Johnson & Johnson reports three-year TREMFYA results in Crohn’s disease, with clinical remission of 91% to 94% and endoscopic remission of up to 61% in GALAXI studies.
Written By: Siddhi Bhadekar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson (J&J) announced on October 12, 2026, three-year (Week 144) results from the Phase 3 GALAXI 2 and 3 studies evaluating TREMFYA® (guselkumab) in adults with moderately to severely active Crohn’s disease (CD). Presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, the findings showed sustained clinical and endoscopic remission among patients who continued treatment. The company reported that safety remained consistent with the established profile of guselkumab in CD.
Week 144 Results Show Different Rates of Endoscopic Remission
At Week 144, clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score below 150, was reported in 94% of patients receiving subcutaneous guselkumab 100 mg every eight weeks (q8w) and 91% receiving 200 mg every four weeks (q4w).
Ninety-day corticosteroid-free clinical remission was 88% in both groups. Endoscopic remission, defined as a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 4 or less, with at least a two-point reduction and no subscore above 1, was achieved by 52% of the q8w group and 61% of the q4w group. Overall, 74% of TREMFYA-treated patients remained on therapy at three years.
The results suggest that clinical remission can persist over extended treatment, while endoscopic outcomes differed between the two maintenance regimens. However, the numerical difference in endoscopic remission does not establish that the more frequent regimen is superior. The reported percentages alone do not demonstrate a statistically significant difference between regimens.
These were as-observed results, not intention-to-treat estimates. The analysis included patients who entered the extension, received at least one extension dose, remained on treatment and had Week 144 data; patients with dose adjustments were excluded. The announcement did not provide denominators for these outcomes. The findings therefore describe a selected group of treatment-persistent patients and should not be interpreted as remission rates among everyone originally randomized.
GALAXI Program Extends Follow-up Beyond Earlier Trials
The GALAXI program (NCT03466411) includes the Phase 2 dose-ranging GALAXI 1 study and the Phase 3 GALAXI 2 and 3 trials. The Phase 3 studies used randomized, double-blind, placebo- and ustekinumab-controlled designs and enrolled adults with inadequate response or intolerance to conventional therapies or biologics.
The initial Phase 3 results were presented at Digestive Disease Week in May 2024. The Week 144 findings extend the follow-up period to three years, with the long-term extension planned to continue for five years. J&J has not specified when the final five-year results will be available.
How the Results Compare With FDA-Approved Evidence
The FDA-approved prescribing information includes guselkumab for adults with moderately to severely active CD. Approved induction options include intravenous dosing at Weeks 0, 4 and 8 or subcutaneous dosing on the same schedule. Maintenance options include 100 mg subcutaneously every eight weeks or 200 mg every four weeks, following the respective induction regimens.
The pivotal placebo-controlled evidence in the prescribing information extends to Week 48. In the subcutaneous induction trial, clinical remission at Week 48 was 59% and 65% across the two maintenance regimens, compared with 17% for placebo. Endoscopic response was 39% and 48%, respectively, versus 5% with placebo.
The Week 144 findings extend the reported follow-up beyond this earlier evidence period. They provide additional information about longer-term outcomes but do not, by themselves, establish comparative superiority or a change in the approved prescribing information.
Mechanism and Safety Considerations
Guselkumab is a human monoclonal antibody that binds the p19 subunit of interleukin-23 (IL-23), blocking its interaction with the IL-23 receptor. J&J also describes binding to CD64 on IL-23-producing cells as a potential additional mechanism, based on in-vitro findings whose clinical significance remains unknown.
The prescribing information identifies infections, hypersensitivity and hepatotoxicity among relevant safety considerations. Treatment requires appropriate tuberculosis evaluation and liver monitoring, while live vaccines should be avoided.
Implications for Long-Term Crohn’s Disease Management
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that can cause abdominal pain, diarrhea, bleeding, weight loss and complications such as fistulas. Sustained symptom control and reduction of intestinal inflammation are important treatment goals.
The GALAXI Week 144 results add longer-term evidence for guselkumab in CD. Nevertheless, the as-observed analysis, missing denominators and absence of a placebo comparison at this time point limit conclusions about outcomes across the original trial population. The planned five-year follow-up may provide further information about the durability of remission and long-term safety.
References
TREMFYA® (guselkumab) demonstrated sustained clinical and endoscopic remission through 3 years in moderately to severely active Crohn’s disease. Johnson & Johnson via PR Newswire, October 12, 2026.
A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn’s Disease (GALAXI), ClinicalTrials.gov ID NCT03466411
About the Writer
Siddhi Rajendra Bhadekar (Linkedin) is an M.Pharm professional with expertise in medical and scientific writing, literature review, publication writing, and evidence synthesis, supported by four peer-reviewed publications.
She brings working knowledge of ICH-GCP, MedDRA, pharmacovigilance, ADR/AE reporting, clinical data management, and regulatory documentation.
With experience across pharmaceutical R&D, Quality Control, and Quality Assurance, she combines scientific research skills with strong attention to accuracy and detail.
Her background in manuscript development, publication planning, and scientific communication enables her to translate complex healthcare information into clear, reliable content.