Adalimumab efficacy in enteropathic spondyloarthritis: A 12-mo observational multidisciplinary study

doi:10.3748/wjg.v23.i39.7139

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World Journal of Gastroenterology

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Observational Study

World J Gastroenterol. Oct 21, 2017; 23(39): 7139-7149
Published online Oct 21, 2017. doi: 10.3748/wjg.v23.i39.7139

Table 1 Enteropathic spondyloarthritis patient features

	ES-AN, n = 52	ES-AN/Ada, n = 30
Crohn’s disease:Ulcerative colitis	31 (60):21 (40)	19 (63):11 (37)
Males:Females	22 (42):30 (58)	17 (57):13 (43)
Age in years	47.2 ± 14.2	46.2 ± 14.4
Disease duration of IBD in years	11.3 ± 10.1	8.8 ± 7.9
Smokers:Ex-smokers	9 (17):20 (38)
HLA-B27 positivity	5 (10)	4 (13)
Prior surgical intervention for IBD	13 (25)	5 (17)
Previous extra-intestinal disease	6 (11)	5 (17)
Eritema nodosum	2	1
Uveitis	3	3
Pioderma gangrenosum	1	1
Crohn’s disease activity by CDAI
Inactive	14 (45)	7 (37)
Moderate	10 (32)	8 (42)
Moderate-to-Severe	7 (23)	4 (21)
Ulcerative colitis activity by partial Mayo
Mild	18 (86)	8 (73)
Moderate	3 (14)	3 (27)
Severe	0	0
Current medication at baseline
Non-steroids anti-inflammatory drugs	3	0
Sulfasalazine	3	2
Mesalazine	25	12
Cyclosporine	1	1
Azathioprine	9	5
Oral steroids	12	7
Topical steroids	3	2
Metotrexate	2	1
Infliximab	6	4
Adalimumab	2	0
Spondyloarthritis features
Ankylosing spondylitis according to Modified New York Criteria	16 (31)	10 (33)
Non-radiographic Axial-Spondyloarthritis by ASAS Criteria	13 (25)	10 (33)
Peripheral- Spondyloarthritis	23 (44)	10 (33)
Type of axial involvement	n = 29	n = 20
Syndesmophytosis	8 (28)	6 (30)
Bamboo spine	2 (7)	2 (10)
Sacroiliitis by MRI and/or X-ray	29 (100)	20 (100)
Type of articular involvement in Crohn’s disease	n = 31	n = 19
Axial	16 (52)	11 (58)
Axial and peripheral	4	3
Peripheral only	15 (48)	8 (42)
Enthesitis	9 (29)	5 (26)
Type of articular involvement in ulcerative colitis	n = 21	n = 11
Axial	13 (62)	9 (82)
Axial and peripheral	9	5
Peripheral only	8 (38)	2 (18)
Enthesitis	4 (19)	2 (18)

Data are presented as n, n (%) or mean ± SD. CDAI: Crohn’s Disease Activity Index; ES-AN: Patient cohort with enteropathic spondyloarthritis from the SPIB Program, Ancona, Italy; ES-AN/Ada: Patients of the ES-AN cohort treated with adalimumab; IBD: Inflammatory bowel disease; NSAID: Non-steroidal anti-inflammatory drug.

Table 2 Clinimetric test for articular-gastrointestinal activity and patient reported outcomes of health-related quality of life

