VIDEO: Guselkumab, golimumab combination therapy shows promising results in UC
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In this Healio exclusive video, Bruce E. Sands, MD, MS, discusses research showing combination Tremfya and Simponi yields higher rates of clinical response, remission and endoscopic improvements in moderate-to-severe ulcerative colitis.
Results of the VEGA phase 2a proof-of-concept study, which compared Tremfya and Simponi (guselkumab and golimumab, Janssen Biotech Inc.) combination therapy with monotherapy, were presented in February at the Congress of European Crohn’s and Colitis Organization.
“This is an extremely significant study,” Sands, chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai, said. “It’s the first study to combine two biologic agents in a blinded randomized controlled fashion and showing at least additive, if not synergistic, efficacy of anti-TNF and anti-IL-23 antibody. This opens the way for other combinations to be explored in [inflammatory bowel disease (IBD)] in the future, hopefully overcoming the efficacy barrier that we’re now seeing.”
According to Sands, 83.1% of patients who received guselkumab and golimumab combination therapy achieved the primary endpoint of clinical response at 12 weeks vs. 74.6% of patients who received guselkumab alone and 61.1% who received golimumab alone. In addition, 36.6% in the combination group achieved clinical remission compared with 21.1% and 22.2% in the guselkumab and golimumab groups, respectively.
Nearly half of the patients on combination therapy achieved endoscopic improvement at week 12 vs. 29.6% and 25% in the monotherapy groups. Further, no deaths, malignancies or tuberculosis cases were reported throughout the duration of the trial.
“We might wonder about the safety of combining these two important biologic agents, but in fact in this 12-week study there did not seem to be additive risk safety events,” Sands said.