Omvoh (mirikizumab) and Entyvio (vedolizumab) work in different ways, but are both approved biologic medications for treating inflammatory bowel diseases (IBD). Understanding how each medication works, how they’re given, and what makes them unique can help you and your healthcare team make the best decision for your personal needs.

What are Omvoh and Entyvio?

Omvoh and Entyvio are two FDA-approved biologic medications. Omvoh belongs to the class of interleukin-23 (IL-23) inhibitors. It works by selectively targeting the p19 subunit of IL-23, a protein that plays a pivotal role in the inflammation involved in ulcerative colitis (UC) and Crohn’s disease (CD). Entyvio is an integrin receptor antagonist, specifically blocking the α4β7 integrin. This gut-selective agent prevents certain white blood cells from entering the gastrointestinal tract, thus reducing inflammation primarily in the gut.

Approved Uses of Entyvio and Omvoh

Both Omvoh and Entyvio are FDA-approved for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. Entyvio was approved by the FDA in 2014, while Omvoh was approved in 2023.

How Omvoh and Entyvio are Given

Omvoh and Entyvio come in intravenous (IV) and subcutaneous (SQ) dosage forms. Patients begin both therapies by getting intravenous infusions, with the option to remain on IV dosing or switch to SQ with Entyvio.

Drug	Induction Phase	Maintenance Phase
Omvoh	UC: 300 mg IV at week 0, 4, and 8 CD: 900 mg IV at week 0, 4, and 8	Monthly subcutaneous (under-the-skin) injection
Entyvio	300 mg IV at week 0 and 2	IV every 8 weeks, or subcutaneous every 2 weeks (Pen), starting at week 6

Omvoh infusions take 30-90 minutes, depending on the condition being treated. Entyvio infusions take approximately 30 minutes.

How They Work (Mechanism of Action)

Even though Omvoh and Entyvio are approved for the same conditions, they work differently from one another:

• Omvoh targets IL-23, a cytokine involved in systemic immune responses. By blocking IL-23, Omvoh interrupts inflammatory pathways across the body, reducing the symptoms and inflammation associated with IBD.
• Entyvio selectively interferes with gut-specific immune cells by blocking the α4β7 integrin, which reduces the migration of inflammation-causing lymphocytes into the gastrointestinal tract. This results in a focused reduction of gut inflammation, rather than systemic immune suppression.

How Effective are Omvoh and Entyvio?

While no head-to-head comparison studies are available, Omvoh and Entyvio demonstrated superiority over placebo in separate clinical trials.

Ulcerative colitis

• Omvoh (LUCENT trials): Showed about 24% of patients achieving remission at 12 weeks and about 50% in remission at 52 weeks. 2-year studies show long-term benefits.
• Entyvio (GEMINI trials): Approximately 17% achieved remission at 6 weeks (short-term), and 42% at 52 weeks (long-term).

Crohn’s disease

• Omvoh (VIVID-1 trials): Showed about 53% remission at 52 weeks.
• Entyvio (GEMINI trials): Showed about 15% remission at 6 weeks, and about 39% at 52 weeks.

Side Effects Comparison: Omvoh vs. Entyvio

When comparing Omvoh (mirikizumab) and Entyvio (vedolizumab), both medications are generally well tolerated, but they carry distinct profiles of potential side effects and risks. Understanding these differences can help patients and healthcare providers make more informed decisions.

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Omvoh (mirikizumab) Side Effects

Common Side Effects:

• Upper respiratory tract infections (such as sinus infections)
• Injection site reactions (redness, pain, or swelling)
• Headache
• Joint pain
• Skin rash
• Elevated liver enzyme tests

Serious Risks:

• Infections: Omvoh increases susceptibility to infections, including serious and potentially life-threatening ones such as sepsis and tuberculosis. Your healthcare provider will typically screen for infections before starting treatment.
• Severe Allergic Reactions: Symptoms can include swelling, trouble breathing, skin reactions, and chest tightness, sometimes requiring immediate medical attention.
• Liver Problems: Omvoh may cause liver damage, sometimes signaled by nausea, jaundice (yellowing of the skin or eyes), loss of appetite, and dark urine. Regular blood monitoring is recommended during treatment.

