Treatment

Clinical Studies of Coxib Efficacy in Osteoarthritis (OA) and Rheumatoid Arthritis (RA): Tables 1 and 2

Part 2: COX-2-Selective Inhibitors in the Treatment of Arthritis

Thomas J. Schnitzer, MD, PhD
Director, Office of Clinical Research and Training
Northwestern University
Chicago, IL
Marc C. Hochberg, MD, MPH
Chief, Department of Rheumatology
University of Maryland School of Medicine
Baltimore, MD
Table 1:
Clinical Studies of Coxib Efficacy in Osteoarthritis

Author N Study Drug Comparator Duration Clinical Response
Simon et al(8) 293 Celecoxib
40 mg BID
(n = 73)
100 mg BID
(n = 76)
200 mg BID
(n = 73)		 Placebo
(n = 71)		 2 weeks All 3 celecoxib regimens superior to placebo in mean improvements of disease status (P ≤ .048)
           
Bensen et al(34) 1,003 Celecoxib
50 mg BID
(n = 203)
100 mg BID
(n = 197)
200 mg BID
(n = 202)

Naproxen
500 mg BID
(n = 198)
Placebo

(n = 203)

 12 weeks Celecoxib 100 mg and 200 mg BID comparable to naproxen, superior to placebo in mean improvements in WOMAC index, global assessments (P ≤ .05)
           
McKenna et al(35) 600 Celecoxib
100 mg BID
(n = 201)

Diclofenac
50 mg TID
(n = 199)
Placebo
(n = 200)

 6 weeks Celecoxib comparable to diclofenac, superior to placebo in mean decrease in VAS pain, percent with 2-grade improvements in disease status (P ‹ .001)
           
Singh et al(36) 13,
194 		Celecoxib
100 mg BID
200 mg BID		 Naproxen
500 mg BID
Diclofenac
50 mg BID		 12 weeks Celecoxib comparable to diclofenac in mean decrease in VAS pain
           
Williams et al(26) 718 Celecoxib
100 mg BID
(n = 243)		 Celecoxib
200 mg QD
(n = 231)
Placebo
(n = 244)		 6 weeks Celecoxib QD, BID regimens comparable, superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments (P ‹ .05)
           
Ehrich et al(39) 672 Rofecoxib
5 mg QD
(n = 149)
12.5 mg QD
(n = 144)
25 mg QD
(n = 137)
50 mg QD
(n = 97)		 Placebo
(n = 145)		 6 weeks Rofecoxib 12.5-mg, 25-mg, 50-mg regimens produced dose-dependent efficacy superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments
(P ‹ .001)
           
Ehrich et al(37) 219 Rofecoxib
25 mg QD
(n = 73)
125 mg QD
(n = 74)		 Placebo
(n = 72)		 6 weeks Both rofecoxib regimens comparable, superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments (P ‹ .001)
           
Day et al(40) 809 Rofecoxib
12.5 mg QD
(n = 244)
25 mg QD
(n = 242)		 Ibuprofen
800 mg TID
(n = 249)
Placebo
(n = 74)		 6 weeks Rofecoxib comparable to ibuprofen, superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments
(P ≤ .009)
           
Geba et al(41) 1,042 Rofecoxib
12.5 mg QD
(n = 424)		 Nabumetone
1,000 mg QD
(n = 410)
Placebo
(n = 208)		 6 weeks Rofecoxib superior to nabumetone (P ‹ .05) and placebo (P ‹ .001) in mean improvements in global assessment
           
Truitt et al(13) 341 Rofecoxib
12.5 mg QD
(n = 118)
25 mg QD
(n = 56)		 Nabumetone
1,500 mg QD
(n = 115)
Placebo
(n = 52)		 6 weeks In patients ≥80 years, rofecoxib comparable to nabumetone, superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments (P ‹ .05)
           
Saag et al(30 736 Rofecoxib
12.5 mg QD
(n = 219)
25 mg QD
(n = 227)		 Ibuprofen
800 mg TID
(n = 221)
Placebo
(n = 69)		 6 weeks Rofecoxib comparable to ibuprofen, superior to placebo in mean improvements in WOMAC index, global assessments
(P ‹ .001)
           
