TREMFYA® (guselkumab) Superior to STELARA® (ustekinumab) in Phase 3 Crohn's Disease Trial

Johnson & Johnson has unveiled the initial Phase 3 results for TREMFYA® (guselkumab) in treating adult patients with moderately to severely active Crohn's disease (CD). The study demonstrated that both subcutaneous maintenance doses (200 mg every 4 weeks and 100 mg every 8 weeks) of TREMFYA® were superior to placebo and ustekinumab in achieving the composite co-primary endpoints. Furthermore, TREMFYA® showed statistically significant and clinically meaningful differences in all pooled endoscopic endpoints when compared to ustekinumab.

The findings were part of the GALAXI 2 and GALAXI 3 studies, involving 508 and 513 patients respectively. These studies are the first double-blind, head-to-head clinical trials to establish the superiority of TREMFYA® over ustekinumab in Crohn's disease. The 48-week, pooled multiplicity-controlled data from these studies highlighted the efficacy of TREMFYA®.

Dr. Remo Panaccione, Professor of Medicine at the University of Calgary and lead investigator, indicated that the results are promising for patients who suffer from persistent and severe symptoms. He suggested that guselkumab could be a potential advanced therapy option, offering lasting remission and easing the disease burden. The GALAXI program underscores the potential of guselkumab and its targeted IL-23 approach for rapid and sustained efficacy in treating Crohn's disease.

TREMFYA® has a robust safety profile, supported by years of patient experience in approved indications and earlier inflammatory bowel disease trials. The safety profile observed in the GALAXI program was consistent with what has been seen in other approved indications. Adverse events, serious adverse events, and discontinuation rates were comparable across the TREMFYA®, placebo, and ustekinumab groups. Serious infections and adverse events of interest were also low.

According to Dr. David Lee, Global Therapeutic Area Head Immunology at Johnson & Johnson Innovative Medicine, the Phase 3 GALAXI program, consisting of rigorous double-blind studies with secondary endpoints comparing TREMFYA to ustekinumab, reaffirms the company's commitment to addressing the needs of Crohn's disease patients and showcases their expertise in inflammatory bowel diseases and IL-23 pathway innovation.

Additionally, Janssen-Cilag International NV, a Johnson & Johnson company, has submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorization Application for TREMFYA® to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease. Regulatory applications seeking approval for TREMFYA® in treating these conditions have also been submitted in the United States and Europe.

The GALAXI program is a comprehensive, global, multicenter Phase 2/3 study designed to evaluate the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease who have not responded adequately to conventional therapies or biologics. The program includes a Phase 2 dose-ranging study (GALAXI 1) and two identically designed Phase 3 studies (GALAXI 2 and 3). The participants in these studies remained on their initially randomized treatment, mirroring real-world clinical practice. Additionally, a long-term extension study will assess clinical, endoscopic, and safety outcomes with guselkumab over five years.

Crohn's disease is a serious chronic inflammatory condition of the gastrointestinal tract, affecting millions worldwide. Despite various treatment options, many patients continue to experience debilitating symptoms. TREMFYA® (guselkumab) is a monoclonal antibody developed by Johnson & Johnson that targets IL-23, a key driver of inflammatory diseases. It is approved for treating plaque psoriasis and active psoriatic arthritis in various countries and is now being explored for its potential in treating Crohn's disease and ulcerative colitis.

The safety information for TREMFYA® emphasizes the risk of serious allergic reactions and infections. Patients are advised to consult their healthcare providers about any medical conditions and medications before starting treatment with TREMFYA®. Common side effects include upper respiratory infections, headaches, and joint pain. The drug is to be used precisely as prescribed by a healthcare provider.