Janssen’s pathway strategy for immune-mediated inflammatory disease shows promise in gastroenterology

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease.

Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet need for patients living with immune-mediated diseases,” said Dr. Jan Wehkamp, Janssen’s vice president, gastroenterology disease area leader.

And thus, a drug like Janssen’s Tremfya (guselkumab), which is now indicated to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults, could find use in gastroenterological conditions such as Crohn’s disease (CD) or ulcerative colitis (UC).

Tremfya selectively blocks the p19 subunit of interleukin (IL)-23.

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Janssen shares new positive Stelara data for Crohn’s disease and ulcerative colitis

Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD).

The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr. Jan Wehkamp, vice president, gastroenterology disease area leader, Janssen Research & Development, in an interview.

In a separate analysis, Stelara led to more persistent therapeutic effects than Humira (adalimumab) at 12 months in bio-naive CD patients. Janssen gathered the CD data from de-identified health insurance claims.

Janssen presented the data, based on new modeling and real-world evidence analyses, at the American College of Gastroenterology Annual Scientific Meeting (ACG).

First-line Stelara patients with moderately to severely active UC tended to have a…

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Janssen presents new safety data for Stelara in older patients

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials.

The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from 13 clinical trials across approved indications, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The analysis included data for up to five years.

“This particular analysis builds on the complete data we have on the safety of Stelara over thousands of patients and literally dozens of clinical trials over 20 years now,” said Dr. Andrew Greenspan, vice president of medical affairs at Janssen Immunology.

The analysis is also noteworthy in its focus on patients 60 and older, Greenspan said.

“Often, we limit patients who are older from the clinical trials, and that’s not …

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Stelara shows promise for long-term management of ulcerative colitis

Janssen’s (NYSE:JNJ) Stelara supported corticosteroid-free remission in about half of ulcerative colitis patients in a 152-week long-term extension UNIFI study.

At the end of the nearly three-year study, 55.2% of volunteers were in symptomatic remission. Of those patients, 96.4% were corticosteroid-free at week 152. Janssen, which is part of Johnson & Johnson, presented the data today at the Congress of the European Crohn’s and Colitis Organisation (ECCO).

Stelara (ustekinumab) enabled more than half of the patients in the trial to achieve remission without the need for steroids. That fact is one of the most critical findings in the recent data, said Dr. Jan Wehkamp, VP and gastroenterology disease area leader at Janssen.

While the human body naturally produces steroids, long-term use of corticosteroids leads to significant side effects in most people. They can lead to everything from high blood pressure, elevated blood sugar, glaucoma and other prob…

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