Janssen Pharmaceutical announced data on Monday from two Ulcerative colitis (UC) trials: the UNIFI trial studying Stelara and the VEGA trial studying guselkumab and golimumab.
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Janssen Pharmaceutical, a Johnson & Johnson company, announced data on Monday from two Ulcerative colitis (UC) trials.
This included data from the Stelara Phase III UNIFI trial and an ongoing analysis from the Phase IIa VEGA trial of guselkumab and golimumab, both for the treatment of Ulcerative colitis (UC).
Final data from the long-term extension (LTE) of the Phase III UNIFI study showed Stelara (ustekinumab) demonstrated efficacy and safety through four years of treatment in adults with moderately to severely active ulcerative colitis. In patients who achieved clinical response with the drug during induction, 64.9% were in symptomatic remission after 44 weeks.
At the four-year mark, or 200 weeks, the proportion of patients was 55.2%. Most of the patients, 96.4%, were not on corticosteroids. Additional data from UNIFI LTE showed that 79.1% of patients on Stelara who received corticosteroids at maintenance baseline who then received Stelara in the LTE could stop using corticosteroids by week 200.
The company presented the data at the United European Gastroenterology (UEG) Week 2022 congress in Vienna.
Study author Waqqas Afif, M.D., associate professor, department of medicine, division of experimental medicine and division of gastroenterology at McGill University Health Centre in Montreal, Canada, noted that the final results from the “UNIFI study demonstrated that Stelara can be an effective long-term treatment option.”
In addition, Afif added the “vast majority of patients who achieved remission in the study were able to eliminate the use of steroids, which can cause significant side effects and are not a long-term treatment solution for the disease.”
Stelara is a human interleukin (IL)-12 and IL-23 antagonist. It is approved in the U.S. for adults and children six years and older with moderate to severe plaque psoriasis who are eligible for phototherapy or systemic therapy; for adults and kids six years and up with active psoriatic arthritis; for adults with moderately to severely active Crohn’s disease; and for adults with moderately to severely active ulcerative colitis.
Phase IIa Vega Trial Shows Promise for Treatment of UC
The second data set, also presented at UEG in Vienna, was from an ongoing analysis of the Phase IIa VEGA trial in adults with moderately to severely active UC. The participants received 12 weeks of combination induction therapy with guselkumab and golimumab.
Patients receiving this therapy hit a clinical remission rate at week 38 of 47.9%. This was higher than induction and maintenance treatment with guselkumab alone (31%) or golimumab alone (20.8%).
Guselkumab is an IL-23p19 subunit antagonist, and golimumab is a tumor necrosis factor-alpha antagonist. Adverse events were about the same across both cohorts.
Patients in the VEGA study with moderately to severely active UC received either a combination of guselkumab and golimumab, guselkumab alone or golimumab alone.
About 47.9% of patients receiving the combination therapy, who then continued with guselkumab. These patients hit clinical remission at week 37 compared to 31.0% in the guselkumab group and 20.8% in the golimumab cohort.
Jan Wehkamp, M.D., Ph.D., VP, gastroenterology disease area leader, Janssen Research & Development, stated the guselkumab and golimumab combination therapy showed promise in UC.
The 12-week data from the study had previously been announced at the 17th Congress of the European Crohn’s and Colitis Organisation on Feb. 19, 2022.
