Safety and efficacy of Profermin® to induce remission in ulcerative colitis

Table 1 Simple Clinical Colitis Activity Index[10]

Symptom	Score
Bowel frequency (d)
1-3	0
4-6	1
7-9	2
> 9	3
Bowel frequency (night)
1-3	1
4-6	2
Urgency of defecation
Hurry	1
Immediately	2
Incontinence	3
Blood in stool
Trace	1
Occasionally frank	2
Usually frank	3
General wellbeing
Very well	0
Slightly below par	1
Poor	2
Very poor	3
Terrible	4
Extracolonic features	1 per manifestation

Table 2 Description of four excluded patients and eight dropouts

Day	SCCAI run in	Reason for discontinuation	SCCAI dropout	Reduction	Increase
Excluded patients
10	8.9	1	6.6	2.3
45	8.0	1	4.1	3.9
100	8.2	1	4.1	4.1
116	11	2	3.6	7.4
Drop-outs
9	8.9	3	6.7	2.2
54	4.6	3	5.1		0.5
73	5.9	3	7.3		1.4
100	5.6	3	8.4		2.8
102	9.0	3	6.7	2.3
127	6.6	3	5.6	1.0
140	6.7	3	5.3	1.4
141	8.3	3	6.3	2.0

Reasons for discontinuation in the study. 1: Excluded because of new medication prescribed for unrelated diseases; 2: Excluded because of new medication prescribed for colitis; 3: Dropouts main reason: Not satisfied with effect of treatment. SCCAI: Simple Clinical Colitis Activity Index.

Table 3 Demographic and baseline clinical characteristics of patients

Characteristic	Profermin, n = 39
Sex, male:female	15/24
Age, yr, median and range	35 (19-50)
Mean duration of disease, yr, median and range	7 (1-21)
Disease location, n (%)
Proctitis	17 (44)
Left-sided colitis/procto-sigmoiditis	11 (28)
Pancolitis	11 (28)
Extraintestinal manifestations, n (%)	17 (43)
Initial CRP, mg/L, median and range	15 (< 1-156)
Initial albumin, g/L, median and range	41 (23-47)

CRP: C-reactive protein.

Table 4 Concomitant medications

	n (%)
Mesalamine oral
Alone	21 (54)
Combined with immunosuppressants	8 (21)
Mesalamine enema or suppository	6 (15)
Azathioprine or 6-mercaptopurine	3 (8)
Corticosteroids oral	0 (0)
Corticosteroids enema	1 (3)
Antibiotics	0 (0)
TNF-α inhibitors	3 (8)
None	3 (8)

TNF-α: Tumor necrosis factor alpha.