Real-life outcome of anti-tumor necrosis factor α in the ambulatory treatment of ulcerative colitis

Table 1 Demographic and clinical baseline characteristics of all 72 patients included in the study n (%)

Characteristic
Anti-TNFα therapy
IFX only	35 (48.6)
ADA only	17 (23.6)
IFX and ADA	15 (20.8)
ADA and IFX	5 (6.9)
Demographic characteristics
Gender (female:male)	39: 33
Age at start of treatment (median; range) (yr)	33 (15-71)
Disease extent according to Montréal classification, n (E1:E2:E3)	5:32:35
Duration of disease at start of anti-TNFα therapy, median (range) (mo)	69.5 (2-480)
Presence of at least one extraintestinal manifestation	30 (41.7)
Smoking status, n (active smokers:non-smokers:ex-smokers)	6:54:5 (n = 65)
BMI, median (range) (kg/m2)	24.1 (17.3-61.9) (n = 69)
Family history of IBD (n positive: n negative)	5:18 (n = 23)
History of colitis medication prior to start of anti-TNFα treatment
Steroids	70 (97.2)
Oral budesonide	21 (29.2)
5-ASA	66 (91.7)
Azathioprine	55 (76.4)
6-Mercaptopurine	3 (4.2)
Methotrexate	12 (16.7)
Tacrolimus	4 (5.6)
Cyclosporine	4 (5.6)
Medications concomitant with IFX therapy at start of therapy (n = 55)
Steroids	37 (67.3)
Oral budesonide	16 (29.1)
5-ASA	35 (63.6)
Azathioprine	16 (29.1)
6-Mercaptopurine	1 (1.8)
Methotrexate	3 (5.5)
Tacrolimus	1 (1.8)
Cyclosporine	0
Medications concomitant with ADA therapy at start of therapy (n = 37)
Steroids	25 (67.6)
Oral budesonide	10 (27.0)
5-ASA	28 (75.7)
Azathioprine	11 (29.7)
6-Mercaptopurine	0 (0)
Methotrexate	1 (2.7)
Tacrolimus	0 (0)
Cyclosporine	0 (0)

ADA: Adalimumab; 5-ASA: 5-Aminosalicylic acid; BMI: Body mass index; IBD: Inflammatory bowel disease; IFX: Infliximab, TNFα: Tumor necrosis factor alpha.

Table 2 Characteristics of patients who achieved steroid-free clinical remission under anti-tumor necrosis factor alpha treatment and of patients who did not achieve remission

Variable	remission (n = 16)	no remission (n = 56)	P value (univariate)	P value (multivariate)
Age, (yr)	32 (15-58)	34 (18-71)	0.755	0.685
Sex (female: male)	11:5	28:28	0.184	0.560
Disease extent according to Montréal (E1:E2:E3)	1:7:8	4:25:27	0.988
Disease duration, (mo)	69.5 (7-288)	66 (2-480)	0.968	0.873
Patients with extraintestinal manifestations	6 (37.5)	24 (42.9)	0.338
Smoking (active:non-smokers: ex-smokers)	2:9:2 (n = 13)	4:45:3 (n = 52)	0.318
BMI, (kg/m2)	23.9 (18.9-30.8)	24.2 (17.3-61.9) (n = 53)	0.654	0.546
Previous medications
Purine analogons	14 (87.5)	42 (75.0)	0.289
Methotrexate	4 (25.0)	8 (14.3)	0.310
Calcineurin inhibitors	2 (12.5)	5 (8.9)	0.671
Concomitant medications
Steroids, (at start of treatment)	12 (75.0)	40 (71.4)	0.778
5-ASA	12 (75.0)	40 (71.4)	0.778
Purine analogons	4 (25.0)	20 (35.7)	0.423
Laboratory parameters before start of treatment with anti-TNFα
CrP, (mg/L)	7.9 (0-45.3) (n = 14)	3.1 (0-88.9) (n = 55)	0.104
Leukocyte number, (G/L)	8.8 (3.6-16.6) (n = 14)	8.8 (2.7-22.0) (n = 55)	0.817
Hemoglobin, (g/dl)	11.3 (8.3-13.9) (n = 14)	12.4 (9.0-17.0) (n = 55)	0.023	0.561
MCV, (fl)	82.5 (65-105) (n = 14)	87 (61-112) (n = 55)	0.374
Platelet number, (G/L)	408 (233-666) (n = 14)	333 (150-850) (n = 55)	0.114
Albumin concentration, (g/L)	41.5 (26.6-45.1) (n = 9)	43.9 (36.0-48.8) (n = 44)	0.009	0.034
Ferritin concentration, (μg/L)	17 (2-201) (n = 8)	27.5 (5-489) (n = 34)	0.223

Data are expressed as n (%) or median (range). 5-ASA: 5-Aminosalicylic acid; BMI: Body mass index, CrP: C-reactive protein (normal: < 5 mg/L); MCV: Mean cell volume.

Table 3 Surrogates of disease activity before and 3 mo after start of infliximab or adalimumab therapy, median (range)

Variable	Before start of therapy		3 mo after start of therapy		P value
	IFX	ADA	IFX	ADA	IFX	ADA
Number of bowel movements per 24 h	6 (1-30)	6 (1-17)	5 (1-40)	5 (1-20)	0.042	0.229
Occurrence of blood in stool (yes/no) (%)	32/47 (68)	23/36 (63.9)	29/50 (58)	19/35 (54.3)	0.678	0.453
CRP, (mg/L)	4.9 (0-51)	3.6 (0-122)	2.9 (0-312)	3.6 (0-145)	0.310	0.435
Leukocyte number (G/L)	9.4 (2.7-17.6)	7.7 (2.5-22)	7.4 (2.2-22.9)	7.3 (3.9-15.4)	0.037	0.524
Platelet number (G/L)	338 (150-879)	335 (194-850)	307 (166-758)	298 (170-787)	0.005	0.007
Hemoglobin (g/dL)	12.2 (8.3-15.9)	12.4 (8.1-17)	12.7 (8.5-15.9)	12.9 (6.4-16.4)	0.084	0.501

ADA: Adalimumab; IFX: Infliximab; CrP: C-reactive protein (normal: < 5 mg/L).

Table 4 Adverse events necessitating discontinuation of infliximab therapy and adalimumab therapy

Adverse events necessitating discontinuation of infliximab therapy

Severe non-preexisting arthralgia with high anti-IFX antibody titer

IFX-induced linear IgA dermatosis after 3rd infusion

Epileptic seizure (first event) directly after start of 1st infusion

IFX-induced hepatitis

Severe non-preexisting arthralgia

Severe anaphylactic reaction

Severe anaphylactic reaction

Allergic reaction after 19 mo of therapy

Severe non-preexistent myalgia and arthralgia

Severe anaphylactic reaction

Adverse events necessitating discontinuation of adalimumab therapy

Generalized pruritus and exanthema, classified as allergic reaction

ADA-induced hepatitis

Acute absceding pyelonephritis

EBV-associated B-cell Hodgkin lymphoma, nodular-sclerosing type, stadium IIIB1

Frequent infections, especially of the upper respiratory tract

¹The patient had been under therapy with azathioprine for one year, subsequently with IFX for 19 mo, and then after a pause with ADA for 6 mo. IgA: Immunoglobulin A; ADA: Adalimumab; EBV: Epstein-Barr virus; IFX: Infliximab.