Patients with Crohn's disease maintained steroid-free remission for three years with Lilly's Omvoh (mirikizumab-mrkz)

Rhea-AI Summary

Eli Lilly (NYSE: LLY) reported long-term VIVID program results showing durable Crohn's disease control with Omvoh (mirikizumab-mrkz): among patients who achieved outcomes at Year 1, clinical remission 92.4%, corticosteroid-free remission 91.2% at Week 152, and sustained bowel urgency improvements.

Post hoc analyses showed nearly 50% fewer Crohn's-related hospitalizations/surgeries weeks 0–12 and nearly 70% fewer during weeks 12–52 versus placebo; Omvoh is approved in 47 countries.

Positive

• Clinical remission 92.4% at Week 152 among Year‑1 responders
• Corticosteroid-free remission 91.2% at Week 152 among Year‑1 responders
• Hospitalizations/surgeries reduced ~50% vs placebo in weeks 0–12 (16.9 vs 30.9 per 100 patient‑years)
• Hospitalizations/surgeries reduced ~70% vs placebo in weeks 12–52 (4.5 vs 14.0 per 100 patient‑years)
• Regulatory approvals in 47 countries for moderate‑to‑severe UC and Crohn's disease

Negative

• Common adverse events ≥5% reported (COVID‑19, nasopharyngitis, upper respiratory infection)
• Key hospitalization comparisons are post hoc and include selected placebo subsets, limiting direct randomized comparison strength

Key Figures

Steroid-free remission: >90% of patients Clinical remission rate: 92.4% Steroid-free remission rate: 91.2% +5 more

8 metrics

Steroid-free remission >90% of patients Maintained steroid-free control through three years in VIVID-2

Clinical remission rate 92.4% CDAI clinical remission at 152 weeks among Week 52 responders

Steroid-free remission rate 91.2% Corticosteroid-free clinical remission at 152 weeks among Week 52 responders

Urgency improvement 82.1% ≥3-point reduction on UNRS at 152 weeks among Week 52 responders

Low urgency (UNRS ≤2) 71.7% Patients with baseline UNRS ≥3 achieving UNRS ≤2 at 152 weeks

Hospitalizations/surgeries early 16.9 vs 30.9 per 100 patient-years Crohn’s-related hospitalizations/surgeries weeks 0–12, Omvoh vs placebo

Hospitalizations/surgeries maintenance 4.5 vs 14.0 per 100 patient-years Crohn’s-related hospitalizations/surgeries weeks 12–52, Omvoh vs placebo

Global approvals 47 countries Regulatory approvals for moderately to severely active UC and Crohn’s disease in adults

Market Reality Check

Price: $1020.56 Vol: Volume 3,234,879 is below...

normal vol

$1020.56 Last Close

Volume Volume 3,234,879 is below the 20-day average of 3,627,408, suggesting no outsized trading response before this release. normal

Technical Shares at $1,020.56 trade above the 200-day MA of $865.45 but sit about 10% below the $1,133.95 52-week high.

Peers on Argus

LLY was down 1.5% while peers were mixed: ABBV, AZN, and NVS declined (down to -...

LLY was down 1.5% while peers were mixed: ABBV, AZN, and NVS declined (down to -2.26%), whereas JNJ and NVO rose (up to 0.81%). With no peers in the momentum scanner and mixed moves, trading appeared more stock-specific than sector-driven.

Common Catalyst Same-day peer news centered on dividends (ABBV) and product-specific oncology updates (AZN), not on inflammatory bowel disease or IL-23 pathways.

Historical Context

5 past events · Latest: Feb 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 18	Clinical trial data	Positive	-1.5%	Phase 3 psoriasis and obesity trial showed superior efficacy for combination therapy.
Feb 17	Collaboration milestone	Positive	-0.4%	Second success milestone in CRISPR collaboration for neurological disease programs.
Feb 16	Conference participation	Neutral	-0.4%	Announcement of fireside chat appearance at a major healthcare conference.
Feb 09	Acquisition deal	Neutral	-1.3%	Agreement to acquire Orna Therapeutics to advance in vivo cell therapies.
Feb 04	Earnings and guidance	Positive	+10.3%	Strong Q4 revenue and 2026 guidance driven by incretin and oncology franchises.

Pattern Detected

R&D and partnership announcements (e.g., psoriasis and CRISPR milestones) have recently seen negative next-day moves, while earnings with strong guidance produced a large positive reaction.

