Aiming to break through IBD therapeutic ceiling | Takeda Stories
Aiming to break through IBD ‘therapeutic ceiling’
Takeda has a comprehensive range of studies under way to address the challenges of a disease that’s becoming more prevalent globally.
“Amazing progress has been made in the treatment of inflammatory bowel disease. But we need to do more, much more. Patients need us to continue to explore the potential of new therapeutic options for them.”
That frank assessment comes from Marcelo Freire, M.D., our vice president of Global Medical Affairs for Gastroenterology. He has spent more than a decade helping transform the lives of people with Crohn’s disease and ulcerative colitis, the two related but distinct conditions that are collectively known as IBD. But he acknowledges that we have now come up against what he calls a "therapeutic ceiling.”
New approaches are needed for this chronic, progressive disease, he says. New strategies, new medical interventions, new treatment models. “There is still a lot of unmet medical need in IBD,” Dr. Freire explains. "Our battle against the disease must be intensified, so that we can achieve the next meaningful breakthroughs.”
While the severity and scope of IBD, as well as treatment response, can vary significantly among patients, many of the estimated 6.8 million people living with IBD globally have experienced enhanced quality of life through advances in treatment and care. But remission rates in ulcerative colitis, for example, have stagnated – only 20-30% of patients achieve remission1 and too many people still require surgery as their disease progresses, despite the new pharmaceutical options.2
IBD patients themselves articulate their fears, uncertainties and unmet needs in this respect. A 2022 qualitative study in the Journal of Crohn’s and Colitis found through focus groups and expert panel discussions that patients expressed concerns about surgery, long-term clinical remission and quality of life, as well as a need for psychological support and improved communication.3
“Takeda is not afraid to move out of its comfort zone and embrace new ideas and new technologies to try to address what remain clear challenges and unmet needs relating to IBD.”
Dr Jean-Frederic Colombel, director IBD Center at the Icahn School of Medicine, Mount Sinai, New York
The global prevalence of IBD is also rising due to societal, environmental and lifestyle changes.4,5 This is putting a strain on healthcare budgets amid shifting patient expectations for treatment affordability and outcomes.
Takeda’s experience, 35-years of leadership in IBD, as well as our 240-year history of innovating for patients puts us in a strong position to address these challenges.
Dr. Freire explains: “We have studies aimed at exploring the all-too-common ‘cycling’ of traditional therapies – where patients are given a succession of medicines, to determine what treatment plan works best for their situation. How can we disrupt that cycling? The point here is that timely intervention with the right therapy, early in the treatment plan is most likely to result in better outcomes.”
“We also want to increase the effectiveness of drug interventions and provide new options,” he adds. “So we have initiated a number of combination therapy studies involving a range of different medicines – ours and those of other companies. The idea is to hit the disease hard by exploring the potential of combination therapy at the initiation of treatment management. We can then tailor maintenance treatment according to how a patient responds and their on-going treatment needs.”
We have further studies under way (see chart) to track how the course of the disease can be changed by identifying new treatment targets, moving away from the traditional symptom management alone to also include diagnostic tools. Histology – the study of tissue and cells under the microscope – is one option. Ultrasound is another.
The latter is a more patient-friendly intervention, Dr. Freire says. It can also help us better assess the healing of all layers of the bowel. “If we find multiple biomarkers and visualizations to help us predict and monitor the disease and its course, we can intervene to reduce the number of flares patients experience and reduce the need for surgery,” he explains. “Who knows, in time we may even be able to prevent the disease from progressing altogether.”
This is the ultimate aim of an international, multi-partner project in which Takeda is a leading contributor. The European INTERCEPT project will launch a trial using biomarkers aimed at preventing the symptomatic onset of the disease before it even begins.
Our continued commitment to expand therapeutic knowledge in the IBD field is gaining attention from external experts. Dr. Jean-Frederic Colombel, director of the IBD Center at the Icahn School of Medicine, Mount Sinai, New York, is one of numerous academic partners with whom we are collaborating in groundbreaking new studies. “Takeda has a clear desire to push the science in order to improve patient outcomes,” he says.
“The company is not afraid to move out of its comfort zone and embrace new ideas and new technologies to try to address what remain clear challenges and unmet needs relating to IBD.”
Takeda’s quest for new insights into inflammatory bowel disease
Takeda is undertaking nine distinct studies, with data readouts that began in 2024 and will continue through 2028. These studies are designed to investigate critical patient needs and generate valuable insights to advance clinical practice in Crohn’s disease and ulcerative colitis.
Six global studies, three U.S. studies, underway and aiming to include:
therapeutics in various combinations or separately
study sites
patients
References
- https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00065-0/abstract
- Dai N, Haidar O, Askari A, Segal JP. Colectomy rates in ulcerative colitis: a systematic review and meta-analysis. Dig Liver Dis 2023;55:13–20.
- Elise Schoefs, Séverine Vermeire, Marc Ferrante, João Sabino, Tessy Lambrechts, Luisa Avedano, Isabella Haaf, Maria Stella De Rocchis, Andrea Broggi, Magdalena Sajak-Szczerba, Roberto Saldaña, Rosanne Janssens, Isabelle Huys, What are the Unmet Needs and Most Relevant Treatment Outcomes According to Patients with Inflammatory Bowel Disease? A Qualitative Patient Preference Study, Journal of Crohn's and Colitis, Volume 17, Issue 3, March 2023, Pages 379–388, https://doi.org/10.1093/ecco-jcc/jjac145
- Global evolution of inflammatory bowel disease across epidemiologic stages. Hracs L, Windsor JW, Gorospe J, Cummings M, Coward S, Buie MJ, Quan J, Goddard Q, Caplan L, Markovinović A, Williamson T, Abbey Y, Abdullah M, Abreu MT, Ahuja V, Raja Ali RA, Altuwaijri M, Balderramo D, Banerjee R, Benchimol EI, Bernstein CN, Brunet-Mas E, Burisch J, Chong VH, Dotan I, Dutta U, El Ouali S, Forbes A, Forss A, Gearry R, Dao VH, Hartono JL, Hilmi I, Hodges P, Jones GR, Juliao-Baños F, Kaibullayeva J, Kelly P, Kobayashi T, Kotze PG, Lakatos PL, Lees CW, Limsrivilai J, Lo B, Loftus EV Jr, Ludvigsson JF, Mak JWY, Miao Y, Ng KK, Okabayashi S, Olén O, Panaccione R, Paudel MS, Quaresma AB, Rubin DT, Simadibrata M, Sun Y, Suzuki H, Toro M, Turner D, Iade B, Wei SC, Yamamoto-Furusho JK, Yang SK, Ng SC, Kaplan GG; Global IBD Visualization of Epidemiology Studies in the 21st Century (GIVES-21) Research Group.Nature. 2025 Apr 30. doi: 10.1038/s41586-025-08940-0. Online ahead of print.
- Emerging role of environmental pollutants in inflammatory bowel disease risk, outcomes and underlying mechanisms. Estevinho MM, Midya V, Cohen-Mekelburg S, Allin KH, Fumery M, Pinho SS, Colombel JF, Agrawal M.Gut. 2025 Feb 6;74(3):477-486. doi: 10.1136/gutjnl-2024-332523.
Share this story