Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by inflammation of the colon and rectum. Recent years have seen significant advancements in UC treatment, offering renewed hope for patients seeking effective and personalized care.
What to Know About Tremfya and Vedolizumab
Tremfya (Guselkumab): Targeting the IL-23 Pathway
Tremfya, or guselkumab, is a monoclonal antibody that inhibits interleukin-23 (IL-23), a cytokine involved in inflammatory processes. Initially approved for psoriasis, its efficacy in UC has been demonstrated in recent clinical trials.
The Phase 3 ASTRO trial evaluated subcutaneous administration of Tremfya in adults with moderately to severely active UC. The study reported significant improvements in clinical and endoscopic outcomes compared to placebo, with 27.6 percent of patients achieving clinical remission at 12 weeks.
Additionally, the QUASAR maintenance trial found that intravenous Tremfya induced high rates of endoscopic remission. These findings led to FDA approval of Tremfya for UC treatment in September 2024.
“We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life. These results further underscore the potential of Tremfya to transform the UC treatment paradigm,” Esi Lamousé-Smith, MD, PhD, vice president, Gastroenterology Disease Area lead, Immunology, Johnson & Johnson Innovative Medicine, said in the release. “Pending approval, Tremfya would be the first IL-23 inhibitor with a fully SC induction and maintenance regimen, increasing options for both patients and healthcare providers.
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Vedolizumab (Entyvio): Gut-Selective Immunomodulation
Vedolizumab is an integrin receptor antagonist that specifically targets the gastrointestinal tract, reducing inflammation without systemic immunosuppression.
The VERDICT trial, an interim analysis of 48 weeks of vedolizumab treatment, demonstrated its efficacy in patients with moderate to severe UC. Furthermore, the EVOLVE study showed that using vedolizumab as a first-line biologic before tumor necrosis factor (TNF)-α inhibitors improved quality-adjusted life-years and was more cost-effective.
In the EFFICACI trial, vedolizumab outperformed infliximab as a second-line therapy for UC, achieving higher rates of steroid-free clinical remission at week 14.
“For quite a while, our field has had a ‘therapeutic ceiling’ where only a percentage of patients respond to available treatments, achieve remission, and sustain control,” said David T. Rubin, MD, the Joseph B Kirsner Professor of Medicine at the University of Chicago. “These studies describe the successful results of two new therapies that were effective in treating moderate to severe ulcerative colitis.”
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Safety, Efficacy, and Access: What the Data Shows
Both Tremfya (guselkumab) and vedolizumab (Entyvio) have emerged as promising treatment options for individuals with moderate to severe ulcerative colitis (UC), especially for those who have not responded adequately to traditional therapies. Clinical trials and real-world data continue to affirm their strong safety profiles and therapeutic value, providing a much-needed expansion in the treatment landscape for UC patients.
Both therapies also show high rates of mucosal healing and steroid-free remission, which are critical benchmarks for improving quality of life in UC patients. These outcomes are not just about symptom relief—they’re about preventing long-term complications like colon damage, surgery, and even cancer.
Access to these treatments is improving, thanks in part to updated insurance policies and expanded FDA indications. Many major insurance plans now cover Tremfya and vedolizumab for UC, especially when prescribed by a specialist and documented through proper medical necessity. Pharmaceutical companies also offer co-pay assistance, patient support programs, and access to specialty pharmacy navigators, making these biologics more accessible to patients who might otherwise face financial obstacles.
Still, disparities in access persist, particularly among underrepresented and underserved communities, including Black and brown patients. It’s important that healthcare systems continue addressing these inequities by advocating for broader insurance coverage, improving cultural competency among providers, and facilitating earlier referrals to GI specialists.
Because early intervention with the right treatment often leads to better outcomes, healthcare providers are now encouraged to introduce advanced biologic options earlier in the treatment process rather than reserving them for when all else fails. This shift in practice recognizes that timely control of inflammation can prevent the progression of UC, reduce hospitalizations, and improve overall long-term health.
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Questions to Ask at Your Next GI Appointment
When preparing for your next gastroenterologist appointment, going in with a set of clear, informed questions can make all the difference. These conversations are opportunities to take an active role in your care, advocate for your needs, and ensure your treatment plan reflects the latest science.
- Is Tremfya or vedolizumab appropriate for my specific case of UC?
- What are the potential side effects, and how do they compare to the ones I’m experiencing now?
- How do these treatments differ in how they work and how they’re administered (injection, infusion, frequency)?
- What tests or monitoring will be needed if I start either of these treatments?
- Are there lifestyle changes I should make to improve their effectiveness?
- Will these medications interact with anything else I’m taking?
- What are the expected timelines for symptom relief or improvement?
- Are there financial assistance programs, co-pay cards, or grants to help cover the cost?
Engaging in an open dialogue with your gastroenterologist can help tailor a treatment plan that aligns with your health goals and lifestyle.
Long-Term Wellness Planning
Managing ulcerative colitis effectively requires more than just medication—it involves creating a lifestyle that supports gut health, reduces inflammation, and improves mental and emotional well-being. Long-term wellness planning is essential not only for maintaining remission but also for reducing the risk of complications and enhancing your overall quality of life.
A balanced, anti-inflammatory diet is one of the most impactful steps UC patients can take. While no single diet fits everyone with UC, many benefit from a diet rich in omega-3 fatty acids, whole grains, leafy greens, and cooked (not raw) vegetables. Reducing processed foods, added sugars, alcohol, and dairy can also help minimize flare-ups. For some patients, food sensitivity testing or a guided elimination diet with a registered dietitian can be beneficial.
Regular exercise is another pillar of UC management. Physical activity has been shown to reduce inflammation markers, improve gut motility, and support mental health. It doesn’t have to be intense—even low-impact options like walking, swimming, or yoga can be incredibly beneficial when practiced consistently.
Stress management is also essential. Stress doesn’t cause UC, but it can exacerbate flares by disrupting gut-brain communication and triggering immune responses. Incorporating mindfulness practices, breathing exercises, therapy, or journaling into your routine can help reduce these flare-ups.
Routine screenings are vital. Colonoscopies, bone density tests (especially for those who have used steroids), and blood work should be part of your annual or semi-annual care plan. Early detection of complications like colon cancer or nutrient deficiencies allows for timely interventions.
Finally, building a relationship with a multidisciplinary care team—including your gastroenterologist, primary care physician, dietitian, and possibly a mental health provider—can help you address the full spectrum of UC’s impact. This approach ensures that you’re not only managing symptoms but also living well with UC.
If you’re living with UC, you’re not alone—and with the right plan, you can thrive.