Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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The OPTION study TOcilizumab Pivotal Trial in methotrexate Inadequate respONders Study population and objectives • Patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate (MTX) – Patients could have been on TNFα-antagonists but not necessarily TNF-failures • Efficacy: reduction in signs and symptoms of RA, in combination with MTX vs placebo infusion (maintaining stable dose of MTX) – Primary endpoint: proportion of patients achieving ACR20 response at week 24 • Safety: adverse events; laboratory assessments; immunogenicity • To explore pharmacokinetics and pharmacodynamics (hsCRP, IL-6, sIL-6R, DAS) 16
Study design • Tocilizumab or placebo q4wk iv (6 infusions) maintaining stable dose of MTX • Total randomised: 623 patients • Early withdrawals and patients entering escape were classified as non-responders for the ACR and <strong>EULAR</strong> analyses TCZ 4 mg/kg + MTX (n=214)* ,§ TCZ 8 mg/kg + MTX (n=205) Placebo + MTX (n=204) 0 2 4 6 8 10 12 14 16 18 20 22 24 * One patient was randomised to tocilizumab 4 mg/kg + MTX but was not dosed §Includes one patient who was randomised to tocilizumab 4 mg/kg + MTX but who received tocilizumab 8 mg/kg + MTX through study 17
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 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 38 and 39: Efficacy: Repeat treatment courses
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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Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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