(infliximab)
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Last Updated: 01/11/2025
Clinical trials evaluating the safety and efficacy of REMICADE were conducted in 5706 REMICADE-treated and 1600 placebo-treated adult patients with rheumatoid arthritis (RA), Crohn's disease (CD), fistulizing CD, ankylosing spondylitis (AS), psoriastic arthritis (PsA), plaque psoriasis (PsO), and ulcerative colitis (UC).1
The majority of the data from clinical trials with REMICADE reflect both single- and repeat-dosing regimens, including chronic maintenance therapy. The average duration of follow-up for studies in RA, CD, fistulizing CD, AS, PsA, plaque PsO, and UC was 45.5 weeks for patients receiving REMICADE and 29.0 weeks for patients receiving placebo.1
In the following Table: Average Body Weight (kg) at Baseline in REMICADE Clinical Trials, you will find a summary of average body weight (kg) at baseline for adult patients enrolled in REMICADE clinical trials.
Treatment Groups | ||||||||
---|---|---|---|---|---|---|---|---|
PBO±MTX | REM 3 mg/kg every 4 weeks±MTX | REM 3 mg/kg every 8 weeks±MTX | REM 5 mg/kg every 6 weeks±MTX | REM 5 mg/kg every 8 weeks±MTX | REM 6 mg/kg every 8 weeks±MTX | REM 10 mg/kg every 4 weeks±MTX | REM 10 mg/kg every 8 weeks±MTX | |
CROHN'S DISEASE | ||||||||
ACCENT 1 | ||||||||
Patients Evaluated (n) | 188 | — | — | — | 192 | — | — | 193 |
Mean±SD | 74.2±19.8 | — | — | — | 68.3± 16.0 | — | — | 71.1± 18.7 |
Median (IQR) | 72.0 (59.3, 84.0) | — | — | — | 66.0 (56.3, 78.2) | — | — | 68.3 (57.8, 79.5) |
Range | (40.0, 157.3) | — | — | — | (38.0, 128.2) | — | — | (37.7, 156.8) |
FISTULIZING CROHN'S DISEASE | ||||||||
ACCENT 2 | ||||||||
Patients Evaluated (n) | 143 | — | — | — | 139 | — | — | — |
Mean±SD | 73.3±18.3 | — | — | — | 72.6± 16.9 | — | — | — |
Median (IQR) | 70.7 (59.0, 82.0) | — | — | — | 70.0 (60.9, 82.4) | — | — | — |
Range | (37.5, 130.0) | — | — | — | (43.2, 130.0) | — | — | — |
ULCERATIVE COLITIS | ||||||||
ACT 1 | ||||||||
Patients Evaluated (n) | 121 | — | — | — | 121 | — | — | 122 |
Mean±SD | 76.8±16.2 | — | — | — | 80.0± 17.8 | — | — | 76.9± 17.1 |
Median (IQR) | 75.0 (65.0, 86.0) | — | — | — | 79.0 (67.0, 90.4) | — | — | 76.1 (64.3, 87.3) |
Range | (46.0, 128.0) | — | — | — | (40.0, 146.4) | — | — | (46.0, 159.0) |
ACT 2 | ||||||||
Patients Evaluated (n) | 123 | — | — | — | 121 | — | — | 120 |
Mean±SD | 76.1±17.4 | — | — | — | 78.4± 17.8 | — | — | 79.6± 20.6 |
Median (IQR) | 74.7 (61.0, 87.1) | — | — | — | 77.0 (64.3, 88.0) | — | — | 75.0 (67.1, 91.9) |
Range | (42.1, 126.0) | — | — | — | (48.0, 125.4) | — | — | (49.4, 177.3) |
RHEUMATOID ARTHRITIS | ||||||||
ATTRACT | ||||||||
Patients Evaluated (n) | 88 | 86 | 86 | — | — | — | 81 | 87 |
Mean±SD | 73.9±18.6 | 75.4± 19.4 | 73.4± 18.6 | — | — | — | 75.5± 19.3 | 78.5± 20.4 |
Median (IQR) | 70.9 (61.1, 82.5) | 71.9 (60.8, 85.3) | 69.6 (60.0, 86.3) | — | — | — | 73.0 (63.5, 85.0) | 75.0 (63.5, 89.3) |
Range | (45.0, 143.0) | (46.8, 154.5) | (40.0, 120.0) | — | — | — | (48.0, 158.6) | (39.6, 150.5) |
ASPIRE | ||||||||
