A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)

Start Date01 Jan 2025

Sponsor / Collaborator

Oregon Health & Science University

[+2]

NCT06651489 / Not yet recruitingPhase 2IIT

Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study

Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing.
Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.
The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.

Start Date01 Nov 2024

Sponsor / Collaborator

Yale University

[+1]

NCT06663332 / RecruitingPhase 3

A Phase 3, Multicenter, Open-label, Basket, LTE Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Start Date28 Oct 2024

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Guselkumab

100 Translational Medicine associated with Guselkumab

100 Patents (Medical) associated with Guselkumab

655

Literatures (Medical) associated with Guselkumab

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

Comparative analysis of persistence and remission with guselkumab versus secukinumab and ixekizumab in the United States

Article

Author: Shah, Aditi ; Zhdanava, Maryia ; Teneralli, Rachel E ; Fitzgerald, Timothy ; Diaz, Lilian ; Feldman, Steven R ; Lefebvre, Patrick ; Pilon, Dominic

Purpose: Real-world data comparing long-term performance of interleukin (IL)-23 and IL-17 inhibitors in psoriasis are limited. This study compared treatment persistence and remission among patients initiating guselkumab versus IL-17 inhibitors.Methods: Adults with psoriasis initiating guselkumab, secukinumab, or ixekizumab treatment (index date) were identified from Merative™ MarketScan^® Research Databases (01/01/2016-10/31/2021). Persistence was defined as no index biologic supply gaps of twice the labeled maintenance dosing interval. Remission was defined using an exploratory approach as index biologic discontinuation for ≥6 months without psoriasis-related inpatient admissions and treatments.Results: There were 3516 and 6066 patients in the guselkumab versus secukinumab comparison, and 3805 and 4674 patients in guselkumab versus ixekizumab comparison. At 18 months, the guselkumab cohort demonstrated about twice the persistence rate as secukinumab (hazard ratio [HR] = 2.15; p < 0.001) and ixekizumab cohorts (HR = 1.77; p < 0.001). At 6 months after index biologic discontinuation, the guselkumab cohort was 31% and 40% more likely to achieve remission than secukinumab (rate ratio [RR] = 1.31; p < 0.001) and ixekizumab cohorts (RR = 1.40; p < 0.001).Conclusions: Guselkumab was associated with greater persistence and likelihood of remission than IL-17 inhibitors, indicating greater disease control and modification potential.

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

A systematic review of recent randomized controlled trials for palmoplantar pustulosis

Review

Author: Branyiczky, Miranda K. ; Torres, Tiago ; Vender, Ronald ; Towheed, Shahnawaz

Background: Palmoplantar pustulosis (PPP) is a chronic inflammatory condition, that leads to significant functional impairment and reduced quality of life. Despite its low incidence, treatment options are diverse and often ineffective, necessitating a review of recent therapeutic advances.Objective: This review aims to evaluate the efficacy and safety of recent therapeutic options for the treatment of PPP, focusing on phototherapy, systemic therapies, and biologics.Materials and methods: A systematic literature search identified 13 studies evaluating phototherapy and systemic therapies, including biologics. Inclusion criteria focused on randomized controlled trials with participants diagnosed with PPP.Results: Phototherapy showed success: excimer laser demonstrated high efficacy for severe disease [PPP Area and Severity Index (PPPASI)-75 of 95.0%], while psoralen plus ultraviolet A therapy with retinoids or fumaric acid esters worked well in milder disease (PPPASI-90 of 90.0 and 81.8%, respectively). Evidence supports the efficacy and safety of guselkumab, brodalumab, and apremilast over a range of disease severity (PPPASI-50 ranged from 57.4 to 78.3% at week 16). Agents including anakinra, secukinumab, spesolimab, and RIST4721 (primary outcomes not achieved) may not be first-line treatments. By targeting multiple inflammatory pathways in PPP, JAK inhibitors may be more effective than biologics in treating PPP; however, more research is needed to confirm their safety and appropriate use.Conclusions: Multiple new treatments exist for PPP with promising results, however longer-term studies with standardized outcome reporting are needed to determine optimal treatment strategies and their comparative efficacy.