Entyvio (vedolizumab) Side Effects

Common Side Effects:

• Cold symptoms (respiratory infections like sinus or throat infections)
• Headache
• Joint pain
• Nausea
• Fever
• Back pain
• Injection site reactions

Serious Risks:

• Infections: Increased risk for serious infections, including bronchitis and sepsis. Patients should report persistent fever, cough, or unusual fatigue to their healthcare provider.
• Serious Allergic Reactions: These can be infusion-related or delayed, and may include rash, itching, swelling, and breathing difficulties, sometimes hours after administration.
• Liver Problems: Signs of liver injury—like nausea, jaundice, and dark urine—require immediate attention.
• Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection that can occur in people with a weakened immune system. Symptoms include confusion, vision changes, weakness, or coordination problems.

Key Considerations When Choosing Between Omvoh and Entyvio

When considering treatment options like Omvoh and Entyvio, it’s important to look beyond just how well they work. Differences in how these medications target the immune system, how they are given, and their potential side effects can all play a role in choosing the best therapy for each person. Keep in mind that these medications are not interchangeable.

• Mode of Action: Omvoh acts systemically through IL-23 pathway inhibition; Entyvio is gut-selective, directly impacting the digestive tract.
• Administration: Differences in how and how often these drugs are given may affect patient preference (monthly vs. every 8 weeks vs. every 2 weeks).
• Maintenance Approach: Omvoh offers a monthly injection (after IV induction), while Entyvio allows for both IV and at-home options after initial infusions.
• Efficacy and Tolerability: Both are effective and generally well tolerated, but due to different mechanisms and sites of action, they are not considered interchangeable.

Bottom Line

Omvoh and Entyvio are both important options for treating ulcerative colitis and Crohn’s disease, but they work in different ways—Omvoh targets systemic inflammation, while Entyvio is gut-selective. Only your healthcare provider can determine which is best for your individual situation.

References

1. Entyvio [package insert]. Updated 2024. Takeda Pharmaceuticals America, Inc. Accessed July 29, 2025 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c
2. Ferrante, M., D'Haens, G., Jairath, V., Danese, S., Chen, M., Ghosh, S., Hisamatsu, T., Kierkus, J., Siegmund, B., Bragg, S. M., Crandall, W., Durand, F., Hon, E., Lin, Z., Lopes, M. U., Morris, N., Protic, M., Carlier, H., Sands, B. E., & VIVID Study Group. 2024. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet (London, England), 404(10470), 2423–2436. https://doi.org/10.1016/S0140-6736(24)01762-8
3. Loftus, E. V., Jr, Feagan, B. G., Panaccione, R., Colombel, J. F., Sandborn, W. J., Sands, B. E., Danese, S., D'Haens, G., Rubin, D. T., Shafran, I., Parfionovas, A., Rogers, R., Lirio, R. A., & Vermeire, S. 2020. Long-term safety of vedolizumab for inflammatory bowel disease. Alimentary pharmacology & therapeutics, 52(8), 1353–1365. https://doi.org/10.1111/apt.16060
4. Omvoh [package insert]. Updated 2025. Eli Lilly and Company. Accessed July 29, 2025 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=472cbe04-263e-433d-9a0f-58c1b50b715a
5. Sands, B. E., D'Haens, G., Clemow, D. B., Irving, P. M., Johns, J. T., Hunter Gibble, T., Abreu, M. T., Lee, S., Hisamatsu, T., Kobayashi, T., Dubinsky, M. C., Vermeire, S., Siegel, C. A., Peyrin-Biroulet, L., Moses, R. E., Milata, J., Arora, V., Panaccione, R., & Dignass, A. 2024. Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflammatory bowel diseases, 30(12), 2245–2258. https://doi.org/10.1093/ibd/izae024

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