Guselkumab, Golimumab Combination Therapy Achieves Clinical Remission Rate of 47.9% in Patients with Ulcerative Colitis

Data from an ongoing analysis of a phase 2a trial showed that adults with moderately to severely active ulcerative colitis (UC) administered 12 weeks of combination induction therapy with guselkumab (Janssen Pharmaceutical Companies of Johnson & Johnson) and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission rate at week 39 of 47.9%.

The rate of clinical remission for the combination therapy was higher than induction and maintenance treatment with either guselkumab alone at 31% or golimumab alone at 20.8%.

“Exploring combinations of advanced therapies is an important step in continuing to innovate for the many patients living with [UC],” Bruce Sands, MD, MS, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai and professor of medicine at the Icahn School of Medicine at Mount Sinai, said in a statement. “These new data from the VEGA [NCT03662542] trial build upon and affirm our initial 12-week findings showing the potential clinical benefit of combining guselkumab and golimumab in treating adults with moderately to severely active [UC].”

Additionally, the endoscopic improvement and the composite histologic-endoscopic endpoint were higher in individuals who received combination therapy followed by treatment with guselkumab compared to those receiving either monotherapy.

Furthermore, endoscopic remission and histologic remission were higher in the combination therapy groups with treatment followed by guselkumab compared to individuals who received golimumab alone.

Individuals administered the combination therapy followed by maintenance treatment with guselkumab and those receiving guselkumab as a monotherapy achieved the same rate of symptomatic remission of 69% at week 38, greater than golimumab as a monotherapy at 59.7%.

The individuals had comparable rates of adverse events (AEs) across the different treatment groups. The combination therapy followed by guselkumab, guselkumab monotherapy, and golimumab monotherapy groups had AE rates of 63.4%, 64.8%, and 76.4%, respectively, and infection rates of 31%, 23.9%, and 31.9%, respectively.

All groups had serious AE rates of 5.6% and the same serious infection rates of 2.8%.

Overall, 13.1% of individuals discontinued their treatment prior to the final dose of study intervention.

The VEGA study was the first randomized controlled trial to evaluate the efficacy and safety of the combination therapy with an interleukin-23p19 subunit antagonist and a tumor necrosis factor-alpha antagonist for UC.

Individuals in the study, with moderately to severely active UC, were randomized 1:1:1 to receive combination therapy with guselkumab and golimumab, guselkumab monotherapy, or golimumab monotherapy. After the endpoints were evaluated at week 12, individuals in the monotherapy groups continued their initially assigned treatment and individuals who were randomized to combination therapy transitioned to guselkumab monotherapy as a maintenance therapy. Clinical remission rate was based on the modified Mayo score as well as the total May score.
The detailed results were presented as an oral presentation at the United European Gastroenterology Week 2022 congress.

Guselkumab alone and in combination with golimumab are under clinical investigation and not approved for the treatment of adults with UC in the United States.

Reference

Results of novel clinical study of guselkumab and golimumab combination therapy show adults with moderately to severely active ulcerative colitis maintained higher rates of clinical, histologic, and endoscopic remission at week 38. News release. Johnson and Johnson. October 10, 2022. Accessed October 12, 2022. https://www.jnj.com/results-of-novel-clinical-study-of-guselkumab-and-golimumab-combination-therapy-show-adults-with-moderately-to-severely-active-ulcerative-colitis-maintained-higher-rates-of-clinical-histologic-and-endoscopic-remission-at-week-38