Autoimmune Diseases More common than you think Randall Stevens, MD

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1 Autoimmune Diseases More common than you think Randall Stevens, MD picture placeholder

2 Autoimmune Diseases More than 60 different disorders Autoimmune disorders (AID) diseases caused by the immune system targeting the body and damaging tissues Single or multiple organ systems may be involved resulting in mild to mortal consequences More than 60 identified AIDs include: psoriasis/ psoriatic arthritis, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjögren s syndrome, multiple sclerosis (MS), idiopathic thrombocytopenia purpura, vitiligo, uveitis and myasthenia gravis Affects ~5 to 8% of the population

3 Autoimmune Diseases Overview Overall, has a female predominance (~65%) Among the leading causes of death in young and middle-aged women. Incidence varies, estimated to range from < 1 scleroderma (SD) per 100,000 person-years (PY). to > 20 rheumatoid arthritis (RA) patients per 100,000 PY. Prevalence rates range from < 5/100,000 PY (e.g. chronic active hepatitis) to >500 per 100,000 PY (Grave s disease, RA)

4 Autoimmune Diseases Overview Age of onset varies from childhood/adolescence (e.g. type 1 diabetes mellitus [DM1]), middle aged (e.g. multiple sclerosis [MS]) or older adults (RA, primary systemic vasculitis ) Differences in incidence with ethnicity and geography seen with specific autoimmune diseases Incidence of specific autoimmune diseases can vary over time, such as increases in type 1 Diabetes Mellitus

5 Female Male Sjog Syn SLE Thyroid ScleroD JIA RA Mult Scler Psoriasis Weg Gran Ank Spon Autoimmune Diseases Gender percentage Diseases Percent

6 Autoimmune Diseases Incidence per 100,000 person years (PY) Psoriasis RA JIA Grave Dis SLE Ank Spon Sjogren Incidence per 10,000 PY Mult Scl Sclerod Weg Gran Autoimmune Diseases

7 Psoriasis Grave Dis RA JIA Mult Scl SLE Log Prevalence Sjogren Myas Grav Sclerod Autoimmune Diseases Prevalence per 100,000 person years (PY) Autoimmune Diseases

8 Autoimmune Diseases Mean age of onset JIA Psoriasis Mult Scler SLE Grave Dis Sclerod RA Wegenr Age of Onset (yrs) Sjogren Child Onset Mid-Adult Onset Late Adult Onset Autoimmune Diseases

9 Selected Autoimmune Diseases Systemic Lupus Erythematosus Systemic lupus erythematosus (also called SLE or lupus) is a chronic inflammatory disease that can affect the skin, joints, kidneys, lungs, nervous system, and/or other organs of the body. The most common symptoms include skin rashes and arthritis, often accompanied by fatigue and fever. The clinical course of SLE varies from mild to severe, and typically involves alternating periods of remission and relapse.

10 Selected Autoimmune Diseases Wegener s Granulomatosis Wegener's Granulomatosis is a rare disorder which causes inflammation of blood vessels (vasculitis) in the upper respiratory tract (nose, sinuses, ears), lungs, and kidneys. Wegener's Granulomatosis is a disease that can affect many organ systems (systemic) and primarily causes lung (pulmonary) and kidney (renal) disease, but is also capable of affecting the skin.

11 Selected Autoimmune Diseases Juvenile Idiopathic Arthritis Juvenile Idiopathic Arthritis (JIA), formerly known as Juvenile Rheumatoid Arthritis (JRA), is the most common form of arthritis in children. Symptoms of JIA are joint inflammation, joint contracture (stiff, bent joint), joint damage and/or change in growth. Other symptoms include joint stiffness or decreased activity level. Children with JIA vary in the degree to which they are affected by particular symptoms.

12 Selected Autoimmune Diseases Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory disease that affects the central nervous system (CNS). MS can cause a variety of symptoms, including changes in sensation, visual problems, muscle weakness, depression, difficulties with coordination and speech, severe fatigue, and pain. Multiple sclerosis may take several different forms, with new symptoms occurring either in discrete attacks or slowly accruing over time

13 Selected Autoimmune Diseases Rheumatoid Arthritis An autoimmune disease in which progressiveinflammation results in: - Swollen and tender joints, tendinitis, joint damage Pain, fatigue, disability Devastating consequences: Up to 70% of pts in 2 yrs have joint destruction 10% of patients stop working after 1 year 50% of patients become disabled within five years

14 Epidemiology of RA Current and predicted prevalence Number of RA patients by region* 1,800,000 1,800,000 1,800,000 Overall prevalence is % 900, , ,000 Approximately 3 times more prevalent in woman than in men 0 USA 0 Europe Japan Incidence increases with age until approximately 75 years and decreases thereafter Decision Resources, 2003 * Projection based on the conservative estimate

15 Single Drug Can Be Effective in Multiple Autoimmune Diseases MabThera has been shown to be effective in multiple Autoimmune diseases, such as: Primary Sjögren s Syndrome Idiopathic Thrombocytopenic Purpura Systemic Lupus Erythematosus Systemic Vasculitis Autoimmune Blistering Diseases Multiple Sclerosis As well as other diseases in case reports and small trials

16 Do We Need Better Treatment? Current treatments aimed at reducing acute symptoms and slowing joint damage, DMARDs are the mainstay of therapy 30 40% of patients don t have adequate control with, or are intolerant to, current biologic therapies 60 80% of patients do not achieve major signs and symptoms control So far, no RA drug has gained regulatory approval for remission, the ultimate goal of therapy RA has an economic burden; e.g., in the UK during 1998 it was estimated to be between 0.8 and 1.3 billion

17 Roche Group in Autoimmune Diseases Building a new therapeutic franchise Launched Phase III Phase II Phase I MabThera / Rituxan Launched in RA anti-tnf inadequate responders in US and EU Actemra Japanese Ph III in DMARD partial responders- filed in Japan Global filing 2007 MabThera / Rituxan Phase III in LN, PPMS, ANCA ass. vasculitis and SLE ongoing Ocrelizumab Phase III program to be finalized and initiated soon R1503 (p38 kinase inhibitor) Phase II initiated in Q4 05 MabThera / Rituxan Phase II in RRMS Phase 1 7 compounds in development for autoimmune diseases

18 Summary for Autoimmune Diseases More common than you may think, with 5-8% of the population having an autoimmune disease Autoimmune diseases can be mild to deadly, and affect any organ and any age Many autoimmune diseases share common mechanisms of disease Roche has a number of molecules and therapies that can effectively treat a broad range of autoimmune diseases.

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