Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil

Table 1 Sociodemographic and disease characteristics of patients at the index date

	CD patients (n = 118)	UC patients (n = 36)
Age (yr), mean ± SD	43.3 ± 12.6	44.9 ± 16.5
Female, n (%)	69 (58.5)	26 (72.2)
Employed, n (%)	36 (36.7)	5 (16.1)
Attended higher education, n (%)	32 (34.4)	5 (23.8)
Body mass index (kg/m2), mean ± SD	24.9 ± 4.7	24.9 ± 5.1
Current smokers, n (%)1	7 (5.9)	0 (0.0)
Family history of IBD, n (%)	15 (12.7)	2 (5.6)
IBD duration (yr), median (IQR)	11.0 (0.5-11.0)	6.5 (0.5-29.1)
Biologic group	11.0 (5.0-16.0)	6.0 (3.0-13.0)
Nonbiologic group	11.5 (4.5-18.5)	10.0 (4.0-17.0)
5-ASA derivates group	9.0 (4.0-13.0)	5.5 (4.0-14.0)
Non-5-ASA derivates group	11.5 (5.0-17.5)	13.0 (4.0-15.0)
Corticosteroid status, n (%)2
Steroid-dependent	17 (14.4)	10 (27.8)
Steroid-refractory disease	5 (4.2)	3 (8.3)
Not applicable (no previous use)	33 (28.0)	3 (8.3)
Unknown	37 (31.4)	15 (41.7)
Location of CD, n (%)
L1 ileal	26 (22.0)	-
L2 colonic	21 (17.8)	-
L3 ileocolonic	71 (60.2)	-
CD Behavior, n (%)
B1 nonstricturing/penetrating	31 (26.3)	-
B2 stricturing	52 (44.1)	-
B3 penetrating	35 (29.7)	-
Symptomatic perianal disease, n (%)	37 (31.6)	-
HBI result (available for 101 CD patients), median (IQR)	5.0 (1.0-9.0)	-
CDAI result (available for 43 CD patients), median (IQR)	200.0 (114.0-274.0)	-
Fecal calprotectin level > 200 µg/g during previous year, n (%)	40 (33.9)	-
Colonoscopy with CD activity 3 during previous year, n (%)	69 (58.5)	-
Extent of UC inflammation - Montreal classification, n (%)
E1 ulcerative proctitis	-	10 (27.8)
E2 left-sided UC	-	8 (22.2)
E3 pancolitis	-	18 (50.0)
Partial Mayo score, median (IQR)	-	6.0 (5.0-6.0)
Total Mayo score (available for 13 UC patients)	-	8.0 (7.0-8.0)
Extra intestinal manifestations4, n (%)	29 (24.6)	8 (22.2)
Patients with at least one IBD surgery during previous 3 yr, n (%)	32 (27.1)	1 (2.8)
Total colectomy	0 (0.0)	1 (2.8)
Fistulectomy	7 (5.9)	0 (0.0)
Enterostomy	6 (5.1)	0 (0.0)
Partial colectomy	5 (4.2)	0 (0.0)
Closure of enterostomy	5 (4.2)	0 (0.0)
Drainage of anorectal abscess	3 (2.5)	0 (0.0)
Jejunostomy/Ileostomy	1 (0.8)	0 (0.0)
Other	15 (12.7)	1 (2.8)
Patients with at least one IBD-related hospitalizations during previous 3 yr, n (%)	51 (43.1)	11 (30.6)

¹Smoking at Day 1 and has smoked 100 cigarettes in his/her lifetime.

²Steroid-dependent disease - defined as: (1) Being unable to reduce steroids below the equivalent of prednisolone at 10 mg/day within 3 mo of starting steroids, without recurrent disease; or (2) having a relapse within 3 mo of stopping glucocorticoids. Steroid-refractory disease - defined as having active disease despite prednisolone of up to 0.75 mg/kg/d over a period of 4 wk.

³As per investigator criteria.

