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ENBREL* (etanercept): A Breakthrough to Sustainable and Repeatable Efficacy in Psoriasis

ENBREL* (etanercept): A Breakthrough to Sustainable and Repeatable Efficacy in Psoriasis. *trademark. Overview. ENBREL* EU Indications for Psoriatic Diseases Overview of Psoriasis Clinical Evidence for the Role of TNF in Psoriasis Pivotal Phase III Trials

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ENBREL* (etanercept): A Breakthrough to Sustainable and Repeatable Efficacy in Psoriasis

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  1. ENBREL*(etanercept):A Breakthrough to Sustainable and Repeatable Efficacy in Psoriasis *trademark

  2. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  3. ENBREL*(etanercept)EU Indications for Psoriatic Diseases ENBREL is the only biologic treatment indicated for both plaque psoriasis and psoriatic arthritis:1 • ENBREL is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. • ENBREL is indicated for the treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. Reference 1. ENBREL Summary of Product Characteristics, Wyeth Pharmaceuticals. *trademark

  4. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  5. Overview of Psoriasis • Psoriasis is a chronic, autoimmune, inflammatory skin disease1,2 • Psoriasis is not contagious and is characterized by skin lesions that can be red, scaly, itchy, painful, and disabling1 • In Europe, an estimated 5.1 million people are affected by psoriasis3 • The most common form of psoriasis is plaque psoriasis, which occurs in approximately 80% of all patients with psoriasis4 • According to a recent review by Brockbank and Gladman, it is estimated that 5% to 42% of patients with psoriasis have psoriatic arthritis5 References 1. Peters BP et al.Am J Health-Syst Pharm 2000;57:645–662. 2. Krueger JG. J Am Acad Dermatol 2002;46:1–23. 3. Christophers E. Clin Exp Dermatol 2001;26:314–320. 4. Lebwohl M. Lancet 2003:361;1197–1204. 5. Brockbank J, Gladman DD. Expert Opin Investig Drugs 2000;9:1511–1522.

  6. The Impact of Psoriasis • Profound reduction in health-related quality of life,1,2 due to - Physical symptoms2 - Psychosocial impairment1,2 - Compromised activities of daily living1 • Psychosocial impact includes - Embarrassment1,3 - Helplessness and anger3 - Feeling unattractive - Increased feelings of depression4 • Annual direct costs for treatment ranging from $US 1400 to $US 67005 • Disability comparable to heart disease, diabetes, cancer, and depression2 • Increased risk of malignancy6 References 1. Krueger G et al. Arch Dermatol 2001;137:280284. 2. Choi J, Koo JYM. J Am Acad Dermatol 2003;49:S57S61. 3. Koo JYM. J Dermatol Clin 1996;14:485496. 4. Devrimci-Ozguven H et al. J Eur Acad Dermatol Venereol 2000;14:267271. 5. Sander HM et al. J Am Acad Dermatol 1993;28:422425. 6. Margolis D et al. Arch Dermatol 2001;137:778783.

  7. Overview of Psoriasis: Common Symptoms Results from the 1998 National Psoriasis Foundation survey. Reference 1. Krueger G et al.Arch Dermatol 2001;137:280–284.

  8. Overview of Psoriasis: Measuring Disease Severity Traditional Metrics • Extent(body surface area; BSA)1,2 • The Psoriasis Area and Severity Index (PASI)3 • Dermatology Life Quality Index (DLQI)4 Proposed Metrics • Disease alters the patient’s quality of life • Unsatisfactory response to treatments with minimal risk • Generally more than 10% of the body surface area is involved • Disease is located on the face, hands, fingernails, feet and genitals • Joint involvement References 1.Krueger GG et al. J Am Acad Dermatol 2000;43:281–285. 2. Weinstein GD, Menter MA. In: Weinstein GD, Gottlieb AB et al. Therapy of moderate-to-severe psoriasis. New York, Marcel Dekker, 2003. 3. Fredriksson T, Pettersson U. Dermatologica 1978;157:238–244. 4. Finlay AY, Khan GK. Clin Exp Dermatol 1994;19:210–216.

