Navigating Ulcerative Colitis: Exploring Treatment Options Including Xeljanz and Velsipity

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects the large intestine, causing symptoms like abdominal pain, bloody diarrhea, and frequent urges to use the bathroom. With an estimated 1.25 million people in the United States living with UC, finding effective treatments is crucial for managing this debilitating condition. While the medications Rexulti, Xeljanz, Libtayo, and Velsipity have been mentioned in connection with UC, not all are directly used for its treatment. In this blog, we’ll explore the landscape of UC treatments, focusing on Xeljanz and Velsipity, and clarify the roles of Rexulti and Libtayo, offering insights into their relevance and the broader UC treatment paradigm.

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Understanding Ulcerative Colitis and Its Challenges

UC is an autoimmune condition where the immune system mistakenly attacks the colon’s lining, leading to inflammation and ulcers. Symptoms can vary in severity, often flaring up unpredictably and impacting physical, emotional, and social well-being. The chronic nature of UC means patients often cycle through multiple treatments to achieve and maintain remission—a state where symptoms are minimal or absent, and the gut shows reduced inflammation.

Traditional UC treatments include aminosalicylates (e.g., mesalamine), corticosteroids, and immunosuppressants like azathioprine. For moderate to severe cases, advanced therapies such as biologics (e.g., Humira, Entyvio) and small molecule drugs have transformed the treatment landscape, offering targeted approaches to reduce inflammation. Among these, Xeljanz and Velsipity stand out as oral options, providing convenience over injectable biologics.

Xeljanz: A Pioneering Oral Therapy for UC

Xeljanz (tofacitinib), developed by Pfizer, is a Janus kinase (JAK) inhibitor approved by the FDA in 2018 for adults with moderately to severely active UC who have not responded well to tumor necrosis factor (TNF) blockers. As the first oral medication approved for chronic UC management, Xeljanz offers a significant advantage for patients hesitant about injections or infusions.

Xeljanz works by blocking JAK enzymes, which are involved in activating the immune response that drives inflammation in UC. Clinical trials have demonstrated its efficacy: in two 8-week placebo-controlled trials, 17–18% of patients taking Xeljanz (10 mg twice daily) achieved remission by week eight, compared to a lower percentage in the placebo group. In a 52-week trial, remission rates reached 34% (5 mg twice daily) and 41% (10 mg twice daily) among responders, with 35–47% achieving sustained corticosteroid-free remission.

However, Xeljanz comes with risks. Common side effects include diarrhea, headaches, and elevated cholesterol levels, while serious risks include infections, shingles, and a boxed warning for malignancies and serious infections like opportunistic infections. It’s not recommended for patients over 65 if other treatments are available, and it should not be combined with biologics or potent immunosuppressants. Despite these risks, Xeljanz’s oral administration and efficacy make it a valuable option for many UC patients.

Velsipity: A New Player in UC Treatment

Approved by the FDA in October 2023, Velsipity (etrasimod) is another oral therapy from Pfizer, marking a significant advancement in UC management. As a selective sphingosine-1-phosphate (S1P) receptor modulator, Velsipity works by preventing immune cells from leaving lymph nodes, reducing their migration to the colon and thus decreasing inflammation. It joins Bristol Myers Squibb’s Zeposia as the second S1P receptor modulator approved for UC.

The ELEVATE UC Phase 3 trials (ELEVATE UC 12 and ELEVATE UC 52) demonstrated Velsipity’s efficacy. In ELEVATE UC 52, 27% of patients achieved clinical remission at week 12 (vs. 7% placebo), and 32% at week 52 (vs. 7% placebo). In ELEVATE UC 12, 26% reached remission at week 12 (vs. 15% placebo). Secondary endpoints, such as endoscopic improvement and mucosal healing, were also met, with some patients seeing reduced bathroom trips in as little as two weeks and less rectal bleeding by four weeks.

Velsipity’s safety profile is generally favorable, with common side effects including headaches, elevated liver tests, and dizziness. However, it can temporarily slow heart rate or cause heart rhythm issues, requiring monitoring during treatment initiation. Its once-daily 2 mg dose and steroid-free remission potential make it an attractive option for patients seeking advanced therapy without injections.

Clarifying Rexulti and Libtayo in UC

While Xeljanz and Velsipity are established UC treatments, Rexulti and Libtayo do not have direct roles in managing this condition based on current evidence.

• Rexulti (brexpiprazole): Rexulti is an atypical antipsychotic primarily used for schizophrenia and major depressive disorder. There is no FDA approval or clinical evidence supporting its use for UC. Its mechanism, which involves dopamine and serotonin receptor modulation, targets neurological conditions, not inflammatory bowel diseases. Any mention of Rexulti in the context of UC may stem from confusion or misinformation.

• Libtayo (cemiplimab): Libtayo is a PD-1 inhibitor used for certain cancers, such as cutaneous squamous cell carcinoma and non-small cell lung cancer. It works by enhancing the immune system’s ability to fight cancer cells, which is the opposite of UC treatment goals, where immune suppression is needed to reduce inflammation. Libtayo has no approved or studied role in UC management.

The inclusion of Rexulti and Libtayo in discussions about UC treatment may reflect a misunderstanding or a desire to explore off-label uses, but no credible data supports their efficacy or safety for this condition.

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The Evolving UC Treatment Landscape

The UC treatment market is highly competitive, with oral therapies like Xeljanz, Velsipity, Zeposia, and AbbVie’s Rinvoq gaining traction due to their convenience. Biologics like Entyvio, Stelara, and Humira remain mainstays, but oral options are increasingly favored, especially for patients new to advanced therapies or those wary of injections. Recent approvals, such as Eli Lilly’s Omvoh (an IL-23 inhibitor) and subcutaneous formulations of Entyvio, further expand options.

Gastroenterologists often prioritize oral therapies for their ease of use, even if slightly less effective than biologics, as they can delay the need for injectable treatments. Velsipity, for instance, is seen as a first-line advanced therapy for some patients, particularly those who’ve failed conventional treatments but haven’t yet tried biologics or JAK inhibitors. The market is expected to grow over the next decade, driven by non-TNF biologics and novel therapies, though biosimilars and generic erosion may temper costs.

Considerations for Patients and Providers

Choosing the right UC treatment involves balancing efficacy, safety, and patient preferences. Xeljanz and Velsipity offer convenient oral options, but their side effects require careful monitoring. Patients should discuss their medical history, including heart conditions, infections, or pregnancy plans, with their healthcare provider to ensure safety. Costs are also a factor—Velsipity’s wholesale price is approximately $6,164 for a 30-day supply, comparable to Xeljanz and Rinvoq but less than Zeposia’s $8,386.

For those with UC, the availability of new treatments like Velsipity is encouraging, offering hope for better symptom control and improved quality of life. While Rexulti and Libtayo don’t fit into the UC treatment paradigm, the focus on Xeljanz, Velsipity, and emerging therapies highlights the rapid advancements in managing this complex disease.

Conclusion

Ulcerative colitis remains a challenging condition, but treatments like Xeljanz and Velsipity are transforming care by providing effective, oral alternatives to biologics. With ongoing research and new approvals, patients have more options than ever to achieve remission and manage symptoms. Always consult a gastroenterologist to tailor a treatment plan that aligns with your needs, and stay informed about the latest advancements to navigate UC with confidence.