TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis
Johnson & Johnson (NYSE: JNJ) announced positive results from the Phase 3b APEX study of TREMFYA® (guselkumab) in treating active psoriatic arthritis (PsA). The study met its primary endpoint of reducing signs and symptoms (ACR20) and major secondary endpoint of reducing structural damage progression at 24 weeks compared to placebo.
TREMFYA® stands as the first and only fully-human, dual-acting monoclonal antibody approved for PsA that blocks IL-23 while binding to CD64. The drug demonstrated significantly less progression of structural damage versus placebo at Week 24, measured by the PsA modified van der Heijde-Sharp (vdH-S) score. The safety profile remained consistent with previous findings, with no new safety signals identified.
The APEX study includes a long-term extension through three years to assess sustained efficacy in structural damage inhibition, with results pending presentation at upcoming medical congresses.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati positivi dallo studio di Fase 3b APEX su TREMFYA® (guselkumab) nel trattamento dell'artrite psoriasica attiva (PsA). Lo studio ha raggiunto il suo obiettivo primario di ridurre i segni e i sintomi (ACR20) e l'importante obiettivo secondario di ridurre la progressione del danno strutturale a 24 settimane rispetto al placebo.
TREMFYA® è il primo e unico anticorpo monoclonale completamente umano e a doppia azione approvato per la PsA, che blocca l'IL-23 mentre si lega al CD64. Il farmaco ha mostrato una progressione significativamente minore del danno strutturale rispetto al placebo alla settimana 24, misurata con il punteggio modificato van der Heijde-Sharp (vdH-S) per la PsA. Il profilo di sicurezza è rimasto coerente con i risultati precedenti, senza nuovi segnali di sicurezza identificati.
Lo studio APEX include un'estensione a lungo termine di tre anni per valutare l'efficacia sostenuta nell'inibizione del danno strutturale, con risultati in attesa di presentazione nei prossimi congressi medici.
Johnson & Johnson (NYSE: JNJ) anunció resultados positivos del estudio de Fase 3b APEX sobre TREMFYA® (guselkumab) en el tratamiento de la artritis psoriásica activa (PsA). El estudio cumplió con su objetivo primario de reducir los signos y síntomas (ACR20) y el importante objetivo secundario de reducir la progresión del daño estructural a las 24 semanas en comparación con el placebo.
TREMFYA® es el primer y único anticuerpo monoclonal completamente humano y de doble acción aprobado para la PsA que bloquea IL-23 mientras se une a CD64. El fármaco mostró una progresión significativamente menor del daño estructural en comparación con el placebo a la semana 24, medido por la puntuación modificada van der Heijde-Sharp (vdH-S) para la PsA. El perfil de seguridad se mantuvo consistente con hallazgos previos, sin nuevos señales de seguridad identificados.
El estudio APEX incluye una extensión a largo plazo de tres años para evaluar la eficacia sostenida en la inhibición del daño estructural, con resultados pendientes de presentación en los próximos congresos médicos.
존슨앤존슨 (NYSE: JNJ)은 TREMFYA® (구셀쿠맙)의 활성 건선 관절염 (PsA) 치료에 대한 3상 b APEX 연구의 긍정적인 결과를 발표했습니다. 이 연구는 위약과 비교하여 24주 동안 징후 및 증상 (ACR20)을 줄이는 주요 목표와 구조적 손상 진행을 줄이는 주요 2차 목표를 달성했습니다.
TREMFYA®는 IL-23를 차단하고 CD64에 결합하는 PsA에 대해 승인된 첫 번째이자 유일한 완전 인간 이중 작용 단클론 항체입니다. 이 약물은 PsA 수정된 반더헤이데-샤프 (vdH-S) 점수로 측정된 24주에 위약 대비 구조적 손상의 진행이 유의미하게 적음을 보여주었습니다. 안전성 프로필은 이전 발견과 일치했으며 새로운 안전성 신호는 확인되지 않았습니다.
APEX 연구에는 구조적 손상 억제의 지속적인 효능을 평가하기 위한 3년의 장기 연장이 포함되어 있으며, 결과는 향후 의학 학회에서 발표될 예정입니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats positifs de l'étude de Phase 3b APEX sur TREMFYA® (guselkumab) dans le traitement de l'arthrite psoriasique active (PsA). L'étude a atteint son objectif principal de réduction des signes et symptômes (ACR20) ainsi que l'objectif secondaire majeur de réduction de la progression des dommages structurels à 24 semaines par rapport au placebo.
