TREMFYA® (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis
Johnson & Johnson (NYSE: JNJ) announced positive Phase 3 ASTRO study results for TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with ulcerative colitis (UC). The study met its primary and all secondary endpoints at Week 12, showing significant improvements versus placebo.
Key achievements include clinical remission (27.6% vs 6.5%), clinical response (65.6% vs 34.5%), and endoscopic improvement (37.3% vs 12.9%). The treatment showed efficacy in both biologic-naïve and biologic-refractory patients, with safety data consistent with TREMFYA's established profile.
TREMFYA received FDA approval for UC treatment in September 2024 with IV induction. A supplemental application for SC induction was submitted in November 2024. If approved, TREMFYA would become the first IL-23 inhibitor offering both IV and SC induction options for UC treatment.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati positivi dello studio di Fase 3 ASTRO per la terapia di induzione sottocutanea (SC) di TREMFYA® (guselkumab) negli adulti con colite ulcerosa (UC). Lo studio ha raggiunto i suoi obiettivi primari e secondari alla Settimana 12, mostrando miglioramenti significativi rispetto al placebo.
I risultati chiave includono remissione clinica (27,6% vs 6,5%), risposta clinica (65,6% vs 34,5%) e miglioramento endoscopico (37,3% vs 12,9%). Il trattamento ha mostrato efficacia sia nei pazienti naïve ai biologici che in quelli refrattari ai biologici, con dati di sicurezza coerenti con il profilo consolidato di TREMFYA.
TREMFYA ha ricevuto l'approvazione della FDA per il trattamento dell'UC nel settembre 2024 con induzione IV. Una domanda supplementare per l'induzione SC è stata presentata nel novembre 2024. Se approvato, TREMFYA diventerebbe il primo inibitore dell'IL-23 a offrire opzioni di induzione sia IV che SC per il trattamento dell'UC.
Johnson & Johnson (NYSE: JNJ) anunció resultados positivos del estudio de Fase 3 ASTRO para la terapia de inducción subcutánea (SC) de TREMFYA® (guselkumab) en adultos con colitis ulcerosa (UC). El estudio alcanzó sus objetivos primarios y secundarios a la Semana 12, mostrando mejoras significativas en comparación con el placebo.
Los logros clave incluyen remisión clínica (27,6% vs 6,5%), respuesta clínica (65,6% vs 34,5%) y mejora endoscópica (37,3% vs 12,9%). El tratamiento mostró eficacia tanto en pacientes naïve a biológicos como en pacientes refractarios a biológicos, con datos de seguridad consistentes con el perfil establecido de TREMFYA.
TREMFYA recibió la aprobación de la FDA para el tratamiento de UC en septiembre de 2024 con inducción IV. Se presentó una solicitud suplementaria para la inducción SC en noviembre de 2024. Si se aprueba, TREMFYA se convertiría en el primer inhibidor de IL-23 que ofrece opciones de inducción tanto IV como SC para el tratamiento de UC.
존슨앤존슨 (NYSE: JNJ)은 성인 궤양성 대장염(UC) 환자를 위한 TREMFYA® (구셀쿠맙) 피하(SC) 유도 요법에 대한 3상 ASTRO 연구의 긍정적인 결과를 발표했습니다. 이 연구는 12주 차에 주요 목표와 모든 부차적 목표를 달성하며, 위약 대비 유의미한 개선을 보여주었습니다.
주요 성과로는 임상 관해 (27.6% 대 6.5%), 임상 반응 (65.6% 대 34.5%), 내시경적 개선 (37.3% 대 12.9%)이 포함됩니다. 이 치료는 생물학적 치료를 받지 않은 환자와 생물학적 치료에 반응하지 않는 환자 모두에서 효과를 보였으며, 안전성 데이터는 TREMFYA의 확립된 프로필과 일치했습니다.
