Beerse, Belgium (18 December 2024) – Johnson & Johnson today announced that The Lancet
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At Week 12, 23% [95/421] of patients treated with induction guselkumab achieved the primary endpoint of significantly greater clinical remission compared to 8% [22/280] of those receiving placebo.1 At Week 44, 50% [95/190] of patients treated with subcutaneous guselkumab 200 mg and 45% [85/188] of patients with 100 mg achieved significantly greater clinical remission compared to 19% [36/190] in the placebo group.1 Symptomatic improvements were observed as early as Week 1,1 and seven of nine prespecified, multiplicity-controlled major secondary endpoints, including clinical, endoscopic, histologic, symptomatic, and patient-reported outcome measures were met in the induction study, with all nine met in the maintenance study for both dose regimens.1 Across the QUASAR programme, safety results were consistent with the known safety profile of guselkumab in its approved indications.1
Additionally, in the QUASAR phase 3 maintenance study, substantive rates of objective measures of disease remission, including endoscopic and histologic remission, were observed.1 These are linked to complete mucosal healing and improved long-term outcomes for patients who achieve these histologic and endoscopic endpoints.1,2
The efficacy of guselkumab was demonstrated in both biologic and JAK inhibitor-naïve patients and in patients with a history of inadequate response or intolerance to biologics and/or JAK inhibitors.1 In conjunction with the demonstrated safety profile, these data suggest that guselkumab has the potential to be a compelling treatment option for both subpopulations.1 Guselkumab is not currently approved for the treatment of ulcerative colitis.
ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, seamless Phase 2b/3 programme 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).2 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, a Phase 3 randomised withdrawal maintenance study, and a long-term extension study through a total of five years.2 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.2
In the Phase 2b randomized QUASAR Induction Study, 701 adult patients were randomized 1:1:1 to three treatment groups: guselkumab IV 200 mg, guselkumab IV 400 mg or IV placebo at Weeks 0, 1-4, and 1-8.1 In the Phase 3 randomised withdrawal QUASAR Maintenance Study, 568 adult patients who demonstrated a clinical response to guselkumab IV induction in the Phase 2 and Phase 3 induction studies at Week 12 were randomised 1:1:1 to three treatment groups: SC guselkumab 200 mg q4w, guselkumab 100 mg q8w or placebo (guselkumab withdrawal).1 Primary endpoints were clinical remission at Week 12 in the phase 3 induction study and clinical remission at Week 44 in the maintenance study.1 Major secondary endpoints evaluated at Week 12 in the induction study were clinical response, endoscopic improvement, histo-endoscopic mucosal improvement (HEMI), endoscopic remission (normalisation), IBDQ remission, fatigue response, and symptomatic remission (weeks I-2, I-4, I-12).1 Major secondary endpoints evaluated at Week 44 in the maintenance study were corticosteroid-free clinical remission, maintenance of clinical remission, maintenance of clinical response, endoscopic improvement, HEMI, endoscopic remission, IBDQ remission, fatigue response, and symptomatic remission.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.3 It is the result of the immune system’s overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhoea, abdominal pain, loss of appetite, weight loss, and fatigue.4 Ulcerative colitis patients also have increased rates of depression.5
ABOUT TREMFYA® (Guselkumab)
Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting 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 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.8 The clinical significance of this finding is not known.
Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.6 It is also approved in the U.S,9 Canada,10 Japan11 and a number of other countries for the treatment of adults with moderate-to-severe 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.
Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash were uncommon ADRs (≥0.1 percent to <1 percent).6
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab in Pso and PsA: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
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/emea or at https://innovativemedicine.jnj.com/emea/. Follow us on LinkedIn. 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 materialise, 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 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.
Media contact:
Sophie Daneau
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Investor contact:
Lauren Johnson
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CP-494304
December 2024