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      First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis

      Late-breaking data from the Phase 3 QUASAR Induction Study show statistically significant and clinically meaningful improvements among ulcerative colitis patients, including bio-naïve patients and those who have experienced treatment failure with advanced therapies

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      SPRING HOUSE, PENNSYLVANIA, May 9, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new efficacy and safety data from the Phase 3 QUASAR Induction Study evaluating the investigational use of TREMFYA® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC)a who had an inadequate response or intolerance to conventionalb and/or advanced therapies.1,c The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures.1 Safety data were also consistent with the known safety profile of TREMFYA in approved indications.1 These data, which were accepted as a late-breaking oral presentation to the Digestive Disease Week® (DDW) Annual Meeting, comprise one of Janssen’s 17 oral and poster presentations at the conference taking place in Chicago, Illinois, May 6-9, 2023.

      “Many people living with ulcerative colitis, especially those who have had inadequate response to other treatments, live with uncertainty and continue to experience debilitating symptoms,” said study author Jessica R. Allegretti, M.D., M.P.H., Medical Director, Crohn’s and Colitis Center at the Brigham and Women’s Hospital, Boston, MA, USA.d “These Phase 3 data represent an important step in the advancement of a new treatment for moderately to severely active ulcerative colitis, as researchers continue to investigate therapeutic options that have the potential to provide relief for individuals at all stages of disease.”

      QUASAR Phase 3 Induction Study Outcomes (Abstract #913b):1
      Among 701 patientse randomized 3:2 to receive intravenous (IV) TREMFYA 200 mg or placebo at Weeks 0, 4, and 8, and observed through Week 12, results demonstrate:

      • A significantly greater proportion of patients treated with TREMFYA compared with placebo (22.6 percent versus 7.9 percent, p<0.001, ∆f=14.9 percent) achieved clinical remissiong at Week 12, the study’s primary endpoint1
      • At Week 4, 22.6 percent of patients receiving TREMFYA achieved symptomatic remissionh versus 12.9 percent placebo (p<0.001, ∆=9.9 percent). At Week 12, 49.9 percent of patients achieved symptomatic remission versus 20.7 percent placebo (p<0.001, ∆=29.4 percent)1
      • Compared to placebo, a greater proportion of TREMFYA-treated patients at Week 12 achieved:
        • Clinical responsei (61.5 percent versus 27.9 percent placebo [p<0.001, ∆=33.8 percent])1
        • Endoscopic improvementj (26.8 percent versus 11.1 percent placebo [p<0.001, ∆=16.0 percent])1
        • Histo-endoscopic mucosal improvementk (23.5 percent versus 7.5 percent placebo [p<0.001, ∆=16.2 percent])1
        • Endoscopic normalizationl (15.0 percent versus 5.0 percent placebo [nominal p<0.001, ∆=10.1 percent])1
      • Frequencies of treatment-emergent adverse events (AEs) in TREMFYA-treated patients were generally comparable to placebo1
      • There were numerically fewer serious AEs (2.9 percent TREMFYA versus 7.1 percent placebo) and AEs leading to discontinuation (1.7 percent TREMFYA versus 3.9 percent placebo) in TREMFYA-treated patients compared with placebo1
      • Overall, safety results through Week 12 were consistent with the known safety profile of TREMFYA in approved indications1

      “Results from the QUASAR study offer insights into the potential utility of TREMFYA for people living with this lifelong chronic condition and reinforce the known safety profile of TREMFYA observed in approved indications,” said Kavitha Goyal, M.D., Head of Global Medical Affairs, Gastroenterology, Janssen Global Services, LLC. “Janssen continues to investigate IL-23 pathway science with TREMFYA for treatment of complex immune-mediated diseases like ulcerative colitis, so that healthcare providers can have a range of treatment options that best fit patients’ needs and can bring them closer to the goal of remission.”

      Further research is currently being conducted on TREMFYA for the treatment of patients with inflammatory bowel disease, which includes ongoing Phase 3 trials in Crohn’s disease (NCT03466411, NCT05197049) and UC (NCT04033445, NCT05528510).2,3,4,5

      TREMFYA is not approved for the treatment of adults living with UC in the U.S.

      Editor’s Notes:

      a. Defined as a baseline modified Mayo score of 5 to 9, inclusive of a rectal bleeding subscore ≥1 and an endoscopy subscore ≥2 evaluated during central review of video endoscopy1

      b. i.e., thiopurines or corticosteroids1

      c. i.e., tumor necrosis factor alpha antagonists, vedolizumab or tofacitinib1

      d. Dr. Allegretti is a paid consultant for Janssen. Dr. Allegretti has not been compensated for any media work.

