Lucrezia Ciotti La Ulcerative colitis It is a chronic inflammatory bowel disease that can significantly impair quality of life in patients with moderate to severe forms. Recently, selective inhibition of interleukin 23 (IL-23) has emerged as a promising strategy for controlling chronic inflammation. In this context, guselkumab It stands out for the possibility of subcutaneous administration, potentially offering clinical and endoscopic efficacy combined with greater convenience for patients.
Ulcerative colitis: Positive results with guselkumab use
in this patients In adults with moderate to severe ulcerative colitis, the use of subcutaneous guselkumab, both in the induction and maintenance phases, has been shown a clinically relevant efficacyThe Phase 3 Astro study, presented by Johnson & Johnson at UEG Week 2025, highlighted how the drug can induce clinical remission in 36,7% of patients and remission endoscopic in 25%.
Silvio Danese, researcher at the IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, explained that the possibility of home administration, after adequate training, offers greater flexibility to patients without reducing the effectiveness of the treatment, allowing clinical and endoscopic benefits that last for an entire year.
Guselkumab acts as a human inhibitor of the p19 subunit of IL-23, blocking the cytokine and binding to the CD64 receptor present on the cells that produce it. IL-23, secreted by activated monocytes/macrophages and dendritic cells, is known to promote immune-mediated diseases such as ulcerative colitis and Crohn's disease. The dual mode of action observed in in vitro studies has not yet had a defined clinical significance, but it represents a distinctive feature of the drug compared to other inhibitors of the same cytokine.
Ulcerative colitis: long-term outcomes with guselkumab use, safety, and recognition
The data at 48 weeks of the Astro study confirm the improvements obtained after just 12 weeks of treatment nucleoside induction. Patients who received guselkumab 400 mg subcutaneously in induction, followed by maintenance of 100 mg every 8 weeks or 200 mg every 4 weeks, demonstrated significant improvements in all clinical and endoscopic parameters compared to placebo.
In detail, the clinical remission was achieved by 36,7% of patients on 100 mg q8w and 42,9% on 200 mg q4w, versus 7,2% of the placebo group; endoscopic improvement by 44,6% and 47,1% versus 11,5%; endoscopic remission by 25,9% and 26,4% versus 5%; symptomatic remission by 47,5% and 53,6% versus 14,4%. These effects were also confirmed in subgroups of patients naïve or refractory to biologic drugs and JAK inhibitors.
Esi Lamousé-Smith, Vice President of Johnson & Johnson, highlighted that the results confirm the company's commitment to providing effective therapies, emphasizing that guselkumab is the only IL-23 inhibitor with a subcutaneous induction option for Crohn's disease, and that data from the Astro study support the extension of this modality to ulcerative colitis as well. The drug is already approved by the FDA for ulcerative colitis and by the European Commission for Crohn's disease, while subcutaneous induction for ulcerative colitis is awaiting European approval following the positive opinion of the CHMP in September 2025.