Key Points

  • Three-Year Triumph: TREMFYA® shines in sustaining clinical remission and endoscopic response for adults with moderately to severely active Crohn's disease, setting a new standard for long-term efficacy.
  • Personalized Regimens: Patients in the GALAXI study's long-term extension experienced tailored maintenance regimens, showcasing the versatility of TREMFYA at different dosage intervals compared to STELARA®.
  • Consistent Safety: TREMFYA's safety profile remained consistent, with low incidence rates of serious adverse events and infections, emphasizing its viability for long-term use in chronic conditions.
  • Patient-Centric Approach: Janssen's commitment to patient well-being is evident in the study's focus on providing lasting relief for those grappling with debilitating Crohn's disease, addressing both efficacy and safety concerns.
  • Future Prospects: Ongoing research, particularly in inflammatory bowel disease, marks a significant stride as Janssen aims to offer a diverse range of treatment options tailored to individual needs.

In a groundbreaking development, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, unveiled compelling data from the GALAXI Phase 2 study's long-term extension (LTE) regarding TREMFYA® (guselkumab).

This selective IL-23 p19 inhibitor has demonstrated robust and enduring clinical and endoscopic efficacy for patients grappling with moderate-to-severe Crohn’s disease (CD) over an impressive three-year period. The findings, part of a suite of 17 presentations by Janssen at the United European Gastroenterology (UEGW) Week 2023, shed light on TREMFYA's sustained impact and safety profile.

Durability Across Key Endpoints

TREMFYA proved its mettle in maintaining critical efficacy endpoints over three years. The study, an extension of the Phase 2 GALAXI trial, focused on clinical remission, patient-reported outcome remission, and endoscopic response. The sustained rates of clinical remission and endoscopic response underscore the potential of TREMFYA in addressing the chronic challenges faced by individuals with moderate-to-severe CD.

Upon completing the Week 48 Phase 2 study, patients seamlessly transitioned into the LTE. Here, they were enrolled in one of three distinct maintenance regimens, adding a layer of personalization to their treatment journey. The regimens included subcutaneous injections of TREMFYA at 100 mg every eight weeks, TREMFYA at 200 mg every four weeks, or STELARA® (ustekinumab) at 90 mg every eight weeks. Both TREMFYA treatment arms showcased comparable benefits, reinforcing its efficacy across different dosages.

An encouraging aspect of the study was the consistent safety profile of TREMFYA, aligning with its already approved indications. Incidence rates of serious adverse events (SAEs) and serious infections were notably low. Even when infections occurred, they were predominantly mild to moderate, leading to a minimal rate of discontinuation. The focus on safety is crucial as it addresses concerns related to the long-term use of therapeutic interventions in chronic conditions.

Commitment to Patient Well-being

Jan Wehkamp, MD, PhD, Vice President, Gastroenterology Disease Area Leader at Janssen, emphasized the commitment to enhancing relief and remission for millions grappling with Crohn’s disease globally. Establishing the long-term efficacy and safety profile of TREMFYA is a pivotal stride, reflecting Janssen's dedication to innovative therapies and a nuanced understanding of the interleukin (IL)-23 pathway.

As the journey with TREMFYA progresses, Janssen is actively engaged in further research, particularly in the realm of inflammatory bowel disease. Phase 3 studies are already underway, exploring the potential of TREMFYA in diverse cohorts of patients. The goal is to offer a spectrum of treatment options tailored to the unique needs of individuals, marking a transformative approach to managing inflammatory conditions.

The groundbreaking data from the GALAXI Phase 2 study's LTE illuminates TREMFYA as a beacon of hope for those navigating the challenges of Crohn's disease. The enduring efficacy and safety demonstrated in this extended study set the stage for a paradigm shift in the therapeutic landscape, underscoring Janssen's commitment to redefining the standard of care for chronic inflammatory conditions.


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