  9. Traditional Therapies: 1998 Usage Pattern Percentage of Patients Receiving Prescription Treatments for Psoriasis Topicals 87 Phototherapy or light Type of Treatment 21 treatment Oral medication 18 n=502 0 20 40 60 80 100 % of Patients Reference 1. Krueger G et al. Arch Dermatol 2001;137:280–284.

  10. Potential Adverse Effects of Traditional Systemic Agents Agent Potential Adverse Effects • Melanoma • Non-melanoma skin cancer • Skin aging UVB1 PUVA1 • Nausea • Melanoma • Non-melanoma skin cancer • Skin aging Methotrexate2 • Hepatotoxicity • Bone marrow toxicity • Teratogenicity • Pulmonary toxicity References 1. Lebwohl M, Ali S. J Am Acad Dermatol 2001;45:487498. 2. Lebwohl M, Ali S. J Am Acad Dermatol 2001;45:649661. 30

  11. Potential Adverse Effects of Currently Available Systemic Agents Agent Potential Adverse Effects Cyclosporine1 • Nephrotoxicity • Hypertension • Malignancy Acitretin1 • Mucocutaneous side effects • Teratogenicity in combination with alcohol • Lipid abnormalities Fumarates2,3 • Potential skin irritation • GI symptoms References1. Lebwohl M, Ali S. J Am Acad Dermatol 2001;45:649661. 2. Mrowietz U et al. Br J Dermatol 1999;141:424429. 3. Altmeyer PJ et al. J Am Acad Dermatol 1994;30:977981. 31

  12. Potential Adverse Effects of Traditional Topical Agents1,2 References 1. Lebwohl M, Ali S. J Am Acad Dermatol 2001;45:487498. 2. Krueger G et al. Arch Dermatol 2001;137:280–284.

  13. Psoriasis Management Goals • The primary goal of treating psoriasis is to improve the disease to a level where it no longer significantly interferes with the patient’s daily life1 • Convenient therapy should not in itself impair daily life1 Reference 1. Greaves MW et al. N Engl J Med 1995;332:581–588.

  14. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  15. Clinical Evidence for the Role of TNF in Psoriasis • Tumor necrosis factor (TNF) production is increased in psoriasis • Elevated serum TNF levels1 • Elevated TNF levels in psoriatic plaque2 • TNF levels correlate with Psoriasis Area and Severity Index (PASI) score1,2 • Reduction of TNF levels1,3 correlates with clinical response References 1. Mussi A et al. J Biol Regul Homeost Agents 1997;11:115–118. 2. Bonifati C et al. Clin Exp Dermatol 1994;19:383–387. 3. Ameglio F et al. Dermatology 1994;189:359–363.

  16. What Is ENBREL*? • ENBREL is a human TNF-receptor fusion protein1 • It is NOT a monoclonal antibody • It has low immunogenicity: no neutralizing antibodies observed in clinical trials • ENBREL has been shown not to lyse T cells in vitro2 † • ENBREL helps restore a natural balance of TNF by binding to TNF and rendering it biologically inactive, thus reducing inflammation in multiple diseases, including psoriasis †Clinical significance is unknown Reference1. ENBREL Summary of Product Characteristics, Wyeth Pharmaceuticals. 2. Data on file, Wyeth Pharmaceuticals. *trademark

  17. ENBREL*: Proven Therapy in Chronic Immune Inflammatory Diseases • ENBREL is a biologic medication shown to be an effective and generally well-tolerated continuous therapy for several inflammatory diseases1 – Rheumatoid arthritis – Juvenile chronic arthritis – Psoriatic arthritis – Ankylosing spondylitis – Psoriasis Reference 1. ENBREL Summary of Product Characteristics, Wyeth Pharmaceuticals. *trademark