Test	Items and interpretation
Bath Ankylosing Spondylitis Disease Index[10]	6 items: (1) fatigue, (2) back pain, (3) peripheral pain/swelling, (4) discomfort at pressure, (5) morning discomfort, and (6) duration of morning stiffness;
	Range from 0 to 10, with lower number representing less severe disease activity;
	Score > 4 = active disease.
Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein[11]	5 items: (1) back pain, (2) morning stiffness, (3) patient global, (4) peripheral pain/swelling, and (5) C-reactive protein;
	Score < 1.3 = inactive disease; Score 1.3 to < 2.1 = moderate activity; Score 2.1 to ≤ 3.5 = high activity; Score > 3.5 = very high activit; Change ≥ 1.1 = clinically important improvement; Change ≥ 2.0 = major improvement.
Crohn’s Disease Activity Index[12]	8 items: (1) liquid stools, (2) abdominal pain, (3) general well-being, (4) extra-intestinal manifestations (including arthralgia), (5) use of anti-diarrheals, (6) abdominal masses, and (7) hematocrit, 8) weight;
	Final score is the sum of items, weighted by different factors;
	Score < 150 = non-active disease; Score > 150 = active disease; Score > 450 = extremely severe disease.
Partial MAYO score[13]	3 items: (1) stool frequency, (2) rectal bleeding, and (3) physician global assessment;
	Range from 0 to 9;
	Score < 2 = disease remission; Score 2-4 = mild disease activity; Score 5-7 = moderate disease activity; Score > 7 = severe disease activity.
Bath Ankylosing Spondylitis Functional Index[14]	10 questions designed to determine the degree of functional limitation;
Bath Ankylosing Spondylitis Functional Index[14]	Final score ranges from 0 to 10, with lower score indicating less functional limitation.
Inflammatory Bowel Disease Questionnaire[15]	32 questions divided into 4 subscales: (1) bowel symptoms (10 questions); (2) systemic symptoms, including sleep disorders and fatigue (5 questions); (3) emotional function, such as depression, aggression and irritation (12 questions); and (4) social function, meaning the ability to participate in social activities and to work (5 questions);
	The patient is invited to choose from 1 to 7 for every question;
	Total score ranges from 32 to 224 points, with lower scores reflecting worse quality of life.
Patient Global Assessment (PtGA)	Collected on a numeric rating scale ranging from 0 to 10 for the question asking the patient: “Considering all the ways your disease affects you, how much do you think is active today?”
Short Form-36 health survey[16]	Generic health status instrument with 8 domains: (1) physical function, (2) body pain, (3) role limitations–physical, (4) general health, (5) vitality, (6) social function, (7) role limitations–emotional, and (8) mental health;
	Greater scores reflect better health status;
	Summarized in two summary scores defined as the (1) physical component score (Sf-36/PCS) and (2) mental component score (Sf-36/MCS).

Table 3 Scores of the clinimetric test for articular-gastrointestinal activity and patient reported outcomes of health-related quality of life

	Baseline	T6	T12
CDAI, n = 19	181.3 ± 93.2	112.3 ± 63.0^b	82.7 ± 48.7^b
pMAYO, n = 11	3.27 ± 1.79	1.81 ± 1.07^a	1.63 ± 1.43^a
IBDQ	145.3 ± 36.8	172.8 ± 36.7^e	180.7 ± 33.0^e
BASDAI	5.5 ± 1.7	3.2 ± 1.8^e	3.3 ± 1.7^e
BASFI	3.2 ± 2.4	1.8 ± 1.4^e	2.0 ± 1.3^a
ASDAS-CRP	3.2 ± 0.8	1.9 ± 0.6^e	1.9 ± 0.6^e
PtGA	61.1 ± 20.6	35.6 ± 19.1^b	33.0 ± 19.1^b
HAQ	4.7 ± 8.5	2.0 ± 4.2^a	1.6 ± 3.5^a
Sf-36/PCS	42.2 ± 9.7	48.4 ± 7.2^e	48.5 ± 7.3^b
Sf-36/MCS	35.4 ± 10.9	39.4 ± 8.8^a	41.4 ± 9.7^a
CRP in mg/dL	2.7 ± 3.7	0.8 ± 1.2^a	0.5 ± 0.6^a

^aP < 0.05,

^bP < 0.01,

^eP < 0.001. ASDAS-CRP: Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; CDAI: Crohn’s Disease Activity Index; CRP: C-Reactive Protein; pMAYO: partial Mayo score; HAQ: Health Assessment Questionnaire; IBDQ: Inflammatory Bowel Disease Questionnaire; PtGA: Patient Global Assessment; SF-36/MCS: Summary of “Mental Component Score” of the Short Form-36 health survey; SF-36/PCS: Summary of “Physical Component Score” of the Short Form-36 health survey; T6 and T12: Results of the evaluation after 6 mo and 12 mo of treatment with adalimumab respectively.

