After 2 years of ustekinumab treatment, one-third of patients with Crohn disease (CD) were in corticosteroid-free clinical remission. These findings were reported in a nationwide, prospective, observational cohort study published in Journal of Crohns and Colitis.

Researchers aimed to evaluate the long-term safety and efficacy of ustekinumab in a cohort of patients with CD (N=252) with a follow-up of 2 years. In addition, investigators set out to assess predictors of clinical response.

Patients who started ustekinumab were included in the nationwide Initiative on Crohn and Colitis (ICC) registry. At the commencement of therapy and at weeks 12, 24, 52, and 104, clinical remission (Harvey Bradshaw index < 4 points), biochemical remission (fecal calprotectin  < 200 µg/g and/or C-reactive protein ≤5 mg/L), perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage, and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104.  

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Among the study participants, over half were women (60.3%) and the median age upon inclusion was 41 years (interquartile range, 32-55 years).  

Of all included patients, the corticosteroid-free clinical remission rates were 32.3% (81/251), 41.4% (104/251), 39.0% (97/249), and 34.0% (84/247) at weeks 12, 24, 52, and 104, respectively.

Regarding patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120), and 32.8% (39/119) at weeks 12, 24, 52, and 104, respectively.  

In all patients, the probability of remaining on ustekinumab treatment after 52 and 104 weeks was 64.3% and 54.8%, respectively.

The main reason for discontinuing treatment after 52 weeks was determined to be loss of response (66.7%). No new safety issues were reported by the investigators.    

This study had several limitations. There remained the possibility of selection bias. Additionally, biochemical data were missing for some patients and thus, underestimated biochemical remission rates are possible.  

In spite of these limitations, ustekinumab was relatively safe and effective in a real-world cohort of patients with CD. Further studies are warranted to ascertain the optimal positioning of ustekinumab in the treatment of CD.

Disclosure: Some study authors declared affiliations with the industry. Please see the original reference for a full list of authors’ disclosures.


Straatmijer T, Biemans VBC, Hoentjen F, et al. Ustekinumab for Crohn disease: two-year results of the initiative on Crohn and colitis (ICC) registry, a nationwide prospective observational cohort study. J Crohns Colitis. Published online April 28, 2021. doi: 10.1093/ecco-jcc/jjab081