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MabThera in daily clinical practice European Patient Cohorts and Registries MIRA Update

MabThera in daily clinical practice European Patient Cohorts and Registries MIRA Update. Professor Patrick DUREZ – UCL, Brussels Professor Filip De Keyser – UZG, Ghent Liège 2008. MabThera in daily clinical practice European Patient Cohorts and Registries. Patrick DUREZ UCL, Brussels

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MabThera in daily clinical practice European Patient Cohorts and Registries MIRA Update

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  1. MabThera in daily clinical practiceEuropean Patient Cohorts and RegistriesMIRA Update Professor Patrick DUREZ – UCL, Brussels Professor Filip De Keyser – UZG, Ghent Liège 2008

  2. MabThera in daily clinical practiceEuropean Patient Cohorts and Registries Patrick DUREZ UCL, Brussels Liège 2008

  3. Importance of analyses on Cohorts and Registries • Reflect use of a drug in daily clinical practice • In general, larger patient numbers • Lower cost • Easily allow long term follow up • safety • efficacy • Allows recommendations on best use of a specific treatment

  4. What trials have shown • REFLEX – Significant Eular responses at 6 months Cohen et al, 2006; Roche, data on file

  5. What trials have shown • REFLEX – Significant DAS28 improvement Cohen et al, 2006

  6. What trials have shown • Efficacy maintained with repeated treatment courses Keystone et al, 2007

  7. Recent MabThera cohort/registry analyses reported at EULAR 08 • SCQM cohort (Switzerland) Finckh OP0249 • STURE registry (Sweden) van Vollenhoven FRI0168 • University of Leeds (UK) Dass AB0352 • RESET cohort (Sweden/Canada) Haraoui AB0360 • Rabbit registry (Germany) Strangfeld AB0386 • AIR registry (France) Gottenberg THU0181

  8. Eular responses at 6 months failed 1 anti TNF failed 1-3 anti TNF

  9. DAS28 improvement at 6 months

  10. DAS28 improvement with repeated treatment coursesDass, University of Leeds, UK Dass, UK, AB0352 Eular 2008 – 100 patients

  11. SCQM cohort (Switzerland) Finckh OP0249 • which subgroup of rheumatoid arthritis patients benefit most from switching to rituximab versus alternative anti-TNF agents after previous failure to anti-TNF agent ? Data from the "Swiss Clinical Quality Management in rheumatoid arthritis" (SCQM-RA) cohort SCQM assesses RA disease activity (DAS28), radiographic damage and various patient outcomes at regular intervals

  12. SCQM cohort (Switzerland) Background ~ 30% resistant to anti-TNF Intensify Treatment(↑ Dose a-TNF, ↑ DMARDs)? Switch to alternative a-TNF ? Different class of biologic therapy(Rituximab, Abatacept…)?

  13. SCQM cohort (Switzerland) Results – Change in DAS28 with therapeutic resistance to anti-TNF without therapeutic resistance to anti-TNF RTX (prior anti-TNF resist) Anti-TNF (prior anti-TNF resist) RTX (no prior anti-TNF resist) Anti-TNF (no prior anti-TNF resist) 0 0.0 -0.2 -0.2 -0.4 -0.4 -0.6 -0.6 -0.8 -0.8 Change in DAS28 (DAS28 units) Change in DAS28 (DAS28 units) -1.0 -1.0 -1.2 -1.2 -1.4 -1.4 -1.6 -1.6 p=0.0024 p=0.10 -1.8 -1.8 0 3 6 9 0 3 6 9 Time (months) Time (months) 327 patients (RTX: 155; anti-TNF: 172)

  14. SCQM cohort (Switzerland) Results – Change in DAS28 with 1 prior anti-TNF agent with several prior anti-TNF agents RTX (1 anti-TNF) Anti-TNF (1 anti-TNF) RTX (several anti-TNF) Anti-TNF (several anti-TNF) 0 0.0 -0.2 -0.2 -0.4 -0.4 -0.6 -0.6 -0.8 -0.8 Change in DAS28 (DAS28 units) Change in DAS28 (DAS28 units) -1.0 -1.0 -1.2 -1.2 -1.4 -1.4 -1.6 -1.6 -1.8 -1.8 0 3 6 9 0 3 6 9 Time (months) Time (months) Effect modification: p=0.48 327 patients (RTX: 155; anti-TNF: 172)

  15. Conclusion • Results in daily clinical practice are consistent with earlier trial results, confirming • Good/moderate Eular response at 6 mo in up to 70% of patients • Significant improvement of DAS28 with at least 1.5-2 units after one treatment course • Further improvement with repeated courses • DAS28 reduction superior compared with alternative anti TNF • DAS28 reduction is at least as pronounced after one anti TNF compared with two or more anti TNF • RTX should be considered as a therapeutic alternative after a 1st aTNF therapy if aTNF failed to produce low disease activity states

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