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Medical Sample 20
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. 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. 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. 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. 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. 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. 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. 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. 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.