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Medical Sample 20

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Medical Sample 20

  1. 1. Osteoarthritis Images from Ruddy S, Harris ED, Sledge CB eds. Kelly’s Textbook of Rheumatology. 6th ed. Philadelphia, PA: W.B. Saunders Company; 2001. Reprinted from Kelley’s Textbook of Rheumatology with permission from Elsevier.
  2. 2. Rheumatoid Arthritis Images from Ruddy S, Harris ED, Sledge CB eds. Kelly’s Textbook of Rheumatology. 6th ed. Philadelphia, PA: W.B. Saunders Company; 2001. Reprinted from Kelley’s Textbook of Rheumatology with permission from Elsevier.
  3. 3. Proposed Pathogenesis of RA Triggering event (Antigenic stimulus) Non-T-Cell Dependent T-Cells (CD4+) Mechanisms • Crucial to early immunological •Aberrant cytokine cascades response •Impaired growth and apoptosis Proinflammatory cascade •Cell-cell interactions • Mediated by cytokines including IL-1, IL-6, IL-18, and GM-CSF • TNFα has pivotal role --Bone and cartilage resorption Inflammation, --HLA class II expression destructive pathways --Collagenase and PGE2 induction --Chemotaxis --á of additional proinflammatory cytokines --Endothelial cell activation via adhesion Ongoing contribution to molecule chronic inflammation --T- and B-cell activation 1. Koopman WJ. JAMA. 2001; 285:648-650. 2. Buch M, et al. Hospital Pharmacist. 2002;9:5-10.
  4. 4. Modifying the Therapeutic Approach to RA — The Old Paradigm • Progressive In tra addition to -a rti foundation of Experimental y cu er drugs/procedures, lar DMARDs, g ur cytotoxics ag starting with c s en edi ts least toxic op ,c Penicillamine, methotrexate, rth or azathioprine tic o al, os c ni te ro a Hydroxychloroquine, sulfasalazine ch id e s M fo rf Antimalarials, gold lar es FOUNDATION: Education, rest, exercise, social services NSAID and/or salicylate therapy 1. Diagram adapted from: Primer on Rheumatic Diseases. 10th ed.Schumacher HR Klippel JH, Koopman WJ. eds. Atlanta, GA: Arthritis Foundation; 1993.
  5. 5. Modifying the Therapeutic Approach to RA — The New Paradigm In tra • Rapid, early addition -a of DMARDs to rti Surgery cu prevent structural lar damage ag en l Biologics + methotrexate ts ica ,c n or ha tic ec os M te Change/add DMARDs ± methotrexate ro id s fo rf lar FOUNDATION: es DMARDs within 3 months ±NSAID, ±Steroids Education, occupational therapy, physical therapy 1. O’Dell JR et al. Patient Care.1997;March 15:81-99. 2. ACR. Arthritis Rheum. 1996;39:713-722. 3. ACR. Arthritis Rheum. 2002;46:328-346. 4. Diagram adapted from: Primer on Rheumatic Diseases. 10th ed.Schumacher HR Klippel JH, Koopman WJ. eds. Atlanta, GA: Arthritis Foundation; 1993.
  6. 6. Demographic Characteristics and Baseline Disease Characteristics1 Meloxicam Meloxicam Meloxicam* Placebo 7.5 mg 15 mg 22.5 mg n=292 n=306 n=293 n=293 Age (years), mean (SD) 53.6 (12.9) 55.7 (11.2) 54.6 (12.0) 55.4 (12.6) Gender Male 21% 18% 23% 18% Female 79% 82% 77% 82% Race Caucasion 89% 90% 90% 90% Black 3% 4% 5% 2% Asian 7% 6% 5% 7% RA History (years), mean (SD) 9.0 (8.6) 10.3 (9.3) 9.3 (8.2) 9.7 (9.0) RA ≤5 Years 42% 37% 39% 39% ≥5 Years 58% 63% 61% 61% Active joints at screening (SD) Painful 14.0 (9.9) 14.3 (10.6) 14.6 (10.8) 13.3 (9.5) Swollen 9.6 (7.5) 9.6 (7.8) 9.7 (7.8) 9.2 (7.2) Number of second-line 0 24% 18% 24% 25% RA therapies used 1 36% 45% 39% 38% 2 32% 30% 27% 28% 3 or more 8% 7% 10% 10% *Meloxicam 22.5 mg is not an approved dosage. In clinical trials, no incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. Higher doses of meloxicam (22.5 mg and greater) have been associated with increased risk of serious gastrointestinal events; therefore the daily dose of meloxicam should not exceed 15 mg. Please see Important Safety Information at the end of this presentation and full Prescribing Information, including boxed WARNING, provided at this presentation. Some sub-columns in table do not add 1. Kivitz A, et al. Poster presented at ACR/ARHP Annual Scientific Meeting, October 2004. up to 100% because of rounding.
  7. 7. ACR 20 Responder Rate at 12 Weeks for Evaluable Patients1 60 53.9† *P=.0008 vs. placebo (158/293) 49.8† †P<.0001 vs. placebo 45.1* (146/293) 50 (138/306) Responders (%) 40 33.2 (97/292) 30 20 10 0 Placebo Mel. 7.5 mg/d Mel. 15 mg/d Mel. 22.5 mg/d ‡ ‡Meloxicam 22.5 mg is not an approved dosage. In clinical trials, no incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. Higher doses of meloxicam (22.5 mg and greater) have been associated with increased risk of serious gastrointestinal events; therefore the daily dose of meloxicam should not exceed 15 mg. Please see Important Safety Information at the end of this presentation and full Prescribing Information, including boxed WARNING, provided at this presentation. 1. Kivitz A, et al. Poster presented at ACR/ARHP Annual Scientific Meeting, October 2004.
  8. 8. ACR 20 Responder Rates Results Over Time1,2 60 50 ** ** * * Responders % 40 * * * 30 20 *P<.05 vs. placebo 10 0 4 Weeks 8 Weeks 12 Weeks Placebo Mel. 7.5 mg Mel. 15 mg Mel. 22.5 mg† †Meloxicam 22.5 mg is not an approved dosage. In clinical trials, no incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. Higher doses of meloxicam (22.5 mg and greater) have been associated with increased risk of serious gastrointestinal events; therefore the daily dose of meloxicam should not exceed 15 mg. Please see Important Safety Information at the end of this presentation and full Prescribing Information, including boxed WARNING, provided at this presentation. 1.Kivitz A et al. Poster presented at ACR/ARHP Annual Scientific Meeting , October 2004. 2. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
  9. 9. Results: Secondary Efficacy Endpoints1 Number of Painful/Tender Joints Over Time Patient Assessment of Pain Over Time *P<.05 vs. placebo for all doses of meloxicam at 4, 8, and 12 weeks (both graphs)2 * * * * * * * * ** * * ** * * * * † † †Meloxicam 22.5 mg is not an approved dosage. In clinical trials, no incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. Higher doses of meloxicam (22.5 mg and greater) have been associated with increased risk of serious gastrointestinal events; therefore the daily dose of meloxicam should not exceed 15 mg. Please see Important Safety Information at the end of this presentation and full Prescribing Information, including boxed WARNING, provided at this presentation.

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