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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.
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.
Reference
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.