Table 4 Correlations between the scores of clinimetric tests for articular-gastrointestinal activity and patient reported outcomes of health-related quality of life scores

	CDAI	pMAYO	IBDQ	BASDAI	BASFI	ASDAS-CRP	PtGA	HAQ	Sf-36/ PCS	Sf-36/ MCS	CRP
At baseline
CDAI	1	1	-0.57^b	0.19	0.29	0.21	0.14	0.12	-0.24	-0.33	0.35
pMAYO	1	1	-0.48^a	0.34	0.38	0.37	0.15	0.18	-0.14	-0.11	0.28
IBDQ	-0.57^b	-0.48^a	1	-0.38^b	-0.34^a	-0.52^b	-0.26	-0.19	0.27	0.67^b	-0.26
BASDAI	0.19	0.34	-0.38^b	1	0.64^b	0.69^b	0.24	0.26	-0.22	-0.31^a	0.00
BASFI	0.29	0.38	-0.34^a	0.64^b	1	0.57^b	0.37^b	0.36^b	-0.44^b	-0.15	0.37^b
ASDAS-CRP	0.21	0.37	-0.52^b	0.69^b	0.57^b	1	0.37^b	0.36^b	-0.30^a	-0.41^b	0.32^a
PtGA	0.14	0.15	-0.26	0.24	0.37^b	0.37^b	1	0.22	-0.14	-0.22	0.14
HAQ	0.12	0.18	-0.19	0.26	0.36^b	0.36^b	0.22	1	-0.46^b	-0.03	0.07
Sf-36/PCS	-0.24	-0.14	0.27	-0.22	-0.44^e	-0.30^a	-0.14	-0.46^b	1	0.05	-0.13
Sf-36/MCS	-0.33	-0.11	0.67^b	-0.31^a	-0.15	-0.41^b	-0.22	-0.03	0.05	1	-0.08
After 12 mo of therapy with adalimumab (ES-AN/Ada cohort)
CDAI	1	1	-0.83^b	0.16	0.56^a	0.54^a	0.53^a	0.53^a	-0.71^b	-0.67^b	0.75^b
pMAYO	1	1	-0.51	0.18	0.49	0.17	0.56	-0.29	-0.14	-0.25	0.6
IBDQ	-0.83^b	-0.51	1	-0.23	-0.56^b	-0.55^b	-0.61^b	-0.36^a	0.53^b	0.66^b	-0.52^b
BASDAI	0.16	0.18	-0.23	1	0.58^b	0.68^b	0.51^b	0.39^a	-0.52^b	-0.11	-0.14
BASFI	0.56^a	0.49	-0.56^b	0.58^b	1	0.56^b	0.64^b	0.54^b	-0.52^b	-0.45^a	0.16
ASDAS-CRP	0.54^a	0.17	-0.55^b	0.68^b	0.56^b	1	0.67^b	0.38^a	-0.62^b	-0.41^a	0.31
PtGA	0.53^a	0.56	-0.61^b	0.51^b	0.64^b	0.67^b	1	0.51^b	-0.37^a	-0.59^b	0.26
HAQ	0.53^a	-0.29	-0.36^a	0.39^a	0.54^b	0.38^a	0.51^b	1	-0.47^b	-0.40^a	0.10
Sf-36/PCS	1	1	-0.83^b	0.16	0.56^a	0.54^a	0.53^a	0.53^a	-0.71^b	-0.67^b	0.75^b
Sf-36/MCS	1	1	-0.51	0.18	0.49	0.17	0.56	-0.29	-0.14	-0.25	0.60
CRP	-0.83^b	-0.51	1	-0.23	-0.56^b	-0.55^b	-0.61^b	-0.36^a	0.53^b	0.66^b	-0.52^b

Correlations between variables were assessed in the 30 patients with enteropathic spondyloarthritis from Ancona, Italy, at baseline and after 6 mo (data not shown) and 12 mo of therapy with adalimumab (ES-AN/Ada), using Pearson’s correlation coefficient;

^aP < 0.05,

^bP < 0.01. ASDAS-CRP: Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; CDAI: Crohn’s Disease Activity Index; CRP: C-Reactive Protein; HAQ: Health Assessment Questionnaire; IBDQ: Inflammatory Bowel Disease Questionnaire; pMAYO: partial Mayo score; PtGA: Patient Global Assessment; SF-36/MCS: Summary of “Mental Component Score” of the Short Form-36 health survey; SF-36/PCS: Summary of “Physical Component Score” of the Short Form-36 health survey.

Citation: Luchetti MM, Benfaremo D, Ciccia F, Bolognini L, Ciferri M, Farinelli A, Rossini M, Mosca P, Triolo G, Gabrielli A. Adalimumab efficacy in enteropathic spondyloarthritis: A 12-mo observational multidisciplinary study. World J Gastroenterol 2017; 23(39): 7139-7149
URL: https://www.wjgnet.com/1007-9327/full/v23/i39/7139.htm
DOI: https://dx.doi.org/10.3748/wjg.v23.i39.7139