Adalimumab Superior to Ustekinumab as First-Line Therapy for Crohn Disease

Adalimumab should be considered first-line treatment for moderate to severe Crohn disease.

First-line treatment with adalimumab proved superior to ustekinumab in achieving endoscopic remission in patients with moderate to severe Crohn disease (CD), although clinically, these biologic treatments appeared equivalent, according to findings published in the European Journal of Gastroenterology & Hepatology.

Researchers in Belgium conducted a real-life cohort study of 64 biological-naive patients with endoscopy-proven CD treated between September 2017 and August 2020 at the University Hospitals Leuven.

Researchers compared the efficacy of 2 potential first-line biologicals, adalimumab and ustekinumab, in achieving endoscopic and clinical remission of CD. A total of 32 patients received adalimumab and 32 received ustekinumab.

Researchers used the Simple Endoscopic Score for Crohn’s Disease (SES-CD) to determine endoscopic remission (SES-CD<3) and the Harvey Bradshaw Index (HBI) or physician’s global assessment to determine clinical remission (HBI<5).

In this real-world cohort study of biological-naive moderate-to-severe Crohn’s disease patients, adalimumab seems superior to ustekinumab as the first-line treatment of
Crohn’s disease patients regarding endoscopic remission at weeks 26-52.

Patients treated with adalimumab demonstrated increased likelihood of achieving endoscopic disease remission between weeks 26 to 52 compared with those treated with ustekinumab (adjusted odds ratio [aOR], 2.73; 95% CI, 1.12-7.36; P =.03). Adalimumab-treated patients were also more likely to achieve endoscopic response than patients in the ustekinumab group (aOR, 2.24; 95% CI, 0.94-5.71; P =.07)

Numerically, more patients receiving adalimumab achieved clinical remission by week 26 than those taking ustekinumab; however, this did not reach statistical significance (aOR, 1.58; 95% CI, 0.54-4.88; P =.41). For patients with active clinical disease at baseline, no significant difference existed between the 2 treatments in terms of clinical remission at week 26 and week 52.

For both treatments, it took a median of 25 weeks before patients underwent endoscopic evaluation (adalimumab range: 23-31 weeks vs ustekinumab range: 24-45 weeks; P =.20).

Four adalimumab-treated patients and 3 ustekinumab-treated patients discontinued treatment due either to lack of response or adverse events or intolerance. During the entire follow-up period of the study, 19 patients reported 41 adverse events in the adalimumab group, while 18 patients reported 27 adverse events in the ustekinumab group. Adverse events did not include death or serious infections.

Additionally, 2 adalimumab-treated patients and 3 ustekinumab-treated patients who failed treatment within the first year required surgery (P =.65).

All patients in the ustekinumab group and 90% of patients in the adalimumab group discontinued use of steroids by week 26. After 1 year of treatment, 88% of adalimumab-treated patients remained steroid-free, while all patients in the ustekinumab group remained steroid-free.

“In this real-world cohort study of biological-naive moderate- to-severe Crohn’s disease patients, adalimumab seems superior to ustekinumab as the first-line treatment of Crohn’s disease patients regarding endoscopic remission at weeks 26–52,” the study authors wrote. “No differences between groups were seen for clinical endpoints or treatment persistence. Thus, both adalimumab and ustekinumab seem clinically equivalent options for the treatment of moderate-to-severe Crohn’s disease.”

Study limitations include the retrospective and observational design, small sample size, and missing clinical data at preset time points.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.