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MabThera retreatment in RA The Belgian perspective

MabThera retreatment in RA The Belgian perspective. Professor Filip DE KEYSER Royal Belgian Society of Rheumatology Aalst 2007. Topics. Efficacy & safety of rituximab retreatment in RA patients Belgian criteria for rituximab retreatment in RA patients

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MabThera retreatment in RA The Belgian perspective

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  1. MabThera retreatment in RAThe Belgian perspective Professor Filip DE KEYSER Royal Belgian Society of Rheumatology Aalst 2007

  2. Topics • Efficacy & safety of rituximab retreatment in RA patients • Belgian criteria for rituximab retreatment in RA patients • MabThera in RA (MIRA) Retreatment Protocol

  3. Efficacy & safety of rituximab retreatment in RA patients Recent data • Keystone et al (EULAR 2007 – SAT 0012) Long-term efficacy • Van Vollenhoven et al (EULAR 2007 – OP 0119) Long-term safety

  4. Long-term efficacy of rituximab in RA Mean DAS28 change from original baseline Patients (%) • 210 ptns ≥ 3 courses; 97 ptns ≥24w post C3 • anti-TNF failures; open label study extensions • each course 2 x (1g RTX + 100 mg MP) • retreatment if ≥20% SJC/TJC↓ and ≥ 8 SJC/TJC • median interval C1-C2 38w and C2-C3 42w • responses at w24 post-course vs baseline Keystone et al. EULAR 2007 – SAT 0012

  5. Long-term safety of rituximab in RA Number of patients over 4 courses: 1053 > 684 > 400 > 142 Infusion reactions % Van Vollenhoven et al. EULAR 2007 – OP 0119

  6. Belgian criteria for rituximab retreatment in RA patients failed on anti-TNF • at least moderate DAS28 response at M4 (w16) • at least M6 (w24) elapsed since previous course • at least current DAS28 of 3.2 DAS28 response DAS28 ≥ 3.2

  7. Value of DAS28 for guiding therapeutic decisions • Literature provides evidence that cumulative DAS28 values correspond with long-term outcome • The Belgian Infliximab Expanded Access Program demonstrated that DAS28 correlates best with therapy decisions in RA patients under biological therapy* (ROC curves has AUC 0.840) * B Vander Cruyssen et al. Arthritis Res Ther. 2005

  8. MabThera in RA (MIRA) Retreatment ProtocolAims • Follow-up of efficacy and safety in daily clinical practice • Longterm therapy survival • Validation of retreatment conditions • Maximalize experience-based information with new compounds

  9. MabThera in RA (MIRA) Retreatment ProtocolPatients and protocol • List A RA patients who entered a MNP with MabThera prior to 31-05-2007 (75 patients in 35 Belgian centres, followed by 45 rheumatologists) • List B RA patients who started on MabThera under reimbursement conditions since 01-06-2007 • Informed consent • Basic information on baseline, w16, w24 and every 2 months thereafter (as requested by reimbursement criteria and good clinical practice) • Timing of every retreatment course • In case therapy is stopped: reason for withdrawal

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