Johnson & Johnson’s Janssen subsidiary has released positive data from an ongoing analysis of the Phase 2a VEGA clinical study of guselkumab and golimumab. The trial focused on adults with moderately to severely active ulcerative colitis (UC).
The study tested the efficacy of 12 weeks of combination induction therapy with the interleukin-23 subunit p19 inhibitor guselkumab and the TNFα inhibitor golimumab. After that period, the participants received guselkumab alone for maintenance.
At week 38, recipients of the guselkumab and golimumab combination therapy had a clinical remission rate of 47.9%. For the sake of comparison, the remission rate for guselkumab alone was 31.0%, while the rate for golimumab alone was 20.8%.
The study defined clinical response using the Mayo score, which is the sum of four subscores related to stool frequency, rectal bleeding, physician’s global assessment and endoscopy findings.
Groups in all three arms had similar adverse event rates.
In the U.S., guselkumab is approved for moderate to severe plaque psoriasis and active psoriatic arthritis.
In 2020, guselkumab became the first IL-23 inhibitor to win an FDA indication for active psoriatic arthritis in 2020.
Using guselkumab alone and in combination with golimumab remains investigational for ulcerative colitis.
In the combination arm, recipients received the first dose of guselkumab as an IV infusion. The second dose of the drug was administered subcutaneously. The first and second doses of golimumab was provided as a subcutaneous injection and placebo to maintain blinding.
Janssen will present the new data at the United European Gastroenterology Week 2022 congress.
The company notes that the VEGA trial is the first randomized controlled study to test the combination therapy with an interleukin (IL)-23p19 subunit antagonist and TNFα antagonist in ulcerative colitis. The VEGA study enrolled a total of 214 participants.
Simponi (golimumab) first won FDA approval for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in 2009.
Filed Under: Gastroenterology
