Value of tofacitinib extended induction therapy in patients with moderate-to-severe ulcerative colitis: A real-world 52-week follow-up study

Table 2 Differences in clinical and biochemical characteristics between patients receiving tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily at baseline and at week 52

Factors	Tofacitinib 5 mg bid, n = 9	Tofacitinib 10 mg bid, n = 19	P value
Quantitative variables [median (range)]
Age in years	43 (23-61)	38 (17-62)	0.247
Disease duration in years	4 (2-15)	8 (1-28)	0.141
BMI in kg/m2	28.1 (19.0-36.2)	23.8 (14.0-36.3)	0.275
Number of previous treatments	1 (0-4)	2 (1-4)	0.241
CRP at baseline in mg/dL	10.1 (3.0-18.0)	4.8 (0.7-17.9)	0.170
Albumin at baseline in g/dL	4.1 (3.1-4.5)	4.3 (3.1-5.2)	0.610
Hb at baseline in g/d	13.2 (8.9-13.6)	13.6 (10.2-15.5)	0.881
PLT at baseline as × 109/L	315 (265-390)	297 (192-705)	0.183
WBC at baseline per mL	8590 (5230-12200)	9600 (6000-16990)	0.522
Granulocytes absolute count at baseline per mL	5160 (2600-9000)	5476 (2881-11060)	0.806
UCEIS at baseline	6 (2-7)	7 (4-10)	0.171
Full Mayo score at baseline	7 (5-10)	9 (5-12)	0.060
NANCY score at baseline	4 (4-4)	3 (3-4)	0.091
CRP in mg/dL at week 52	5.0 (0.5-40.0)	1.0 (0.1-69.0)	0.263
Albumin in g/dL at week 52	4.1 (3.9-4.3)	4.5 (3.6-5.0)	0.175
Hb at week 52	13.2 (10.1-14.6)	12.8 (11.3-16.3)	0.918
PLT as × 109/L at week 52	311.5 (221.0-391.0)	300.0 (199.0-572.0)	0.934
WBC per mL at week 52	7010 (4390-10600)	6800 (4550-9400)	0.881
Granulocytes absolute count at week 52	4408.0 (2742.0-7290.0)	4544.5 (3440.0-6950.0)	0.826
Qualitative variables [n (%)]
Sex as male/female	4/5 (44.4/55.5)	11/8 (57.9/42.1)	0.505
Montreal classification as E1/E2/E3	0/4/5 (0/44.4/55.5)	0/4/15 (21.1/78.9)	0.201
Family history of IBD	2 (22.2)	1 (5.3)	0.175
Smoking for current/in the past	0/2 (0/22.2)	1/3 (5.3/15.8)	0.735
Extraintestinal manifestations	4 (44.4)	3 (15.8)	0.102
Musculoskeletal as peripheral arthritis/axonal arthritis/both	2/1/1 (22.2/11.1/11.1)	1/0/0 (5.3/0/0)	0.072
Dermatological as pyoderma gangrenosum/psoriasis	0	0/1 (0/5.3)	0.483
Other	0	0	NA
Active extraintestinal manifestation	2 (22.2)	1 (5.3)	0.175
Indication of treatment initiation			0.103
Inadequate response or loss of response in previous treatments	7 (77.8)	19 (100)
Intolerance to previous treatment	1 (11.1)	0
Contraindications for other treatment modality	0	0
Steroid dependency	1 (11.1)	0
Previous treatment	6 (66.7)	19 (100)	0.008a
Steroids	8 (88.9)	16 (84.2)	0.741
5-ASA	8 (88.9)	13 (68.4)	0.243
Azathioprine	5 (55.6)	8 (42.1)	0.505
MTX	0	1 (5.3)	0.483
Biologics	6 (66.7)	19 (100)	0.008a
Anti-TNFα as infliximab/adalimumab/golimumab	6 (66.7) [5 (55.6)/2 (22.2)/1 (11.1)]	18 (89.5) [14 (73.7)/5 (26.3)/2 (10.5)]	0.141 (0.337/0.815/0.963)
Vedolizumab	4 (44.4)	11 (57.9)	0.505
Anti-IL12/23	2 (22.2)	2 (10.5)	0.409
Bloody stool at baseline			0.255
Traces of blood < 50%	5 (55.6)	4 (21.2)
Blood > 50%	4 (44.4)	12 (63.2)
Only blood	0	1 (5.3)
Number of bowel movements at baseline			0.484
1-2 more than normal	2 (22.2)	4 (21.1)
3-4 more than normal	6 (66.7)	9 (47.4)
Bloody stool at baseline	1 (11.1)	6 (31.6)
Traces of blood < 50%			0.222
Blood > 50%	4 (44.4)	3 (15.8)
Only blood	3 (33.3)	7 (36.8)
Severe disease	2 (22.2)	9 (47.4)
Urgency at baseline			0.114
In 5 minutes	5 (55.5)	6 (31.6)
In 1 minute	2 (22.2)	1 (5.3)
Incontinence	1 (11.1)	1 (5.3)
5-ASA coadministration at baseline	5 (55.6)	9 (47.4)	0.686
Steroids coadministration at baseline	5 (55.6)	12 (63.2)	0.700
Endoscopic Mayo score (0/1/2/3) at baseline	0/0/4/4 (0/0/44.4/44.4)	1/0/4/10 (5.3/0/21.1/52.6)	0.452
Bloody stool at week 52			0.110
Traces of blood < 50%	0	5 (26.3)
Blood > 50%	0	2 (10.5)
Only blood	0	0
Number of bowel movements at week 52			0.448
1-2 more than normal	3 (33.3)	7 (36.8)
3-4 more than normal	0	3 (15.8)
≥ 5 more than normal	0	1 (5.3)
PGA at week 52			0.215
Mild disease	2 (22.2)	6 (31.6)
Moderate disease	0	4 (21.1)
Severe disease	0	0
Urgency at week 52			0.272
In 5 minutes	1 (11.1)	0
In 1 minute	0	1 (5.3)
Incontinence	0	0
5-ASA coadministration at week 52	3 (33.3)	8 (42.1)	0.657
Steroids coadministration at week 52	1 (11.1)	1 (5.3)	0.512

^aP < 0.05.

BMI: Body mass index; CRP: C-reactive protein; Hb: Hemoglobin; PLT: Platelets; WBC: White blood counts; UCEIS: Ulcerative Colitis Endoscopic Index of Severity; IBD: Inflammatory bowel disease; 5-ASA: 5-aminosalicylic acid; anti-TNFα: Anti-tumor necrosis factor alpha; IL: Interleukin; MTX: Methotrexate; PGA: Physician’s global assessment; bid: Twice daily; NA: Not available.