Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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Efficacy: Repeat treatment courses Patients with inadequate response to DMARDs or prior TNF inhibitors 38
Study design Open-label extension study of rituximab in RA Phase II/III Open-label extension study of rituximab treatment Course 1 of rituximab Course Repeated 2 courses Course 3 Phase IIa Placebo Rituximab 2 x 1000 mg Rituximab 2 x 1000 mg + cyclophosphamide Rituximab 2 x 1000 mg Timing of repeat treatment courses was variable, depending on clinical need Rituximab 2 x 1000 mg + methotrexate Placebo Rituximab 2 x 1000 mg Long-term follow-up Phase IIb DANCER Rituximab 2 x 500 mg + methotrexate Rituximab 2 x 1000 mg + methotrexate Phase III REFLEX Placebo Rituximab 2 x 1000 mg + methotrexate All patients in the open-label extension study received weekly methotrexate (10–25 mg) and methylprednisolone 100 mg iv on Days 1 and 15 plus oral prednisone 60 mg/day on Days 2–7 and 30 mg/day on Days 8–14 39
Page 2 and 3: Roche Analyst Meeting EULAR 2007 Ba
Page 4 and 5: Introduction Dr. Karl Mahler Head o
Page 6 and 7: Roche’s key therapeutic areas Cur
Page 8 and 9: RA: A very concentrated market 6.00
Page 10 and 11: Increased penetration of biologics
Page 12 and 13: Actemra: The OPTION trial results P
Page 14 and 15: Elevated IL-6 plays central role in
Page 16 and 17: The OPTION study TOcilizumab Pivota
Page 18 and 19: Demographics Intent-to-treat popula
Page 20 and 21: Results: Efficacy and safety 20
Page 22 and 23: Rapid onset of action with tocilizu
Page 24 and 25: Tocilizumab induces rapid CRP norma
Page 26 and 27: Most frequently reported AEs Incide
Page 28 and 29: Adverse events Consistent with thos
Page 30 and 31: MabThera: Longer-term repeat treatm
Page 32 and 33: Rituximab selectively targets CD20-
Page 34 and 35: Rituximab: Advancing in RA Initial
Page 36 and 37: Inhibition of radiographic progress
Page 40 and 41: Patient exposure to repeat courses
Page 42 and 43: ACR scores are sustained Repeated c
Page 44 and 45: Consistent time intervals between t
Page 46 and 47: More than 2400 patient-years As of
Page 48 and 49: No increase in infection rates with
Page 50 and 51: IgM RF levels by treatment course o
Page 52 and 53: Rates of serious infection Similar
Page 54 and 55: Roche’s franchise in autoimmune d
Page 56 and 57: Overview of autoimmune disorders IN
Page 58 and 59: Not all patients respond to current
Page 60 and 61: Major players are active in this ar
Page 62 and 63: Actemra Potential to become a signi
Page 64 and 65: Ocrelizumab in autoimmune diseases
Page 66 and 67: Multiple sclerosis An emerging ther
Page 68 and 69: Prevalence of MS in Europe ~260,000
Page 70 and 71: Development hurdles & treatment cha
Page 72 and 73: Roche in autoimmune disorders Roche

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