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WASHINGTON, May 20, 2024 /PRNewswire/ -- Johnson & Johnson today announced the first data from the Phase 3 QUASAR Maintenance Study (Abstract #759) that showed 50.0 percent (p<0.001) of patients with moderately to severely active ulcerative colitisa (UC) receiving subcutaneous (SC) TREMFYA® (guselkumab) 200 mg every four weeks (q4w) and 45.2 percent (p<0.001) of patients receiving SC TREMFYA® 100 mg every eight weeks (q8w) achieved the primary endpoint of clinical remissionb at Week 44 compared to placebo (18.9 percent).1 In additional analyses of patients who were in clinical remission, 67 percent and 71 percent, respectively, were also in endoscopic remission at Week 44 (Mayo endoscopic subscore [MES]= 0), indicating they had normal appearance of intestinal mucosa.2 "These data suggest the potential of guselkumab to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalization and histologic remission, which represent the kind of progress needed in new treatments for this inflammatory bowel disease," said David T. Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago and lead study investigator.f "The clinical results measured at Week 44 in the QUASAR Maintenance Study suggest that treatment with guselkumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that impact their daily lives." Both TREMFYA® treatment groups also met all nine major secondary endpoints with high statistical significance and clinically meaningful improvements versus placebo. A summary of select secondary endpoints from the 44-week Maintenance Study include:1 The proportion of patients with more than one adverse event (AE) was similar across treatment groups: SC TREMFYA® 200mg q4w, 70.0 percent; SC TREMFYA® 100mg q8w, 64.5 percent; placebo, 68.2 percent.1 The most common AEs in the combined TREMFYA® group compared to placebo were COVID-19 (11.2 percent vs. 14.1 percent), UC (11.2 percent vs. 29.7 percent) and joint pain (6.1 percent vs. 6.8 percent), respectively.1 The safety results were consistent to the safety profile of TREMFYA® in the approved indications of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).1,e "The Phase 3 QUASAR Maintenance Study continues to demonstrate the promise of TREMFYA to unlock potential treatment options for patients living with ulcerative colitis who continue to experience debilitating symptoms despite the availability of treatments today," said David Lee, M.D., Ph.D., Global Therapeutic Area Head, Immunology, Johnson & Johnson. "These findings underscore our commitment to elevate the standard of care in ulcerative colitis and strengthen our resolve to advance inflammatory bowel disease science." These data are among 28 oral and poster presentations that Johnson & Johnson is presenting at Digestive Disease Week 2024, highlighting the company's commitment and leadership in advancing the science of inflammatory bowel disease. This year, Johnson & Johnson submitted regulatory applications seeking the approval of TREMFYA® for the treatment of adults with moderately to severely active UC in countries or regions including the United States and Europe. Editor's Notes: a. Baseline modified score of 5 to 9 with a Mayo rectal bleeding subscore of ≥ 1 and a Mayo endoscopy subscore ≥ 2 based on central review.1 b. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1 c. Endoscopic remission (normalization) was defined as a MES of 0.1 d. Histologic-endoscopic mucosal improvement was defined as achieving a combination of histologic improvement (neutrophil infiltration in <5 percent of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue per Geboes grading system) and endoscopic improvement.1 e. TREMFYA® is not approved for the treatment of adults living with UC in the U.S. f. Dr. Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. g. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1 h. Clinical response was defined as a decrease from induction baseline in the modified Mayo score by ≥30 percent and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.1 ABOUT THE QUASAR PROGRAM (NCT04033445) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, seamless Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy (e.g., thiopurines or corticosteroids), other biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, or tofacitinib).3 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, a Phase 3 randomized withdrawal maintenance study, and a long-term extension study through a total of 5 years. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.2 In the Phase 3 randomized withdrawal QUASAR Maintenance Study, adult patients who demonstrated a clinical response to 12 weeks of TREMFYA® IV induction in the Phase 2 and Phase 3 induction studies were randomized 1:1:1 to three treatment groups: SC TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w or placebo (TREMFYA® withdrawal).1 The major secondary endpoints included corticosteroid-free clinical remission, maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, endoscopic normalization, Inflammatory Bowel Disease Questionnaire (IBDQ) remission, and fatigue response at Week 44 (56 weeks after initiation of treatment).1 ABOUT ULCERATIVE COLITIS Ulcerative colitis 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.4 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. UC patients also have increased rates of depression.3 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a receptor on cells that produce IL-235. IL-23 is an important driver of the pathogenesis of inflammatory diseases.4 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.6,7,8,9 TREMFYA® is approved in the U.S. and a number of other countries for the treatment of adults with moderate to severe plaque PsO who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active PsA.4,10 It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.11 Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. IMPORTANT SAFETY INFORMATION4 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 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. 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: upper respiratory 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. 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 @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. 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. SOURCE Johnson & Johnson

Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn's disease, which each achieved their primary endpoints1,2 BEERSE, Belgium, May 1, 2024 /PRNewswire/ -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. The submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn's disease.1,2,3,4,5 In the Phase 3 QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms, measures of disease activity including stringent endpoints such as endoscopic normalization and histo-endoscopic mucosal healing, and patient-reported outcomes such as fatigue.1,3,4 The safety results were consistent with the known safety profile of guselkumab in approved indications.3,4,a In the Phase 3 GALAXI 2 and 3 studies, guselkumab achieved co-primary endpoints at Week 12 and demonstrated statistically significant and clinically meaningful improvements relative to placebo in corticosteroid free clinical remission and endoscopic response at Week 48.2,5 Safety results were consistent with the known safety profile of guselkumab in approved indications.2,5 "People living with chronic, immune-mediated disease such as ulcerative colitis and Crohn's disease often spend a considerable amount of time cycling from one treatment to another in search of relief and sustained remission," said David Lee, MD, PhD, Global Therapeutic Area Head Immunology. "This submission is an important step in our mission to develop novel, effective therapies for the millions of people worldwide living with ulcerative colitis and Crohn's disease who are experiencing persistent and debilitating symptoms." Guselkumab is the first approved fully-human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.6 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 ulcerative colitis and Crohn's disease.7 Guselkumab is approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.6 "Inflammatory bowel disease, which includes ulcerative colitis and Crohn's disease, affects as many as four million people in Europe annually," said Ludovic de Beaucoudrey, PhD, Senior Director, Therapeutic Area Lead, Immunology, Janssen-Cilag Limited, a company of Johnson & Johnson. "We look forward to working closely with the EMA during review of these applications and are deeply committed to rapidly innovating for those patients who live with immune-mediated diseases like ulcerative colitis and Crohn's disease where considerable needs remain." Clinical data from the Phase 3 QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week Annual Meeting and results from the Phase 3 QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting.3 Clinical data from the long-term extension of the GALAXI Phase 2 study through three years were presented at United European Gastroenterology Week 2023 and results from the Phase 3 studies through 48 weeks will be presented at an upcoming medical meeting.5 In March 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of guselkumab for treatment of adults with moderately to severely active ulcerative colitis. Editor's Notes: a. Guselkumab is not approved to treat ulcerative colitis or Crohn's disease. ABOUT THE QUASAR PROGRAM (EudraCT 2018-004002-25) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, seamless Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, or tofacitinib).1 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, a Phase 3 randomized withdrawal maintenance study, and a long-term extension study through a total of 5 years.1 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.1 ABOUT THE GALAXI PROGRAM (EudraCT 2017-002195-13) 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 (immunomodulators, corticosteroids) and/or biologics (TNF antagonists, vedolizumab).2 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).2 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.2 ABOUT ULCERATIVE COLITIS Ulcerative colitis 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.8 It is the result of the immune system's overactive response.8 Symptoms vary, but may include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.8 ABOUT CROHN'S DISEASE Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated four million people across Europe.9 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.10 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. There is currently no cure for Crohn's disease.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.6 IL-23 is an important driver of the pathogenesis of inflammatory diseases.7 TREMFYA® is approved in the U.S., Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis.12,13,14 It is also approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.6 Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. 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 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. 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: upper respiratory 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. 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 @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. 