麻豆传媒

In data presented during the annual Digestive Disease Week conference, investigators found that guselkumab (Tremfya) resulted in clinically meaningful improvements compared with placebo in patients with moderately to severely active ulcerative colitis.

In this exclusive video, Jan Wehkamp, MD, PhD, vice president and gastroenterology disease area leader of Janssen Research & Development, talks about the positive data and what is next in the study.

Following is a transcript of his remarks:

IL [interleukin]-23 is a critical component of inflammation in immunology and I would say we started the space, Janssen, with Stelara [ustekinumab], which is an IL-23, IL-12 inhibitor. It did show unprecedented safety, and that basically started this overall direction.

We have a large focus on IL-23 in our portfolio. It does address a critical unmet need of patients with ulcerative colitis and Crohn's disease. At the same time, we are continuing to invest in our portfolio. So we have programs within IL-23. We have a combination program, which is also including an IL-23 component, but we also have compounds in the portfolio beyond, which target on new compounds and new mechanisms of action reflecting the complexity of different forms of inflammatory bowel disease.

So what we presented here is week 12 data, so early confirmation in phase III. Everything we see here is consistent with our very high-bar expectations. We see a strong remission rate compared to placebo -- endoscopy, histology, everything. Very early improvement for patients. So everything we see is good.

Most importantly for us, safety, the safety profile is consistent with everything we already know from other indications. There's no difference with placebo. We have a very low autoantibody formation, 1.5%, which we explained by the uniqueness of full human antibody, which is different from other IL-23 inhibitors. We have to see in long-term studies what that means and how that translates into clinical efficacy.

Throughout the year, we are continuing to gather more data, and we are still running a study in ulcerative colitis for guselkumab. We are also still running a study for Crohn's disease called . Because of the unique molecular profile of IL-23, we only need a proportion of the drug compared to other compounds. We explain that with the CD64 binding to the tissue. And that's why we are in the unique position to develop a subcutaneous treatment.

So we have two studies, one in Crohn's disease, one in ulcerative colitis, where we test subcutaneous induction for guselkumab, and these studies are also still ongoing.

So I can't tell you an exact launch date yet. I can just tell you that all of our teams are very, very excited, and busy. Momentum is building throughout the year. We are waiting for more critical data.

And then as soon as we can, we will launch, and I think we will talk more throughout the year -- I am very, very confident that there's much more to talk about.

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