Interesting study, results of combo of two biologic-strength meds (tremfya and xeljanz) on UC patients versus those biologics individually.
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Results of Novel Clinical Study Show Adults with Moderately to Severely Active Ulcerative Colitis Achieved Higher Rates of Clinical Response, Clinical Remission, and Endoscopic Improvement at 12 Weeks with Guselkumab and Golimumab Combination Therapy Versus Either Monotherapy Alone
The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12
The VEGA study represents a first-of-its-kind biologic combination assessment of an interleukin (IL)-23p19 subunit antagonist with a tumor necrosis factor-alpha (TNFα) antagonist in ulcerative colitis
Janssen Pharmaceutical Companies of Johnson & Johnson logo (PRNewsfoto/Janssen Pharmaceutical Companie)
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Janssen Pharmaceutical Companies of Johnson & Johnson
Feb 19, 2022, 08:00 ET
SPRING HOUSE, Pa., Feb. 19, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a Phase 2a clinical trial that showed the combination of guselkumab, an interleukin (IL)-23p19 subunit antagonist, and golimumab, a tumor necrosis factor-alpha (TNFα) antagonist, induced higher rates of clinical response,a clinical remission,b endoscopic improvement,c and a composite histologic-endoscopic endpointc,d at 12 weeks than either treatment alone in adults with moderately to severely active ulcerative colitis (UC).1 Rates of adverse events (AEs) were comparable among treatment groups.1 Detailed results of the VEGA trial were presented today as an oral presentation (OP36) at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO) taking place virtually from February 16-19.1 Guselkumab as well as the combination of guselkumab and golimumab are not currently approved for the treatment of adults with UC in the U.S.
"There remains an unmet need for patients who are struggling with ulcerative colitis," said presenting study author Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, and the Mount Sinai Hospital.e "The initial VEGA study results combining IL-23p19 and TNFα antagonists are encouraging as we continue the development of this potential treatment option for moderately to severely active ulcerative colitis."
VEGA 12-week study results show:1
Clinical response:a A greater proportion of patients who received combination therapy of guselkumab and golimumab achieved the primary endpoint of clinical responsea at week 12 (83.1 percent [59/71]) versus 74.6 percent (53/71) of patients who received guselkumab alone, or 61.1 percent (44/72) of those who received golimumab alone.1
Clinical remission:b 36.6 percent (26/71) of patients in the combination group achieved clinical remissionb based on the full Mayo score at week 12 versus 21.1 percent (15/71) and 22.2 percent (16/72) in the guselkumab and golimumab groups, respectively.1 Additionally, 46.5 percent (33/71) of patients in the combination group achieved clinical remissionb based on the modified Mayo score at week 12 versus 23.9 percent (17/71) and 25 percent (18/72) in the guselkumab and golimumab groups, respectively.1
Endoscopic outcomes:
A higher proportion of patients who received combination therapy achieved endoscopic improvementc (49.3 percent [35/71]) at week 12 compared with those who received either monotherapy (guselkumab: 29.6 percent [21/71]; golimumab: 25 percent [18/72]).1
Percentages of patients with endoscopic normalizationf were nearly double with combination therapy versus either monotherapy (combination therapy: 18.3 percent [13/71]; guselkumab: 8.5 percent [6/71]; golimumab: 9.7 percent [7/72]).1
Composite histologic-endoscopic outcomes:
40.8 percent (29/71) of patients in the combination group achieved the composite endpoint of histologic remissiond and endoscopic improvementc versus 26.8 percent (19/71) and 15.3 percent (11/72) in the guselkumab and golimumab groups, respectively.1
Percentages of patients with both histologic remissiond and endoscopic normalizationf were double with combination therapy versus either monotherapy (combination therapy: 15.5 percent [11/71]; guselkumab: 7 percent [5/71]; golimumab: 4.2 percent [3/72]).1
Source:
https://www.prnewswire.com/news-releases/results-of-novel-clinical-study-show-adults-with-moderately-to-severely-active-ulcerative-colitis-achieved-higher-rates-of-clinical-response-clinical-remission-and-endoscopic-improvement-at-12-weeks-with-guselkumab-and-golimumab-301486054.html