31 Dec 2024·The Journal of dermatological treatment

Successful treatment of generalized pustular psoriasis with guselkumab

Article

Author: Part, Martina

The purpose of the article: Generalized pustular psoriasis (GPP) is a rare auto-inflammatory disease. Patients with GPP may develop life-threatening complications, including sepsis, acute renal failure, neutrophilic cholangitis, high-output congestive heart failure, acute respiratory distress syndrome and death. The therapy of GPP is very limited and the course of the disease is unpredictable.Materials and methods: We report a 60-year-old woman presenting with widespread and confluent erythematous-desquamative plaques with numerous small pustules covering almost 70% of the body surface area. Over the past years patient had undergone different types of conservative treatment regimens including topical therapy, acitretin, cyclosporin, methotrexate and long-term treatment with systemic corticosteroids. Considering the patient's overall clinical condition, we proceed to initiate the biologic therapy with guselkumab.Results: Guselkumab (anti-IL-23) in the standard dose of 100 mg was administered subcutaneously at weeks 0, 4 and followed by a maintenance dose every 8 weeks. The remission of GPP was observed already after 12 weeks of treatment. The maintenance treatment in the period of 18 months shows stable clinical response.Conclusions: Our results support the evidence that guselkumab could provide an effective therapeutic approach in the treatment of GPP.