Patients Evaluated (n) | 296 | — | 372 | — | — | 376 | — | — |
Mean±SD | 77.7±19.1 | — | 77.4± 17.1 | — | — | 78.5± 18.3 | — | — |
Median (IQR) | 74.9 (64.5, 87.0) | — | 75.0 (66.0, 85.9) | — | — | 76.4 (65.0, 89.5) | — | — |
Range | (40.9, 163.0) | — | (38.1, 147.7) | — | — | (43.0, 146.0) | — | — |
START | ||||||||
Patients Evaluated (n) | 362 | — | 360 | — | — | — | — | 361 |
Mean±SD | 72.8±17.9 | — | 72.7± 16.7 | — | — | — | — | 73.8± 18.2 |
Median (IQR) | 70.0 (60.0, 82.0) | — | 70.0 (61.0, 83.0) | — | — | — | — | 70.0 (61.0, 86.0) |
Range | (38.0, 132.0) | — | (38.0, 156.0) | — | — | — | — | (40.0, 151.0) |
PSORIATIC ARTHRITIS | ||||||||
IMPACT 2 | ||||||||
Patients Evaluated (n) | 100 | — | — | — | 100 | — | — | — |
Mean±SD | 84.5±20.3 | — | — | — | 87.9± 16.5 | — | — | — |
Median (IQR) | 81.9 (72.0, 96.4) | — | — | — | 86.8 (74.6, 98.1) | — | — | — |
Range | (46.8, 175.0) | — | — | — | (56.3, 155.5) | — | — | — |
ANKYLOSING SPONDYLITIS | ||||||||
ASSERT | ||||||||
Patients Evaluated (n) | 78 | — | — | 201 | — | — | — | — |
Mean±SD | 79.5±15.8 | — | — | 77.5± 13.5 | — | — | — | — |
Median (IQR) | 76.0 (68.0, 88.0) | — | — | 77.0 (68.0, 86.0) | — | — | — | — |
Range | (52.0, 133.4) | — | — | (43.0, 115.4) | — | — | — | — |
PLAQUE PSORIASIS | ||||||||
EXPRESS | ||||||||
Patients Evaluated (n) | 77 | — | — | — | 298 | — | — | — |
Mean±SD | 89.3±18.7 | — | — | — | 85.9± 20.1 | — | — | — |
Median (IQR) | 89.1 (76.0, 101.0) | — | — | — | 85.0 (72.7, 95.9) | — | — | — |
Range | (51.0, 138.0) | — | — | — | (43.0, 162.3) | — | — | — |
EXPRESS II | ||||||||
Patients Evaluated (n) | 208 | — | 313 | — | 314 | — | — | — |
Mean±SD | 91.1±22.6 | — | 92.0± 22.5 | — | 92.2± 23.2 | — | — | — |
Median (IQR) | 88.9 (75.4, 102.0) | — | 88.9 (77.5, 104.7) | — | 88.8 (75.9, 105.0) | — | — | — |
Range | (49.9, 166.0) | — | (44.3, 184.2) | — | (48.6, 167.8) | — | — | — |
SPIRIT | ||||||||
Patients Evaluated (n) | 51 | — | 99 | — | 99 | — | — | — |
Mean±SD | 95.3±26.6 | — | 90.2± 19.9 | — | 95.3± 24.7 | — | — | — |
Median (IQR) | 92.5 (73.0, 110.0) | — | 88.0 (77.0, 102.0) | — | 92.5 (77.1, 108.0) | — | — | — |
Range | (52.0, 187.0) | — | (52.0, 164.6) | — | (56.4, 175.0) | — | — | — |
Abbreviations: IQR, interquartile range; MTX, methotrexate; PBO, placebo; REM, REMICADE; SD, standard deviation. |
1 | Centocor, Inc. Protocol ISS; DoF. |
2 | Centocor, Inc. Protocol C0168T21; page 1741; DoF; 2001. |
3 | Centocor, Inc. Protocol C0168T26; page 1072; DoF; 2002. |
4 | Centocor, Inc. Protocol C0168T37; page 66; DoF; 2005. |
5 | Centocor, Inc. Protocol C0168T46; page 63; DoF; 2005. |
6 | Centocor, Inc. Protocol C0168T22; page 59; DoF; 1998. |
7 | Centocor, Inc. Protocol C0168T29; page 83; DoF; 2003. |
8 | Centocor, Inc. Protocol C0168T41; page 144; DoF; 2004. |
9 | Centocor, Inc. Protocol C0168T50; page 75; DoF; 2004. |
10 | Centocor, Inc. Protocol C0168T51; page 58; DoF; 2004. |
11 | Centocor, Inc. Protocol C0168T38; page 65; DoF; 2004. |
12 | Centocor, Inc. Protocol C0168T44; page 70; DoF; 2005. |
13 | Centocor, Inc. Protocol C0168T31; page 86; DoF; 2003. |