TREMFYA® (guselkumab) demonstrates robust results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis

Beerse, Belgium (October 10, 2024) – Johnson & Johnson today announced TREMFYA® (guselkumab) data in both Crohn’s disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa.^1,2 These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of guselkumab in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of guselkumab in adults with moderately to severely active UC.^1,2 These findings are among the 19 Johnson & Johnson abstracts presented at the United European Gastroenterology Week (UEGW) 2024, taking place in Vienna, from 12 to 15 October 2024. Guselkumab is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA).

“These results show the potential of guselkumab to offer a differentiated treatment option for patients with CD and UC, including those starting on a biologic for the first time and those who have failed prior biologics and traditionally have been less likely to respond to other therapies,” stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Guselkumab builds upon our nearly three decades of leadership in IBD therapy and focused innovation in the IL-23 pathway to address the needs of people living with ulcerative colitis and delivering meaningful improvements in symptoms and the potential for sustained remission.”

Endoscopic remission in biologic-naïve patients
In the pooled Phase 3 GALAXI 2 & 3 dataset, guselkumab demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-naïve patients with CD. Endoscopic remission was achieved in 44% of patients treated with guselkumab 100 mg every eight weeks (q8w) subcutaneous (SC) injection and 46.1% of patients treated with guselkumab 200 mg every four weeks (q4w) SC injection, versus 29.8% of patients treated with ustekinumab.¹

In the Phase 3 QUASAR study, guselkumab demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-naïve patients with UC. Endoscopic remission was achieved in 38.1% of patients treated with guselkumab 100 mg q8w SC injection and 41.7% of patients treated with guselkumab 200 mg q4w SC injection, versus 20.4% of patients treated with placebo.²

Endoscopic remission in patients with a history of inadequate response or intolerance to biologics/JAK inhibitors
In the pooled Phase 3 GALAXI 2 & 3 dataset, guselkumab demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-refractory patients with CD. Endoscopic remission was achieved in 28.1% of patients treated with guselkumab 100 mg q8w SC injection and 28.6% of patients treated with guselkumab 200 mg q4w SC injection, versus 20.5% of patients treated with ustekinumab.¹

In the Phase 3 QUASAR study, guselkumab demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-refractory patients with UC. Endoscopic remission was achieved in 31.2% of patients treated with guselkumab 100 mg q8w SC injection and 23.9% of patients treated with guselkumab 200 mg q4w SC injection, versus 8% of patients treated with placebo.²

“Achieving endoscopic remission is increasingly recognised as a pivotal marker in predicting improved long-term outcomes for patients living with CD and UC. These compelling results emphasise the efficacy of guselkumab, demonstrating its potential as a robust therapeutic option to reach this critical milestone, irrespective of previous biologic therapy exposure,” stated Ludovic de Beaucoudrey, PhD, Senior Director, Therapeutic Area Lead, Immunology, Janssen-Cilag Limited, a company of Johnson & Johnson. “This shift towards prioritising endoscopic outcomes underscores the broader movement in clinical research to align treatment goals with the tangible, long-term benefits that matter most to patients.”

Adverse events for these subpopulations were consistent with the overall populations, and no new safety concerns were identified.²

For a full list of abstracts presented please click here.

Johnson & Johnson also submitted a regulatory application seeking the approval of guselkumab for the treatment of adults with moderately to severely active UC in Europe and for the treatment of adults with moderately to severely active CD in countries or regions including the United States and Europe. Guselkumab received U.S. Food and Drug Administration (FDA) approval in September 2024 for the treatment of adults with moderately to severely active UC.

ABOUT THE GALAXI PROGRAM (NCT03466411, EudraCT 2017-002195-13)
GALAXI is a randomised, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicentre Phase 2/3 programme designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab).³ GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).³ Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.³ Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo.³ Participants randomised to placebo were able to receive ustekinumab if clinical response was not met at Week 12.³ Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (41.8 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance.¹

ABOUT THE QUASAR STUDY (NCT04033445, EudraCT 2018-004002-25)
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, Phase 2b/3 programme designed to evaluate the efficacy and safety of guselkumab in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib).⁴ QUASAR included a Phase 2b dose- ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study.⁴ In the induction study, patients received either guselkumab 200 mg or placebo by intravenous infusion at Week 0, Week 4, and Week 8.⁴ In the maintenance study, patients received a subcutaneous maintenance regimen of either TREMFYA 100 mg every 8 weeks, guselkumab 200 mg every 4 weeks, or placebo.⁴ Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.⁴ Of the 568 individuals included in the QUASAR maintenance study, 240 (42.3 percent) had a history of inadequate response or intolerance to biologics or JAK inhibitors, 309 (54.4 percent) were biologic/JAK inhibitor naïve, and 19 (3.3 percent) were biologic/JAK inhibitor experienced without documented inadequate response or intolerance.²

ABOUT CROHN’S DISEASE
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated an estimated two million people across Europe.^5,6 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.⁷ Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.⁷

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.⁸ 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.⁸

ABOUT GUSELKUMAB
Developed by Johnson & Johnson, 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.⁹ IL-23 is an important driver of the pathogenesis of inflammatory diseases.¹⁰

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.⁹ It is also approved in the U.S,¹¹ Canada,¹² Japan¹³ 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).⁹

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://innovativemedicine.jnj.com/emea/ or at https://innovativemedicine.jnj.com/. Follow us at J&J Innovative Medicine Europe, Middle East & Africa (EMEA). Janssen-Cilag International NV, 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., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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