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C-1 Etanercept (Enbrel ® ) for the Treatment of Ankylosing Spondylitis Backup Visuals FDA Arthritis Advisory Committee June 24, 2003.

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Presentation on theme: "C-1 Etanercept (Enbrel ® ) for the Treatment of Ankylosing Spondylitis Backup Visuals FDA Arthritis Advisory Committee June 24, 2003."— Presentation transcript:

1 C-1 Etanercept (Enbrel ® ) for the Treatment of Ankylosing Spondylitis Backup Visuals FDA Arthritis Advisory Committee June 24, 2003

2 BA-2 ASAS 20 at Week 12 Influence of Associated Diseases* With Associated Diseases 28 59 0 20 40 60 80 (N = 29) 27 61 0 20 40 60 80 (N = 107)(N = 109) Without Associated Diseases (N = 32) *Psoriasis, IBD, ReA % Subjects Study 016.0037 PlaceboEtanercept

3 BA-3 Study 016.0037 Baseline Spinal Mobility Status Mean (median), cm Placebo N = 139 Etanercept N = 138 Modified Schober’s Test 3.0 (3.0) 3.1 (3.0) Chest Expansion Score 3.2 (3.0) 3.3 (3.0) Occiput-to-wall Measurement 5.3 (3.0) 5.6 (4.8)

4 BA-4 Pivotal Program ASAS 20 Response by Injection Site Reactions %PlaceboEtanercept Study 016.0037 With Injection site reactions N = 13 N = 41 23%56% Without Injection site reactions N = 126 N = 97 28%62% Study 47687 With Injection site reactions N = 6 N = 15 33%67% Without Injection site reactions N = 33 N = 30 21%57%

5 BA-5 Study 016.0037 ASAS 20 Response by Age %PlaceboEtanerceptP-value < 34 years N = 38 N = 31 Week 12 32%74%  0.001 Week 24 32%71%  0.001 34 – 41 years N = 25 N = 37 Week 12 24%65%  0.01 Week 24 20%54%  0.01 42 - 49 years N = 35 N = 41 Week 12 29%56%  0.05 Week 24 20%61%  0.001  0.001 50+ years N = 41 N = 29 Week 12 24%45% 0.07 0.07 Week 24 20%45%  0.05

6 SA-6 Uveitis / Iritis PlaceboEtanerceptPlaceboEtanercept N = 139N = 138N = 39N = 45 Baseline History4339613 Flare During Study8310 New Diagnosis0000 Study 016.0037Study 47687 Pivotal Program Number of Subjects


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