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      EMEA/Newsroom/Immunology/New post-hoc analysis pooling two clinical trials demonstrates endoscopic response as a predictor of positive long-term patient outcomes in Crohn’s disease, including clinical remission and improved quality of life
      Immunology

      New post-hoc analysis pooling two clinical trials demonstrates endoscopic response as a predictor of positive long-term patient outcomes in Crohn’s disease, including clinical remission and improved quality of life

      Pooled data for guselkumab and ustekinumab in moderate-to severe Crohn’s disease demonstrated a higher percentage of patients with endoscopic response at year 1 achieved long-term response and remission at year 2 vs patients with no endoscopic response.1

      October 10, 2024
      5 min read

      Beerse, Belgium (10 October, 2024) – Johnson & Johnson today announced the results of a new post-hoc analysis of data from 461 patients from the GALAXI-1 and IM-UNITI randomised clinical trials evaluating the impact of endoscopic response at year 1 on long-term patient outcomes including clinical response, clinical remission, and quality of life in moderate-to-severe Crohn’s disease.1 Results demonstrated a higher percentage of patients with endoscopic response at year 1 achieved long-term 2-year clinical response, clinical remission, or Inflammatory Bowel Disease Questionnaire (IBDQ) remission compared with those without endoscopic response at year 1.1 In addition, endoscopic response at the end of maintenance, was also associated with lower odds of long- term extension C-reactive Protein abnormality, a marker for inflammation and disease activity.1 Lastly, patients with endoscopic response experienced numerically fewer hospitalisations and surgeries than those without endoscopic response.1

      This data will be presented in the science lounge in a moderated oral poster presentation (MP153) session and was selected as one of the best among the abstracts accepted for poster presentation. It is among the 19 abstracts that the company is presenting at the 2024 United European Gastroenterology (UEG) Week, taking place 12-15 October in Vienna. These results demonstrate Johnson & Johnson’s continued commitment to enhancing patient care standards and the ambition to advance therapy from symptomatic remission to disease modification.

      In 2021, the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) programme, by the International Organization for the Study of IBD (IOIBD), issued updated guidelines to include endoscopic healing as a long-term treatment target.2 With endoscopic and mucosal healinga becoming increasingly recognised as significant markers in predicting improved long-term outcomes for patients,3 the availability of long-term clinical trial data is also a vital component in demonstrating that this treatment goal is achieveable.

      Editor’s Notes
      a. There is a present lack of a standardised and validated definition of endoscopic healing. The updated STRIDE-II guidelines recommend targeting MH as defined by SES-CD ≤ 3 points or the absence of ulcerations in CD, and MES= 0 or UCEIS ≤ 1 in UC.2

      ABOUT THE IM-UNITI PROGRAMME4,5 (EudraCT: 2010-022760-12, NCT01369355)
      IM-UNITI, a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of STELARA maintenance therapy in adult patients with moderate to severe Crohn’s disease.4,5 Patients who had responded to a single intravenous dose of ustekinumab in the UNITI-1 or UNITI-2 induction studies were randomised equally to receive maintenance subcutaneous ustekinumab 90 mg q8w or q12w, or placebo.4,5 There were 1,281 patients enrolled in the maintenance study.6 In randomised patients who met loss of response criteria between weeks 8–32, a one-time dose adjustment to 90 mg q8w occurred. 4,5 All patients completing week 44 were eligible to enter the long-term extension programme, continuing their current regimen up to week 252.5

      ABOUT THE GALAXI PROGRAMME7,8 (EudraCT 2017-002195-13, NCT03466411)
      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 (immunomodulators, corticosteroids) and/or biologics (TNF antagonists, vedolizumab).7,8 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).7,8 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. 7,8

      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 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
      [email protected]
      +33 6 3178 8798

      Investor contact:
      Lauren Johnson
      [email protected]

      CP-480871
      October 2024

      1 Neff-Baro, S., Gauthier, A., Sanon, M. et al. Oral poster presentation. MP153. Endoscopic response at 1-year and association with long-term Crohn’s disease outcome: A pooled clinical trial analysis adjusting for 1-year clinical remission status. Presented at UEGW 2024, October 12-15.
      2 Turner, D., Ricciuto, A., Lewis, A., D’amico, F., Dhaliwal, J., Griffiths, A. M., ... & Dignass, A. (2021). STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology, 160(5), 1570-1583. https://pubmed.ncbi.nlm.nih.gov/33359090/
      3 Neurath, M. F., & Travis, S. P. (2012). Mucosal healing in inflammatory bowel diseases: a systematic review. Gut, 61(11), 1619-1635. https://pubmed.ncbi.nlm.nih.gov/22842618/
      4 EU Clinical Trials Register. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease. Identifier: EudraCT 2010-022760-12. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022760-12/results. Accessed September 2024.
      5 Clincialtrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease (IMUNITI). Identifier: NCT01369355 Available at: https://clinicaltrials.gov/ct2/show/NCT01369355. Accessed September 14, 2020.
      6 Sandborn, W, et al., Efficacy and Safety of Ustekinumab for Crohn’s Disease Through 5 Years: Final Results from the IM-UNITI Long-term Extension (Abstract OP110). Presented at the UEGW Virtual 2020 Congress October 11—13.
      7 EU Clinical Trials Register. 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: EudraCT 2017-002195-13. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002195-13. Accessed May 2024.
      8 Clinicaltrials.gov. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411?term=galaxi&rank=1. Accessed September 2024.