128

News (Medical) associated with Guselkumab

07 Nov 2024

·www.prnewswire.com

Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024

New data for investigational nipocalimab in Sjögren's Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation SPRING HOUSE, Pa., Nov. 7, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 43 presentations showcasing the Company's rheumatology pipeline and portfolio will be featured at the American College of Rheumatology (ACR) 2024 Annual Meeting. Presentations include three oral sessions and a plenary session, highlighting new data for investigational nipocalimab in SjD and new research on the impact of TREMFYA® in PsA. "Johnson & Johnson is proud to share new data and analyses that demonstrate the potential of nipocalimab and support the well-established efficacy and safety profile of TREMFYA®," said Terence Rooney, M.D., Vice President, Medical Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "This is a testament to our decades-long legacy of innovation and continued exploration of new ways to meet the needs of patients with rheumatic diseases, focusing on treatments that improve patient outcomes." Progressing research in autoantibody-driven diseases The plenary session will feature data from the Phase 2 DAHLIAS study presented earlier this year. The data showed that adult patients who received nipocalimab 15 mg/kg every two weeks demonstrated a greater than 70% relative average improvement on the primary endpoint compared to patients who received placebo.1 More than twice as many patients on 15 mg/kg nipocalimab compared to placebo experienced at least a 50% increase in saliva production at Week 24 in a post-hoc analysis.1 Additional nipocalimab data highlights include: SjD pharmacokinetics (PK), pharmacodynamics (PD), and biomarker data: Two posters will show decreases in rheumatoid factor, circulating immune complexes and all IgG subclasses, and will demonstrate through PK/PD modeling that the median for the maximum potential reduction in total IgG is greater than 77%, providing evidence of interaction of nipocalimab with FcRn and its mechanism of action (MOA) (Abstract #1427 and #2294) Assessment of nipocalimab as an immunoselective investigational therapy: Two posters will be shared showing that nipocalimab-treated study participants respond to vaccines by increasing anti-vaccine IgG levels. In addition, a majority of rheumatoid arthritis (RA) patients treated with nipocalimab showed anti-vaccine antibody levels consistently above protective thresholds during treatment. (Abstract #1988 and #1976) Driving leadership in IL-23 research across patient types Interim results from the PsABIOnd study, an ongoing, prospective, observational cohort study, assessing the effect of TREMFYA® and IL-17 inhibitors on patient-perceived impact of PsA will be presented during the abstract session as an oral presentation. The study highlights reductions in joint pain, skin symptoms, and overall disease activity, demonstrating the positive impact of TREMFYA® in PsA. Additional data across broad patient types and disease manifestations (domains) will highlight the benefits of treatment with TREMFYA® for moderate to severe plaque psoriasis (PsO) and active PsA. The full list of accepted Johnson & Johnson abstracts is below. Data presentation highlights: ACR Convergence – November 14-19 **denotes encore About Sjögren's Disease Sjögren's disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.2 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.3,4 SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glands. Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.2 More than 50% of SjD patients have a moderate to severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus and is often associated with impaired quality of life and functional capacity.5, 3,6 About Rheumatoid Arthritis Rheumatoid arthritis (RA) is a chronic, symmetric, inflammatory disease involving the synovial joints.7 RA occurs when the immune system loses its normal state of balanced control and activates sustained inflammation in the soft inner lining of joints, called synovial tissue.8 This inflammation produces joint pain, swelling, and stiffness, and can lead to permanent damage and deformity in structural joint elements like cartilage and bone.8 Significantly reduced physical function and health-related quality of life typically accompany these features.9 Antibody systems, such as rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPAs) are associated with RA, having been identified based on the antigens these antibodies bind to.10 RA is the most common inflammatory arthritis and affects an estimated 13 million people worldwide.11 It is estimated that 1.5 million people in the United States are affected by RA.8,12 About Systemic Lupus Erythematosus Lupus is a chronic, inflammatory autoimmune disorder that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain.13 Systemic lupus erythematosus (SLE), the most common form of lupus, can range from mild to severe and is characterized by inflammation of any organ system including kidneys, nervous system, brain or brain vasculature, as well as potential hardening of the arteries or coronary artery disease.14 The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian American, Native Hawaiian and Pacific Islander (AAHPI) and Native American descent compared to Caucasian women.15 Lupus is estimated to affect at least 5 million people worldwide.16 About Idiopathic Inflammatory Myopathies Idiopathic inflammatory myopathies (IIM), generally referred to as myositis, are a heterogeneous group of rare, chronic, autoimmune diseases that are characterized by progressive muscle weakness and damage to joints and major organs.17 It is thought to be caused by an overactive immune system that attacks the body's own muscles, skin and other organs, but the specific cause of the disease is unknown.17 The most common symptom of IIM is muscle weakness in the large muscles of the shoulders, neck or hips and can result in difficulty performing typical daily-life activities such as swallowing, walking, driving, climbing stairs, rising from a seated position, turning over in bed and raising arms overhead.17 It is currently estimated that 5-10 people per million are diagnosed with a type of IIM each year.17 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).18,19,20 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.21 Nearly half of patients with PsA experience moderate fatigue and about 30% suffer from severe fatigue as measured by the modified fatigue severity scale.22 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.23 Studies show up to 30% of people with plaque PsO also develop PsA.24 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.25 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.26 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. People with UC also have increased rates of depression.27 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.28,29 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.30 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. About Nipocalimab Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology.1,31,32,33,34,35,36,37,38 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.39,40 The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including: U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 by the FDA EU EMA Orphan medicinal product designation for HDFN in October 2019 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 U.S. to treat: 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.41 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . Important Safety Information for TREMFYA® 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: 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: 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 , by calling 1-877-311-8972, or emailing [email protected]. 