⁴During the entire study period (3 retrospective years and 1 year of prospective follow-up), extraintestinal manifestations included arthralgia, arthritis, sacroiliitis, ankylosing spondylitis, erythema nodosum, pyoderma gangrenosum, pustular dermatitis, psoriasis, uveitis, sclerosing cholangitis, cholelithiasis, nephrolithiasis, autoimmune disease, hypertension, and dyslipidemia. SD: Standard deviation; IBD: Inflammatory bowel disease; UC: Ulcerative colitis; CD: Crohn’s disease; HBI: Harvey-Bradshaw index; CDAI: Crohn’s disease activity index; pMayo: Partial Mayo score; 5-ASA: 5-aminosalicylate; IQR: Interquartile.

Table 2 Treatment patterns and medical appointments during the follow-up period (Crohn’s disease and ulcerative colitis patients)

	CD patients (n = 118)	UC patients (n = 36)
IBD treatment at index date appointment, n (%)1	111 (94.1)	35 (97.2)
5-ASA derivates	36 (30.5)	33 (91.7)
Corticosteroids	56 (47.5)	21 (58.3)
Immunosuppressants	65 (55.1)	21 (58.3)
Biologics	74 (62.7)	14 (38.9)
Patients who received at least one corticosteroid for ≥ 3 mo, n (%)2	31 (26.3)	18 (50.0)
Treatments at the start of 12-mo follow-up (index date), n (%)
IBD treatment initiated or maintained	112 (94.9)	35 (97.2)
Biologic therapy
Maintained or initiated at index date	75 (63.6)	14 (38.9)
Maintained	69 (58.5)	11 (30.6)
Initiated new	6 (5.1)	3 (8.3)
Naïve to biologics3	1 (0.8)	1 (2.8)
Discontinued at index date	0 (0.0)	0 (0.0)
Immunosuppressants
Maintained or initiated at index date	73 (61.9)	19 (52.8)
Maintained	71 (60.2)	14 (38.9)
Initiated new	2 (1.7)	5 (13.9)
Discontinued at index date	1 (0.8)	0 (0 .0)
5-ASA compounds
Maintained or initiated at index date	19 (16.1)	27 (75.0)
Maintained	17 (14.4)	20 (55.6)
Initiated new	2 (1.7)	5 (13.9)
Naïve to 5-ASA compounds	2 (1.7)	5 (13.9)
Discontinued at index date	1 (0.8)	0 (0.0)
Corticosteroids
Maintained or initiated at index date	16 (13.6)	15 (41.7)
Maintained	9 (7.6)	6 (16.7)
Initiated new	6 (5.1)	8 (22.2)
Naïve to corticosteroids3	2 (1.7)	1 (2.8)
Discontinued at index date	2 (1.7)	4 (11.1)
Any antibiotic initiated at index date	12 (10.2)	5 (13.9)
Treatment changes during 12-mo follow-up period
New treatment initiated during follow-up	77 (65.3)	31 (86.1)
Discontinuation or dose change during follow-up2	77 (68.1)	33 (94.3)
Median (IQR) number of treatment changes by patient	2 (2-5)	4 (3-7)
Biologic therapy
Initiated	45 (38.1)	6 (16.7)
Naïve to biologics4	13 (11.0)	1 (2.8)
Discontinued	23 (19.5)	5 (13.9)
Dose change	14 (11.9)	4 (11.1)
Immunosuppressants
Initiated	24 (20.3)	14 (38.9)
Naïve to immunosuppressants4	4 (3.4)	2 (5.6)
Discontinued	20 (16.9)	11 (9.3)
Dose change	7 (5.9)	7 (19.4)
5-ASA derivates
Initiated	10 (8.5)	21 (58.3)
Naïve to 5-ASA compounds4	1 (0.8)	2 (5.6)
Discontinued	7 (5.9)	8 (22.2)
Dose change	4 (3.4)	14 (38.8)
Corticosteroids
Initiated	24 (20.3)	16 (44.4)
Naïve to corticosteroids4	5 (4.2)	2 (5.6)
Discontinued	23 (19.5)	17 (47.2)
Any antibiotic initiated after index date	23 (19.5)	5 (13.9)

¹Inflammatory bowel disease (IBD) treatment patients were receiving at the time of enrollment, irrespective of the physician’s decision to continue or discontinue it at the end of the medical appointment.

²Percentages calculated from 113 Crohn’s disease and 35 ulcerative colitis patients, since two patients had no IBD medication and four had no medical appointments during follow-up.

³Assuming the information from the previous 3 year.

