TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn's disease
Johnson & Johnson (NYSE: JNJ) announced positive Phase 3 GRAVITI study results for TREMFYA® (guselkumab), showing significant effectiveness in treating Crohn's disease through subcutaneous administration. At Week 12, 56.1% of TREMFYA-treated patients achieved clinical remission versus 21.4% for placebo. By Week 48, clinical remission rates were 60.0% for the 100mg dose and 66.1% for the 200mg dose, compared to 17.1% for placebo. Endoscopic response rates at Week 48 reached 44.3% and 51.3% for the two TREMFYA doses respectively, versus 6.8% for placebo. The drug maintained its established safety profile and could become the first IL-23 inhibitor offering both subcutaneous and intravenous options for Crohn's disease treatment.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati positivi dello studio di Fase 3 GRAVITI per TREMFYA® (guselkumab), dimostrando una significativa efficacia nel trattamento della malattia di Crohn tramite somministrazione sottocutanea. Alla settimana 12, il 56,1% dei pazienti trattati con TREMFYA ha raggiunto la remissione clinica rispetto al 21,4% del gruppo placebo. Alla settimana 48, i tassi di remissione clinica erano del 60,0% per la dose di 100 mg e del 66,1% per la dose di 200 mg, rispetto al 17,1% per il placebo. I tassi di risposta endoscopica alla settimana 48 hanno raggiunto il 44,3% e il 51,3% per le due dosi di TREMFYA rispettivamente, rispetto al 6,8% per il placebo. Il farmaco ha mantenuto il suo profilo di sicurezza stabilito e potrebbe diventare il primo inibitore dell'IL-23 a offrire opzioni sia sottocutanee che endovenose per il trattamento della malattia di Crohn.
Johnson & Johnson (NYSE: JNJ) ha anunciado resultados positivos del estudio de Fase 3 GRAVITI para TREMFYA® (guselkumab), mostrando una eficacia significativa en el tratamiento de la enfermedad de Crohn a través de la administración subcutánea. En la semana 12, el 56,1% de los pacientes tratados con TREMFYA alcanzaron la remisión clínica, frente al 21,4% del placebo. A la semana 48, las tasas de remisión clínica fueron del 60,0% para la dosis de 100 mg y del 66,1% para la dosis de 200 mg, en comparación con el 17,1% para el placebo. Las tasas de respuesta endoscópica a la semana 48 alcanzaron el 44,3% y el 51,3% para las dos dosis de TREMFYA, respectivamente, frente al 6,8% para el placebo. El medicamento mantuvo su perfil de seguridad establecido y podría convertirse en el primer inhibidor de IL-23 que ofrece tanto opciones subcutáneas como intravenosas para el tratamiento de la enfermedad de Crohn.
존슨 & 존슨 (NYSE: JNJ)는 TREMFYA® (구셀쿠맙)의 3상 GRAVITI 연구 결과가 양호하다고 발표했으며, 피하 주사를 통한 크론병 치료에서 상당한 효과를 보였습니다. 12주 차에 TREMFYA 치료를 받은 환자의 56.1%가 임상 관해에 도달한 반면, 위약 그룹은 21.4%였습니다. 48주 차에는 100mg 용량에서 임상 관해율이 60.0%, 200mg 용량에서 66.1%에 달했으며, 위약은 17.1%였습니다. 48주 차 내시경 반응률은 TREMFYA의 두 가지 용량에 대해 각각 44.3%와 51.3%에 도달했으며, 위약은 6.8%였습니다. 약물은 기존의 안전성 프로필을 유지했으며, 크론병 치료에 있어 피하 및 정맥 내 옵션을 모두 제공하는 첫 번째 IL-23 억제제가 될 수 있습니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats positifs de l'étude de phase 3 GRAVITI pour TREMFYA® (guselkumab), montrant une efficacité significative dans le traitement de la maladie de Crohn par administration sous-cutanée. À la semaine 12, 56,1 % des patients traités avec TREMFYA ont atteint la rémission clinique contre 21,4 % pour le placebo. À la semaine 48, les taux de rémission clinique étaient de 60,0 % pour la dose de 100 mg et de 66,1 % pour la dose de 200 mg, par rapport à 17,1 % pour le placebo. Les taux de réponse endoscopique à la semaine 48 ont atteint 44,3 % et 51,3 % pour les deux doses de TREMFYA respectivement, contre 6,8 % pour le placebo. Le médicament a maintenu son profil de sécurité établi et pourrait devenir le premier inhibiteur de l'IL-23 à offrir des options sous-cutanées et intraveineuses pour le traitement de la maladie de Crohn.
