SMC accepts TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis for use within NHS Scotland

Following the Scottish Medicines Consortium’s (SMC) acceptance today and National Institute for Health and Care Excellence’s (NICE) recommendation in August 2025, guselkumab is now accessible through the NHS for eligible patients across Scotland, England, and Wales.^1,2,3,4

Guselkumab is the first IL-23 inhibitor that could offer a fully subcutaneous induction and maintenance regimen in Crohn’s disease and ulcerative colitis recommended for use in the NHS, allowing for the treatment to be taken at home or hospital, depending on clinical suitability.^3-9

Over 50,000 people in Scotland live with inflammatory bowel disease (IBD), the highest proportion of the population anywhere in the UK.¹⁰

High Wycombe, UK (11 November 2025) – Johnson & Johnson has announced that the Scottish Medicines Consortium (SMC) has accepted TREMFYA^® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.^1,2 Guselkumab can be used as an option for Crohn’s disease for those who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.¹ Guselkumab can be used for ulcerative colitis as an option for those who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.²

This acceptance is based on multiple Phase 3 trials which evaluated the efficacy and safety of guselkumab in Crohn’s disease and ulcerative colitis.^1,2,b For Crohn’s disease, both the GALAXI and GRAVITI studies found that patients treated with guselkumab demonstrated statistically significant higher rates of clinical remission and endoscopic response compared to placebo at week 12.^5,11 In ulcerative colitis, the QUASAR studies reported statistically significant improvements in clinical remission for guselkumab recipients verus placebo, at both week 12 (induction) and week 44 (maintenance, QUASAR only).¹² The safety results from the GALAXI, GRAVITI and QUASAR studies proved similar to the known safety profile of guselkumab in approved indications ^5,11,12,c

The most prevalent forms of IBD are Crohn’s disease and ulcerative colitis. In Scotland, these conditions affect one in every 103 people, with the capital, Edinburgh, exhibiting some of the highest known rates of IBD in the world. In Lothian, Edinburgh’s region, the prevalence of people living with either ulcerative colitis or Crohn’s disease is one in 125. This is predicted to rise to one in 98 by 2028.^10,13,14,a

“The SMC’s acceptance represents an important step forward for people living with Crohn’s disease and ulcerative colitis in Scotland, ensuring that eligible patients in Scotland can benefit from therapies that offer flexibility and have the potential to improve quality of life,” said Amanda Cunnington, Senior Director of Patient Access, Johnson & Johnson Innovative Medicine UK. “We are committed to ensuring health equity and access across the UK by advocating for the unmet needs of all people living with IBD, ensuring that our innovation and collaborations provide further options for those who are living with these lifelong chronic conditions.”

The SMC’s acceptance follows the August publication of Final Guidance from the National Institute for Health and Care Excellence (NICE) recommending the use of the treatment for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.^3,4 In May this year, the Medicines and Healthcare products Regulatory Agency’s (MHRA) issued the marketing authorisation of guselkumab for moderately to severely active Crohn’s disease and ulcerative colitis.¹⁵ MHRA marketing authorisation for guselkumab subcutaneous induction for moderately to severely active ulcerative colitis was received in August 2025, based on data from the Phase 3 ASTRO trial.¹⁸

#ENDS#

Editor’s Notes:
a) Crohn’s disease can occur anywhere in the digestive tract, most often in the small intestine and colon, and is usually diagnosed before age 30.¹⁶ Ulcerative colitis primarily affects the colon and rectum and is most commonly diagnosed between ages 15 and 25.¹⁷

b) Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that works by blocking IL-23, a cytokine that is known to be a driver of Crohn’s disease and ulcerative colitis, and binding to CD64, a receptor on cells that produces IL-23.^5-9 This is based on in-vitro studies in an inflammatory monocyte model. The clinical significance of these findings is unknown.

c) Safety results of:

