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. Author manuscript; available in PMC: 2018 Dec 5.
Published in final edited form as: Mucosal Immunol. 2018 Jun 15;11(6):1558–1570. doi: 10.1038/s41385-018-0050-3

Table 1.

Summary of key registration trial efficacy data for approved biologics in Crohn’s disease

Biologic Clinical remission or response Mucosal healing
Anti-TNF-α
Infliximab Induction: 81% vs 17% clinical response week 4 [Targan et al.]16
Maintenance: 39% vs 21% clinical remission week 30 [ACCENT I]18
Fistulizing: 36% vs 19% complete fistula closure at week 54 [ACCENT II]19 		43.9% IFX + AZA combination vs 30.1% IFX monotherapy vs 16.5% AZA monotherapy week 26 [SONIC]104
Adalimumab Induction: 36% vs 12% clinical remission, 59% vs 37% clinical response week 4 [CLASSIC I]21
Maintenance: 40% vs 17% clinical remission week 26, 36% vs 12% clinical remission week 56 [CHARM]22
Fistulizing (subgroup analysis): 30% vs 13% fistula closure week 26, 33% vs 13% fistula closure week 56 [CHARM]22 		27% vs 13% week 12 [EXTEND]23
24% vs 0% week 52 [EXTEND]23
Certolizumab Induction: 37% vs 26% clinical response week 6 [PRECISE I]25 Maintenance: 62% vs 34% clinical response, 48% vs 29% clinical remission week 26 [PRECISE II]26
Fistulizing (subgroup analysis): 36% vs 17% fistula closure week 26 [PRECISE II]28 		27% endoscopic remission (CDEIS <6), 8% mucosal healing with no ulcers week 54 [MUSIC]27
Anti-integrin
Natalizumab Induction: 51% vs 37% clinical response week 4, 26% vs 16% clinical remission week 12 [ENCORE]44
Maintenance: 61% vs 28% clinical response, 44% vs 26% clinical remission week 36 [ENACT II]45
Vedolizumab Induction: Clinical remission 14.5% vs 6.8%, clinical response 31.4% vs 25.7% (NS) week 6 [GEMINI II]52
Maintenance: Clinical remission 39% vs 21.6% week 52 [GEMINI II]52
Anti-IL-12/23
Ustekinumab Induction: Clinical response 33.7% vs 21.5% [UNITI-1; anti-TNF non-responder] 55.5% vs 28.7% [UNITI -2] week 6. Clinical remission 18.5% vs 8.9% [UNITI-1; anti-TNF non-responder] 34.9% vs 17.7% [UNITI -2] week 655
Maintenance: Clinical remission 53.1% vs 35.9%, clinical response 59.4% vs 44.3% week 44 [IM-UNITI]55

Note: The above-listed trials differ in patient selection criteria, prior exposure to other biologic therapies, and study end points