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 , 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 STELARA® (ustekinumab) STELARA® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat: adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). adults and children 6 years and older with active psoriatic arthritis. adults 18 years and older with moderately to severely active Crohn's disease. adults 18 years and older with moderately to severely active ulcerative colitis.42 Johnson & Johnson maintains exclusive worldwide marketing rights to STELARA®. Important Safety Information for STELARA® (Ustekinumab) STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including: Serious Infections STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®. If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®. You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay. Before starting STELARA®, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB, or have been in close contact with someone with TB. After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL–12) and interleukin 23 (IL–23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections. Cancers STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths. Posterior Reversible Encephalopathy Syndrome (PRES) PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems. Serious Allergic Reactions Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash. Lung Inflammation Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®. Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you: have any of the conditions or symptoms listed above for serious infections, cancers, or PRES. ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure. are allergic to latex. The needle cover on the prefilled syringe contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®. have any new or changing lesions within psoriasis areas or on normal skin. are receiving or have received allergy shots, especially for serious allergic reactions. receive or have received phototherapy for your psoriasis. are pregnant or plan to become pregnant. It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you will receive STELARA® if you are breastfeeding or plan to breastfeed. It is thought that STELARA® passes into your breast milk. talk to your doctor about the best way to feed your baby if you receive STELARA®. Tell your doctor about all the medicines you take, including prescription and over–the–counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. When prescribed STELARA®: Use STELARA® exactly as your doctor tells you to. STELARA® is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been shown how to inject STELARA® by your doctor or nurse. Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information. Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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 or at \ Follow us at @JanssenUS and @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 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 , 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. 1 ClinicalTrials.gov Identifier: NCT04968912. Available at: . Last accessed: February 2024. 2 Huang H, Xie W, Geng Y, Fan Y, Zhang Z. Mortality in patients with primary Sjögren's syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179. 3 Nat Rev Rheumatol 20, 158–169 (2024). 4 Beydon, M., McCoy, S., Nguyen, Y. et al. Epidemiology of Sjögren syndrome. 5 Hackett KL, et al. Arthritis Care Res (Hoboken). 2012;64(11):1760-1764. 6 Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: 7 Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018 Oct 2;320(13):1360-1372. doi: 10.1001/jama.2018.13103. PMID: 30285183. 8 Arthritis Foundation. Rheumatoid Arthritis: Causes, Symptoms, Treatments and More. Accessed November 2023. Available at . 9 Malm K, Bergman S, Andersson ML, Bremander A, Larsson I. Quality of life in patients with established rheumatoid arthritis: A phenomenographic study. SAGE Open Med. 2017 Jun 7;5:2050312117713647. doi: 10.1177/2050312117713647. PMID: 28611920; PMCID: PMC5466281. 10 Myrthe A.M. van Delft, Tom W.J. Huizinga, An overview of autoantibodies in rheumatoid arthritis, Journal of Autoimmunity, Volume 110, 2020, 102392, ISSN 0896-8411, . 11 Cieza A, et al. "Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019." The Lancet 396, no. 10267 (2020): 2006-2017. doi: (20)32340-0. 12 World Health Organization. The global burden of disease: 2004 update. Geneva: WHO Press, 2008. Accessed November 2023. Available at . 13 Mayo Clinic. Lupus. Available at: . Accessed October 2024. 14 Lupus Foundation of America. Different Types of Lupus. Available at . Accessed October 2024. 15 Lupus Research Alliance. About Lupus. Available at . Accessed October 2024. 16 Lupus Foundation of America. What is Lupus? Available at . Accessed October 2024. 17 Myositis Support & Understanding. What is Myositis? Available at: 18 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: . Accessed October 2024. 19 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: . Accessed October 2024. 20 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: . Accessed October 2024. 21 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: . Accessed October 2023. 22 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: . Accessed October 2024. 23 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: . Accessed October 2024. 24 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: . Accessed October 2024. 25 Cassell S., Kavanaugh A. Psoriatic arthritis: pathogenesis and novel immunomodulatory approaches to treatment. J Immune Based Ther Vaccines 2005 Sep 2;3:6. Available at: . Accessed October 2023. 26 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 27 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. 28 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: . Accessed September 2024. 29 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. 30 Crohn's & Colitis Foundation. What is Crohn's disease? Available at: . Accessed September 2024. 31 ClinicalTrials.gov Identifier: NCT04951622. Available at: . Last accessed: October 2024. 32 ClinicalTrials.gov Identifier: NCT05327114. Available at: . Last accessed: October 2024 33 ClinicalTrials.gov Identifier: NCT04119050. Available at: . Last accessed: October 2024. 34 ClinicalTrials.gov Identifier: NCT05379634. Available at: . Last accessed: October 2024. 35 ClinicalTrials.gov Identifier: NCT05912517. Available at: . Last accessed: October 2024 36 ClinicalTrials.gov Identifier: NCT06028438. Available at: . Last accessed: October 2024. 37 ClinicalTrials.gov Identifier: NCT04882878. Available at: . Last accessed: October 2024. 38 ClinicalTrials.gov. NCT03842189. Available at: . Last accessed: October 2024 39 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x. Last accessed: October 2024. 40 Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499. 41 TREMFYA® Prescribing Information. Available at: Accessed September 2024. 42 STELARA® Prescribing information. Available at: Accessed September 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultOrphan DrugFast TrackDrug ApprovalPhase 2