• The GALAXI programme: ¹¹Through Week 48, the number of patients with ≥1 serious adverse events (AEs), and AEs leading to discontinuation were similar across patients who received guselkumab, placebo, or ustekinumab. The proportion of patients with serious infections were low; 0.3 percent for guselkumab 100mg SC q8w and 1.0 percent for guselkumab 200 mg SC q4w.
• The GRAVITI programme:⁵ Through Week 48, the number of patients with ≥1 AE on placebo, guselkumab 100mg SC q8w and guselkumab 200mg SC q4w was 65.8 percent, 82.6 percent and 80 percent, respectively. The proportions of patients with serious infections were low; 1.7 percent for guselkumab 100 mg SC q8w and 0.9 percent for guselkumab 200mg SC q4w.
• The QUASAR programme:¹² The proportion of patients in the maintenance study with ≥1 AE was similar across treatment groups: guselkumab 100mg q8w, 65 percent; guselkumab 200mg q4w, 70 percent; placebo, 68 percent. The proportion of patients with serious AEs and AEs leading to discontinuation were low; 3 percent and 4 percent for guselkumab 100mg q8w subcutaneously and 6 percent and 3 percent for guselkumab 200mg q4w subcutaneously.

ABOUT THE ASTRO PROGRAMME (EudraCT 2023-504719-34)^18,19
ASTRO is a randomized, double-blind, placebo-controlled, parallel group, multicenter, treat-through Phase 3 study designed to evaluate the efficacy and safety of guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors.^18,19
Patients (n = 418) were randomized 1:1:1 to receive guselkumab 400 mg SC induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg SC every 4 weeks (q4w); or guselkumab 400 mg SC induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg SC every 8 weeks (q8w); or placebo. 19 The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.^19,20

ABOUT THE GALAXI PROGRAMME (EudraCT 2017-002195-13)^11,21
GALAXI is a treat-through, 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 (immunomodulators, corticosteroids) and/or biologics (TNF antagonists, vedolizumab). GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3, n=1021). 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 that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of approximately five years.

ABOUT THE GRAVITI Phase 3 study (EudraCT 2020-006165-11)^5,22
GRAVITI is a treat-through, double-blind, placebo-controlled, parallel group, multicentre study to evaluate the efficacy and safety of guselkumab subcutaneous induction therapy in participants with moderately to severely active Crohn’s disease with inadequate response or failure to tolerate previous conventional therapy (corticosteroids or immunomodulators) or biologic therapy (infliximab, adalimumab, certolizumab pegol, vedolizumab). The study has a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of approximately five years.

ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)¹²
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, Phase 2b/3 program 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). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study. In the Phase 3 induction study, patients received either guselkumab 200 mg or placebo by intravenous infusion at Week 0, Week 4, and Week 8. In the Phase 3 maintenance study, patients received a subcutaneous maintenance regimen of either guselkumab 100 mg every 8 weeks, guselkumab 200 mg every 4 weeks, or placebo for 44 weeks.

ABOUT CROHN’S DISEASE
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.²³ Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.²⁴

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.²⁵ It is the result of the immune system’s overactive response.²⁵ 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.²⁵ People with ulcerative colitis also have increased rates of depression.²⁶

ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is a fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.^5,6 Based on in vitro studies in an inflammatory monocyte model. The clinical significance of these findings is unknown.²⁷

The indication for both Crohn’s disease and ulcerative colitis allows patients to receive guselkumab through subcutaneous injection for induction and maintenance dosing.^1,2,7

Guselkumab is approved in the EU and UK 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), alone or in combination with methotrexate, in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.⁷

IMPORTANT SAFETY INFORMATION
For a full list of side effects and information on dosage and administration, contraindications, special warnings and precautions when using guselkumab, please refer to the Summary of Product Characteristics for further information.

Report an Adverse Event. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ . By reporting side effects, you can help provide more information on the safety of this medicine.

Janssen-Cilag International NV, the marketing authorisation holder for guselkumab in the EU, Janssen-Cilag Limited and Janssen-Cilag GmbH, are a Johnson & Johnson company.

The marketing authorisation holder for guselkumab in the UK is:
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK

Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.

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/uk/.

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©Janssen-Cilag Limited, a Johnson & Johnson Company. All rights reserved.

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 behaviour 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, 2024, 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.