Novel Therapeutic Options for People with Ulcerative Colitis: An Update on Recent Developments with Janus Kinase (JAK) Inhibitors

Figures & data

Table 1 Main Results from Phase 3 Studies (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) Evaluating Tofacitinib in Moderate-to-Severe Ulcerative Colitis (Ref ³⁶). For Induction Trials, Endpoints Were Evaluated at 8 Weeks; for Sustain Trial, Endpoints Were Evaluated at 52 Weeks

	OCTAVE Induction 1			OCTAVE Induction 2			OCTAVE Sustain
	Placebo N=122	10 mg N=476	P value	Placebo N=112	10 mg N=429	P value	Placebo N=198	5 mg N=198	P value	10 mg N=197	P value
Primary endpoint
Clinical remission	10 (8.2%)	88 (18.5%)	0.007	4 (3.6%)	71 (16.6%)	<0.001	22 (11.1%)	68 (34.3%)	<0.001	80 (40.6%)	<0.001
Secondary endpoint
Mucosal healing	19 (15.6%)	149 (31.3%)	<0.001	13 (11.6%)	122 (28.4%)	<0.001	26 (13.1%)	74 (37.4%)	<0.001	90 (45.7%)	<0.001
Clinical response	40 (32.8%)	285 (59.9%)	<0.001	32 (28.6%)	236 (55%)	<0.001	40 (20.2%)	102 (51.5%)	<0.001	122 (61.9%)	<0.001
IBDQ remission	46 (37.7%)	250 (52.5%)	0.004	29 (25.9%)	212 (49.4%)	<0.001	40 (20.2%)	95 (48%)	<0.001	113 (57.4%)	<0.001

Abbreviation: IBDQ, Inflammatory Bowel Disease Questionnaire.

Table 2 Main Adverse Events Reported in Tofacitinib Groups During Phase 3 Trials (Ref ³⁶)

Adverse Events	%
Any infection	26%
Nasopharyngitis	7.7%
Herpes Zoster	1.4%
Serious infections	0.8%
Headache	7.2%
Arthralgia	4.5%
Cardiovascular events	0.5%
Non-melanoma skin cancers	0.4%
Abnormal laboratory test results*
Hypercholesterolemia	19.3%
Hypertriglyceridemia	3.9%
Rise in creatine kinase levels	13.5%

Note: *Laboratory data were missing for some patients in the original work.

Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723–1736. doi:10.1056/NEJMoa1606910

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