Johnson & Johnson (NYSE: JNJ) hat positive Ergebnisse der Phase-3-Studie GRAVITI für TREMFYA® (Guselkumab) bekannt gegeben, die eine signifikante Wirksamkeit bei der Behandlung der Morbus Crohn durch subkutane Verabreichung zeigen. Nach 12 Wochen erreichten 56,1% der mit TREMFYA behandelten Patienten eine klinische Remission im Vergleich zu 21,4% in der Placebo-Gruppe. Nach 48 Wochen lagen die Remissionsraten bei 60,0% für die 100 mg-Dosis und 66,1% für die 200 mg-Dosis, verglichen mit 17,1% für das Placebo. Die endoskopischen Ansprechquoten nach 48 Wochen lagen bei 44,3% und 51,3% für die beiden TREMFYA-Dosen im Vergleich zu 6,8% für das Placebo. Das Medikament behielt sein etabliertes Sicherheitsprofil bei und könnte der erste IL-23-Inhibitor werden, der sowohl subkutane als auch intravenöse Optionen zur Behandlung der Morbus Crohn anbietet.
- High clinical remission rates at Week 48 (60-66.1% for TREMFYA vs 17.1% placebo)
- Strong endoscopic response rates (44.3-51.3% for TREMFYA vs 6.8% placebo)
- Rapid onset of action observed as early as Week 4
- Potential to be first IL-23 inhibitor with both subcutaneous and IV options
- Recent FDA approval for ulcerative colitis treatment (September 2024)
- None.
Insights
The Phase 3 GRAVITI study results for TREMFYA® represent a significant advancement in Crohn's disease treatment. The data shows remarkably high clinical remission rates of
The endoscopic response and remission rates are particularly impressive, with
This development strengthens J&J's position in the inflammatory bowel disease market. TREMFYA®'s potential dual administration options (SC and IV) would provide a significant competitive advantage over other IL-23 inhibitors. The gastroenterology market, particularly for Crohn's disease, represents a substantial opportunity with the global Crohn's disease therapeutics market valued at over
The recent FDA approval for ulcerative colitis and pending Crohn's disease application could drive significant revenue growth. The strong efficacy data and convenient administration options position TREMFYA® to potentially capture meaningful market share from existing treatments, including TNF inhibitors and other biologics.
A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo
TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn's disease (CD), pending FDA approval
"The GRAVITI results show that induction treatment with subcutaneous guselkumab is as rapid and robust as we have seen with the IV induction, which could offer a welcome new option for Crohn's disease treatment," stated Remo Panaccione, MD, FRCPC, Study Investigator and Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary. "The one-year results of this study suggest that SC induction with guselkumab is a promising approach to help people with CD manage their symptoms and achieve meaningful endoscopic improvements."
GRAVITI SC Induction Week 12 Results:
- More than half of patients treated with TREMFYA® (400 mg administered subcutaneously at Weeks 0, 4, and 8) achieved clinical remission versus those in the placebo group (56.1 percent versus 21.4 percent).1
- Endoscopic response was achieved in 41.3 percent of patients treated with TREMFYA® SC induction therapy versus 21.4 percent in the placebo group.1
- Greater improvements in clinical remission were seen as early as Week 4 with TREMFYA® compared with placebo, demonstrating rapid onset of action.1
GRAVITI SC Induction Week 48 Results:
- The rate of clinical remission was more than three times higher with both maintenance doses of TREMFYA® versus placebo (60.0 percent for 100 mg SC every eight weeks (q8w) and 66.1 percent for 200 mg SC every four weeks (q4w) versus 17.1 percent.1
- Endoscopic response was achieved in 44.3 percent and 51.3 percent of patients in the TREMFYA® 100 mg SC q8w group and 200 mg SC q4w group respectively versus 6.8 percent in the placebo group.1
- Endoscopic remission was achieved in 30.4 percent and 38.3 percent of patients in the TREMFYA® 100 mg SC q8w group and 200 mg SC q4w group respectively versus 6.0 percent in the placebo group.1
"These results show that TREMFYA has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn's disease, and, if approved, will offer choice and flexibility for people living with CD," stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "The convenience of self-administration from the start of treatment is part of our commitment to delivering innovative therapeutic solutions to people with Crohn's disease."
The results reinforced the well-established safety profile of TREMFYA®.
TREMFYA® received
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).2 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.2 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 16.2
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).3 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).3 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab 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 a biologic active control; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (41.8 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance.4 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD. Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints.
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
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.
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:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue, or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- 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:
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than normal
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, Janssen Biotech, Inc. and Janssen-Cilag International NV 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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.
1Panaccione, R, et al. Efficacy and Safety of Subcutaneous Guselkumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease: Results Through Week 48 From the Phase 3 GRAVITI Study. Oral presentation (OP72) at American College of Gastroenterology (ACG) 2024.
2National Institutes of Health: Clinicaltrials.gov. A study of guselkumab 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.
3National 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 September 2024.
4Danese S, et al. Week 48 efficacy of guselkumab and ustekinumab in Crohn's disease based on prior response/exposure to biologic therapy: Results from the GALAXI 2 & 3 Phase 3 Studies. Poster presentation (Abstract MP672) at United European Gastroenterology Week (UEGW) 2024. October 2024.
5Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed September 2024.
6Ng 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.
7Crohn's & Colitis Foundation. What is Crohn's disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed September 2024.
8Crohn'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.
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FAQ
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