⁴Assuming the information from the previous 3 years and index date. Values are n (%), and percentages calculated within the total of the study population in each group, except if otherwise mentioned. SD: standard deviation; IBD: Inflammatory bowel disease; UC: Ulcerative colitis; CD: Crohn’s disease; 5-ASA: 5-aminosalicylate.

Table 3 Sociodemographic, clinical and treatment characteristics of ulcerative colitis and Crohn’s disease patients at the index date according to the final disease activity assessment

Characteristics at index date	CD patients (n = 82)			UC patients (n = 25)
	Moderate-to-severe activity (n = 18)	No or mildactivity (n = 64)	P value	Moderate-to-severe activity (n = 5)	No or mild activity (n = 20)	P value
Age (yr), mean ± SD	42.0 ± 13.0	43.1 ± 12.7	0.7323	38.0 ± 14.4	46.9 ± 17.5	0.3104
Female, n (%)	12 (66.7)	39 (60.9)	0.7865	4 (80.0)	15 (75.0)	> 0.9995
Employed, n (%)	4 (23.5)	22 (45.8)	0.3286	1 (20.0)	2 (10.5)	0.9775
Attended higher education, n (%)	2 (12.5)	20 (42.6)	0.0296	1 (20.0)	2 (18.2)	0.4625
Body Mass Index (kg/m2), mean ± SD	27.5 ± 3.7	24.2 ± 4.4	0.0074	25.4 ± 7.5	24.8 ± 5.5	0.8383
Current smokers, n (%)1	2 (12.5)	4 (7.0)	0.6075	0 (0.0)	0 (0.0)	NA
IBD duration (yr), median (IQR)	6.0 (1-27)	13.0 (0-45)	0.04333	5 (1-23)	6.5 (1-23)	0.70324
Time since moderate to severe IBD (yr), median (IQR)	5.5 (1-25)	7.0 (0-26)	0.88393	2 (0-18)	3.5 (1-16)	0.81013
Extra intestinal manifestation, n (%)	3 (50.0)	17 (51.5)	0.9466	1 (33.3)	4 (40.0)	NA
HBI result, median (IQR)	9.0 (7-13)	4.0 (1-8)	NA	-	-	-
CDAI result, median (IQR)	200.0 (114-311)	224.0 (113-281)	NA	-	-	-
Previous calprotectin level > 200 µg/g, n (%)	3 (16.7)	24 (37.5)	0.0976	-	-	-
Previous colonoscopy with CD activity, n (%)	12 (66.7)	33 (51.6)	0.2566	-	-	-
Ileocolonic disease, n (%)	13 (72.2)	36 (56.3)	0.2825	-	-	-
Stricturing or penetrating CD behavior, n (%)	11 (61.1)	48 (75.0)	0.2476	-	-	-
Symptomatic perianal disease, n (%)	10 (55.6)	19 (30.2)	0.0666	-	-	-
Partial Mayo score, median (IQR)	-	-	-	7.0 (5-8)	6.0 (5-6)	NA
Left-sided or pancolitis UC, n (%)	-	-	-	3 (60.0)	15 (75.0)
Current IBD treatment at baseline2, n (%)	15 (83.3)	61 (95.3)	0.2335	5 (100.0)	19 (95.0)	0.8715
Treatment ongoing or initiated at index, n (%)	16 (88.9)	62 (96.9)	0.4165	5 (100.0)	20 (100.0)	NA
5-ASA compounds	2 (12.5)	10 (16.1)	3 (60.0)		16 (80.0)
Biologic therapy	13 (81.3)	41 (66.1)	3 (60.0)		4 (20.0)
Corticosteroids	3 (18.8)	9 (14.5)	3 (60.0)		9 (45.0)
Immunosuppressants	5 (31.3)	44 (71.0)	3 (60.0)		10 (50.0)

¹Smoking at Day 1 and has smoked 100 cigarettes in his/her lifetime.

²Ongoing or discontinued at baseline.

³P values from theMann-Whitney test.

⁴t-test.

⁵Fisher’s exact test.

⁶Chi-square test. SD: Standard deviation; IBD: Inflammatory bowel disease; UC: Ulcerative colitis; CD: Crohn’s disease; HBI: Harvey-Bradshaw index; CDAI: Crohn’s disease activity index; pMayo: Partial Mayo score; 5-ASA: 5-aminosalicylate; NA: Not applicable.