Express For the treatment of ulcerative enteritis, Janssen announces the latest clinical results of innovative antibody therapy

Today, Janssen, a subsidiary of Johnson & Johnson, announced the results
of a Phase 2a clinical trial of its anti-IL-23 antibody guselkumab in combination with the anti-TNFα antibody golimumab for the treatment of moderate to severe ulcerative enteritis (UC).
The trial results showed that patients who received this combination of therapies achieved a clinical response of 47.
9% after 38 weeks, which was better than the effect
of guselkumab or golimumab alone.

At the same time, the company announced the final results
of a long-term expanded study of the IL-12/IL-23 inhibitor Stelara (ustekinumab).
The data showed that 55.
2% of patients who achieved remission during induction therapy were still in symptomatic remission after nearly 4 years
.

Ulcerative enteritis, a type of inflammatory bowel disease, is a chronic disease
that affects the colon.
As a result of an overactive immune system, the lining of the colon becomes inflamed and ulcerates, and 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 US FDA for the treatment of moderate to severe plaque psoriasis, as well as psoriatic arthritis
.
The phase 2a clinical trial called VEGA is the first randomized controlled trial
evaluating the combination of guselkumab with the anti-TNFα antibody golimumab for the treatment of moderate to severe ulcerative enteritis, the press release noted.
Patients received combination therapy, guselkumab monotherapy, or golimumab monotherapy, respectively, and patients treated with combination therapy switched to guselkumab as maintenance therapy
after 12 weeks.

Image source: 123RF

The trial results showed a clinical response rate of 47.
9% at 38 weeks in the combination therapy group, 31.
0% in the guselkumab monotherapy group, and 20.
8%
in the golimumab monotherapy group.
Endoscopic histological assessment was also better in the combination therapy group than in the monotherapy group
.

"The 38-week data from the VEGA study show the potential of
the guselkumab/golimumab combination in the treatment of patients with moderate to severe ulcerative enteritis.
" Dr.
Jan Wehkamp, head of the field of R&D gastrointestinal diseases at Janssen, said
.

Stelara (ustekinumab) is an IL-12/IL-23 inhibitor that has been approved by the FDA for the treatment of adults with
moderate to severe ulcerative enteritis.
In a clinical trial called UNIFI, patients first receive at least 8 weeks of induction phase therapy, patients who achieve clinical remission during the induction phase are eligible for maintenance therapy, and patients who maintain remission at 44 weeks of maintenance therapy can be enrolled in an additional 3 years of long-term extension studies
.

The results of the trial showed that 64.
9% of patients who achieved remission during the induction phase maintained symptom relief
after a 44-week maintenance treatment period.
At 200 weeks (4 years), 55.
2% of patients maintained symptom remission, of which 96.
4% did not receive corticosteroids
.

In addition, trial data 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 enteritis.
" Professor Waqqas Afif, from McGill University Health Centre, one of the leaders of the clinical trial, said: "It is important that the majority of patients who achieve remission are able to avoid corticosteroid use, which has significant side effects and is not a long-term treatment option
for this disease.
”