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. EU Clinical Trials Register: Clinicaltrialsregister.eu. A Phase 2b/3, randomized, double-blind, placebo-controlled, parallel-group, multicenter protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (QUASAR). Identifier: 2018-004002-25. Available at: . Accessed April 2024. EU Clinical Trials Register. Clinicaltrialsregister.eu. A Phase 2/3, randomized, double-blind, placebo- and active-controlled, parallel-group, multicenter protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease (GALAXI). Identifier: 2017-002195-1. Available at: . Accessed April 2024. Allegretti, J, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the Phase 3 QUASAR induction study. Presented at Digestive Disease Week, May 6-9. Peyrin-Biroulet L, et al. Guselkumab in patients with moderately to severely active ulcerative colitis: QUASAR Phase 2b induction study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1. PMID: 37659673. Afzali, A, et al. Efficacy and safety of guselkumab for Crohn's disease through 3 years: GALAXI-1 Long-Term extension. Presented at United European Gastroenterology Week 2023, October 14-17. EU SmPC: European Medicines Agency. TREMFYA Summary of Product Characteristics. Last Updated July 2022. Available at: . Accessed April 2024. Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. Available at: . Accessed April 2024. Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 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. Crohn's & Colitis Foundation. What is Crohn's disease? Available at: . Accessed April 2024. Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at: . Accessed April 2024. US Food and Drug Administration. TREMFYA® prescribing information. Available at: . Accessed April 2024. The Canadian Agency for Drugs & Technologies in Health. TREMFYA prescribing information. Available at: . Accessed April 2024. Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the deliberation results. Available at: . Accessed April 2024. Media contact: Sophie Daneau +33 6 3178 8798 Craig Stoltz +1 215-779-9396 Investor contact: Raychel Kruper [email protected] SOURCE Johnson & Johnson

Bioelectronic medicine researchers at the Feinstein Institutes for Medical Research, in collaboration with GE Research, publish a paper in the journal Brain Stimulation MANHASSET, N.Y.--(BUSINESS WIRE)-- We’ve all seen ultrasound images from glowing moms-to-be; now, researchers at The Feinstein Institutes for Medical Research, in collaboration with GE Research, have harnessed ultrasound technology to non-invasively reduce inflammation in the body. Results from human studies published in the journal Brain Stimulation point to the possibility of using bioelectronic medicine and neuromodulation to treat inflammatory diseases traditionally treated only with drugs. This press release features multimedia. View the full release here: Drs. Sangeeta Chavan (left) and Stavros Zanos (right) helped lead the new study which published in the journal Brain Stimulation. (Credit: Feinstein Institutes) Led by Feinstein Institutes’ Sangeeta S. Chavan, PhD, and Stavros Zanos, MD, PhD, along with GE Research’s Christopher Puleo, PhD, senior principal engineer and Jeff Ashe, MS, principal engineer in biomedical electronics, delivered spleen-focused ultrasound stimulation (FUS) or sham stimulation, to 70 healthy participants. Through careful blood analyses and measurements, they investigated the levels of endotoxin-induced tumor necrosis factor (TNF), an inflammatory protein that is released by white blood cells and circulates in the bloodstream. They found that spleen FUS has an anti-inflammatory effect, lowering TNF production from blood cells for more than 2 hours, with TNF returning to baseline levels by 24 hours after stimulation; sham stimulation has no effect on TNF production. “From diabetes and obesity to cardiovascular diseases and cancer, inflammation is a major pathogenic mechanism in many diseases,” said Dr. Zanos, associate professor at the Feinstein Institutes’ Institute of Bioelectronic Medicine. “These first-in-human results are exciting because they demonstrate the potential ultrasound stimulation therapy holds to treat diseases, non-invasively, with existing technology.” Preclinical research previously conducted by the Feinstein Institutes and others has shown that FUS targeting the spleen activates anti-inflammatory responses; this new study demonstrates these effects for the first time in humans. In 2021, the Feinstein Institutes and GE Research team showed the anti-inflammatory effects of liver-focused ultrasound on obesity in preclinical models. In 2022, Drs. Chavan and Zanos, along with GE Research and other collaborators, showed the ability of ultrasound to reverse diabetes in preclinical studies. “The idea that we can use non-invasive ultrasound stimulation rather than drugs to treat inflammatory diseases is exciting,” said Dr. Chavan, professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes. “Building off decades of research, these results in humans help set the stage for more clinical studies that may one day lead to additional therapies for patients in need of care, beyond traditional pharmaceuticals.” Our body’s immune response to infection and disease is controlled through neural mechanisms mediated via the vagus nerve. Discovered in the lab of Kevin J. Tracey, MD, the Feinstein Institutes’ president and CEO, they dubbed this communication pathway the “inflammatory reflex,” which helped create the field of bioelectronic medicine. “We are at a tipping point because it is increasingly becoming clear that new technology, new devices and new stimulation can treat inflammatory diseases,” said Dr. Tracey, Karches Family Distinguished Chair in Medical Research. “Drs. Chavan and Zanos’ work with GE Research is a major advance in the field of bioelectronic medicine.” The Feinstein Institutes is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience and biomedical engineering. At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury. Built on years of research in molecular mechanisms of disease and the link between the nervous and immune systems, Feinstein Institutes researchers discover neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants or ultrasound technologies, to control the body's immune response and inflammation. If inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, Crohn’s disease, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn.