J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 7, Number 11, November 2015, pages 884-889

Combination Therapy With Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Refractory Ulcerative Colitis

Figure 1. Changes in the mean full Mayo scores (A) and endoscopic subscore (B) between baseline and 10 weeks in nine cases. No. 4 patient, who received total colectomy, was excluded from this analysis. The data are presented as means ± SE values, and comparisons were made by using a paired t-test. A significance level of 0.01 was used for all statistic tests, and two-tailed tests were applied when appropriate.

Figure 2. Cumulative remission rate of patients receiving combination therapy of ADA plus intensive GMA for 10 weeks and subsequent maintenance monotherapy of ADA. A Kaplan-Meier plot with a fitted curve of cumulative remission rate over time is shown. The solid circles represent event occurrences and censoring is indicated by the open circles.

**Table 1.** Baseline Demographic Variables of the 10 Cases With UC Refractory to Medications Including TAC Who Were Selected for This Combination Therapy With ADA Plus Intensive GMA
Demographic	Number of patients
The data are presented as means or median values.
Male/female	6/4
Age (range)	57.1 (34 - 85)
Mean disease duration, years (range)	8.3 (0.2 - 20)
Disease location (n, %)
Extensive	8 (80)
Left-sided	2 (20)
Concurrent medication (n, %)
5-ASA	10 (100)
Corticosteroids	10 (100)
TAC	2 (20)
Baseline full Mayo scores (mean)	9.3
Median CRP levels (range)	1.28 (0.03 - 27.9)
Doses of corticosteroids, mg/day (mean)	26.5
Corticosteroid-dependent/refractory (n, %)
Dependent	7 (70)
Refractory	3 (30)

Table 1. Baseline Demographic Variables of the 10 Cases With UC Refractory to Medications Including TAC Who Were Selected for This Combination Therapy With ADA Plus Intensive GMA

Demographic

Number of patients

The data are presented as means or median values.

Male/female

6/4

Age (range)

57.1 (34 - 85)

Mean disease duration, years (range)

8.3 (0.2 - 20)

Disease location (n, %)

Extensive

8 (80)

Left-sided

2 (20)

Concurrent medication (n, %)

5-ASA

10 (100)

Corticosteroids

10 (100)

TAC

2 (20)

Baseline full Mayo scores (mean)

9.3

Median CRP levels (range)

1.28 (0.03 - 27.9)

Doses of corticosteroids, mg/day (mean)

26.5

Corticosteroid-dependent/refractory (n, %)

Dependent

7 (70)

Refractory

3 (30)

**Table 2.** Clinical Course Over 52 Weeks
No.	Age (years)	Sex	Disease location	Pretreated	Baseline	Treated	At 10 weeks	At 24 weeks	At 52 weeks	Clinical course
One patient received total colectomy at 4 weeks because of no response to combination therapy of ADA plus intensive GMA. TAC: tacrolimus; LOR: loss of response; PSL: prednisolone; CRP: C-reactive protein; ADA: adalimumab; GMA: granulocyte and monocyte adsorptive apheresis; p Mayo: partial Mayo; CR: clinical remission; failed: failure to achieve clinical remission; AZA: azathioprine; AE: adverse events.
1	50	M	Left-sided	-	5	8	3	0.04	+	+	5	2	-	0.04	0	0	0.02	1	1	+	0.02	+	-	-	-
2	34	F	Left-sided	-	5	6	2	0.3	+	+	2	1	+	0.13	0	1	0.06	2	1	+	0.06	+	32	50	-
3	65	M	Extensive	+	40	11	3	2.52	+	+	2	1	+	0.34	0	1	0.14	2	1	+	0.1	+	-	-	-
4	71	F	Extensive	-	40	12	3	27.9	+	+	12 (4 weeks)		ope		40 (4 weeks)										-
5	43	M	Extensive	-	60	12	3	0.55	+	+	6	1	-	0.03	0	1	0.03	1	0	+	0.03	+	12	25	+
6	85	M	Extensive	-	60	9	2	1.7	+	+	1	1	+	1.1	0	0	0.09	1	1	+	0.25	+	-	-	+
7	52	M	Extensive	-	15	10	3	2.03	+	+	1	1	+	0.08	0	0	0.09	3	1	-	0.3	+	56	50	-
8	35	F	Extensive	-	10	6	1	0.03	+	+	0	0	+	0.03	0	0	0.03	1	1	+	0.03	+	-	-	-
9	77	F	Extensive	+	15	10	3	1.55	+	+	3	2	-	0.09	0	1	0.03	2	1	+	0.03	+	10	25	+
10	59	M	Extensive	-	15	9	2	1.0	+	+	7	2	-	0.12	10	2	0.03	3	1	-	0.03	+	10	25	-

Table 2. Clinical Course Over 52 Weeks

No.

Age (years)

Sex

Disease location

Pretreated

Baseline

Treated

At 10 weeks

At 24 weeks

At 52 weeks

Clinical course

TAC LOR

PSL (mg)

Full Mayo

Endo scores

CRP (mg/dL)

ADA

Intensive GMA

Full Mayo

Endo scores

CRP (mg/dL)

PSL (mg)

p Mayo

CRP (mg/dL)

Full Mayo

Endo scores

CRP (mg/dL)

ADA continued

Failed/flare (weeks)

AZA (mg)

One patient received total colectomy at 4 weeks because of no response to combination therapy of ADA plus intensive GMA. TAC: tacrolimus; LOR: loss of response; PSL: prednisolone; CRP: C-reactive protein; ADA: adalimumab; GMA: granulocyte and monocyte adsorptive apheresis; p Mayo: partial Mayo; CR: clinical remission; failed: failure to achieve clinical remission; AZA: azathioprine; AE: adverse events.

Left-sided

0.04

0.02

Left-sided

0.3

0.13

0.06

Extensive

2.52

0.34

0.14

0.1

Extensive

27.9

12 (4 weeks)

ope

40 (4 weeks)

Extensive

0.55

0.03

Extensive

1.7

1.1

0.09

0.25

Extensive

2.03

0.08

0.09

0.3

Extensive

0.03

Extensive

1.55

0.09

0.03

Extensive

1.0

0.12

0.03