TREMFYA는 2024년 9월 UC 치료를 위해 FDA 승인을 받았으며, IV 유도 요법에 대한 승인이었습니다. SC 유도 요법에 대한 보충 신청이 2024년 11월에 제출되었습니다. 승인될 경우, TREMFYA는 UC 치료를 위한 IV 및 SC 유도 옵션을 모두 제공하는 첫 번째 IL-23 억제제가 될 것입니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats positifs de l'étude de Phase 3 ASTRO pour la thérapie d'induction sous-cutanée (SC) de TREMFYA® (guselkumab) chez les adultes atteints de colite ulcéreuse (UC). L'étude a atteint ses objectifs principaux et tous les objectifs secondaires à la Semaine 12, montrant des améliorations significatives par rapport au placebo.
Les résultats clés comprennent remission clinique (27,6% vs 6,5%), réponse clinique (65,6% vs 34,5%), et amélioration endoscopique (37,3% vs 12,9%). Le traitement a montré son efficacité tant chez les patients naïfs aux biologiques que chez ceux réfractaires aux biologiques, avec des données de sécurité conformes au profil établi de TREMFYA.
TREMFYA a reçu l'approbation de la FDA pour le traitement de l'UC en septembre 2024 avec induction IV. Une demande complémentaire pour l'induction SC a été soumise en novembre 2024. Si elle est approuvée, TREMFYA deviendrait le premier inhibiteur de l'IL-23 à offrir des options d'induction tant IV que SC pour le traitement de l'UC.
Johnson & Johnson (NYSE: JNJ) hat positive Ergebnisse der Phase-3-Studie ASTRO zur subkutanen (SC) Induktionstherapie mit TREMFYA® (Guselkumab) bei Erwachsenen mit Colitis ulcerosa (UC) bekannt gegeben. Die Studie erreichte ihre primären und sekundären Endpunkte in Woche 12 und zeigte signifikante Verbesserungen im Vergleich zur Placebo-Gruppe.
Wichtige Ergebnisse umfassen klinische Remission (27,6% vs. 6,5%), klinische Antwort (65,6% vs. 34,5%) und endoskopische Verbesserung (37,3% vs. 12,9%). Die Behandlung zeigte Wirksamkeit sowohl bei biologisch-naiven als auch bei biologisch-refraktären Patienten, wobei die Sicherheitsdaten mit dem etablierten Profil von TREMFYA übereinstimmten.
TREMFYA erhielt im September 2024 die FDA-Zulassung zur Behandlung von UC mit IV-Induktion. Ein ergänzender Antrag für SC-Induktion wurde im November 2024 eingereicht. Wenn genehmigt, würde TREMFYA der erste IL-23-Inhibitor sein, der sowohl IV- als auch SC-Induktionsoptionen zur Behandlung von UC anbietet.
- Phase 3 ASTRO study met all primary and secondary endpoints
- Significant clinical remission rates: 27.6% vs 6.5% for placebo
- Strong clinical response: 65.6% vs 34.5% for placebo
- Endoscopic improvement: 37.3% vs 12.9% for placebo
- Safety profile consistent with established data
- Potential to be first IL-23 inhibitor with both IV and SC options
- None.
Insights
The Phase 3 ASTRO study results mark a pivotal moment for Johnson & Johnson's TREMFYA in the competitive inflammatory bowel disease (IBD) market. The achievement of 27.6% clinical remission and 65.6% clinical response rates demonstrates robust efficacy that could significantly strengthen TREMFYA's market position.
The potential approval of subcutaneous (SC) induction therapy represents a strategic advantage in several key areas:
- Enhanced Patient Experience: SC administration offers greater convenience and flexibility, particularly beneficial for the typically younger UC patient population with active lifestyles
- Market Differentiation: Being the first IL-23 inhibitor with both IV and SC induction options would create a unique competitive advantage in the crowded IBD space
- Healthcare System Benefits: SC administration typically requires fewer healthcare resources and could reduce administration costs
The efficacy demonstrated in both biologic-naïve and biologic-refractory patients is particularly noteworthy, as it positions TREMFYA as a viable option across multiple lines of therapy. The consistent safety profile further strengthens its potential for broad adoption.
