Ustekinumab Treatment of Ulcerative Colitis May Lead to Steroid-Free Remission

ulcerative colitis
ulcerative colitis, UC
Ustekinumab treatment of moderate-to-severe ulcerative colitis (UC) was effective for some patients, according to recent research.

Ustekinumab treatment of moderate-to-severe ulcerative colitis (UC) was effective in some patients, according to results of a research paper published in Alimentary Pharmacology and Therapeutics.

Patients with UC treated with Ustekinumab (N=103) at 20 Groupe d’ Etude Thérapeutique des Affections Inflammatoires du tube Digestif centers in the year 2019 were included. Ustekinumab was intravenously administered with a primer dose of 6 mg/kg followed by 90 mg injected subcutaneously every 8 to 12 weeks, for up to 16 weeks. Patients were assessed for steroid-free clinical remission as indicated by a partial Mayo Clinic score of 2 or below and a rectal bleeding subscore greater than 1 at 12 to 16 weeks. Remission rates were calculated based on the patient’s prior use of immunomodulator, anti-tumor necrosis factor (TNF), and Vedolizumab treatments.

The participant population comprised highly refractory patients with prior drug failures. Most patients had a history of 1 or more failed treatments of their UC symptoms, including 84.5% treated with immunomodulators, 99.0% with anti-TNF treatment, and 85.4% with Vedolizumab.

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A total of 36 (35%) of patients achieved steroid-free clinical remission. Researchers found that remission rates were negatively correlated with previous anti-TNF and Vedolizumab treatments (27.3% vs 80%, respectively; P <.001) when compared with patients who had not been exposed to the 2 drugs. Patients with a high partial Mayo Clinic score (>6) at the start of Ustekinumab treatment showed a similarly negative correlation with remission when compared with patients with a lower score (18.6% vs 46.7%, respectively; P =.003). The investigators reported an odds ratio of remission for a high Mayo Clinic score (>6) of 0.24 (95% CI, 0.10-0.61).

Adverse effects were experienced by 8 (7.8%) patients and serious effects causing treatment disruption were observed in 4 (3.9%) patients.

One limitation of this study was its retrospective design, which may have introduced recall bias.

The study authors concluded that in this highly refractory population, Ustekinumab treatment allowed over 30% of patients to achieve steroid-free clinical remission of UC, and that remission rates were negatively correlated with severity and drug history.

Disclosures: Some authors declared receiving consulting or funding from the pharmaceutical industry. A complete list of disclosures can be found in the original study.

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Amiot A, Filippi J, Abitbol V, et al. Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real-world cohort study. Aliment Parmacol Ther 2020;00:1-8. doi:10.1111/apt.15717.