31 Oct 2024

·pmlive.com

Johnson & Johnson’s Tremfya shows promise in ‘special site’ plaque psoriasis

Johnson & Johnson (J&J) has shared positive results from a late-stage study of its dual-acting IL-23 inhibitor Tremfya (guselkumab) in plaque psoriasis patients. The phase 3b SPECTREM trial has been evaluating the drug in adults with low body surface area (BSA) moderate plaque psoriasis with special site involvement who had failed topical treatment. Affecting more than 125 million people worldwide, plaque psoriasis is an immune-mediated disease characterised by inflamed, scaly plaques that may be itchy or painful. Sensitive or highly visible areas affected by the condition, including the scalp, face and genitals, are considered ‘special sites’ and can have significant impact on patients’ daily lives. Despite this, these patients remain largely under-treated, J&J outlined. Already holding approvals to treat certain cases of plaque psoriasis, active psoriatic arthritis and ulcerative colitis, Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor. Data presented at this year’s Fall Clinical Dermatology Conference showed that a significantly greater proportion of patients who received Tremfya in SPECTREM achieved the primary endpoint of an Investigator’s Global Assessment (IGA) score of zero or one (clear/almost clear skin) compared to those who received placebo, at 74.2% versus 12.4%. In scalp, facial, intertriginous and genital areas, IGA scores of zero or one were achieved by 75%, 87.8%, 86.5% and 78% of Tremfya-treated patients, and complete clearance of each special site was consistently achieved in the majority of patients who received Tremfya versus placebo. Statistically significant improvements were also achieved across all major secondary endpoints, with 52.9% of Tremfya-treated patients achieving a Psoriasis Area Severity Index of 90 compared to 6.2% of those who received placebo. SPECTREM investigator, Linda Stein Gold, Henry Ford Health, said: “People who have special site plaque psoriasis with lesions that cover a smaller total area of their body are often only prescribed topical treatments and not considered candidates for advanced therapies, as treatment decisions are often driven by body surface area coverage and not symptomatic burden. “Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis, as the majority of patients treated with Tremfya achieved clear or almost clear skin.”