TREMFYA® est le premier et unique anticorps monoclonal entièrement humain à double action approuvé pour la PsA, qui bloque l'IL-23 tout en se liant au CD64. Le médicament a montré une progression des dommages structurels significativement moindre par rapport au placebo à la semaine 24, mesurée par le score modifié van der Heijde-Sharp (vdH-S) pour la PsA. Le profil de sécurité est resté cohérent avec les résultats précédents, sans nouveaux signaux de sécurité identifiés.
L'étude APEX comprend une extension à long terme de trois ans pour évaluer l'efficacité durable dans l'inhibition des dommages structurels, avec des résultats en attente de présentation lors des prochains congrès médicaux.
Johnson & Johnson (NYSE: JNJ) hat positive Ergebnisse aus der Phase 3b APEX-Studie zu TREMFYA® (guselkumab) bei der Behandlung von aktiver psoriatischer Arthritis (PsA) bekannt gegeben. Die Studie erreichte ihr primäres Ziel, die Zeichen und Symptome (ACR20) zu reduzieren, sowie das wichtige sekundäre Ziel, das Fortschreiten struktureller Schäden nach 24 Wochen im Vergleich zu Placebo zu verringern.
TREMFYA® ist der erste und einzige vollständig humane, dual wirkende monoklonale Antikörper, der für PsA zugelassen ist und IL-23 blockiert, während er an CD64 bindet. Das Medikament zeigte nach 24 Wochen eine signifikant geringere Progression struktureller Schäden im Vergleich zu Placebo, gemessen am modifizierten van der Heijde-Sharp (vdH-S) Score für PsA. Das Sicherheitsprofil blieb konsistent mit früheren Ergebnissen, ohne dass neue Sicherheitszeichen identifiziert wurden.
Die APEX-Studie umfasst eine langfristige Erweiterung über drei Jahre, um die anhaltende Wirksamkeit bei der Hemmung struktureller Schäden zu bewerten, wobei die Ergebnisse in kommenden medizinischen Kongressen präsentiert werden sollen.
- First and only IL-23 inhibitor to show significant structural damage inhibition in PsA
- Met both primary (ACR20) and secondary endpoints at Week 24
- Demonstrated superior efficacy compared to placebo in structural damage reduction
- Maintained consistent safety profile with no new concerns
- None.
Insights
Johnson & Johnson's TREMFYA® has achieved a significant clinical milestone that strengthens its competitive positioning in the psoriatic arthritis (PsA) treatment landscape. The Phase 3b APEX study results demonstrate two critical efficacy measures: reduction in signs and symptoms (ACR20) and inhibition of structural damage progression (modified vdH-S score) at 24 weeks compared to placebo.
What sets these results apart is TREMFYA's designation as the first and only IL-23 inhibitor to demonstrate significant inhibition of structural damage in PsA. This differentiation is particularly valuable in a crowded immunology market where preventing joint destruction represents a critical treatment goal. The dual mechanism (IL-23 blockade plus CD64 binding) provides a mechanistic explanation for these outcomes.
From a commercial perspective, these results strengthen TREMFYA's value proposition as a first-line treatment option. Structural damage prevention is a key consideration for clinicians treating PsA patients, as joint destruction is irreversible and significantly impacts quality of life. The maintenance of TREMFYA's established safety profile, with no new safety signals identified, further supports its overall benefit-risk profile.
While the topline results are promising, the planned three-year extension study will provide crucial long-term data on sustained structural damage inhibition – potentially further differentiating TREMFYA from competing mechanisms of action in the immunology space and reinforcing JNJ's strong position in this therapeutic area.
TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study
Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis
TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA 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 active psoriatic arthritis.2,3,4,5,6
In the Phase 3b APEX study, TREMFYA®-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA® with no new safety signals identified.1
"Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities," said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health."
APEX is a Phase 3b study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA® on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses.
Editor's notes:
a. ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7
ABOUT APEX STUDY (NCT04882098)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.8
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).9,10,11 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.12 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.13 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.14 Studies show up to
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.10
TREMFYA® is approved in
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:
o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat | o trouble breathing or throat tightness o chest tightness o skin rash, hives o 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:
o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis | o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal |
- 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:
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 https://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 product development and the potential benefits and treatment impact of nipocalimab. 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. 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. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
REFERENCES
1 Data on file
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.
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9 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed March 2025.
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13 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed March 2025.
14 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed March 2025.
15 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed March 2025.
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FAQ
What are the main results of TREMFYA's Phase 3b APEX study for psoriatic arthritis?
How does TREMFYA differ from other psoriatic arthritis treatments?
What is the duration of the TREMFYA APEX study extension?
Were there any safety concerns identified in the TREMFYA APEX trial?