  18. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  19. Design of Pivotal Phase III Clinical Trials Phase III Global Trial (Dose-reduction Data)1 • 12-week randomized, placebo-controlled, double-blind; followed by 36-week open label • 583 patients at 50 centers • 3 arms: placebo plus 2 ENBREL* dose groups (50 mg BIW; 25 mg BIW) • Primary end point: percentage of patients achieving PASI 75 at week 12 (≥75% improvement from baseline) Phase III U.S. Trial (Re-treatment Data)1,2 • 24-week double-blind, randomized • Placebo-controlled for first 12 weeks • 652 patients • 47 U.S. centers • Placebo-controlled, randomized, double-blind groups • 4 arms: placebo plus 3 ENBREL dose groups (50 mg BIW; 25 mg BIW; 25 mg QW) • Primary end point: percentage of patients achieving PASI 75 at week 12 • Responders were discontinued and re-treated for an additional 24 weeks References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Leonardi CL et al. N Engl J Med 2003;349:2014–2022. *trademark

  20. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  21. Design of Phase III Global Trial (Dose-Reduction Data) Double blind Open-label Screen and Washout ENBREL* 50 mg twice weekly (n=203) ENBREL 25 mg twice weekly (n=204) 25 mg twice weekly (n=557) Placebo (n=204) Week 12 (primary end point) Day 1 Week 48 N=611 randomized (583 patients received at least one dose of blinded study medication) References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  22. Key Patient Eligibility CriteriaPhase III Global Trial (Dose-Reduction Data) • Exclusion • Any previous ENBREL* treatment, or antibody to TNF • Investigational drugs, biologics, systemic psoriasis therapy, systemic corticosteroids, or PUVA within 4 weeks of study drug administration • UVB within 2 weeks of study drug administration • Topical corticosteroids, topical vitamin A or D analogue preparations, UVB, or anthralin within 2 weeks of study drug administration • Anti-CD4 or diphtheria IL-2 fusion protein within 6 months • Severe infection within 4 weeks, or antibiotics within 1 week of study drug administration Inclusion • Active but clinically stable plaque psoriasis involving 10% of BSA • Minimum screening PASI score of 10 • 1 previous phototherapy or systemic psoriasis therapy, or a candidate for such therapy • 18 years of age Reference 1. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  23. Key Efficacy MeasuresPhase III Global Trial (Dose-Reduction Data)1,2 Primary end point: • % of patients in each treatment group achieving PASI 75 at week 12 Secondary end points: • % of patients with PASI 50, PASI 75, and PASI 90 at different time points • Dermatologist’s Static Global Assessment of Psoriasis (DSGAP) (05) • Dermatology Life Quality Index (DLQI) (030) • Patient Global Assessment of Psoriasis (PGAP) • Short Form-36 Health Survey (SF-36) References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112.

  24. Similar Baseline Demographics/Clinical Characteristics Across Groups1 Phase III Global Trial (Dose-Reduction Data) Reference 1. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  25. Rapid, Significant Response With ENBREL*1 Phase III Global Trial (Dose-Reduction Data) Placebo 80 68% ENBREL 25 mg BIW † 70 ENBREL 50 mg BIW † 57% 60 † 50 † Mean % Improvement From Baseline PASI score † 40 30 † † 20 † 10 0.2% 0 2 0 4 8 12 Weeks †P < 0.0001 vs. placebo Reference 1. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  26. Sustained PASI 75 Following Dose Reduction1,2 Phase III Global Trial (Dose-Reduction Data) 80 Placebo/ENBREL* 25 mg BIW ENBREL 25 mg BIW 70 ENBREL 50 mg BIW/25 mg BIW 55% 60 ‡ 46% 50 % of Patients Achieving PASI 75 40 ‡ ‡ 30 20 ‡ † 10 3% 0 0 4 8 12 16 20 24 Weeks 2 †P < 0.001 vs. placebo; ‡P < 0.0001 vs. placebo References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  27. PASI 75 Response Improved from Week 12 to Week 24 Despite Decrease in Dose Overall Response • 54% of patients at week 24 (ENBREL* 25 mg BIW after crossover) achieved a PASI 75 response compared to 49% at week 12 (ENBREL 50 mg BIW)1,2 Responders vs. Non-Responders from Week 12 to Week 24 • Nearly 80% of patients who achieved PASI 75 at week 12 sustained a PASI 75 at Week 241,2† • More than 30% of patients who did not achieve PASI 75 at week 12 achieved a PASI 75 response at week 241,2 †Patients with assessment data available at both week 12 and 24 References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  28. Sustained Benefit Demonstrated Through Week 481 Phase III Global Trial (Dose-Reduction Data) ENBREL* 25 mg BIW (n=196) 60 Placebo (n=193) 50 40 † % of Patients Achieving PASI 75 Response 30 † 20 10 0 0 4 8 12 16 20 24 28 32 36 40 44 48 Weeks †P < 0.001 vs. placebo ENBREL is indicated for 24 weeks administration *trademark Reference 1. Data on file, Amgen, Thousand Oaks, Calif.

