Real-world disease activity and sociodemographic, clinical and treatment characteristics of moderate-to-severe inflammatory bowel disease in Brazil

Table 1 Sociodemographic characteristics and clinical features of Crohn’s disease and ulcerative colitis patients by geographic region of Brazil

	Total		Southeast		South		Northeast/Midwest
	CD (n = 264)	UC (n = 143)	CD (n = 196)	UC (n = 94)	CD (n = 34)	UC (n = 21)	CD (n = 34)	UC (n = 28)
Age (yr)	41.0 [20-72]	45.0 [19-84]	41.0 [21-72]	44.0 [20-78]	37.5 [20-67]	44.0 [19-66]	41.0 [24-68]	51.0 [26-84]
Female	143 (54.2)	81 (56.6)	111 (56.6)	54 (57.4)	14 (41.2)	9 (42.9)	18 (52.9)	18 (64.3)
Disease duration (yr)	10.0 [0.5-45.0]	10.0 [0.5-31.0]	11.0 [1.0-45.0]	10.0 [0.5-31.0]	8.0 [1.0-30.0]	14.0 [1.0-29.0]	9.0 [1.0-31.0]	6.0 [1.0-22.0]
Age at diagnosis (yr)	29.0 [12-70]	34.0 [14-70]	28.0 [12-70]	33.0 [15-64]	29.0 [18-63]	32.0 [14-64]	42.0 [20-70]	32.0 [18-60]
Educational level1
Not literate	3 (1.4)	0 (0.0)	2 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	1 (4.3)	0 (0.0)
Primary school	52 (25.1)	38 (38.8)	47 (29.2)	26 (39.4)	3 (13.0)	2 (12.5)	2 (8.7)	10 (62.5)
Secondary school	83 (40.1)	37 (37.7)	66 (41.0)	26 (39.4)	5 (21.7)	6 (37.5)	13 (56.5)	5 (31.3)
Higher education	69 (33.3)	23 (23.5)	46 (28.6)	14 (21.2)	15 (65.2)	8 (50.0)	7 (30.4)	1 (6.2)
Missing	57	45	35	28	11	5	11	12
Professional situation
Employed	101 (44.3)	53 (42.7)	77 (44.0)	32 (40.5)	13 (54.2)	13 (72.2)	11 (37.9)	8 (29.6)
Unemployed	61 (26.8)	33 (26.6)	44 (25.1)	21 (26.6)	4 (16.7)	3 (16.7)	13 (44.8)	9 (33.3)
Retired	30 (13.2)	15 (12.1)	24 (13.7)	11 (13.9)	5 (20.8)	0 (0.0)	1 (3.4)	4 (14.8)
Student	10 (4.4)	5 (4.0)	8 (4.6)	3 (3.8)	2 (8.3)	1 (5.6)	0 (0.0)	1 (3.7)
Other	26 (11.4)	18 (14.5)	22 (12.6)	12 (15.2)	0 (0.0)	1 (5.6)	4 (13.8)	5 (18.5)
Missing	36	19	21	15	10	3	5	1
Health system
Public	197 (74.6)	110 (76.9)	159 (81.1)	82 (87.2)	11 (32.4)	3 (14.3)	27 (79.4)	25 (89.3)
Private	67 (33.3)	33 (23.1)	37 (18.9)	12 (12.8)	23 (67.6)	18 (85.7)	7 (20.6)	3 (10.7)
Family history of IBD	33 (12.5)	15 (10.5)	27 (13.8)	10 (10.6)	3 (8.9)	3 (14.3)	3 (8.8)	2 (7.1)
Smoking habits2
Current smoker	24 (9.9)	3 (2.3)	20 (10.5)	3 (3.3)	3 (10.7)	0 (0.0)	1 (4.3)	0 (0.0)
Former smoker	47 (19.4)	38 (28.8)	30 (15.7)	21 (23.1)	10 (35.7)	5 (26.3)	7 (30.4)	12 (54.5)
Never smoked	171 (70.7)	91 (68.9)	141 (73.8)	67 (73.6)	15 (53.6)	14 (73.7)	15 (65.2)	10 (45.5)
Missing	22	11	5	3	6	2	11	6
Any EIM3	54 (37.8)	30 (38.0)	41 (38.7)	21 (42.0)	6 (25.0)	4 (25.0)	7 (53.8)	5 (38.5)
Use of steroids4
Steroid dependent	31 (14.8)	23 (19.3)	21 (13.8)	9 (11.8)	6 (19.4)	11 (55.0)	4 (15.4)	3 (13.0)
Steroid refractory	16 (7.7)	11 (9.2)	10 (6.6)	7 (9.2)	2 (6.5)	2 (10.0)	4 (15.4)	2 (8.7)
No previous use	87 (41.6)	36 (30.3)	66 (43.4)	22 (28.9)	10 (32.3)	3 (15.0)	11 (42.3)	11 (47.8)
Unknown	75 (35.9)	49 (41.2)	55 (36.2)	38 (50.0)	13 (41.9)	4 (20.0)	7 (26.9)	7 (30.4)
Missing	55	24	44	18	3	1	8	5

