Outcomes of 5-aminosalicylates withdrawal due to non-adherence in ulcerative colitis patients: A step toward evaluating intermittent therapy

Table 1 Demographic characteristics, clinical and laboratory findings of patients with 5-aminosalicylate withdrawal, n (%)

Characteristics	Total (n = 30)
Age at onset of IBD (years), median (IQR)	31.0 (22.0-36.0)
Female/male	13 (43.3)/17 (56.7)
Smoking status (current/ex/non-smokers)	7/8/15
Family history of IBD	6 (20.0)
BMI (kg/m2), median (IQR)	23.5 (20.6-27.5)
Total disease duration (months), median (IQR)	175.0 (86.0-254.3)
Duration of remission before 5-ASA withdrawal (months), median (IQR)	140.5 (20.3-192.3)
Follow-up time from 5-ASA withdrawal (months), median (IQR)	26.0 (16.8-65.0)
Disease extension
Proctitis	6 (20.0)
Left-sided UC	21 (70.0)
Extensive UC	3 (10.0)
Extra-intestinal manifestations	14 (46.7)
Prior medications
5-ASA tablet	25 (83.3)
5-ASA granule	2 (6.7)
5-ASA enema	28 (93.3)
5-ASA suppository	5 (16.7)
Sulfasalazine	1 (3.3)
Steroids	9 (30.0)
Thiopurine	3 (10.0)
Adalimumab	0 (0.0)
Infliximab	2 (6.7)
Vedolizumab	0 (0.0)
Ustekinumab	0 (0.0)
Steroid dependence	3 (10.0)
Withdrawal 5-ASA formula
5-ASA tablet	25 (83.3)
5-ASA granule	2 (6.7)
5-ASA enema	18 (60.0)
5-ASA suppository	6 (20.0)
Relapse	12 (40.0)
Baseline CRP (mg/L), median (IQR)	5.0 (5.0-5.0)
Baseline hemoglobin (g/dL), median (IQR)	13.0 (12.0-13.0)
Baseline albumin (g/dL), median (IQR)	4.0 (4.0-4.2)
Baseline eMayo subscore, median (IQR)	1.0 (1.0-1.3)
Baseline pMayo score, median (IQR)	5.0 (5.0-5.0)

Data presented as ‘baseline’ represent ‘at the time of initial diagnosis’. IBD: Inflammatory bowel disease; IQR: Interquartile range; BMI: Body mass index; UC: Ulcerative colitis; CRP: C-reactive protein; 5-ASA: 5-aminosalicylates; eMayo: Endoscopic Mayo subscore; pMayo: Partial Mayo score.

Table 2 Comparison of demographic characteristics, clinical and laboratory findings between relapse and non-relapse groups, n (%)

Characteristics	Relapse (n = 12) (40.0%)	Non-relapse (n = 18) (60.0%)	P value
Age at onset of IBD (years), median (IQR)	31.0 (21.5-34.8)	31.5 (22.0-37.8)	0.5451
Female/male	4 (33.3)/8 (66.7)	9 (50.0)/9 (50.0)	0.3672
Smoking status
Current-smokers	3 (25.0)	4 (22.2)	0.9993
Ex-smokers	3 (25.0)	5 (27.8)
Non-smokers	6 (50.0)	9 (50.0)
Family history of IBD	3 (25.0)	3 (16.7)	0.6603
BMI (kg/m2), median (IQR)	23.2 (20.3-25.8)	23.7 (20.4-31.6)	0.6391
Total disease duration (months), median (IQR)	193.5 (89.3-270.8)	167.5 (69.5-237.5)	0.4651
Duration of remission before 5-ASA treatment withdrawal (months), median (IQR)	152.0 (26.0-206.5)	122.0 (15.3-172.3)	0.3911
Follow-up time from 5-ASA withdrawal (months), median (IQR)	23.5 (14.3-67.3)	29.0 (17.3-61.3)	0.6021
Disease extension
Proctitis	3 (25.0)	3 (16.7)	0.6003
Left-sided UC	7 (58.3)	14 (77.8)
Extensive UC	2 (16.7)	1 (5.6)
Extra-intestinal manifestations	5 (41.7)	9 (50.0)	0.6542
Previous medications
5-ASA tablet	9 (75.0)	16 (88.9)	0.6223
5-ASA granule	2 (16.7)	0 (0.0)	0.1523
5-ASA enema	7 (58.3)	11 (61.1)	0.9993
5-ASA suppository	2 (16.7)	3 (16.7)	0.9993
Sulfasalazine	1 (8.3)	0 (0.0)	0.4003
Steroids	6 (50.0)	3 (16.7)	0.1023
Thiopurine	2 (16.7)	1 (5.6)	0.5483
Biologic agents	1 (8.3)	1 (5.6)	0.9993
Steroid dependence	2 (16.7)	1 (5.6)	0.5483
Withdrawal 5-ASA formula
5-ASA tablet	9 (75.0)	16 (88.9)	0.3643
5-ASA granule	2 (16.7)	0 (0.0)	0.1523
5-ASA enema	7 (58.3)	11 (61.1)	0.9993
5-ASA suppository	2 (16.7)	4 (22.2)	0.9993
Baseline CRP (mg/L), median (IQR)	5.0 (5.0-5.0)	5.0 (4.2-5.0)	0.9171
Hemoglobin (g/dL), median (IQR)	13.0 (12.0-13.0)	13.0 (12.0-13.7)	0.4191
Albumin (g/dL), median (IQR)	4.0 (4.0-4.0)	4.0 (4.0-4.5)	0.1091
Baseline eMayo subscore, median (IQR)	1.0 (1.0-1.8)	1.0 (1.0-1.3)	0.8191
Baseline pMayo score, median (IQR)	5.0 (5.0-5.0)	5.0 (4.2-5.0)	0.6621

¹Mann-Whitney U test.

²Pearson’s χ² test.

³Fisher’s exact test.

Data presented as ‘baseline’ represent ‘at the time of initial diagnosis’. IBD: Inflammatory bowel disease; IQR: Interquartile range; BMI: Body mass index; UC: Ulcerative colitis; CRP: C-reactive protein; 5-ASA: 5-aminosalicylates; eMayo: Endoscopic Mayo subscore; pMayo: Partial Mayo score.

Table 3 Subgroup analysis of results in patients with relapse, n (%)

Characteristics	Total (n = 12)
Time interval between 5-ASA withdrawal and relapse (months), median (IQR)	20.0 (12.3-52.3)
Duration time after relapse (months), median (IQR)	6.5 (0.0-46.5)
Treatment for remission in relapse
5-ASA tablet	9 (75.0)
5-ASA granule	1 (8.3)
5-ASA oral	10 (83.3)
5-ASA enema	6 (50.0)
5-ASA suppository	2 (16.7)
Sulfasalazine	0 (0.0)
Steroid	3 (25.0)
Thiopurine	1 (8.3)
Biologic agents	0 (0.0)
Surgery	0 (0.0)

5-ASA: 5-aminosalicylates; IQR: Interquartile range.