  29. Efficacy for Patients Who Failed Prior Systemic or Photo Therapies Phase III Global Trial (Dose-Reduction Data) Did not fail prior therapy (n=184) 60 Failed prior therapy (n=337) 51 All patients in study (n=583) 49 50 40 37 40 34 % Patients With PASI 75 Response at Week 12 28 30 20 10 3 2 2 0 Placebo 25 mg BIW 50 mg BIW ENBREL* dose Reference 1. Data on file, Wyeth Pharmaceuticals. *trademark

  30. Significant PASI Responses at Week 121,2 Phase III Global Trial (Dose-Reduction Data) † 77 80 Placebo † ENBREL* 25 mg BIW 70 64 ENBREL 50 mg BIW 60 † % of Patients 49 50 † 40 34 † 30 21 † 20 11 9 10 3 1 0 PASI 50 PASI 75 PASI 90 †P < 0.0001 vs. placebo for all comparisons References1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  31. Patient Quality of Life Significantly Improved Within 2 Weeks1,2 Phase III Global Trial (Dose-Reduction Data) Placebo 80 ‡ 70% ENBREL* 25 mg BIW ‡ 70 ENBREL 50 mg BIW 65% 60 ‡ ‡ ‡ 50 Mean % Improvement in DLQI From Baseline ‡ 40 ‡ 30 † 20 6% 10 0 2 0 4 8 12 Weeks †P = 0.0002 vs. placebo ‡P < 0.0001 vs. placebo References 1.Data on file, Amgen, Thousand Oaks, Calif. 2. Kreuger G et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p120. *trademark

  32. Dermatologist’s Static Global Assessment of Psoriasis:Percent of Patients Achieving Clear or Almost Clear Status1 Phase III Global Trial (Dose-Reduction Data) 80 70 Placebo 57 60 ENBREL* 25 mg BIW ENBREL 50 mg BIW 50 % of Patients Achieving Clear or Almost-Clear Status 39 40 30 20 10 4 0 12 Weeks DSGAP significantly improved vs. placebo for both doses by week 4 P < 0.0001 vs. placebo for both ENBREL dose groups at week 12 Reference 1. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  33. 70 Placebo 55 ENBREL* 25 mg BIW 60 ENBREL 50 mg BIW 50 40 40 % of Patients 30 20 5 10 0 12 Weeks P < 0.0001 vs. placebo for both dose groups in Patient Global Assessment of Psoriasis Patient’s Global Assessment of Psoriasis:1Patients Achieving a Score of 0 or 1 (0 to 5 Scale) Phase III Global Trial (Dose-Reduction Data) 80 Reference 1.Data on file, Amgen, Thousand Oaks, Calif. *trademark

  34. ENBREL* Was Generally Well ToleratedWeek 12 Safety: Most common adverse events (% of patients)1,2 Phase III Global Trial (Dose-Reduction Data) Adverse events occurring in3% in any treatment group Reference 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  35. Phase III Global Trial (Dose-Reduction Data)Patient 2365 6 Months Baseline 3 Months 5.7 6.0 57.3 PASI score 90 PASI % improvement 89 Patient was initially treated with ENBREL* 50 BIW and crossed over to 25 mg BIW at 3 months. *trademark Reference 1.Data on file, Amgen, Thousand Oaks, Calif.

