▎WuXi AppTec Content Team Editor
Today, Janssen, a subsidiary of Johnson & Johnson, announced the combination of its anti-IL-23 antibody guselkumab and anti-TNFα antibody golimumab in the treatment of Results of a phase 2a clinical trial in severe ulcerative colitis (UC). Results of the trial showed that 47.9% of patients receiving this combination therapy achieved clinical remission after 38 weeks, which was better than the effect of guselkumab or golimumab alone.
Meanwhile, the company announced final results from a long-term extension study of the IL-12/IL-23 inhibitor Stelara (ustekinumab). The data showed that 55.2% of patients who achieved remission during induction treatment were still in remission nearly 4 years later.
Ulcerative colitis is a type of inflammatory bowel disease, a chronic disease that affects the colon. Due to an overactive immune system, the lining of the colon becomes inflamed and ulcers develop. Symptoms include persistent diarrhea, abdominal pain, blood in the stool, poor appetite, weight loss, and exhaustion.
Guselkumab is a monoclonal antibody that selectively inhibits IL-23 signaling by binding to the p19 subunit of the IL-23 receptor. It has been approved by the FDA for the treatment of moderate to severe plaque psoriasis, as well as psoriatic arthritis. The press release states that the Phase 2a clinical trial, called VEGA, is the first randomized controlled clinical trial evaluating guselkumab in combination with the anti-TNFα antibody golimumab in the treatment of moderate to severe ulcerative colitis. Patients received combination therapy, guselkumab monotherapy, or golimumab monotherapy, and patients who received combination therapy switched to guselkumab as maintenance therapy after 12 weeks.
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Trial results showed that the clinical response rate at 38 weeks was 47.9% in the combination group, 31.0% in the guselkumab monotherapy group, and 20.8% in the golimumab monotherapy group. . Endoscopy-assessed histological indicators in the combination therapy group were also better than those in the single-agent group.
“The 38-week data from the VEGA study show the potential of the guselkumab/golimumab combination in patients with moderate-to-severe ulcerative colitis,” said Jan Wehkamp, PhD, Head of Gastrointestinal Diseases R&D at Janssen.
Stelara (ustekinumab) is an IL-12/IL-23 inhibitor approved by the FDA for the treatment of adults with moderate to severe ulcerative colitis. In the clinical trial, called UNIFI, patients first received at least 8 weeks of induction treatment, patients who achieved clinical remission during the induction period were eligible for maintenance treatment, and those who maintained remission at 44 weeks of maintenance treatment could be enrolled for an additional 3 years Long-term extension study.
Trial results showed that64.9% of patients who achieved remission during the induction period remained in remission after a 44-week maintenance treatment period. At 200 weeks (4 years), the proportion of patients who maintained remission was 55.2%, of whom 96.4% were not receiving corticosteroids.
In addition, data from the trial showed that 79.1% of patients who used corticosteroids during maintenance therapy were able to avoid corticosteroids at 200 weeks.
“This result demonstrates that Stelara can be an effective long-term treatment option for patients with moderate to severe ulcerative colitis.” Co-leader of the clinical trial, McGill University Professor Waqqas Afif from the McGill University Health Centre said, “Importantly, the majority of patients in remission are able to avoid corticosteroids, which have significant side effects and are not a long-term treatment option for this disease.”
References:
[1] STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved October 10, 2022, from https:https://www.janssen.com/stelarar-ustekinumab-demonstrated-sustained-symptomatic-and-corticosteroid-free-remission-through
[2] Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38. Retrieved October 10, 2022, from https:https://www.janssen.com/results-novel-clinical-study-guselkumab-and-golimumab-combination-therapy-show-adults-moderately
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