When combination therapy isn’t working: Emerging therapies for the management of inflammatory bowel disease

Table 1 Clinical response defined as decrease in Crohn’s disease activity index > 100

Therapeutic agent	Disease tested	Response vs placebo	Target patients	Ref.
Ustekinumab	Crohn’s disease	Clinical response: 69.4% vs 42.5%, P < 0.001Remission: 41.7% vs 27.4%, P = 0.03	Adult patients with moderate to severe Crohn’s disease with failure to anti-tumour necrosis factor (TNF) therapy	[43]
Vedolizumab	Crohn’s disease	Clinical response: 31.4% vs 25.6%, P = 0.23Remission at week 52: 14.5% vs 6.8%, P = 0.02	Adult patients with active Crohn’s disease (Crohn’s disease activity index, 220-450) with previously documented lack of response to glucocorticoids or immunosuppressive agents or anti-TNF agents	[52,53]
	Ulcerative colitis	Clinical response: 47.1% vs 25.5%, P < 0.001Remission at week 52: 41.8%, 44.8% (8 and 4 wk dosing interval, respectively) vs 15.9%, P < 0.001	Adult patients with active ulcerative colitis (Mayo score 6 to 12) with disease at least 15 cm proximal from anal verge, with previously documented unsuccessful treatment with glucocorticoids or immunosuppressive medications or anti-TNF
Tofacitinib	Ulcerative colitis	Clinical response: 32%, 48%, 61%, 78% [at dose 0.5 mg (P = 0.39), 3 mg (P = 0.55), 10 mg (P = 0.10), and 15 mg (P < 0.001)] vs 42% for placeboClinical remission: 13%, 33%, 48%, 41% [at dose 0.5 mg (P = 0.76), 3 mg (P = 0.01), 10 mg (P < 0.001), and 15 mg (P < 0.001)], vs 10% for placebo	Adults patients with moderate to severe ulcerative colitis	[52]