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 https://www.jocmr.org

Case Report

Volume 15, Number 3, March 2023, pages 181-186

Induction Therapy With a Combination of Weekly Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Ulcerative Colitis and Failure of Conventional Agents, Biologics and Janus Kinase Inhibitor

Figure 1. Changes in mean full Mayo score (a), endoscopic subscore (b) and CRP value (c) between baseline and 10 weeks in six cases. Cases 1 and 2, in which the patients received additional drug because of insufficient response to this combination therapy, were excluded from analysis. Data are presented as mean ± standard error. Comparisons were made using the Wilcoxon signed-rank test for paired data. A significance level of 0.05 was used for all statistical tests, and two-tailed tests were applied as appropriate. CRP: C-reactive protein.

**Table 1.** Baseline Demographic Variables of the Six Cases
Demographic	Number of patients
Baseline demographic variables of the 6 cases with ulcerative colitis refractory to medications including ustekinumab and tofacitinib, who were selected for combination therapy with every-week adalimumab maintenance following standard induction regimen plus intensive granulocyte and monocyte adsorptive apheresis. Data are presented as mean value and range or number and percentage. CRP: C-reactive protein.
Male/female	4/2
Age, years (range)	34.5 (24 - 48)
Mean disease duration, years (range)	3.75 (0.15 - 10)
Disease location (n, %)
Extensive	3 (50)
Left-sided	1 (17)
Distal	2 (33)
Disease severity (n)
Moderate/severe	2/4
Concurrent medication (n, %)
5-aminosalicylic acid	5 (83)
Corticosteroids	5 (83)
Azathioprine	2 (33)
Prior exposure (n, %)
Ustekinumab	1 (17)
Tofacitinib	1 (17)
Mean baseline full Mayo scores	10.1
Mean CRP level, mg/dL (range)	1.53 (0.03 - 4.11)
Mean corticosteroids dose (mg/day)	19.0
Corticosteroid-dependent/-refractory (n, %)
Dependent	3 (50)
Refractory	2 (33)

Table 1. Baseline Demographic Variables of the Six Cases

Demographic

Number of patients

Baseline demographic variables of the 6 cases with ulcerative colitis refractory to medications including ustekinumab and tofacitinib, who were selected for combination therapy with every-week adalimumab maintenance following standard induction regimen plus intensive granulocyte and monocyte adsorptive apheresis. Data are presented as mean value and range or number and percentage. CRP: C-reactive protein.

Male/female

4/2

Age, years (range)

34.5 (24 - 48)

Mean disease duration, years (range)

3.75 (0.15 - 10)

Disease location (n, %)

Extensive

3 (50)

Left-sided

1 (17)

Distal

2 (33)

Disease severity (n)

Moderate/severe

2/4

Concurrent medication (n, %)

5-aminosalicylic acid

5 (83)

Corticosteroids

5 (83)

Azathioprine

2 (33)

Prior exposure (n, %)

Ustekinumab

1 (17)

Tofacitinib

1 (17)

Mean baseline full Mayo scores

10.1

Mean CRP level, mg/dL (range)

1.53 (0.03 - 4.11)

Mean corticosteroids dose (mg/day)

19.0

Corticosteroid-dependent/-refractory (n, %)

Dependent

3 (50)

Refractory

2 (33)

**Table 2.** Clinical Course Within 10 Weeks
No.	Age	Sex	Disease duration (years)	Disease location	Pretreated	Baseline	Treated	At 10 weeks
^aPartial Mayo score excluding endoscopic subscore. ^bMean (range). ^cMedian (IQR). Two cases (cases 1 and 2) received additional AZA at 4 and 8 weeks, respectively, because of insufficient response to this combination therapy. M: male; F: female; AZA: azathioprine; UST: ustekinumab; TOF: tofacitinib; PSL: prednisolone; Bude: budesonide; full Mayo: full Mayo score; Endo scores: Mayo endoscopic subscores; CRP: C-reactive protein; ew-ADA: every-week adalimumab maintenance following standard induction regimen; GMA: granulocyte and monocyte adsorptive apheresis; CR: clinical remission; IQR: interquartile range; wks: weeks.
1	24	F	0.15	Extensive		20	11	3	4.11	+	+	9^a (4 wks)		0.12	-	0
2	31	F	1	Extensive		40	11	2	0.03	+	+	7^b (8 wks)		0.03	-	0
3	30	M	10	Extensive	AZA	0	11	3	2.83	+	+	1	1	0.07	+	-
4	48	M	1.5	Distal	UST, TOF	Bude 2	7	3	0.03	+	+	9	3	1.02	-	0
5	31	M	5	Left-sided		30	10	2	0.79	+	+	3	1	0.01	-	0
6	43	M	5	Distal	AZA	5	11	2	1.4	+	+	3	2	0.06	-	0
	34.5 (24 - 48)^b						11 (10 - 11)^c		1.10 (0.03 - 2.83)^c			3 (2 - 6)^c		0.065 (0.03 - 0.12)^c

Table 2. Clinical Course Within 10 Weeks

No.

Age

Sex

Disease duration (years)

Disease location

Pretreated

Baseline

Treated

At 10 weeks

Previous treatment

PSL (mg)

Full Mayo

Endo scores

CRP (mg/dL)

ew-ADA

Intensive GMA

Full Mayo

Endo scores

CRP (mg/dL)

PSL (mg)

^aPartial Mayo score excluding endoscopic subscore. ^bMean (range). ^cMedian (IQR). Two cases (cases 1 and 2) received additional AZA at 4 and 8 weeks, respectively, because of insufficient response to this combination therapy. M: male; F: female; AZA: azathioprine; UST: ustekinumab; TOF: tofacitinib; PSL: prednisolone; Bude: budesonide; full Mayo: full Mayo score; Endo scores: Mayo endoscopic subscores; CRP: C-reactive protein; ew-ADA: every-week adalimumab maintenance following standard induction regimen; GMA: granulocyte and monocyte adsorptive apheresis; CR: clinical remission; IQR: interquartile range; wks: weeks.

0.15

Extensive

4.11

9^a (4 wks)

0.12

Extensive

0.03

7^b (8 wks)

0.03

Extensive

AZA

2.83

0.07

1.5

Distal

UST, TOF

Bude 2

0.03

1.02

Left-sided

0.79

0.01

Distal

AZA

1.4

0.06

34.5 (24 - 48)^b

11 (10 - 11)^c

1.10 (0.03 - 2.83)^c

3 (2 - 6)^c

0.065 (0.03 - 0.12)^c