Saag et al(30) 693 Rofecoxib
12.5 mg QD
(n = 231)
25 mg QD
(n = 232)		 Diclofenac
50 mg TID
(n = 230)		 52 weeks Rofecoxib 25 mg comparable to diclofenac, superior to placebo in mean improvements in WOMAC index, global assessments
(P ‹ .001)
           
Cannon et al(11) 784 Rofecoxib
12.5 mg QD
(n = 259)
25 mg QD
(n = 257)		 Diclofenac
50 mg TID
(n = 268)		 26 weeks Rofecoxib comparable to diclofenac, superior to placebo in mean improvements in VAS pain, WOMAC index (taken to week 26), global assessments
           
Geba et al (42) 382 Rofecoxib
12.5 mg QD
(n = 96)
25 mg QD
(n = 95)		 Celecoxib
200 mg QD
(n = 97)
Acetaminophen
1,000 mg QID
(n = 94)		 6 weeks Rofecoxib 25 mg statistically superior to celecoxib, acetaminophen in mean improvements in VAS pain, WOMAC index, global assessments, onset of relief
           
Schnitzer et al(43) 1,082 Rofecoxib
25 mg QD
(n = 471)		 Celecoxib
200 mg QD
(n = 460)
Placebo
(n = 151)		 6 weeks Rofecoxib statistically superior to celecoxib, placebo in mean improvements in VAS pain, WOMAC index, global assessments, onset of relief
           
Eskiyurt(46) 138 Rofecoxib
12.5 mg QD		 Rofecoxib
25 mg QD		 6 weeks In Turkish population, rofecoxib regimens comparable in mean improvements in WOMAC, Lequesne Algofunctional indices
           
Fiechtner et al(47) 642 Valdecoxib
0.4 mg BID
1.25 mg BID
2.5 mg BID
5 mg BID
10 mg QD
10 mg BID		 Naproxen
500 mg BID
Placebo 		6 weeks Valdecoxib produced dose-dependent efficacy comparable to naproxen at 5 mg BID, 10 mg QD, and 10 mg BID; superior to placebo at all dosages except .5 mg BID in mean improvements in VAS pain, WOMAC index, global assessments (P ≤ .004)
           
Curtis et al(32) 617

Etoricoxib
5 mg QD
(n - 117)
10 mg QD
(n = 114)
30 mg QD
(n = 102)
60 mg QD
(n = 112)
90 mg QD
(n = 112)

 Placebo
(n = 60)		 6 weeks
(Part I)		 Etoricoxib produced dose-dependent efficacy superior to placebo in mean improvements in VAS pain, global assessments (P ‹ .05)
           
Curtis et al(32) 617 Etoricoxib
30 mg QD
60 mg QD
90 mg QD		 Diclofenac
50 mg TID		 46 weeks
(Part II)		 Etoricoxib 60-mg, 90-mg regimens superior to 30-mg regimen in mean improvements in VAS pain, global assessments
           
Fisher et al(33) 496 Etoricoxib
60 mg QD
(n = 222)		 Naproxen
500 mg BID
(n = 218)
Placebo
(n = 56)		 12 weeks
(Part I)		 Etoricoxib 60 mg comparable to naproxen, superior to placebo in mean improvements in VAS pain, WOMAC index, global assessments
           
Fisher et al(33) 496 Etoricoxib
60 mg QD
(n = 248)		 Naproxen
500 mg BID
(n = 248)		 40 weeks (Part II) Etoricoxib 60 mg comparable to naproxen in mean improvements in VAS pain, WOMAC index, global assessments
           
Schnitzer et al(48) 583 COX-189
50 mg BID
100 mg BID
200 mg BID
400 mg BID		 Diclofenac SR
74 mg BID
Placebo 		4 weeks All regimens of COX-189 comparable to diclofenac, superior to placebo in mean improvements in VAS pain, WOMAC index, HAQ index, global assessments