Data are shown as n (%) or median [range].

¹Highest level attended.

²Current smokers: patients who were smoking at enrollment and had smoked 100 cigarettes in their lifetime. Former smokers: Patients who were not smoking at enrollment but had smoked 100 cigarettes in their lifetime.

³Extraintestinal manifestations observed: For the Crohn’s disease population–arthralgia (reported in all regions), arthritis (in the Southeast and Northeast/Midwest), sacroiliitis (only in the Southeast), erythema nodosum (only in the Southeast), pyoderma gangrenosum (only in the Southeast), uveitis (only in the Southeast), cholelithiasis (only in the Southeast), nephrolithiasis (only in the Southeast), hypertension (only in the Southeast), other (not specified) (reported in all regions); for the Ulcerative colitis population–arthralgia (reported in the Southeast and Northeast/Midwest), arthritis (only in the Southeast), sacroiliitis (in the South and Northeast/Midwest), pyoderma gangrenosum (only in the Northeast/Midwest), psoriasis (only in the Southeast), uveitis (only in Southeast), sclerosing cholangitis (in the Southeast and South), nephrolithiasis (only in Southeast), hypertension (in Southeast and Northeast/Midwest), other (not specified) (in the Southeast and South).

⁴Steroid-dependent disease: Patients who either (1) were unable to reduce steroid use to below the equivalent of prednisolone 10 mg/d within 3 mo of starting steroids, without recurrent disease; or (2) had a relapse within 3 mo of stopping glucocorticoids; steroid-refractory disease: Active disease despite the use of up to 0.75 mg/kg/d of prednisolone over 4 wk. CD: Crohn’s disease; EIM: Extraintestinal manifestations; UC: Ulcerative colitis; IBD: Inflammatory bowel diseases.

Table 2 Montreal classification and activity scores at enrollment by inflammatory bowel diseases type and geographic region