Clinical ResultPhase 3

29 Oct 2024

·www.biospace.com

Lilly and J&J Face Off in Crohn’s Disease With Phase III Readouts at ACG 2024

2D illustration of the gut with microorganisms iStock, ArtemisDiana Eli Lilly and Johnson & Johnson are seeking label expansions for Omvoh and Tremfya, respectively, in Crohn’s disease following approvals for ulcerative colitis. GlobalData projects total sales for Tremfya to reach $7.8 billion globally by 2029. Eli Lilly ’s Omvoh and Johnson & Johnson ’s Tremfya induced strong respective remission and response rates in patients with Crohn’s disease, according to Phase III readouts from the companies at the 2024 American College of Gastroenterology Annual Scientific Meeting, held Oct. 25-30 in Philadelphia. J&J on Monday presented findings from the Phase III GRAVITI study , which showed 56.1% of patients treated with a subcutaneous formulation of Tremfya achieved clinical remission at 12 weeks, versus 21.4% in the placebo group. Endoscopic remission rate at this time point was 41.3% in the Tremfya arm, compared with 21.4% for placebo At 48 weeks, the clinical remission rate jumped to 60% for patients taking the 100-mg maintenance dose of subcutaneous Tremfya, given every eight weeks. Tremfya maintenance at 200 mg every four weeks resulted in a 66.1% clinical remission rate. Placebo counterparts, meanwhile, saw only 17.1% clinical remission at this time point. Esi Lamousé-Smith, gastroenterology disease area lead at J&J Innovative Medicines, in a statement said that these findings point to Tremfya’s “potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease.” If its expansion into this indication is approved, Tremfya will offer patients a more convenient option to self-administer treatment from the start of their regimens, Lamousé-Smith said. In a report published last week , data and analytics firm GlobalData highlighted the potential of Tremfya to set a “new standard” in the treatment of Crohn’s disease, particularly given its “patient-friendly” administration profile. Tremfya’s “positive clinical profile, coupled with its unique dual-binding mechanism, positions it as a differentiated option within its class,” GlobalData immunology analyst Sumaira Malik said in a statement, calling its subcutaneous regimen a “significant step forward for patients.” GlobalData expects Tremfya’s global sales to hit $7.8 billion by 2029. Also on Monday, Lilly posted long-term Crohn’s disease data for Omvoh, showing that the anti-IL23p19 antibody elicited a 96% clinical response rate in patients, as measured by the Crohn’s Disease Activity Index. Long-term results showed that 87% of patients reached clinical remission, 76% showed endoscopic response and 54% were in endoscopic remission. Lilly also presented follow-up data for Omvoh in moderate to severely active ulcerative colitis, touting an 81% long-term clinical remission rate and an 82% long-term endoscopic remission rate. The pharma’s readout also showed that 72% and 79% of patients achieved mucosal healing and corticosteroid-free clinical remission, respectively. Mark Genovese, Lilly’s senior vice president of immunology development, in a statement said Omvoh “is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn’s disease.” Both Lilly and J&J are seeking to expand their respective treatments into Crohn’s disease, following approvals for ulcerative colitis. J&J submitted its supplemental Biologics License Application for Tremfya in June 2024, following Phase III data from the GALAXI program, which showed that Tremfya elicited significantly better endoscopic outcomes than the blockbuster drug Stelara. Lilly announced in May 2024 that it had filed for Omvoh’s expansion . Earlier this month, the pharma released data from the late-stage VIVID-1 trial, demonstrating that Omvoh also outperformed Stelara in terms of histologic response.

