TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis
Johnson & Johnson (NYSE: JNJ) reported 48-week Phase 3 ASTRO results showing subcutaneous TREMFYA (guselkumab) achieved sustained clinical and endoscopic outcomes in adults with moderately to severely active ulcerative colitis.
At Week 48 TREMFYA 100 mg q8w and 200 mg q4w produced clinical remission 36.7% and 42.9%, endoscopic remission 25.9% and 26.4%, and symptomatic remission 47.5% and 53.6%, versus placebo 7.2%/5%/14.4% respectively. Results were consistent across biologic/JAK-naïve and refractory subgroups and safety matched the established profile. TREMFYA is the first IL-23 inhibitor with a fully subcutaneous regimen and has recent U.S. FDA SC induction approval for UC.
Johnson & Johnson (NYSE: JNJ) ha riportato i risultati di Fase 3 ASTRO a 48 settimane mostrando che TREMFYA subcutaneo (guselkumab) ha raggiunto esiti clinici ed endoscopici sostenuti in adulti con colite ulcerosa moderatamente‑severamente attiva.
Alla settimana 48 TREMFYA 100 mg q8w e 200 mg q4w hanno prodotto remissione clinica 36.7% e 42.9%, remissione endoscopica 25.9% e 26.4%, e remissione sintomatica 47.5% e 53.6%, rispetto al placebo 7.2%/5%/14.4% rispettivamente. I risultati sono stati coerenti tra i sottogruppi biologici/JAK‑naïve e refrattari e la sicurezza è in linea con il profilo consolidato. TREMFYA è il primo inibitore IL‑23 con un regime interamente sottocutaneo e ha recentemente ottenuto l'approvazione SC di induzione da parte della FDA degli Stati Uniti per UC.
Johnson & Johnson (NYSE: JNJ) informó resultados de Fase 3 ASTRO a 48 semanas mostrando que TREMFYA subcutáneo (guselkumab) alcanzó resultados clínicos y endoscópicos sostenidos en adultos con colitis ulcerosa moderada a severa activa.
En la Semana 48, TREMFYA 100 mg cada 8 semanas y 200 mg cada 4 semanas generaron remisión clínica del 36,7% y 42,9%, remisión endoscópica del 25,9% y 26,4%, y remisión sintomática del 47,5% y 53,6%, frente a placebo 7,2%/5%/14,4% respectivamente. Los resultados fueron consistentes en subgrupos biológico/naïve a JAK y refractarios, y la seguridad coincidió con el perfil establecido. TREMFYA es el primer inhibidor de IL‑23 con un régimen completamente subcutáneo y recientemente tiene aprobación de inducción SC de la FDA de EE. UU. para UC.
Johnson & Johnson (NYSE: JNJ)가 48주 Phase 3 ASTRO 결과를 발표했습니다. 피하 주사 TREMFYA(guselkumab)가 중등도에서 중증 활성 우궤양성 대장염을 가진 성인에서 지속적인 임상 및 내시경적 결과를 달성했습니다.
48주 차에 TREMFYA 100 mg q8w와 200 mg q4w는 각각 임상 현저 감소 36.7% 및 42.9%, 내시경적 현저 감소 25.9% 및 26.4%, 증상적 완화 47.5% 및 53.6%를 나타냈으며 위약은 각각 7.2%/5%/14.4%였습니다. 결과는 생물학적/JAK-naïve 및 난치 하위그룹에서 일관되었고 안전성은 확립된 프로파일과 일치했습니다. TREMFYA는 완전한 피하 투여를 가진 최초의 IL-23 억제제이며 UC에 대한 최근 미국 FDA의 피하 투여 유도 승인도 받았습니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats de phase 3 ASTRO à 48 semaines montrant que TREMFYA sous-cutané (guselkumab) a obtenu des résultats cliniques et endoscopiques soutenus chez les adultes atteints de colite ulcéreuse actif modéré à sévère.
À la semaine 48, TREMFYA 100 mg q8w et 200 mg q4w ont produit une rémission clinique de 36,7% et 42,9%, une rémission endoscopique de 25,9% et 26,4% et une rémission symptomatique de 47,5% et 53,6%, comparé au placebo 7,2%/5%/14,4% respectivement. Les résultats étaient cohérents dans les sous-groupes biologiques/JAK-naïfs et réfractaires, et la sécurité correspondait au profil établi. TREMFYA est le premier inhibiteur IL‑23 avec un schéma entièrement sous-cutané et a récemment reçu l’approbation SC d’induction par la FDA américaine pour l’UC.
Johnson & Johnson (NYSE: JNJ) meldete 48-wöchige Phase-3 ASTRO Ergebnisse, die zeigen, dass TREMFYA subkutan (Guselkumab) bei Erwachsenen mit moderat bis schwer aktiver Colitis ulcerosa anhaltende klinische und endoskopische Ergebnisse erzielt hat.
Woche 48 führten TREMFYA 100 mg q8w und 200 mg q4w zu klinischer Remission 36,7% bzw. 42,9%, endoskopischer Remission 25,9% bzw. 26,4% und symptomatischer Remission 47,5% bzw. 53,6%, verglichen mit Placebo 7,2%/5%/14,4% respectively. Die Ergebnisse waren konsistent über biologic/JAK-naïve- und refraktäre Untergruppen hinweg und die Sicherheit entsprach dem etablierten Profil. TREMFYA ist der erste IL‑23‑Inhibitor mit einer vollständig subkutanen Verabreichung und hat kürzlich die SC-Induktionsfreigabe der FDA für UC erhalten.
Johnson & Johnson (NYSE: JNJ) أبلغت عن نتائج المرحلة 3 ASTRO لمدة 48 أسبوعًا تُظهر أن TREMFYA تحت الجلد (guselkumab) حقق نتائج سريرية وتنظيرية مستمرة لدى البالغين المصابين بالتهاب القولون التقرّحي act المستوى المتوسط إلى الشديد.
في الأسبوع 48، أدى TREMFYA بجرعة 100 mg كل 8 أسابيع و200 mg كل 4 أسابيع إلى انعدام أعراض سريرية بنسبة 36.7% و42.9%، انعدام تنظيري بنسبة 25.9% و26.4%، وانعدام أعراضى بنسبة 47.5% و53.6%، مقارنة بالدواء الوهمي بنسبة 7.2%/5%/14.4% على التوالي. كانت النتائج متسقة عبر مجموعات فرعية تحتوي على مرضى لم يتلقوا علاجات بيولوجية/JAK وأولئك المتحملين، وكانت السلامة مطابقة للملف المعروف. TREMFYA هو أول مثبط IL-23 بنظام إعطاء تحت جلّي بالكامل وقد حصل مؤخرًا على موافقة FDA الأمريكية للإعطاء تحت الجلد كمرحلة ابتدائية لـ UC.
Johnson & Johnson (NYSE: JNJ) 公告了为期 48 周的 ASTRO Phase 3 结果，显示皮下注射 TREMFYA（guselkumab）在中度至重度活动性溃疡性结肠炎的成人患者中实现了持续的临床和内镜结局。
第 48 周，TREMFYA 100 mg q8w 与 200 mg q4w 分别产生 临床缓解 36.7% 与 42.9%、内镜缓解 25.9% 与 26.4%，以及 症状缓解 47.5% 与 53.6%，对照安慰剂分别为 7.2%/5%/14.4%。结果在生物制剂/JAK‑naïve 与难治亚组中均一致，安全性与已知谱系一致。TREMFYA 是首个完全皮下给药的 IL‑23 抑制剂，且近期美国 FDA 已批准其用于 UC 的皮下诱导治疗。
- Clinical remission 36.7% (100 mg q8w) at Week 48 versus 7.2% placebo
- Clinical remission 42.9% (200 mg q4w) at Week 48 versus 7.2% placebo
- Endoscopic remission 25.9%–26.4% at Week 48 versus 5% placebo
- Symptomatic remission 47.5%–53.6% at Week 48 versus 14.4% placebo
- Consistent efficacy across biologic/JAK-naïve and refractory subgroups
- U.S. FDA approval of SC induction option for ulcerative colitis
- Statistical claims reported as nominal p<0.001 without multiplicity adjustment
- Mechanism-of-action findings cited are based on in vitro studies only
Insights
TREMFYA® shows sustained subcutaneous efficacy through
Mechanism supports the result: TREMFYA® (guselkumab) combines IL-23 blockade and CD64 binding, and the Phase 3 ASTRO data report
Dependencies and risks are explicit and limited to the disclosed facts: safety is described as consistent with the established profile, and SC induction has recent U.S. FDA approval for UC per the release. The clinical effect sizes versus placebo are substantial by the reported metrics, but durability beyond
Concrete items to watch in the near term include regulatory labeling language and uptake now that SC induction is approved (
Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (
Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups
TREMFYA ® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis
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
The ASTRO Week 48 data build on the previously reported Week 12 SC induction data, which showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures.7 Data through Week 48 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo (all nominal p<0.001).1
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At Week 48: |
TREMFYA® 100 mg |
TREMFYA® 200 mg |
Placebo |
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Clinical remissiona |
36.7 % |
42.9 % |
7.2 % |
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Endoscopic improvementb |
44.6 % |
47.1 % |
11.5 % |
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Endoscopic remissionc |
25.9 % |
26.4 % |
5 % |
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Symptomatic remissiond |
