(infliximab)
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Last Updated: 01/11/2025
Rutgeerts et al1 reported on two placebo-controlled, randomized, double-blind Phase 3 trials (ACT 1 and ACT 2) that were conducted to evaluate The safety and efficacy of REMICADE in adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response to conventional oral therapies. Other references of data on this topic are also cited within the clinical trials data as appropriate.
Treatment Groups | |||
---|---|---|---|
Placebo (%) (n=121) | REMICADE 5 mg/kg (%) (n=121) | REMICADE 10 mg/kg (%) (n=122) | |
Clinical Responsec | |||
Week 8 | 37.2 | 69.4 (P<0.001) | 61.5 (P<0.001) |
Week 30 | 29.8 | 52.1 (P<0.001) | 50.8 (P=0.002) |
Week 54 | 19.8 | 45.5 (P<0.001) | 44.3 (P<0.001) |
Clinical Remission c | |||
Week 8 | 14.9 | 38.8 (P<0.001) | 32.0 (P=0.002) |
Week 30 | 15.7 | 33.9 (P=0.001) | 36.9 (P<0.001) |
Week 54 | 16.5 | 34.7 (P=0.001) | 34.4 (P=0.001) |
Sustained Response a, c | |||
Week 8 and Week 30 | 23.1 | 48.8 (P<0.001) | 45.9 (P<0.001) |
Week 8, 30 and 54 | 14 | 38.8 (P<0.001) | 36.9 (P<0.001) |
Sustained Remissionb, c | |||
Week 8 and Week 30 | 8.3 | 23.1 (P=0.001) | 26.2 (P<0.001) |
Week 8, 30 and 54 | 6.6 | 19.8 (P=0.002) | 20.5 (P=0.002) |
Mucosal Healing c | |||
Week 8 | 33.9 | 62.0 (P<0.001) | 59.0 (P<0.001) |
Week 30 | 24.8 | 50.4 (P<0.001) | 49.2 (P<0.001) |
Week 54 | 18.2 | 45.5 (P<0.001) | 46.7 (P<0.001) |
Clinical Remission off Corticosteroids | |||
Week 30 | 10.1 | 24.3 (P=0.030) | 19.2 (P=0.125) |
Week 54 | 8.9 | 25.7 (P=0.006) | 16.4 (P=0.149) |
Refractory to corticosteroid therapy | |||
Clinical Response Week 8 | 35.3 | 77.4 (P<0.001) | 67.7 (P=0.010) |
Not refractory to corticosteroid therapy | |||
Clinical Response Week 8 | 37.9 | 66.7 (P<0.001) | 59.3 (P=0.005) |
a b cPatients who had a prohibited change in medication, had an ostomy or colectomy, or discontinued study infusions due to lack of efficacy are considered to not be in clinical response, clinical remission or mucosal healing from the time of the event onward. |
Treatment Groups | |||
---|---|---|---|
Placebo (n=121) | REMICADE 5 mg/kg (n=121) | REMICADE 10 mg/kg (n=122) | |
Mean weeks in study | 24.2 | 34.8 | 33.3 |
Any adverse event | 85.1% | 87.6% | 91.0% |
Serious adverse events | 25.6% | 21.5% | 23.8% |
Discontinued infusions due to adverse event | 9.1% | 8.3% | 9.0% |
Acute infusion reactions | 10.7% | 9.9% | 12.3% |
Possible delayed hypersensitivity reactions | 1.7% | 1.7% | 0.0% |
Serious infections | 4.1% | 2.5% | 6.6% |
Patients with antibodies to REMICADE | N/A | 7.8% | 4.4% |
Treatment Groups | |||
---|---|---|---|
Placebo (%) (n=123) | REMICADE 5 mg/kg (%) (n=121) | REMICADE 10 mg/kg (%) (n=120) | |
Clinical Responsec | |||
Week 8 | 29.3 | 64.5 (P<0.001) | 69.2 (P<0.001) |
Week 30 | 26 | 47.1 (P<0.001) | 60.0 (P<0.001) |
Clinical Remissionc | |||
Week 8 | 5.7 | 33.9 (P<0.001) | 27.5 (P<0.001) |
Week 30 | 10.6 | 25.6 (P=0.003) | 35.8 (P<0.001) |
Sustained Responsea, c | |||
Week 8 and 30 | 15.4 | 41.3 (P<0.001) | 53.3 (P<0.001) |
Sustained Remissionb, c | |||
Week 8 and 30 | 2.4 | 14.9 (P<0.001) | 22.5 (P<0.001) |
Mucosal Healingc | |||
Week 8 | 30.9 | 60.3 (P<0.001) | 61.7 (P<0.001) |
Week 30 | 30.1 | 46.3 (P=0.009) | 56.7 (P<0.001) |
Clinical Remission and Off Steroids | |||
Week 30 | 3.3 | 18.3 (P=0.010) | 27.3 (P<0.001) |
Refractory to corticosteroid therapy | |||
Clinical Response Week 8 | 37.5 | 63.3 (P=0.053) | 65.5 (P=0.011) |
Not refractory to corticosteroid therapy | |||
Clinical Response Week 8 | 26.4 | 64.8 (P<0.001) | 70.3 (P<0.001) |
aResponse at both weeks 8 and 30. bRemission at both weeks 8 and 30. cPatients who had a prohibited change in medication, had an ostomy or colectomy, or discontinued study infusions due to lack of efficacy are considered to not be in clinical response, clinical remission or mucosal healing from the time of the event onward. |
Treatment Groups | |||
---|---|---|---|
Placebo (n=123) | REMICADE 5 mg/kg (n=121) | REMICADE 10 mg/kg (n=120) | |
Mean weeks in study | 14.4 | 19.3 | 18.6 |
Any adverse events | 73.2% | 81.8% | 80.0% |
Serious adverse events | 19.5% | 10.7% | 9.2% |
Discontinued infusions due to adverse event | 9.8% | 1.7% | 4.2% |
Acute infusion reactions | 8.1% | 11.6% | 11.7% |
Possible delayed hypersensitivity reactions | 0.0% | 0.0% | 0.8% |
Serious infections | 0.8% | 1.7% | 2.5% |
Patients with antibodies to REMICADE | N/A | 9.5% | 3.2% |
A literature search of MEDLINE®
Summarized in this response are data from the pivotal phase 3 trials ACT 1 and ACT 2 which evaluated REMICADE treatment for adults with moderately to severely active UC.
1 | Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. New Engl J Med. 2005;353(23):2462-2476. |
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