ne in the Mayo score by ≥30% and ≥3 points, accompanied
by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.Clinical Response, Clinical Remission, and Mucosal Healing
In both Study UC I and Study UC II, greater percentages of patients in both infliximabgroups achieved clinical response, clinical remission and mucosal healing than in the placebogroup.
Each of these effects was maintained through the end of each trial (Week 54 in StudyUC I, and Week 30 in Study UC II). In addition, a greater proportion of patients in infliximabgroups demonstrated sustained response and sustained remission than in the placebo groups(Table 5).
Of patients on corticosteroids at baseline, greater proportions of patients in the infliximabtreatment groups were in clinical remission and able to discontinue corticosteroids at Week30 compared with the patients in the placebo treatment groups (22% in infliximab treatmentgroups vs. 10% in placebo group in Study UC I; 23% in infliximab treatment groups vs. 3%in placebo group in Study UC II). In Study UC I, this effect was maintained through Week 54(21% in infliximab treatment groups vs. 9% in placebo group). The infliximab-associatedresponse was generally similar in the 5 mg/kg and 10 mg/kg dose groups.
Table 5 Response, remission and mucosal healing in ulcerative colitis studies
Study UC I Study UC II
Placebo 5 mg/kg
infliximab
10 mg/kg
infliximab Placebo 5 mg/kg
infliximab
10 mg/kg
infliximab
Patients
randomized 121 121 122 123 121 120
Clinical Responsea,d
Week 8 37% 69%* 62%* 29% 65%* 69%*
Week 30 30% 52%* 51%** 26% 47%* 60%*
Week 54 20% 45%* 44%* NA NA NA
Sustained Responsed
(Clinical
response at
both Week 8
and 30)
23% 49%* 46%* 15% 41%* 53%*
(Clinical
response at
Week 8, 30
and 54)
14% 39%* 37%* NA NA NA
Clinical Remissionb,d
Week 8 15% 39%* 32%** 6% 34%* 28%*
Week 30 16% 34%** 37%* 11% 26%** 36%*
Week 54 17% 35%** 34%** NA NA NA
Sustained Remissiond
(Clinical
response at
both Week 8
and 30)
8% 23%** 26%* 2% 15%* 23%*
(Clinical
response at
Week 8, 30
and 54)
7% 20%** 20%** NA NA NA
Mucosal Healingc, d
Week 8 34% 62%* 59%* 31% 60%* 62%*
Week 30 25% 50%* 49%* 30% 46%** 57%*
Week 54 18% 45%* 47%* NA NA NA
* P < 0.001, ** P < 0.01 a Defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease inthe rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. (The Mayo score consists of the sumof four subscores: stool frequency, rectal bleeding, physician’s global assessment and endoscopy findings.)
b Defined as a Mayo score ≤2 points, no individual subscore >1.
c Defined as a 0 or 1 on the endoscopy subscore of the Mayo score.
d Patients who had a prohibited change in medication, had an ostomy or colectomy, or discontinued studyinfusions due to lack of efficacy are considered to not be in clinical response, clinical remission or mucosalhealing from the time of the event onward.
The improvement with infliximab was consistent across all Mayo subscores through Week 54(Study UC I shown in Table 6; Study UC II through Week 30 was similar).
Table 6 Proportion of patients in Study UC I with Mayo subscores indicating inactiveor mild disease through Week 54
Study UC I
Infliximab
Placebo 5 mg/kg 10 mg/kg
(n = 121) (n = 121) (n = 122)
Stool frequency
Baseline 17% 17% 10%
Week 8 35% 60% 58%
Week 30 35% 51% 53%
Week 54 31% 52% 51%
Rectal bleeding
Baseline 54% 40% 48%
We |