Table 2: Clinical Studies of Coxib Efficacy in Rheumatoid Arthritis

Author N Study Drug Comparator Duration Clinical Response
Simon et al(8) 330 Celecoxib
40 mg BID
(n = 81)
200 mg BID
(n = 82)
400 mg BID
(n = 82)		 Placebo
(n = 85)		 4 weeks Celecoxib 200-mg, 400-mg regimens superior to placebo in mean improvements in global assessment (P ‹ .001); number tender, swollen joints (P ≤ .005); percent improved by ACR 20 criteria (P ≤ .025)
           
Simon et al(12) 1,149 Celecoxib
100 mg BID
(n = 240)
200 mg BID
(n = 235)
400 mg BID
(n = 218)		 Naproxen
500 mg BID
(n = 225)
Placebo
(n = 231)		 12 weeks Celecoxib 200-mg, 400-mg regimens comparable to naproxen, superior to placebo in mean improvements in global assessments; HAQ index; number tender, swollen joints; percent improved by ACR 20 criteria
(P ‹ .05)
           
Emery et al(31) 655 Celecoxib
200 mg BID
(n = 326)		 Diclofenac SR
75 mg BID
(n = 329)		 24 weeks Celecoxib comparable to diclofenac in mean improvements in VAS pain; global assessments; HAQ index; number tender, swollen joints; percent improved by ACR 20 criteria
           
Bensen et al(51) 1,089 Valdecoxib
10 mg QD
20 mg QD
40 mg QD		 Naproxen
500 mg BID
Placebo 		12 weeks Valdecoxib, all doses, comparable to naproxen, superior to placebo in ACR 20 response
           
Schnitzer et al(15) 658 Rofecoxib
5 mg QD
(n = 158)
25 mg QD
(n = 171)
50 mg QD
(n = 161)		 Placebo
(n = 168)		 8 weeks Rofecoxib 25-mg, 50-mg regimens superior to placebo in mean improvements in VAS pain; global assessments; HAQ index; number tender, swollen joints; percent improved by ACR 20 criteria (P ‹ .001)
           
Truitt et al(49) 1,058 Rofecoxib
25 mg QD
(n = 315)
50 mg QD
(n = 297)		 Naproxen
500 mg BID
(n = 147)
Placebo
(n = 299)		 12 weeks Rofecoxib comparable to naproxen, superior to placebo in mean improvements in VAS pain; HAQ index; number tender, swollen joints; percent improved by ACR 20 criteria (P ‹ .05)
           
Truitt et al(50) 909 Rofecoxib
12.5 mg QD
(n = 148)
25 mg QD
(n = 311)		 Naproxen
500 mg BID
(n = 149)
Placebo
(n = 301)		 12 weeks Rofecoxib 25 mg comparable to naproxen, superior to placebo in iprovements in VAS pain; global assessments; number tender, swollen joints; percent improved by ACR 20 criteria; rofecoxib 12.5 mg superior to placebo in VAS pain, global assessments, and percent improved by ACR criteria
           
Curtis et al(52) 581

Etoricoxib
10 mg QD
(n = 78)
60 mg QD
(n = 126)
90 mg QD
(n = 134)
120 mg QD
(n = 120)

 Placebo
(n = 123)		 8 weeks Etoricoxib 90-mg and 120-mg regimens superior to placebo in mean improvements in VAS pain, global assessments, HAQ index (P ‹ .05)
           
Melian et al(53) 816 Etoricoxib
90 mg QD
(n = 323)		 Naproxen
500 mg BID
(n = 170)
Placebo
(n = 323)		 12 weeks Etoricoxib superior to naproxen, placebo in mean improvements in HAQ index; number tender, swollen joints; percent improved by ACR 20 criteria (P ‹ .05)

Schnitzer TJ, Hochberg MC. COX-2-selective inhibitors in the treatment of arthritis. Cleve Clin J Med 2002;69:SI20-30.

Last Updated: 09/12/2006
Continue Reading: Clinical Trials of Coxibs in Osteoarthritis (OA)
What is This?
Related Articles on SpineUniverse
To help you navigate through this wealth of information, the Editorial Board of SpineUniverse presents links to "Related Articles" at the end of each article . In addition, to help you find additional information you need, we encourage you to use the "Search" tool located at the top of each page.

Related Articles on this Topic