-
Clinical remission rates were over 85% for both TREMFYA® maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies
-
TREMFYA® is the only IL-23 inhibitor to demonstrate durable endoscopic and clinical remission with a fully subcutaneous regimen in moderately to severely active Crohn’s disease
Phoenix, Az., (October 27 2025) – Johnson & Johnson (NYSE: JNJ) today announced new 96-week data from the long-term extensions (LTE) of the Phase 3 GRAVITI, GALAXI 2 and GALAXI 3 studies, which show the durability of TREMFYA® (guselkumab) in adults with moderately to severely active Crohn’s disease (CD) at two years.1 These findings are among 23 Johnson & Johnson abstracts being presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG).
TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies. 2 3 4 5 6
At Week 96, patients treated with TREMFYA® 400 mg subcutaneous (SC) induction (GRAVITI) or 200 mg intravenous (IV) induction (GALAXI) followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) show high rates of long-term clinical remission, endoscopic response, endoscopic remission, and deep remission.
*The as observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 96; participants who had a dose adjustment (GALAXI only) were not included at Week 96.
Safety data through 96 weeks in the LTE periods of the GALAXI and GRAVITI studies were consistent with the well-established safety profile of TREMFYA®.
“Crohn’s disease is a chronic condition that can greatly impact a patient’s quality of life,” said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago.e “These results show that guselkumab can provide endoscopic remission through either SC or IV induction, allowing people with moderate to severely active Crohn’s disease to manage their condition with greater independence and confidence.”
The GRAVITI study evaluated TREMFYA® SC induction and maintenance therapy versus placebo.7 The GALAXI 2 and 3 studies evaluated TREMFYA® IV induction and SC maintenance therapy versus placebo and STELARA® (ustekinumab).8 Previously presented pooled data from the GALAXI clinical program showed TREMFYA® was superior to STELARA® for all endoscopic endpoints at Week 48, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. 9
“As the only IL-23 inhibitor approved for both subcutaneous SC and IV induction in Crohn’s disease and now also in ulcerative colitis, TREMFYA provides patients and their providers with meaningful choices in how they begin treatment with proven long-term benefits,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “These results underscore our legacy of delivering innovations that address the diverse needs of people living with IBD, while continuing to provide treatment options that deliver deep and sustained remission over time.”
TREMFYA® has received U.S. Food and Drug Administration (FDA) approval for both SC and IV induction options for the treatment of adults with moderately to severe active Crohn’s disease and for the treatment of adults with moderately to severely active ulcerative colitis.
For a full list of all Johnson & Johnson data being presented at ACG visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology
Editor’s Notes:
a. Clinical remission was defined as a CDAI score <150.
b. Endoscopic response was defined as a ≥50% improvement in SES-CD (GALAXI/GRAVITI) or an SES-CD ≤2
(GALAXI only).
c. Endoscopic remission was defined as an SES-CD ≤4, with a ≥2-point reduction and no subscore >1 on any subcomponent.
d. Deep remission was defined as achieving both clinical remission and endoscopic remission, as defined above.
e. Dr. David Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
ABOUT THE GRAVITI STUDY (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab). Patients received guselkumab 400 mg SC q4w (x3) followed by guselkumab 200 mg SC q4w; or guselkumab 400 mg SC q4w (x3) followed by guselkumab 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn’s disease). Similar to GALAXI, GRAVITI employed a treat-through design, in which patients are randomized to guselkumab at Week 0 and remain on that regimen throughout the study, regardless of clinical response status at the end of induction. Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16. The GRAVITI study includes a long-term extension (LTE) period starting at Week 24, during which clinical and endoscopic endpoints will be assessed through a total of two years, and safety outcomes with guselkumab treatment through a total of five years. Participants entered the LTE period receiving the same maintenance treatment they received prior to the LTE.8
ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). Each GALAXI study employed a treat-through design and includes a long-term extension period that will assess clinical, endoscopic, and safety outcomes with guselkumab treatment through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or ustekinumab; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Participants entered the LTE period receiving the same maintenance treatment they received prior to the LTE. Between Weeks 52 and 80, participants who were not in clinical response dose-escalated or “sham” adjusted to 200 mg SC every 4 weeks.8
ABOUT CROHN’S DISEASE
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.10 11 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.12 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease. 13
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.
TREMFYA® is a prescription medicine approved in the U.S. to treat:
-
adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
-
adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.
-
adults with moderately to severely active ulcerative colitis.
-
adults with moderately to severely active Crohn’s disease.
TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn’s disease and adults with moderate-to-severe ulcerative colitis.
The legal manufacturer for TREMFYA® is Janssen Biotech, Inc.
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Footnotes:
1 D’Haens GR, Rubin DT, et al. Efficacy and Safety of Guselkumab Through Week 96 After Intravenous or Subcutaneous
Induction in Participants With Crohn’s Disease: Phase 3 Long-term Extension Data From GALAXI 2, GALAXI 3, and GRAVITI. Oral presentation 70 at ACG Annual Scientific Meeting 2025. October 2025.
2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn’s and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
7 National Institutes of Health: Clinicaltrials.gov. A study of uselkumab subcutaneous therapy in participants with moderately to severely active Crohn’s disease (GRAVITI). Identifier: NCT05197049. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05197049. Accessed September 2024.
8 National Institutes of Health: Clinicaltrials.gov. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411. Accessed April 2024
9 Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.
10 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed September 2024.
11 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
12 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed September 2024.
13 Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed September 2024.