Data from GALAXI 2 & 3 showed TREMFYA® was superior to STELARA ® in all pooled endoscopic endpoints
WASHINGTON, DC, USA I May 21, 2024 I Johnson & Johnson today announced the first Phase 3 results for TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), which demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) versus placebo and ustekinumab.1 Data showed that both maintenance doses of TREMFYA® met the composite co-primary endpoints compared to placebo in each individual study.1,b In results versus ustekinumab, both doses of TREMFYA® demonstrated statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints.1 These findings were featured as a late-breaking oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024.1
The GALAXI 2 (n=508) and GALAXI 3 (n=513) studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD. A summary of select data from the 48-week pooled, multiplicity-controlled endpoints is as follows:1
| Endpoint | TREMFYA® 200mg SC q4w versus ustekinumab | TREMFYA® 100mg SC q8w versus ustekinumab | Ustekinumab | |
| Endoscopic endpoints | Endoscopic responsed | 52.7% (p<0.001) | 47.9% (p=.009) | 37.1 % |
| Endoscopic remissione | 37.2% (p=0.001) | 33.2% (p=0.024) | 24.7 % | |
| Clinical remission and endoscopic response | 47.3% (p<0.001) | 41.6% (p=0.049) | 33.7 % | |
| Deep remissionf | 33.8% (p=0.002) | 29.7% (p=0.040) | 22.3 % | |
| Clinical endpoint | Clinical remissiong | 70.3% (p=.058) | 65.4% (p=.512) | 62.9 % |
“These results are promising for those who continue to experience persistent and debilitating symptoms and offer the possibility of guselkumab as a future-first advanced therapy or after failure of other advanced therapies that may deliver the lasting remission patients deserve to relieve the burden of disease,” said Remo Panaccione, M.D., Professor of Medicine, University of Calgary and lead study investigator.a “The GALAXI program demonstrates the potential of guselkumab and this targeted IL-23 approach for rapid and sustained efficacy in the treatment of Crohn’s disease.”
TREMFYA® has a well-studied safety profile and years of patient experience in approved indications and earlier inflammatory bowel disease trials. In the GALAXI program, the safety profile was consistent with that of the currently approved indications.1 Through Week 48, the number of patients with at least one or more (≥1) adverse events (AE), ≥1 serious AEs, and AEs leading to discontinuation were similar across patients who received TREMFYA®, placebo, or ustekinumab.1 The proportions of patients with serious infections and AEs of interest were low.1
“The Phase 3 GALAXI program, comprised of two rigorous, double-blind studies with secondary endpoints comparing TREMFYA to ustekinumab, reiterate our dedication to addressing the needs of patients with Crohn’s disease and our deep scientific expertise in inflammatory bowel disease and focused innovation in the IL-23 pathway,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine. “These findings demonstrate the promise of TREMFYA for patients living with moderately to severely active Crohn’s disease compared to conventional and advanced therapies.”
This year, Janssen-Cilag International NV, a Johnson & Johnson company, announced submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and moderately to severely active CD. Additionally, Johnson & Johnson submitted regulatory applications seeking the approval of TREMFYA® for the treatment of adults with moderately to severely active UC in countries or regions including the United States and Europe.
Editor’s Notes:
a. Dr. Panaccione is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
b. TREMFYA® is not currently approved to treat Crohn’s disease.
c. Design in which patients in the active treatment arms remained on the therapy to which they were initially randomized, regardless of clinical response at Week 12, with the exception of nonresponders in the placebo arm, who crossed over to blinded ustekinumab treatment.1
d. Endoscopic response is defined as ≥50 percent improvement from baseline in the Simple Endoscopic Score in Crohn’s disease (SES-CD) (primary efficacy analysis set (nonresponder imputation)).1
e. Endoscopic remission is defined as an endoscopy subscore of 0.1
f. Deep remission endpoint consists of clinical remission and endoscopic remission together.1
g. Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of <150 (primary efficacy analysis set (nonresponder imputation)).1
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 (immunomodulators, corticosteroids) and/or biologics (TNF antagonists, vedolizumab).2 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).1 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized, reflecting real-world clinical practice, and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.1
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.3,4 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.5 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. There is currently no cure for Crohn’s disease.6
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a receptor on cells that produce IL-23.7 IL-23 is an important driver of the pathogenesis of inflammatory diseases.8 Findings for dual acting 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.8,9,10,11
TREMFYA® is approved in the U.S.,8 Canada,12 Japan13 and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis (PsA).8 It is also approved in the EU for the treatment of moderate-to-severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.14
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
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. Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
1 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.
2 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.
3 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed May 2024.
4 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.
5 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed May 2024
6 Crohn’s & Colitis Foundation. Signs and Symptoms of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed May 2024.
7 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed May 2024.
8 Mehta H, et al. Differential Changes in inflammatory mononuclear phagocyte and T-Cell profiles within psoriatic skin during treatment with guselkumab vs. secukinumab. J Invest Dermatol 2021;141(7):1707-1718. Available at: https://pubmed.ncbi.nlm.nih.gov/33524368/. Accessed April 2024.
9 Wang Y, et al. Monocytes/Macrophages play a pathogenic role in IL-23 mediated psoriasis-like skin inflammation. Sci Rep. 2019;9(1):5310. Available at: https://pubmed.ncbi.nlm.nih.gov/30926837/. Accessed May 2024.
10 Matt P, et al. Up-regulation of CD64-expressing monocytes with impaired FcγR function reflects disease activity in polyarticular psoriatic arthritis. Scand J Rheumatol 2015; 44(6):464-473. Available at: https://pubmed.ncbi.nlm.nih.gov/26084203/. Accessed May 2024.
11 McGonagle D, et al. Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64+ myeloid cells and potently neutralises IL-23 produced from the same cells. Presented at EULAR 2023, May 31-June 3.
12 The Canadian Agency for Drugs & Technologies in Health. TREMFYA Prescribing Information. Available at: https://pdf.hres.ca/dpd_pm/00042101.pdf. Accessed May 2024.
13 Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the Deliberation Results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed May 2024.
14 European Commission: Tremfya (guselkumab). Available at: http://ec.europa.eu/health/documents/community-register/html/h1234.htm. Accessed May 2024.
SOURCE: Johnson & Johnson