  36. Phase III Global Trial (Dose-Reduction Data)Patient 3066 1 month Baseline 3 months 6 months PASI score 31.6 5.7 1.3 0.6 82 96 PASI % improvement 98 Patient was initially treated with ENBREL* 50 mg BIW and crossed over to 25 mg BIW at 3 months. Reference 1. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  37. Summary of Efficacy Data from Phase III Global Trial (Dose-Reduction Data)1–3 ENBREL* can provide rapid, sustained, and clinically meaningful efficacy in plaque psoriasis • Significant differences from placebo seen as early as week 2 in % improvement in PASI and DLQI • 50 mg BIW and 25 mg BIW were both significantly effective at week 12 in multiple measures • PASI 50/75/90 • DSGAP • DLQI • PGAP • Efficacy was sustained across 24 weeks regardless of dose or regimen References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. 3. Krueger G et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p120. *trademark

  38. Summary of Tolerability from Phase III Global Trial (Dose-Reduction Data)1,2 ENBREL* was well tolerated • Frequency of injection-site reactions in both groups receiving ENBREL was higher than placebo at week 12 • Incidence of infections in both ENBREL groups was comparable to placebo at week 12 • No increased incidence of adverse events was seen in patients receiving 50 mg BIW versus 25 mg BIW References 1. Data on file, Amgen, Thousand Oaks, Calif. 2. Papp K et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p112. *trademark

  39. Overview • ENBREL* EU Indications for Psoriatic Diseases • Overview of Psoriasis • Clinical Evidence for the Role of TNF in Psoriasis • Pivotal Phase III Trials - Phase III Global Trial (Dose-reduction Data) - Phase III U.S. Trial (Re-treatment Data) - Discontinuation and Re-treatment - Pooled Safety Data 5. Conclusions and Important Treatment Considerations *trademark

  40. Design of Phase III U.S. Trial (Re-treatment Data)1–3 Discontinuation and Re-treatment Double Blind E* 50 mg twice weekly PASI 50 E 25 mg twice weekly Discontinue drug E50 mg twice weekly (n=168) E 25 mg once weekly E 25 mg twice weekly (n=167) Blinded re-treatment with week 24 dose at time of relapse E 25 mg once weekly (n=169) 25 mg twice weekly Placebo (n=168) PASI <50 25 mg twice weekly Day 1 Week 12 Week 24 Primary Time Point Assess Responder Status E = ENBREL *trademark References 1. Leonardi CL et al. N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oak, Calif. 3. Gottlieb AB et al. Poster presented at 10th International Psoriasis Symposium, June 10–13, 2004, Toronto. Abstracts, p110.

  41. Key Patient Eligibility CriteriaPhase III U.S. Trial (Re-treatment Data)1,2 • Exclusion • Any previous treatment with ENBREL* or antibody to TNF treatment • Investigational drugs, biologics, systemic psoriasis therapy, systemic corticosteroids, or PUVA within 4 weeks of study drug administration • Topical corticosteroids, topical vitamin A or D analogue preparations, UVB, or anthralin within 2 weeks of study drug administration • Anti-CD4 or diphtheria IL-2 fusion protein within 6 months of study drug administration • Severe infection within 4 weeks, or antibiotics within 1 week of study drug administration Inclusion • Active but clinically stable plaque psoriasis involving  10% BSA • Minimum screening PASI score of 10 • At least one previous phototherapy or systemic psoriasis therapy, or a candidate for such therapy • At least 18 years of age References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  42. Key Efficacy MeasuresPhase III U.S. Trial (Re-treatment Data) Primary end point1 • % of patients in each treatment group achieving PASI 75 at week 12 Secondary end points1,2 • % of patients with PASI 50, PASI 75, and PASI 90 at different time points • Dermatologist’s Static Global Assessment of Psoriasis (DSGAP) (05) • Dermatology Life Quality Index (DLQI) (030) • Patient Global Assessment of Psoriasis (PGAP) • Health status “feeling thermometer” (0100) References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif.

  43. Similar Baseline Demographics/Clinical Characteristics Across Groups1,2 Phase III U.S. Trial (Re-treatment Data) References 1. Leonardi CL et al.N Engl J Med 2003;349: 2014–2022. 2. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  44. Significant Improvement in PASI Score as Early as Week 21,2 Phase III U.S. Trial (Re-treatment Data) 80 Placebo 71.1% ENBREL* 25 mg QW 70 ENBREL 25 mg BIW ENBREL 50 mg BIW ‡ 62.1% 60 ‡ 50 50.3% ‡ ‡ 40 ‡ Mean% Improvement from Baseline PASI Score ‡ ‡ 30 ‡ ‡ †P≤ 0.003 vs. placebo ‡P < 0.0001 vs. placebo ‡ 20 † † 10 0 0 4 8 12 16 20 24 2 Weeks References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif. *trademark