      e. Mean age, 40.5 years; female, 43.1 percent; mean UC duration, 7.5 years; mean modified Mayo score, 6.9; Mayo endoscopy subscore of 3 indicating severe disease, 67.9 percent; median fecal calprotectin, 1641.0mg/kg; median C-reactive protein, 4.2mg/L; baseline oral corticosteroid use, 43.1 percent. Baseline demographic and disease characteristics were balanced across the two treatment groups. While half of the patients were receiving a biologic for the first time, approximately 50 percent of patients had a prior failure to advanced therapies for UC, and nearly half (47.4 percent) of these patients failed two or more advanced therapy classes, reflecting highly refractory disease.1

      f. Adjusted treatment difference based on Wald statistic with Cochran-Mantel-Haenszel weight1

      g. Clinical remission: A Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy1

      h. Symptomatic remission: A stool frequency subscore of 0 or 1 and not increased from baseline and a rectal bleeding subscore of 01

      i. Clinical response: A decrease from baseline in the modified Mayo score by ≥30 percent and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 11

      j. Endoscopic improvement: An endoscopy subscore of 0 or 1 with no friability present on the endoscopy1

      k. Histo-endoscopic mucosal improvement: Achieving a combination of histologic improvement (neutrophil infiltration in <5 percent of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system, i.e., Geboes score ≤3.1) and endoscopic improvement (endoscopy subscore of 0 or 1, with no friability present on the endoscopy) 1

      l. Endoscopic normalization: An endoscopy subscore of 01

      About Digestive Disease Week® (DDW)
      Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

      About the QUASAR Study (NCT04033445)
      The QUASAR study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study evaluates long-term TREMFYA treatment. Efficacy, safety, pharmacokinetics, immunogenicity and biomarkers are assessed at specified time points.3 The QUASAR Phase 3 Induction Study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of TREMFYA, an interleukin-23 p19 subunit antagonist, as induction therapy in patients with moderately to severely active UC who had an inadequate response or intolerance to conventional (i.e., thiopurines or corticosteroids) and/or advanced therapies (i.e., tumor necrosis factor-alpha antagonists, vedolizumab or tofacitinib).1

      About Inflammatory Bowel Disease
      Inflammatory Bowel Disease (IBD) is an umbrella term for two conditions – Crohn’s disease (CD) and ulcerative colitis (UC) – that cause chronic inflammation of the gastrointestinal (GI) tract.6 Prolonged inflammation results in damage to the GI tract.6 The exact cause of IBD is unknown but may be the result of the immune system’s response to environmental triggers or genetic predisposition.6 Symptoms may vary but may include persistent diarrhea, abdominal pain, rectal bleeding, bloody stool, weight loss and fatigue.6

      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.7 It is the result of the immune system’s overactive response.7 Symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhea, abdominal pain, bloody stool, loss of appetite, weight loss and fatigue.8

      About TREMFYA® (guselkumab)
      Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.9 IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).9 TREMFYA is approved in the U.S., Canada, Japan and a number of other countries for the treatment of adults with moderate to severe plaque 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.9 It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.9

      The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.

      IMPORTANT SAFETY INFORMATION7

      What is the most important information I should know about TREMFYA®?

      TREMFYA® is a prescription medicine that may cause serious side effects, including:

      • Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
        • fainting, dizziness, feeling lightheaded (low blood pressure)
        • swelling of your face, eyelids, lips, mouth, tongue or throat
        • trouble breathing or throat tightness
        • chest tightness
        • skin rash, hives
        • itching
      • Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.

      Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

      • fever, sweats, or chills
      • muscle aches
      • weight loss
      • cough
      • warm, red, or painful skin or sores on your body different from your psoriasis
      • diarrhea or stomach pain
      • shortness of breath
      • blood in your phlegm (mucus)
      • burning when you urinate or urinating more often than normal

      Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

      Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:

      • have any of the conditions or symptoms listed in the section “What is the most important information I should know about TREMFYA®?”
      • have an infection that does not go away or that keeps coming back.
      • have TB or have been in close contact with someone with TB.
      • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®.
      • are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
      • are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.

      Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

      What are the possible side effects of TREMFYA®?

      TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”

      The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.

      These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.

      Use TREMFYA® exactly as your healthcare provider tells you to use it.

      Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.

      You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088.

      About the Janssen Pharmaceutical Companies of Johnson & Johnson
      At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

      Learn more at www.janssen.com.

      Follow us at www.twitter.com/JanssenGlobal.

      Janssen Research & Development, LLC is a part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

      Cautions Concerning Forward-Looking Statements
      This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of TREMFYA® (guselkumab). 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, any of the other Janssen Pharmaceutical Companies, 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 January 1, 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 the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

      # # #

      References

      1. Allegretti, J, et al. The Efficacy and Safety of Guselkumab Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: Results from the Phase 3 QUASAR Induction Study. Presented at Digestive Disease Week, May 6-9.

      2. National Institutes of Health: 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/ct2/show/NCT03466411. Accessed May 2023.

      3. National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Subcutaneous Therapy in Participants with Moderately to Severely Active Crohn’s Disease (GRAVITI). Identifier: NCT05197049. Available at https://clinicaltrials.gov/ct2/show/NCT05197049. Accessed May 2023.

      4. National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. Available at: https://clinicaltrials.gov/ct2/show/NCT04033445. Accessed May 2023.

      5. National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. Available at https://clinicaltrials.gov/ct2/show/NCT05528510. Accessed May 2023.

      6. Centers for Disease Control and Prevention. What is Inflammatory Bowel Disease (IBD)? Available at: https://www.cdc.gov/ibd/what-is-ibd.htm. Accessed May 2023.

      7. Crohn’s & Colitis Foundation of America. The Facts About Inflammatory Bowel Diseases. Available at https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed May 2023.

      8. Crohn’s & Colitis Foundation. What is Ulcerative Colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed May 2023.

      TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed May 2023.

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      Email: cstoltz@its.jnj.com

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