Clinical ResultPhase 3BiosimilarDrug Approval

100 Deals associated with Guselkumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10438	Guselkumab	L04AC16	DB11834

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ulcerative colitis, active moderate	US	Janssen Biotech, Inc.	11 Sep 2024
Ulcerative colitis, active moderate	US	Johnson & Johnson (China) Investment Ltd.	11 Sep 2024
Ulcerative colitis, active severe	US	Johnson & Johnson (China) Investment Ltd.	11 Sep 2024
Ulcerative colitis, active severe	US	Janssen Biotech, Inc.	11 Sep 2024
Erythrodermic psoriasis	JP	Janssen Global Services LLC	23 Mar 2018
Psoriasis	JP	Janssen Global Services LLC	23 Mar 2018
Pustular psoriasis	JP	Janssen Global Services LLC	23 Mar 2018
Arthritis, Psoriatic	EU	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	IS	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	LI	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	NO	Janssen-Cilag International NV	10 Nov 2017
Plaque psoriasis	US	Janssen Biotech, Inc.	13 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn's disease, active moderate	NDA/BLA	US	Johnson & Johnson (China) Investment Ltd.	20 Jun 2024
Crohn's disease, active severe	NDA/BLA	US	Johnson & Johnson (China) Investment Ltd.	20 Jun 2024
Colitis, Ulcerative	NDA/BLA	EU	Janssen-Cilag International NV	02 May 2024
Crohn Disease	NDA/BLA	CN	Xian Janssen Pharmaceutical Ltd.	06 Mar 2024
Pediatric Crohn's Disease	Phase 3	US	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	JP	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	AT	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	BE	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	FR	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	IL	Janssen Research & Development LLC	13 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06039189 (SPECTREM, NEWS) Manual	Phase 3	Plaque psoriasis	-	Tremfya (guselkumab)	bwbavhumyk(ivexnkuqxo) = dagdoikoeq datcoejqdy (xmsqfceogu ) View more	Positive	31 Oct 2024
				Placebo	bwbavhumyk(ivexnkuqxo) = ebelofyjnh datcoejqdy (xmsqfceogu ) View more
NCT05197049 (GRAVITI, Company_Website) Manual	Phase 3	Crohn Disease	-	TREMFYA® 400 mg SC q4w	dwltddmjuf(rirkoeoggv) = nnwzypjtuf fbkjljnevr (ebrborzumr ) View more	Positive	28 Oct 2024
				TREMFYA® 100 mg SC q8w	dwltddmjuf(qvulgcayjw) = flbwrkurht enhgdpvcay (nuhdabavjl ) View more
NCT05784129 (PROGRESS, CTgov)	Phase 3	Crohn Disease	4	Guselkumab (Guselkumab 200 mg + Guselkumab 100 mg)	sxfflnozpk(jmzdqgjraq) = wyhxgvngze dzbvltaxil (efnmruqfvo, lvygasajar - vtxswrcdoh) View more	-	28 Oct 2024
				placebo+guselkumab (Placebo)	sxfflnozpk(jmzdqgjraq) = spcrzjqtcg dzbvltaxil (efnmruqfvo, tfkhtekqqx - whfakxyamc) View more
UEGW	Not Applicable	Ulcerative colitis, active moderate	-	Guselkumab 200 mg SC q4w	bzhgtmtaxf(frghvsjwle) = eorgwvligj iqcjyhrxum (pnaqggvfsx ) View more	-	13 Oct 2024
				Guselkumab 100 mg SC q8w	bzhgtmtaxf(frghvsjwle) = robckzoatb iqcjyhrxum (pnaqggvfsx )
NCT04033445 (QUASAR, UEGW)	Phase 3	Colitis, Ulcerative Maintenance	203	Guselkumab 200 mg	rfcxtujjgv(dvkrnngpxq) = Adverse events (AEs) were reported for 78.0% of GUS Week I-24 responders, serious AEs for 5.7%, and serious infections for 1.6%. No opportunistic infections or deaths occurred. No new safety concerns were identified. ayllaeioof (wmkbqbtade )	Positive	13 Oct 2024
UEGW	Not Applicable	-	-	Guselkumab (GUS)	pezvqhfazz(durjpjhxac) = eyhqsqxamq ngqieszlst (umerjawcub )	-	13 Oct 2024
				Risankizumab (RZB)	pezvqhfazz(durjpjhxac) = euwvhtxblj ngqieszlst (umerjawcub )
NCT04033445 (QUASAR Maintenance Study, UEGW)	Phase 3	Ulcerative colitis, active severe Maintenance	568	Guselkumab 200 mg SC q4w	cnoctjtioa(kyhfnpviny) = embfupufjg pbgpgqyhje (xcxrlranis ) View more	Positive	13 Oct 2024
				Guselkumab 100 mg SC q8w	cnoctjtioa(kyhfnpviny) = owxchppltn pbgpgqyhje (xcxrlranis ) View more
UEGW	Not Applicable	Ulcerative colitis, active moderate	-	Guselkumab 200mg q4w	flqsahfwmd(ocnphirned) = 11.2% vs 14.1% in the combined GUS group vs withdrawal group mqpfraeltl (hxslzhakot ) View more	-	13 Oct 2024
				Guselkumab 100mg q8w
NCT04033445 (QUASAR, UEGW)	Phase 3	Ulcerative colitis, active moderate Maintenance CD64	568	Guselkumab 200 mg SC q4w	edyybmvwsn(xwkfddotoo) = ncksctiupt badprishkc (uhgdqyzexx ) View more	Positive	13 Oct 2024
				Guselkumab 100 mg SC q8w	edyybmvwsn(xwkfddotoo) = owfdrvjicy badprishkc (uhgdqyzexx ) View more
NCT04683029 (CTgov)	Phase 2	Scleroderma, Systemic	56	Guselkumab Dose 2 (Group A: Guselkumab)	czwguvdhla(dkxzakcamy) = qrcbjnljfc elsppgodqx (tafhsgyjhg, emhmntxqeg - fownisepje) View more	-	09 Oct 2024
				Placebo (Group B: Placebo)	czwguvdhla(dkxzakcamy) = yjjwzozxbj elsppgodqx (tafhsgyjhg, eeoeythber - emenwwiwqj) View more

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