  45. 25 PASI 75 Response Significant at Week 12 and Sustained at Week 241,2 Phase III U.S. Trial (Re-treatment Data) Placebo 80 ENBREL* 25 mg QW 70 ENBREL 25 mg BIW 59 ENBREL 50 mg BIW 60 ‡ 49 50 44 % of Patients with PASI 75 Response ‡ 40 34 †P < 0.05 vs. placebo ‡P < 0.0001 vs. placebo 30 † 20 14 10 4 0 12 Weeks 24 Weeks References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif. *trademark

  46. PASI 50 and 90 Response Rates Improved During Treatment1,2 Phase III U.S. Trial (Re-treatment Data) † 77 80 74 Placebo 70 ENBREL* 25 mg QW 70 ENBREL 25 mg BIW † 58 58 ENBREL 50 mg BIW 60 % of Patients 50 † 41 40 30 30 † †P < 0.0001 vs. placebo 22 20 20 † 14 12 6 10 3 1 0 12 Weeks 24 Weeks 12 Weeks 24 Weeks (PASI 50) (PASI 50) (PASI 90) (PASI 90) References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif. *trademark

  47. Patient Quality of Life Significantly Improved Within 2 Weeks1,2DLQI Percentage Improvement in Total Score Phase III U.S. Trial (Re-treatment Data) Placebo 80 ENBREL* 25 mg QW 74% ENBREL 25 mg BIW 70 ENBREL 50 mg BIW ‡ 59% 60 ‡ 54% ‡ 50 ‡ ‡ 40 ‡ Mean % Improvement in DLQI From Baseline ‡ ‡ ‡ 30 † ‡ † 20 10 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks †P = 0.01 vs. placebo ‡P = 0.0001 vs. placebo References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif. *trademark

  48. Dermatologist’s Static Global Assessment of Psoriasis: Percentage of Patients Achieving Clear or Almost Clear Status1,2 Phase III U.S. Trial (Re-treatment Data) Placebo 80 ENBREL* 25 mg QW ENBREL 25 mg BIW 70 ENBREL 50 mg BIW 55 60 † 49 50 39 % of Patients Achieving Clear or Almost-Clear Status † 34 40 † 26 30 23 20 5 10 0 12 Weeks 24 Weeks † P<0.0001 vs. placebo References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on File, Amgen, Thousand Oaks, Calif. *trademark

  49. Patient’s Global Assessment of Psoriasis:Patients Achieving a Score of 0 or 1 (0 to 5 Scale)1,2 Phase III U.S. Trial (Re-treatment Data) Placebo 80 ENBREL* 25 mg QW 66 70 ENBREL 25 mg BIW ENBREL 50 mg BIW 60 † 50 46 50 % of Patients Achieving Score of 0 or 1 † 35 40 31 30 † 17 20 5 10 0 12 Weeks 24 Weeks †P < 0.0001 vs. placebo References 1. Leonardi CL et al.N Engl J Med 2003;349:2014–2022. 2. Data on file, Amgen, Thousand Oaks, Calif. *trademark

  50. Tolerability Data for Dose-Ranging Period Placebo ENBREL* ENBREL Weeks 1–12 Weeks 12–24 Weeks 1–24 Placebo 25 mg BIW 25 mg QW 25 mg BIW 50 mg BIW Injection-site reaction 7% 7% 14% 20% 16% Upper respiratory infection 11% 6% 14% 14% 12% Headache 7% 5% 5% 12% 9% Asthenia 3% 1% 6% 7% 3% Myalgia 2% 2% 5% 7% 4% Sinusitis 1% 1% 6% 6% 5% Rash 2% 0% 2% 4% 6% Nausea 1% 1% 5% 3% 3% Injection-site ecchymosis 4% 2% 7% 3% 5% Adverse events and infections occurring in  5% of patients in any dose group Reference 1. Leonardi CL et al. N Engl J Med 2003;349:2014–2022. *trademark

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