Guselkumab plus golimumab shows promise in Phase 2a ulcerative colitis trial

Janssen’s (NYSE:JNJ) has announced positive data from the first randomized controlled trial to test the safety and efficacy of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumor necrosis factor-alpha (TNFα) antagonist (golimumab) in ulcerative colitis.

In the Phase 2a VEGA study, 48% of patients who received combination induction therapy with guselkumab and golimumab were in clinical remission. By comparison, 31% of patients who received guselkumab alone had reached that state, while 21% of those on golimumab alone did.

Dr. Jan Wehkamp, vice president of Janssen R&D’s gastroenterology disease area, said the company received significant positive feedback on the study at the United European Gastroenterology (UEG) Week conference held earlier this month in Vienna.

The VEGA study provided the first positive data on a combination therapy in immunology, Wehkamp said. Combination therapy is established…

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Janssen’s guselkumab and golimumab combination fares well in Phase 2a ulcerative colitis study

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 s…

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