47.5 % |
53.6 % |
14.4 % |
Furthermore, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA® demonstrated clinically meaningful results across all 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®.1
"For many patients, having a subcutaneous induction option is an important step forward—offering the flexibility of at-home administration after proper training without compromising efficacy," said Prof. Silvio Danese, IRCCS Ospedale San Raffaele and University VitaSalute San Raffaele in
"These results reflect our unwavering commitment to advancing the science that delivers both meaningful outcomes and more choices for healthcare providers and their patients," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "TREMFYA is the only IL-23 inhibitor to offer a subcutaneous induction option in both Crohn's disease and ulcerative colitis, the latter of which was recently approved by the
TREMFYA® has received
For a full list of all Johnson & Johnson data being presented at UEG Week visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology
Editor's Notes:
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Clinical remission was 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. |
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Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
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Endoscopic remission (normalization) was defined as a Mayo endoscopic subscore (MES) of 0. |
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Symptomatic remission per Mayo score was defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). |
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Prof. Danese is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. |
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 (UC) 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.8
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.9
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 cells 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.
- adults with moderately to severely active Crohn's disease.5
TREMFYA® is approved in
The legal manufacturer for TREMFYA® is Janssen Biotech, Inc.
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®?
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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o fainting, dizziness, feeling lightheaded (low blood
o swelling of your face, eyelids, lips, mouth, tongue |
o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching |
- 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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o fever, sweats, or chills o muscle aches o weight loss o cough
o warm, red, or painful skin or sores on your body |
o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus)
o burning when you urinate or urinating more often |
- Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
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o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes |
o nausea o stomach pain (abdominal) o loss of appetite o dark urine |
Do not use 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, stomach pain, 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 as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as 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.
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 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
References:
1 Allegretti JR, et al. Efficacy and safety of subcutaneous guselkumab induction and maintenance therapy in patients with ulcerative colitis: results through week 48 from the phase 3 ASTRO study. Oral presentation OP203 at United European Gastroenterology (UEG) Week 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;
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].
5 Skyrizi® [Prescribing Information].
6 Omvoh™ [Prescribing Information].
7 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.
8 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 March 2025.
9 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed March 2025
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FAQ
What Week 48 clinical remission rates did TREMFYA achieve in the ASTRO study (JNJ, Oct 7 2025)?
What endoscopic remission did TREMFYA report at Week 48 in ASTRO (JNJ)?
Does TREMFYA have U.S. FDA approval for subcutaneous induction in ulcerative colitis (JNJ, 2025)?
Were TREMFYA safety results through Week 48 consistent with prior data (JNJ ASTRO Oct 7 2025)?
What dosing regimens were evaluated in the ASTRO Week 48 data (JNJ)?
