Microsoft PowerPoint - Roche IR Event EULAR Final.ppt

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Adverse events Consistent with those seen in previous studies • Infusions generally well tolerated • Low incidence of adverse GI events (1 peridiverticular abscess, 1 gastroenteritis) • Transient ALT elevation – no evidence of clinical hepatitis or hepatic failure • Lipid levels initially increased and subsequently stabilised at the upper level of normal - no relevant change in atherogenic risk index • Slight increase in infections (including serious infections) over placebo – No occurrence of TB 28
Conclusions Rapid and significant improvements in signs and symptoms of RA • Dose response observed • Strength of tocilizumab at more clinically relevant ACR 50/70 scores • CRP normalised with 8 mg/kg dose – Suggests benefit in reducing inflammatory cascade Safety: Tocilizumab is well tolerated • Increases in LDL cholesterol within normal limits accompanied by increases in HDL - Leading to neutral impact on atherogenic index • Occurrence of infections is at lower end seen with biologic agent IL-6 receptor inhibition with tocilizumab may offer a promising future therapeutic approach to RA 29
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 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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