For Johnson & Johnson, this development could significantly enhance their immunology portfolio's commercial potential. The IBD market represents a substantial opportunity, with UC treatment market size expected to grow significantly. TREMFYA's expanded administration options could drive increased adoption and market share gains, particularly important as competition intensifies in the IL-23 inhibitor space.
Phase 3 ASTRO study achieves primary and all secondary endpoints at Week 12 in ulcerative colitis patients
The only SC induction data for an IL-23 inhibitor show statistically significant and clinically meaningful improvements across clinical and endoscopic measures versus placebo, consistent with IV induction
"The Week 12 results from the ASTRO study build on data from the QUASAR study demonstrating that both guselkumab SC and IV induction achieved clinically differentiated results in patients with moderately to severely active UC," said Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (IBD) Unit at Nancy University Hospital in
At Week 12, significantly greater proportions of patients treated with TREMFYA® 400 mg SC induction compared with patients receiving placebo achieved all of the following multiplicity-controlled endpoints:
- Clinical remission (
27.6% vs6.5% ; P<0.001) b - Clinical response (
65.6% vs34.5% ; P<0.001) c - Endoscopic improvement (
37.3% vs12.9% ; P<0.001) d
In prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA® demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients.
Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA®. The proportions of patients with ≥1 adverse event (AE), serious AE, or AE leading to treatment discontinuation were similar across the TREMFYA® and placebo treatment groups.
"We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life. These results further underscore the potential of TREMFYA to transform the UC treatment paradigm," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "Pending approval, TREMFYA would be the first IL-23 inhibitor with a fully SC induction and maintenance regimen, increasing options for both patients and healthcare providers."
TREMFYA® is the first and only approved fully-human, 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.1,2,3,4,5
Applications seeking approval of TREMFYA® for both UC and Crohn's disease (CD) have been submitted in
For a full list of all data being presented at ECCO visit: https://innovativemedicine.jnj.com/our-innovation/focus-areas/immunology/gastroenterology/gastroenterology-newsroom
Editor's Notes:
a. Dr. Peyrin-Biroulet is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0, or 1 with no friability present on the endoscopy.
c. Clinical response was defined as a decrease from induction baseline in the modified Mayo score by ≥30 percent and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
d. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
ABOUT THE ASTRO STUDY (NCT05528510)
ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study designed to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC every 4 weeks (q4w); or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.6
ABOUT THE QUASAR PROGRAM (NCT04033445)
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the Phase 3 induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase 3 maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.7
ABOUT ULCERATIVE COLITIS
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.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.9 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. Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.10
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved 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 cell that produce IL-23). 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.
TREMFYA® is a prescription medicine approved in the
- adults 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 with active psoriatic arthritis.
- adults with moderately to severely active ulcerative colitis.2
TREMFYA® is approved
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA® (guselkumab)?
TREMFYA® is a prescription medicine that may cause serious side effects, including:
- Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
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- Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
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Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.
Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?"
- have an infection that does not go away or that keeps coming back.
- have TB or have been in close contact with someone with TB.
- have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®.
- are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. - are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"
The most common side effects of TREMFYA® include respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
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.
Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.
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.innovativemedicine.jnj.com
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Peyrin-Biroulet, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with Ulcerative Colitis: Results through week 12 from the phase 3 ASTRO study. Results from the Phase 3 ASTRO study. Oral presentation (#OP10) at the 20th Congress of the European Crohn's and Colitis Organization (ECCO). February 2025.
2 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
3 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed October 2024.
4 Skyrizi® [Prescribing Information].
5 Omvoh™ [Prescribing Information].
6 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. https://clinicaltrials.gov/study/NCT05528510?term=astro&intr=guselkumab&rank=1. Accessed January 2025.
7 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. https://classic.clinicaltrials.gov/ct2/show/NCT04033445. Accessed January 2025.
8 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 2024.
9 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed October 2024.
10 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed October 2024.
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FAQ
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