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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Co-antibody combination therapy showed positive results in patients with IBD with inadequate response to two or more systemic therapies. At week 48, high dose co-antibody combination outperformed golimumab. CHICAGO \u2014 Combining golimumab and guselkumab into JNJ-78934804, a fixed-dose co-antibody therapy, helped overcome treatment failure in inflammatory bowel disease and exceeded dose-dependent benefits of either drug alone, according to data. Two parallel phase 2b trials combining the anti-tumor necrosis factor and anti-interleukin-23 medications in Crohn\u2019s disease and ulcerative colitis, DUET-CD and DUET-UC, were presented by lead authors at Digestive Disease Week.
\u201cResults show that people with Crohn\u2019s disease who have had inadequate response to two or more systemic therapies do strikingly better with combination therapy of two drugs with different mechanisms of action, specifically with golimumab, an anti-TNF antibody, and guselkumab, an anti-IL-23 antibody, rather than with treatment with either one alone,\u201d Bruce E. Sands, MD, MS, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Health System and lead author of the CD study, told Healio. Similar results were observed in the parallel UC trial, according to lead author Maria T. Abreu, MD, executive director at F. Widjaja IBD Institute at Cedars-Sinai Medical Center. \u201cThe study highlights that there is a path forward for UC patients who have been on more than two types of mechanisms of action of medications,\u201d she told Healio. \u201cCombining anti-TNF and anti-IL-23 was safe and showed superiority in the toughest to treat UC patients.\u201d Crohn\u2019s study results In the DUET-CD study, 693 adults with Crohn\u2019s disease (57% men) were randomly assigned to receive guselkumab (Tremfya, Janssen), golimumab (Simponi, Janssen), low-, mid- or high-dose JNJ-78934804 (JNJ-4804, Johnson & Johnson) or placebo. Half of the patients had a prior inadequate response to two or more classes of systemic therapy. The coprimary endpoints were clinical and endoscopic remission at week 48, while other key endpoints included endoscopic remission, deep remission and corticosteroid-free clinical remission at that time point. High-dose JNJ-4804 achieved higher rates of the co-primary endpoints than golimumab, including clinical remission (difference = 25.7; P < .001) and endoscopic response (difference = 18.5; nominal P < .001), with similar or greater efficacy compared with guselkumab. The researchers also found that differences in treatment were greater among those who were refractory to two or more systemic therapy classes. At week 48, high-dose JNJ-4804 demonstrated clinically meaningful improvements in both clinical remission and endoscopic response compared with golimumab (27.3 and 21.2, respectively), guselkumab (21.2 and 11.7) and placebo (39.4 and 35). Exposure-adjusted safety events with JNJ-4804 were similar to or lower than those reported with placebo or golimumab. Most serious adverse events were gastrointestinal-related and serious infections were uncommon. Safety was comparable to that observed with monotherapies. This \u201cfixed-dose combination of golimumab and guselkumab outperformed either one alone\u201d in refractory Crohn\u2019s disease without increased risk for adverse events compared with monotherapy, Sands told Healio. UC study results For the UC study, 572 individuals (57% men) were also randomly assigned to the same medications in the same way as the CD trial. Patients had a mean UC duration of 9 years (standard deviation, 7.5). Most patients had severe endoscopic disease, with 72% scoring 3 on the Mayo Endoscopy Subscore, 70% having modified Mayo scores of 7\u20139 and 45% reporting an inadequate response to two or more systemic therapy classes. Abreu and colleagues reported findings consistent with the DUET-CD study: High-dose JNJ-4804 was significantly superior to golimumab (28.4; P < .001) and comparable to guselkumab (6.3) in the study\u2019s primary endpoint. At week 48, treatment responses were greater in patients who were refractory to two or more systemic therapy classes. In this subgroup, high-dose JNJ-4804 resulted in clinically meaningful improvements in clinical remission, corticosteroid-free clinical remission, endoscopic improvement and histologic remission and endoscopic improvement compared with golimumab (22.9, 20.5, 31.9, and 27.3, respectively), guselkumab (12.5, 12.3, 17.3, 16.9) and placebo (19.7, 17.2, 28.3, 23.6). Safety events per 100 patient-years in the JNJ-4804 groups were either comparable or lower than those observed in the other treatment groups. As in the DUET-CD study, most serious adverse events were GI-related with low rates of serious infection. \u201cCombinations of IBD medications with distinct mechanisms of action can be superior to either alone,\u201d Abreu told Healio. \u201cThe impact appears to be greatest for those patients who have already been on more than two types of therapy.\u201d Both parallel trials are set to continue to phase 3 trials based on data, according to a press release on Sands\u2019 and Abreu\u2019s presentations. \u201cThese results suggest the power of combination therapy after attempts at treatment with single agents fail,\u201d said Sands . For more information: Maria T. Abreu, MD, can be reached at maria.abreu@cshs.org. Bruce E. Sands, MD, MS, is Dr. Burrill B. Crohn Professor of Medicine at Icahn School of Medicine at Mount Sinai. He can be reached at bruce.sands@mssm.edu. Published by: Sources\/Disclosures Source: Sands BE, et al. Efficacy and safety of the first co-antibody therapy, JNJ-78934804, in patients with moderately to severely active Crohn\u2019s disease refractory to systemic therapies. Presented at: Digestive Disease Week; May 2-5, 2026; Chicago. Reference: Abreu MT, et al. Efficacy and safety of the first co-antibody therapy, JNJ-78934804, in patients with moderately to severely active ulcerative colitis refractory to systemic therapies. Presented at: Digestive Disease Week; May 2-5, 2026; Chicago.
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