Beerse,
The submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn's disease.1,2,3,4,5 In the Phase 3 QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms, measures of disease activity including stringent endpoints such as endoscopic normalization and histo-endoscopic mucosal healing, and patient-reported outcomes such as fatigue.1,3,4 The safety results were consistent with the known safety profile of guselkumab in approved indications.3,4,a
In the Phase 3 GALAXI 2 and 3 studies, guselkumab achieved co-primary endpoints at Week 12 and demonstrated statistically significant and clinically meaningful improvements relative to placebo in corticosteroid free clinical remission and endoscopic response at Week 48.2,5 Safety results were consistent with the known safety profile of guselkumab in approved indications.2,5
'People living with chronic, immune-mediated disease such as ulcerative colitis and Crohn's disease often spend a considerable amount of time cycling from one treatment to another in search of relief and sustained remission,' said
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.6 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including ulcerative colitis and Crohn's disease.7 Guselkumab is approved in the
'Inflammatory bowel disease, which includes ulcerative colitis and Crohn's disease, affects as many as four million people in
Clinical data from the Phase 3 QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week Annual Meeting and results from the Phase 3 QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting.3 Clinical data from the long-term extension of the GALAXI Phase 2 study through three years were presented at United European Gastroenterology Week 2023 and results from the Phase 3 studies through 48 weeks will be presented at an upcoming medical meeting.5 In
Editor's Notes:
a. Guselkumab is not approved to treat ulcerative colitis or Crohn's disease.
ABOUT THE QUASAR PROGRAM (EudraCT 2018-004002-25)
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, seamless Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, or tofacitinib).1 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, a Phase 3 randomized withdrawal maintenance study, and a long-term extension study through a total of 5 years.1 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.1
ABOUT THE GALAXI PROGRAM (EudraCT 2017-002195-13)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program 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).2 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).2 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.2
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.8 It is the result of the immune system's overactive response.8 Symptoms vary, but may include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.8
ABOUT CROHN'S DISEASE
Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated four million people across Europe.9 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.10 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. There is currently no cure for Crohn's disease.11
ABOUT TREMFYA (guselkumab)
Developed by
TREMFYA is approved in the
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA (guselkumab)?
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:
o fever, sweats, or chills
o muscle aches
o weight loss
o cough
o warm, red, or painful skin or sores on your body different from your psoriasis
o diarrhea or stomach pain
o shortness of breath
o blood in your phlegm (mucus)
o burning when you urinate or urinating more often than normal
Do not use 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 1-800-FDA-1088.
ABOUT
At
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
1.
2.
3. 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,
4. Peyrin-Biroulet L, et al. Guselkumab in patients with moderately to severely active ulcerative colitis: QUASAR Phase 2b induction study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023
5. Afzali, A, et al. Efficacy and safety of guselkumab for Crohn's disease through 3 years: GALAXI-1 Long-Term extension. Presented at United European Gastroenterology Week 2023,
6. EU SmPC:
7. Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829. Accessed
8. Crohn's &
9. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies.
10. Crohn's &
11. Crohn's &
12.
13. The
14. Japan
Media contact:
+33 6 3178 8798
+1 215-779-9396
Investor contact:
investor-relations@its.jnj.com
(C) 2024 Electronic News Publishing, source