Adalimumab induction therapy for ulcerative colitis with intolerance or lost response to infliximab: An open-label study

Table 1 Baseline characteristics of the 10 patients

Patient No.	Age (yr)	Sex(M/F)	Diseaseduration (yr)	Diseaseextent	Currentsomoker	Indication ofadalimumab	Infliximabinfusions (n)	Prior medications	Diseaseseverity	CRPconcentration (mg/L)	Concurrentmedications
1	60	M	3	E	No	LR	6	5-ASA, steroid, AZA	Severe	12.0	None
2	57	M	7	LS	No	I	7	5-ASA, steroid, AZA	Mild-moderate	0.8	AZA
3	29	F	8	LS	Yes	I	9	Steroid, AZA	Mild-moderate	19.3	AZA
4	42	M	3	E	No	LR	8	5-ASA, steroid, AZA	Mild-moderate	14.3	None
5	24	M	4	E	No	LR	13	Steroid, AZA, MTX	Mild-moderate	10.7	MTX
6	29	F	3	E	No	LR	7	5-ASA, Steroid, AZA, MTX	Severe	14.2	5-ASA
7	36	M	11	LS	No	I	6	Steroid, AZA, MTX	Severe	32.0	AZA
8	61	M	5	E	No	LR	10	Steroid, AZA, MTX, CSA	Severe	55.0	AZA
9	25	M	5	E	No	I	7	Steroid, AZA, MTX, CSA	Severe	40.0	AZA
10	45	M	4	E	No	LR	9	Steroid, AZA	Severe	24.0	AZA

E: extensive; LS: left-sided; LR: Loss of response to infliximab; I: Intolerance to infliximab; AZA: Azathioprine; MTX: Methotrexate; 5-ASA: 5-aminosalycilates; CSA: Cyclosporine.

Table 2 Clinical efficacy (ITT population)

Therapy/Response	n (%)
Response rates in all patients (n = 10):
Remission	1/10 (10)
Clinical improvement	3/10 (30)
No response1	6/10 (60)
Response rates in severe colitis (n = 6):
Remission	0
Clinical improvement	1/6 (16.6)
No response1	5/6 (83.3)

¹2 patients underwent colectomy.