Issue 01

Clinical Question

How efficacious is ustekinumab (UST) for induction and remission in moderate-to-severe Crohn’s disease (CD)?

Editor’s Bottom Line

Ustekinumab is effective induction and maintenance therapy in Crohn’s disease irrespective of prior anti-TNF exposure.

References

Feagan BG, Sandborn WJ, Gasink C, et al; UNITI–IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med. 2016 Nov 17;375(20):1946–60. https://www.ncbi.nlm.nih.gov/pubmed/27959607

Synopsis

Induction trial (weeks 0–6)

Adults diagnosed with CD (CDAI 220–450) and who failed anti-TNFs (UNITI-1) and/or failed immunosuppressant therapies (UNITI-2) were enrolled. Stable doses of immunosuppressants, mesalamine, antibiotics or prednisone (≤40 mg/d) or budesonide (≤9 mg/d) were continued throughout. Patients were randomized 1:1:1 to a single infusion of 130 mg UST or 6 mg UST per kg body weight, or placebo. The primary endpoint was clinical response at week 6 defined as a reduction of ≥100 points in the CDAI at baseline.

Maintenance trial (weeks 8–44)

Patients who had a clinical response to UST by week 8 were randomized 1:1:1 to receive subcutaneous injections of 90 mg UST every 8 weeks or 12 weeks, or placebo. Oral glucocorticoids were tapered beginning at week 8. The primary endpoint was clinical remission (CDAI <150) at week 44.

Details

Study Design: Double-blind, placebo-controlled trials
Funding: Janssen Research and Development
Allocation: n/a
Setting: 260 sites in 27 countries
Level of Evidence: 1b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.