NICE issues final guidance recommending TREMFYA^® (guselkumab) for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in the UK

NICE Final Guidance recommends treatment for use in adult patients with moderately to severely active Crohn’s disease and ulcerative colitis who have previously received conventional or biological treatment , or a Janus kinase (JAK) inhibitor (for ulcerative colitis), that has not worked or cannot be tolerated, and when a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated, or is not suitable.^1,2

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.^1-7

Over 500,000 people in the UK live with inflammatory bowel disease (IBD). Approximately 115,000 have Crohn’s disease and nearly half have moderately to severely active Crohn’s disease. Around 296,000 people have ulcerative colitis and over half have moderately to severely active ulcerative colitis.^8-11

High Wycombe, UK (28 August 2025) – Johnson & Johnson today announced that the National Institute for Health and Care Excellence (NICE) has recommended TREMFYA® (guselkumab) in the Final Guidance for the treatment of adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.^1,2 For Crohn’s disease, guselkumab can be used as an option when a conventional or biological treatment has not worked or cannot be tolerated, and when tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated, or is not suitable.¹ For ulcerative colitis, guselkumab can be used as an option when a conventional or biological treatment, or a Janus kinase (JAK) inhibitor, has not worked or cannot be tolerated, and when a TNF-alpha inhibitor has not worked, cannot be tolerated, or is not suitable.²

NICE’s recommendation is based on multiple Phase 3 trials evaluating the efficacy and safety of guselkumab in Crohn’s disease and ulcerative colitis.^1,2,c In Crohn’s disease, the GALAXI programme showed higher rates of clinical remission and endoscopic response for those on guselkumab compared to placebo at week 12.¹² The GRAVITI study also demonstrated statistically significant clinical remission and endoscopic response for those on guselkumab compared to placebo at week 12.³ In ulcerative colitis, the QUASAR studies demonstrated statistically significant clinical remission at Week 12 and Week 44.¹³

Safety results from the GALAXI, GRAVITI and QUASAR studies were similar to the known safety profile of guselkumab in approved indications.^3,12,13,d

In the UK, the most prevalent forms of IBD are Crohn’s disease and ulcerative colitis, affecting one in every 123 people.^8,a

“Ulcerative colitis and Crohn’s disease can flare at any time and therefore can be challenging to manage. In addition to the significant symptoms relating to gut inflammation, their unpredictability can add greater emotional stress and impact on the daily lives of patients who live with this condition.” said Professor James Lindsay, FRCP PhD BM BCh, Professor of Inflammatory Bowel Disease at Barts and the London School of Medicine and Dentistry, Queen Mary University of London and a Consultant Gastroenterologist at Barts Health NHS Trust.^b “Whilst progress has been made in terms of new treatment strategies, today’s NICE recommendation of guselkumab is an important milestone in broadening the clinical community’s options to manage this challenging condition.”

“Crohn’s and colitis are lifelong conditions affecting more than half a million people in the UK. They tell us all the time how painful and debilitating their symptoms can be, and many will have waited a long time for a diagnosis. There is no cure and existing treatments may not work for some, or may stop working over time,” said Marianne Radcliffe, CEO of Crohn’s & Colitis UK. “People with Inflammatory Bowel Disease don’t want to be stuck in hospital, they want to be out living their lives. Expanding the treatment options for eligible people living with Crohn’s and colitis can only be a good thing.”

“We welcome NICE’s recommendation, which we believe represents meaningful progress for people affected by chronic conditions like Crohn’s disease and ulcerative colitis, reflecting the importance of continued innovation and collaboration to address unmet needs in inflammatory bowel disease,” said Amanda Cunnington, Senior Director of Patient Access, Johnson & Johnson Innovative Medicine UK. “It is vital that eligible patients have access to treatment options that can offer greater flexibility and the potential to enhance their quality of life. We remain committed to supporting the IBD community and continuing to work with stakeholders to ensure equitable access to new treatment options.”

This Final Guidance follows the Medicines and Healthcare products Regulatory Agency’s (MHRA) marketing authorisation of guselkumab for moderately to severely active Crohn’s disease and ulcerative colitis in May this year. MHRA marketing authorisation for guselkumab subcutaneous induction for moderately to severely active ulcerative colitis was received on 19 August 2025, based on data from the Phase 3 ASTRO trial.

#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 30.¹⁵ Ulcerative colitis primarily affects the colon and rectum, and is most commonly diagnosed between ages 15 and 25.⁹
b) Professor James Lindsay is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
c) 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.^3-7 This is based on in-vitro studies in an inflammatory monocyte model. The clinical significance of these findings is unknown.
d) Safety results of:

• The GALAXI programme:¹² Through 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:³ 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:¹³ 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 and 6 percent and 3 percent for guselkumab 200mg.
  

ABOUT THE GALAXI PROGRAMME (EudraCT 2017-002195-13)^12,16
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)^3,17
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)¹³
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.¹⁸ Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.¹⁹

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.²⁰ 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.²⁰ People with ulcerative colitis also have increased rates of depression.¹⁹

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.^3,4 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.²²

The indication for both Crohn’s disease and ulcerative colitis allows patients to receive guselkumab through subcutaneous injection for induction and maintenance dosing.⁵

Guselkumab is approved in the EU and UK for the treatment of moderately to severely active 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.⁵

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/.

Follow us at https://www.linkedin.com/company/jnjinnovativemedicineuk/ and www.x.com/JNJInnovMedUK

©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.