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

Table 1 Baseline characteristics of the study population, n = 37

Quantitative variable	Median (range)/n	IQR/percent (%)
Age in years	39 (17-64)	32
Disease duration in years	6 (1-28)	13
BMI in kg/m2	23.35 (14.00-36.30)	10.76
Number of previous treatments	2 (0-4)	1
CRP in mg/dL	8.6 (0.5-61.6)	13.98
Albumin in g/dL	4.1 (3.0-5.2)	0.33
Hb in g/dL	13.3 (8.9-15.7)	1.68
PLT as × 109/L	315 (127-705)	181.25
WBC per mL	8935 (4400-16990)	2760.7
Granulocytes (absolute count) per mL	5300.0 (2600.0-11060.5)	2526.4
UCEIS	6.5 (2.0-10.0)	3
Total Mayo score	9 (5-12)	4
NANCY score	3 (3-4)	1
Sex as male/female	19/18	51.4/48.6
Montreal classification as E1/E2/E3	0/10/27	0/27/73
Family history of IBD	3	8.1
Smoking as current/in the past	4/7	10.8/18.9
Extraintestinal manifestations	11	29.7
Musculoskeletal as peripheral arthritis/axonal arthritis/both	6/2/1	16.2/5.4/2.7
Dermatological as pyoderma gangrenosum/psoriasis	1/1	2.7/2.7
Liver/biliary	0	0
Stomal	0	0
Ocular (uveitis)	1	2.7
Other	0	0
Active extraintestinal manifestation	6	16.2
Previous treatment	32	86.5
Steroids	33	89.2
5-ASA	30	81.1
Azathioprine	18	48.6
MTX	2	5.4
Biologics	33	89.2
Anti-TNFα as infliximab/adalimumab/golimumab	29 (24/11/5)	78.4 (64.9/29.7/13.5)
Vedolizumab	19	51.4
Anti-IL12/23	6	16.2
Bloody stool
Traces of blood < 50%	11	29.7
Blood > 50%	22	9.5
Only blood	1	2.7
Number of bowel movements
1-2 more than normal	6	16.2
3-4 more than normal	17	45.9
≥ 5 more than normal	13	35.1
PGA
Mild disease	8	21.6
Moderate disease	14	37.8
Severe disease	15	40.5
Urgency
In 5 minutes	15	40.5
In 1 minute	3	8.1
Incontinence	3	8.1
5-ASA coadministration	20	54.1
Steroids coadministration	23	62.2
Endoscopic Mayo score as 0/1/2/3	1/0/11/19	2.7/0/29.7/51.4

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; IQR: Interquartile range.

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.

Table 3 Baseline factors associated with clinical remission at week 52, n = 28

Factors	OR (95%CI)	P value
Age	1.003 (0.949-1.061)	0.909
Male sex	0.778 (0.173-3.493)	0.743
Montreal classification	1.500 (0.288-7.807)	0.630
Disease duration	1.030 (0.918-1.154)	0.616
Family history of IBD	1.571(0.126-19.668)	0.726
Current smoker	1.250 (0.173-9.019)	0.825
BMI	1.026 (0.906-1.163)	0.684
Extraintestinal manifestations	2.773 (0.357-14.454)	0.384
Active extraintestinal manifestation	1.571 (0.126-19.668)	0.726
Previous treatment	0.545 (0.043-6.889)	0.639
Number of previous treatments	0.636 (0.051-7.965)	0.726
Partial Mayo	1.461 (0.928-2.301)	0.102
Coadministration of 5-ASA at week 52	0.115 (0.020-0.665)	0.015a
Coadministration of steroids at week 52	0.786 (0.044-14.026)	0.870
CRP	1.002 (0.866-1.159)	0.981
Albumin	0.654 (0.132-3.247)	0.603
Hb	0.790 (0.474-1.316)	0.365
PLT	0.999 (0.992-1.006)	0.862
WBC	1.00 (1.000-1.000)	0.881
Gran	1.00 (1.000-1.001)	0.725
Endoscopic Mayo	0.383 (0.083-1.761)	0.218
Full Mayo score	1.478 (0.902-2.423)	0.121
Dose of tofacitinib at week 52	0.556 (0.106-2.901)	0.486

^aP < 0.05.

IBD: Inflammatory bowel disease; BMI: Body mass index; CRP: C-reactive protein; Hb: Hemoglobin; PLT: Platelets; WBC: White blood counts; Gran: Granulocytes; 5-ASA: 5-aminosalicylic acid; CI: Confidence interval; OR: Odds ratio.

Table 4 Factors associated with drug discontinuation at week 52

Factors	OR (95%CI)	P value
Age	1.040 (0.979-1.105)	0.208
Male sex	1.442 (0.319-6.529)	0.635
Montreal classification	1.400 (0.238-8.240)	0.710
Disease duration	1.012 (0.911-1.125)	0.819
Family history of IBD	NA
Current smoker	16.500 (1.353-201.290)	0.028a
BMI	1.008 (0.883-1.150)	0.910
Extraintestinal manifestations	2.400 (0.500-11.519)	0.274
Active extraintestinal manifestation	4.167 (0.667-26.017)	0.127
Previous treatment	0.960 (0.087-10.573)	0.973
Number of previous treatments	0.866 (0.445-1.687)	0.673
Partial Mayo	1.193 (0.779-1.827)	0.417
CRP	1.056 (0.985-1.132)	0.127
Albumin	0.553 (0.141-2.159)	0.394
Hb	1.155 (0.730-1.829)	0.538
PLT	1.001 (0.994-1.007)	0.854
WBC	1.000 (1.000-1.000)	0.857
Gran	1.000 (1.000-1.001)	0.224
Endoscopic Mayo	1.290 (0.343-4.848)	0.706
Full Mayo score	1.385 (0.835-2.297)	0.207

^aP < 0.05.

IBD: Inflammatory bowel disease; BMI: Body mass index; CRP: C-reactive protein; Hb: Hemoglobin; PLT: Platelets; WBC: White blood counts; Gran: Granulocytes; CI: Confidence interval; NA: Not available; OR: Odds ratio.