Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

B. E. Sands; W. J. Sandborn; R. Panaccione; C. D. O'Brien; H. Zhang; J. Johanns; O. J. Adedokun; K. Li; L. Peyrin-Biroulet; G. Van Assche; S. Danese; S. Targan; M. T. Abreu; T. Hisamatsu; P. Szapary; C. Marano; Marieke Pierik; UNIFI Study Group

doi:10.1056/NEJMoa1900750

Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

B. E. Sands^*, W. J. Sandborn, R. Panaccione, C. D. O'Brien, H. Zhang, J. Johanns, O. J. Adedokun, K. Li, L. Peyrin-Biroulet, G. Van Assche, S. Danese, S. Targan, M. T. Abreu, T. Hisamatsu, P. Szapary, C. Marano, Marieke Pierik, UNIFI Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.

MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).

ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P

ConclusionsUstekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.)

Original language	English
Pages (from-to)	1201-1214
Number of pages	14
Journal	New England Journal of Medicine
Volume	381
Issue number	13
DOIs	https://doi.org/10.1056/NEJMoa1900750
Publication status	Published - 26 Sept 2019

Keywords

ACTIVITY INDEXES
INFLIXIMAB
INFECTIONS
EFFICACY

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10.1056/NEJMoa1900750

Cite this

Sands, B. E., Sandborn, W. J., Panaccione, R., O'Brien, C. D., Zhang, H., Johanns, J., Adedokun, O. J., Li, K., Peyrin-Biroulet, L., Van Assche, G., Danese, S., Targan, S., Abreu, M. T., Hisamatsu, T., Szapary, P., Marano, C., Pierik, M., & UNIFI Study Group (2019). Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine, 381(13), 1201-1214. https://doi.org/10.1056/NEJMoa1900750

@article{2509dd2686024c0383c96659c8935674,

title = "Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis",

abstract = "BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (PConclusionsUstekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.)",

keywords = "ACTIVITY INDEXES, INFLIXIMAB, INFECTIONS, EFFICACY",

author = "Sands, {B. E.} and Sandborn, {W. J.} and R. Panaccione and O'Brien, {C. D.} and H. Zhang and J. Johanns and Adedokun, {O. J.} and K. Li and L. Peyrin-Biroulet and {Van Assche}, G. and S. Danese and S. Targan and Abreu, {M. T.} and T. Hisamatsu and P. Szapary and C. Marano and Marieke Pierik and {UNIFI Study Group}",

note = "Funding Information: Presented in part at the annual meeting of the American College of Gastroenterology, Philadelphia, October 5–10, 2018; United European Gastroenterology Week 2018, Vienna, October 20–24, 2018; the 14th Congress of the European Crohn{\textquoteright}s and Colitis Organization, Copenhagen, March 6–9, 2019; and Digestive Disease Week 2019, San Diego, CA, May 18–21, 2019. Supported by Janssen Research and Development. Publisher Copyright: Copyright {\textcopyright} 2019 Massachusetts Medical Society.",

year = "2019",

month = sep,

day = "26",

doi = "10.1056/NEJMoa1900750",

language = "English",

volume = "381",

pages = "1201--1214",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "13",

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Sands, BE, Sandborn, WJ, Panaccione, R, O'Brien, CD, Zhang, H, Johanns, J, Adedokun, OJ, Li, K, Peyrin-Biroulet, L, Van Assche, G, Danese, S, Targan, S, Abreu, MT, Hisamatsu, T, Szapary, P, Marano, C, Pierik, M & UNIFI Study Group 2019, 'Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis', New England Journal of Medicine, vol. 381, no. 13, pp. 1201-1214. https://doi.org/10.1056/NEJMoa1900750

TY - JOUR

T1 - Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

AU - Sands, B. E.

AU - Sandborn, W. J.

AU - Panaccione, R.

AU - O'Brien, C. D.

AU - Zhang, H.

AU - Johanns, J.

AU - Adedokun, O. J.

AU - Li, K.

AU - Peyrin-Biroulet, L.

AU - Van Assche, G.

AU - Danese, S.

AU - Targan, S.

AU - Abreu, M. T.

AU - Hisamatsu, T.

AU - Szapary, P.

AU - Marano, C.

AU - Pierik, Marieke

AU - UNIFI Study Group

N1 - Funding Information: Presented in part at the annual meeting of the American College of Gastroenterology, Philadelphia, October 5–10, 2018; United European Gastroenterology Week 2018, Vienna, October 20–24, 2018; the 14th Congress of the European Crohn’s and Colitis Organization, Copenhagen, March 6–9, 2019; and Digestive Disease Week 2019, San Diego, CA, May 18–21, 2019. Supported by Janssen Research and Development. Publisher Copyright: Copyright © 2019 Massachusetts Medical Society.

PY - 2019/9/26

Y1 - 2019/9/26

N2 - BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (PConclusionsUstekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.)

AB - BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (PConclusionsUstekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.)

KW - ACTIVITY INDEXES

KW - INFLIXIMAB

KW - INFECTIONS

KW - EFFICACY

U2 - 10.1056/NEJMoa1900750

DO - 10.1056/NEJMoa1900750

M3 - Article

C2 - 31553833

SN - 0028-4793

VL - 381

SP - 1201

EP - 1214

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 13

ER -