Shots:
- Jennifer talked about the results from QUASAR Induction Study-I evaluating Tremfya in adults with moderately to severely active ulcerative colitis presented at the 2022 American College of Gastroenterology Annual Meeting
- He also gave an overview of Trefmya focusing on major advances. He also spoke about the epidemiology and etiology of Ulcerative Colitis
- The interview shows how Janssen Pharmaceutical is working to advance its lead product Tremfya boosting its Immunology portfolio
Smriti: Can you tell us more about the outcomes obtained from the QUASAR Induction Study 1?
Jennifer Davidson: The new data from the Phase 2b QUASAR Induction Study 1 in adults with moderately to severely active ulcerative colitis (UC) with inadequate responses to previous treatments showed an overall clinical response rate of approximately 80 percent in patients who were randomized to TREMFYA® (guselkumab). Clinical response at weeks 12 or 24 of the study was ultimately achieved by 80.2 percent of patients who were randomized to intravenous (IV) TREMFYA 200 mg arm and by 78.5 percent of patients who were randomized to IV TREMFYA 400 mg arm. A mean of 52.1 percent of patients randomized to IV TREMFYA who did not achieve clinical response at week 12 and continued treatment with subcutaneous (SC) TREMFYA, achieved clinical response at week 24.
For reference, these data are in follow-up to the 12-week data of patient outcomes from the Phase 2b QUASAR Induction Study 1 Janssen previously announced at the 17th Congress of the European Crohn’s and Colitis Organization on February 18, 2022.
Smriti: Throw some light on the epidemiology and etiology of Ulcerative Colitis.
Jennifer Davidson: Ulcerative colitis is a chronic disease of the large intestine, also known as the colon, that affects the lining of the colon and causes inflammation that can lead to ulceration or ulcers of the colon. Those ulcers produce pus and mucus, which cause abdominal pain and the need to frequently empty your colon.
Ulcerative colitis is the result of several factors that are not yet well understood but it’s thought to be an abnormal immune response, genetics, microbiome and environmental factors that all contribute to ulcerative colitis.
Ulcerative colitis symptoms include but are not limited to loose and more urgent bowel movements, bloody stool, abdominal pain and cramps, loss of appetite, weight loss, persistent diarrhea and fatigue.
Smriti: Tell in brief about Tremfya, its MOA, and other formulation details.
Jennifer Davidson: Developed by Janssen, TREMFYA (guselkumab) 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.
TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque psoriasis (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 psoriatic arthritis (PsA).
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.
Smriti: What are the other existing therapies or tech under development in the pipeline for the diagnosis of ulcerative colitis?
Jennifer Davidson: Across Janssen’s Immunology portfolio, we focus where the impact of disease on patients is highest and gaps in treatment remain greatest. We have an active and growing Immunology R&D program with 21 first-in-class programs in Phase 2 or 3 and are leveraging our pathways-based strategy to expand our pipeline. The data presented at ACG can help patients and healthcare providers make more informed treatment decisions, ultimately helping to reduce the daily burden of chronic diseases, like inflammatory bowel disease. Janssen remains deeply committed to the patients and their loved ones impacted by immune-mediated diseases.
Smriti: What you do think are the major advances associated with the approval of Tremfya?
Jennifer Davidson: With a life-long progressive condition like ulcerative colitis, it’s critical to investigate potential new treatment options and mechanisms of action, with the understanding that remission, and helping more patients feel well, is the goal.
The data presented at ACG further underscore our continued commitment to investigating pathway science in the development of additional therapies that can potentially address the multifaceted nature of immune-mediated diseases like ulcerative colitis and encourage the potential approval of TREMFYA in ulcerative colitis.
Smriti: Are you looking for any future collaboration for the further development of the TREMFYA?
Jennifer Davidson: A Phase 3 clinical trial evaluating TREMFYA for the treatment of moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis is ongoing and enrolling participants. You can learn more about the trial and future plans at globaltrialfinder.janssen.com/. We will share more as it becomes available.
Image Source: Canva
About the Author:
Jennifer Davidson is the Vice President, Medical Affairs at Janssen Immunology. She leads the Immunology medical and scientific roadmap and clinical differentiation strategy team in the U.S. Jennifer also serves on the Immunology Leadership Team. Jennifer has over 18 years of in-depth experience working across global medical affairs, research & development, and commercial, and business development within many therapeutic areas, including, cardiovascular, metabolics, pain, gastroenterology, women’s health, pediatrics, and orphan drugs. Jennifer earned her Doctor of Osteopathic Medicine from the University of Health Sciences, College of Osteopathic Medicine, and her Bachelor of Science in biology at Oklahoma State University.