CD classification	CD patients (n = 264)	Southeast (n = 196)	South (n = 34)	Northeast/Midwest (n = 34)
Location1
L1-ileal	67 (25.4)	50 (25.5)	10 (29.4)	7 (20.6)
L2-colonic	42 (15.9)	26 (13.3)	5 (14.7)	11 (32.4)
L3-ileocolonic	150 (56.8)	116 (59.2)	18 (52.9)	16 (47.1)
L4-upper GI tract disease	17 (6.4)	11 (5.6)	2 (5.9)	4 (11.8)
Behavior
B1-Nonstricturing/nonpenetrating	58 (22.0)	33 (16.8)	9 (26.5)	16 (47.1)
B2-Stricturing	110 (41.7)	89 (45.4)	14 (41.2)	7 (20.6)
B3-Penetrating	91 (34.5)	70 (35.7)	10 (29.4)	11 (32.4)
Perianal disease	105 (39.8)	87 (44.4)	12 (35.3)	6 (17.6)
HBI score	2.0 [0-37]	2.0 [0-37]	2.0 [0-17]	3.5 [0-12]
Missing	34	32	0	2
CDAI	137.0 [-25-495]	141.0 [-25-495]	NA	93.0 [-22-292]
Missing	187	137	34	16
Active CD2	118 (44.7)	89 (45.4)	13 (38.2)	16 (47.0)
HBI ≥ 8 or CDAI ≥ 220	46 (17.4)	UNK	UNK	UNK
Fecal calprotectin > 200 μg/g	40 (15.2)	UNK	UNK	UNK
Colonoscopy result suggestive of disease activity during the previous year	69 (26.1)	UNK	UNK	UNK
UC classification	UC patients (n = 143)	Southeast (n = 94)	South (n = 21)	Northeast/Midwest (n = 28)
Extension
E1-distal UC	43 (30.1)	27 (28.7)	8 (38.1)	8 (28.6)
E2-left-sided	26 (18.2)	12 (12.8)	2 (9.5)	12 (42.9)
E3-pancolitis	74 (51.7)	55 (58.5)	11 (52.4)	8 (28.6)
Severity
S0-asymptomatic	57 (39.9)	36 (38.3)	9 (42.9)	12 (42.9)
S1-mild UC	32 (22.4)	25 (26.6)	3 (14.3)	4 (14.3)
S2-moderate UC	40 (28.0)	25 (26.6)	7 (33.3)	8 (28.6)
S3-severe UC	14 (9.8)	8 (8.5)	2 (9.5)	4 (14.3)
Mayo endoscopic subscore (n = 71)
Normal	16 (22.5)	9 (19.1)	1 (12.5)	6 (37.5)
Mild disease	18 (25.4)	13 (27.7)	2 (25.0)	3 (18.8)
Moderate disease	28 (39.4)	20 (42.6)	3 (37.5)	5 (31.3)
Severe disease	9 (12.7)	5 (10.6)	2 (25.0)	2 (12.5)
Missing	72	47	13	12
Total Mayo score	2.0 [0.0-10.0]	3.0 [0.0-9.0]	2.5 [0.0-10.0]	2.0 [0.0-8.0]
Missing	72	47	13	12
Partial Mayo score	1.0 [0.0-9.0]	1.5 [0.0-9.0]	1.0 [0.0-9.0]	1.5 [0.0-8.0]
Active UC2	36 (25.2)	19 (20.2)	5 (23.8)	12 (42.9)

Data are shown as n (%) or median [range].

¹More than one possible option: L4 includes isolated upper gastrointestinal (GI) tract disease or upper GI tract disease combined with L1, L2 or L3.

²Active disease at enrollment was defined as presenting Harvey-Bradshaw index ≥ 8 or Crohn’s disease activity index ≥ 220 or fecal calprotectin > 200 mg/g or colonoscopy suggestive of inadequate control during the previous year (for Crohn’s disease patients) and partial Mayo score ≥ 5 (for ulcerative colitis patients). CD: Crohn’s disease; CDAI: Crohn’s disease activity index; HBI: Harvey-Bradshaw index; UC: Ulcerative colitis; UNK: Unknown; GI: Gastrointestinal.

Table 3 Inflammatory bowel diseases treatment at enrollment and use of health care resources during the previous 3 years by inflammatory bowel diseases type and by geographic region

