Combination treatment shows promise for ulcerative colitis
Tremfaya is a combination of guselkumab and golimumab.
A combination of 2 drugs, one for ulcerative colitis (UC) and the other for plaque psoriasis, shows promise as a new treatment for moderate to severe active UC.
According to Janssen,1 results from a phase 2a clinical trial have shown that guselkumab (Tremfya), a combination of a monoclonal antibody against IL-23 used to treat plaque psoriasis, and golimumab (Simponi), a factor antagonist tumor necrosis alpha (TNFα), induced higher rates of clinical response, clinical remission, endoscopic improvement and a histological-endoscopic composite endpoint at 12 weeks than either treatment alone in patients with disappointed.
Although guselkumab, as well as the combination guselkumab and golimumab, are not currently approved for the treatment of adults with UC in the United States, the combination treatment shows tremendous promise, Jan Wehkamp, MD, PhD, lead field of gastroenterology disease for Janssen Research & Development Told Drug Topics®.
Janssen’s VEGA study “represents a first-of-its-kind experimental evaluation of a biological combination therapy in ulcerative colitis: an IL-23p19 subunit antagonist with a TNFα antagonist,” Wehkamp said.
“This is important because while there are patients living with UC who have responded to their current therapies, there are still many other patients, such as refractory patients, who have failed or lost response to current advanced therapies. Combination therapy represents an exciting and significant opportunity to leverage our journey strategy and scientific expertise to deliver novel treatment options that can address the unmet needs of UC patients,” added Wehkamp. .
Golimumab has been approved by the FDA for the treatment of moderate to severe active UC in adult patients since 2013. Guselkumab, although approved for other indications, is currently under investigation and is not approved for treatment of adults with UC in the United States, Wehkamp said. .
“We are in an important race to innovate for patients with disease where the need remains. With life-changing conditions like UC and Crohn’s disease, it’s critical that we investigate new treatment options and potential mechanisms of action with the knowledge that remission and helping more patients feel well is the ultimate goal,” Wehkamp said.
In the VEGA study, a greater proportion of patients who received a combination of guselkumab and golimumab achieved the primary endpoint of clinical response at week 12 (83%) compared to 74.6% who received guselkumab alone or 61% who received golimumab alone.
Notably, 36.6% of patients in the combination group achieved clinical remission based on the full Mayo score at week 12 compared to 21.1% and 22.2% in the guselkumab and golimumab groups, respectively.
Additionally, 46.5% of patients in the combination group achieved clinical remission based on the modified Mayo score at week 12 compared to 23.9% and 25% in the guselkumab and golimumab groups, respectively.
A higher proportion of patients who received combination therapy achieved endoscopic improvement (49.3%) at week 12 compared to those who received either monotherapies (guselkumab: 29.6% and golimumab 25 percent), Janssen said.
The next step for Janssen in studying long-term combination therapy in inflammatory bowel disease is the Phase 2b studies DUET-UC and DUET-CD, 1-year dosing studies comparing combination therapy to monotherapy.
1. Results of a new clinical study show that adults with moderate to severe active ulcerative colitis achieved higher rates of clinical response, clinical remission and endoscopic improvement at 12 weeks with guselkumab and golimumab combined compared to either monotherapies alone. Press release. Janssen. February 19, 2022. Accessed March 17, 2022. https://www.janssen.com/results-novel-clinical-study-show-adults-moderately-severely-active-ulcerative-colitis-achieved