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‘Strikingly better’: Co-antibody combination tops golimumab, guselkumab in refractory IBD
This reports phase 2b trial results showing a fixed-dose combination of two biologics (anti‑TNF + anti‑IL‑23) improved outcomes in people with refractory IBD compared with one biologic alone.
For patients who have failed multiple prior therapies, combining mechanisms may offer a new treatment strategy if later trials confirm benefit and safety.
Adults with Crohn’s disease or ulcerative colitis who have had inadequate response to multiple therapies, clinicians who treat IBD, researchers and those following biologic development for refractory IBD.
What To Know
What to know Two parallel phase 2b trials (DUET-CD for Crohn’s disease and DUET-UC for ulcerative colitis) tested a fixed-dose co-antibody product JNJ-78934804 / JNJ-4804 that combines golimumab (anti-TNF) and guselkumab (anti–IL-23) versus each drug alone and placebo.
At week 48, the high-dose combination showed higher rates of clinical and endoscopic remission than golimumab and had similar or greater efficacy compared with guselkumab, with safety events comparable to monotherapy. The benefits were most pronounced in patients who had an inadequate response to two or more prior systemic therapy classes.
Both trials reported mostly gastrointestinal serious adverse events and low rates of serious infections; exposure-adjusted safety with the combination was similar to or lower than with placebo or golimumab. The investigators reported the programs will move toward phase 3 based on these phase 2b results.
The article summarizes trial outcomes presented at Digestive Disease Week and quotes lead investigators describing the combination as superior in refractory patients.
These are phase 2b results presented at a conference (Digestive Disease Week). Phase 3 trials are planned; results here do not yet change standard care. Safety and long-term outcomes will need confirmation in larger, later‑stage studies. The article is a news summary of the trial presentation.