	CD patients (n = 264)	Southeast (n = 196)	South (n = 34)	Northeast/Midwest (n = 34)
Any CD treatment at enrollment1	256 (97.0)	189 (96.4)	33 (97.1)	34 (100.0)
CD treatment at enrollment2
5-ASA derivates	39 (14.8)	24 (12.2)	7 (20.6)	8 (23.5)
Biological therapy	189 (71.6)	140 (71.4)	21 (61.8)	28 (82.4)
Infliximab	106 (40.2)	NA	NA	NA
Adalimumab	78 (29.5)	NA	NA	NA
Vedolizumab	4 (1.5)	NA	NA	NA
Certolizumab	1 (0.4)	NA	NA	NA
Ustekinumab	1 (0.4)	NA	NA	NA
Immunosuppressors	178 (67.4)	133 (67.9)	18 (52.9)	27 (79.4)
Thiopurines	165 (62.5)	NA	NA	NA
Methotrexate	14 (5.3)	NA	NA	NA
Corticosteroids	30 (11.4)	21 (10.7)	2 (5.9)	7 (20.6)
Prednisone	29 (11.0)	NA	NA	NA
Hydrocortisone	1 (0.4)	NA	NA	NA
Methylprednisolone	1 (0.4)	NA	NA	NA
Antibiotics	14 (5.3)	9 (4.6)	1 (2.9)	4 (11.8)
Any previous CD-related surgery3	67 (25.4)	58 (29.6)	8 (23.5)	1 (2.9)
CD-related surgeries per patient	1.0 [1-5]	1.0 [1-5]	1.5 [1-3]	2.0
Any previous CD-related hospitalization	101 (38.3)	71 (36.2)	14 (41.2)	16 (47.0)
CD-related hospitalizations per patient	1.0 [1-5]	1.0 [1-5]	1.0 [1-4]	1.0 [1-3]
Previous CD appointments per patient	11.0 [1-45]	11.0 [1-45]	13.5 [4-43]	10.0 [1-21]
	UC patients (n = 143)	Southeast (n = 94)	South (n = 21)	Northeast/Midwest (n = 28)
Any UC treatment at enrollment1	138 (96.5)	89 (94.7)	21 (100.0)	28 (100.0)
UC treatment at enrollment2
5-ASA derivates	100 (69.9)	60 (63.8)	13 (61.9)	27 (96.4)
Biological therapy	41 (28.7)	30 (31.9)	7 (33.3)	4 (14.3)
Infliximab	31 (21.7)	NA	NA	NA
Adalimumab	9 (6.3)	NA	NA	NA
Vedolizumab	2 (1.4)	NA	NA	NA
Immunosuppressors	63 (44.1)	41 (43.6)	12 (57.1)	10 (35.7)
Thiopurines	59 (41.3)	NA	NA	NA
Methotrexate	3 (2.1)	NA	NA	NA
Tacrolimus	1 (0.7)	NA	NA	NA
Corticosteroids	26 (18.2)	15 (16.0)	6 (28.6)	5 (17.9)
Prednisone	24 (16.8)	NA	NA	NA
Hydrocortisone	2 (1.4)	NA	NA	NA
Prednisolone	2 (1.4)	NA	NA	NA
Antibiotics	7 (4.9)	6 (6.4)	1 (4.8)	NA
Any previous UC-related surgery4	4 (2.8)	4 (4.3)	0 (0.0)	0 (0.0)
UC-related surgeries per patient	2.0 [1-2]	2.0 [1-2]	-	-
Any previous UC-related hospitalization	28 (19.6)	13 (13.8)	9 (42.9)	6 (21.4)
UC-related hospitalizations per patient	1.0 [1-5]	1.0 [1-2]	2.0 [1-5]	1.0 [1-2]
Previous UC appointments per patient	10.0 [1-39]	10.0 [1-39]	14.0 [4-38]	9.0 [1-17]

Data are shown as n (%) or median [range]. Percentages were calculated for the total group of patients.

¹Any inflammatory bowel diseases treatment ongoing or initiated at the study appointment.

²More than one possible option: patients could have combined treatment.

³The most common surgeries were fistulectomy/anal fistulectomy (20.4% of patients), partial colectomy (12% of patients) and enterotomy and/or enterorrhaphy with suture/resection (12%).

⁴Two total colectomies and two enterostomy closures.

CD: Crohn’s disease; 5-ASA: 5-Aminosalicylic acid; NA: Not available; UC: Ulcerative colitis.