured by its ROC-curve

  4. Performance of a diagnostic test measured by its ROC-curve

  5. Why DAS 28 ? Because DAS 28 best correlates with the expert’s satisfaction about control of disease activity • Belgian EAP of IFX in RA (2000-2001) • 511 Belgian RA patients were included • IFX 3mg/kg at w 0,2,6 and every 8 w thereafter (+ MTX) • IFX dose increase in case of insufficient control of disease activity • decided at w22 by treating rheumatologist • 102 patients received a dose increase • Which parameter/test (single or composite) corresponds best with decision for dose increase? • The performance of a diagnostic test can be measured by its ROC-curve

  6. 2) Which cut-off should alert for a change in therapy? A cut-off value provides a good balance between sensitivity and specificity for change of therapy • Belgian EAP of IFX in RA (2000-2001) • 511 Belgian RA patients were included • IFX 3mg/kg at w 0,2,6 and every 8 w thereafter (+ MTX) • IFX dose increase in case of insufficient control of disease activity • decided at w22 by treating rheumatologist • 102 patients received a dose increase • Which parameter/test (single or composite) corresponds best with decision for dose increase? • DAS 28 of at least 3.7 classifies patients eligible for change in therapy with a sensitivity of 90% and specifity of 58%

  7. 3) Rituximab and DAS 28 Belgian criteria for rituximab retreatment in RA patients failed on anti-TNF DAS 28 response (w16) DAS 28 ≥ 3.2

  8. MIRA - Aims • Efficacy, safety and long-term continuation rate of MabThera in daily clinical practice • Validation of (Belgian) retreatment conditions • As of mid 2008 • 232 patients included (30% at least 2 courses) • Mean disease duration 12 years • Number of previous anti-TNF compounds: 1 compound in 45%, 2 compounds in 36%, 3 compounds in 18%

  9. MIRA - Evolution of DAS 28 following rituximab treatment • Baseline DAS= 5.7 (SD= 1) • Week 16 DAS = 4 (SD = 1.2) • Week 48 DAS = 3.6 (SD = 1.2)

  10. MIRA – Validation of DAS 28-based retreatment conditions • At each follow-up visit (every 2 months) • DAS 28 score ? • Would you like to retreat at this time ? • Analysis to follow shortly

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