Recent Company History

Over recent months, Lilly has paired strong financial performance with intensive pipeline activity. Q4 2025 results showed revenue of $19.3B and drove a 10.33% gain the next day, while guidance for $80–$83B 2026 revenue underlined growth expectations. Strategic moves included the planned Orna Therapeutics acquisition (up to $2.4B) and a CRISPR collaboration milestone exceeding $1.5B in potential payments. Recent immunology and obesity-related trial wins preceded modest share pullbacks, showing that pipeline news has not always translated into short-term gains.

Market Pulse Summary

This announcement highlights durable three-year Crohn’s disease control with Omvoh, including more t...

Analysis

This announcement highlights durable three-year Crohn’s disease control with Omvoh, including more than 90% steroid-free remission maintenance and reduced Crohn’s-related hospitalizations from 30.9 to 16.9 and then 4.5 vs 14.0 per 100 patient-years versus placebo. Placed alongside Lilly’s recent clinical wins and strong Q4 2025 earnings, it reinforces the immunology franchise. Investors may focus on long-term safety, real-world uptake, and future combination trial readouts as key metrics to monitor.

Key Terms

crohn's disease, ulcerative colitis, il-23p19 inhibitor, open-label extension, +3 more

7 terms

crohn's disease medical

"New long-term data from Eli Lilly and Company ... in adults with moderately to severely active Crohn's disease."

A chronic inflammatory condition of the digestive tract in which the body's immune response causes repeated damage and irritation, leading to symptoms like abdominal pain, persistent diarrhea, weight loss and fatigue. It matters to investors because it creates ongoing demand for medications, medical devices and care services, shapes healthcare spending and insurance costs, and drives research and regulatory activity—think of it as a long-term market for treatments where an overactive security system attacks a vital pipeline.

ulcerative colitis medical

"Additional data presented from the Phase 3 VIVID-1 (Crohn's disease) and LUCENT-3 (UC) clinical trials..."

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

il-23p19 inhibitor medical

"Omvoh now stands alone as the only IL-23p19 inhibitor to show strong and durable efficacy..."

A medication that blocks the p19 part of interleukin‑23, a signaling protein that tells certain immune cells to cause inflammation; by stopping that signal these drugs calm inappropriate immune attacks seen in conditions like psoriasis and inflammatory bowel disease. For investors, successful IL‑23p19 inhibitors can mean clear clinical trial pathways, recurring prescriptions and sizable market demand—think of them as turning down a misfiring thermostat to prevent damage elsewhere in the house.

open-label extension medical

"These data from the Phase 3 VIVID-2 open-label extension study were presented..."

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

c-reactive protein medical

"sustained improvement in inflammation, as measured by the continued decrease in inflammatory biomarkers (C-reactive protein and fecal calprotectin)..."

C-reactive protein (CRP) is a blood biomarker that rises when the body has inflammation or infection, acting like a smoke detector that signals something is wrong. For investors, CRP matters because it is used in clinical tests and drug trials to show whether treatments reduce inflammation, can influence regulators’ and doctors’ decisions, and therefore affects the commercial prospects of diagnostics and therapeutic products.

fecal calprotectin medical

"continued decrease in inflammatory biomarkers (C-reactive protein and fecal calprotectin) up to three years."

A fecal calprotectin test measures the level of a specific protein shed into stool when the intestines are inflamed; higher levels signal active inflammation in the gut. Investors watch this marker because it is used in clinical trials, diagnostic labs, and treatment decisions to show whether therapies for inflammatory bowel diseases are working or if patients need further care, making it a practical indicator of market demand for diagnostics and drugs.

monoclonal antibody medical

"studies in UC with eltrekibart ... a monoclonal antibody that targets neutrophil-driven inflammation..."

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. Not financial advice.

Landmark VIVID-2 data showed more than 90% of patients who achieved steroid-free remission at one year maintained steroid-free control through three years 

Additional new data revealed exceptionally low surgery and hospitalization rates in Omvoh-treated patients across both Crohn's disease and ulcerative colitis (UC), underscoring its potential to fundamentally change disease trajectory 

Omvoh now stands alone as the only IL-23p19 inhibitor to show strong and durable efficacy with simple, consistent monthly dosing over four years in UC and three years in Crohn's disease

INDIANAPOLIS, Feb. 19, 2026 /PRNewswire/ -- New long-term data from Eli Lilly and Company (NYSE: LLY) showed Omvoh (mirikizumab-mrkz) delivered durable efficacy through three years in adults with moderately to severely active Crohn's disease.¹ These data from the Phase 3 VIVID-2 open-label extension study were presented at the 21st Congress of the European Crohn's and Colitis Organisation (ECCO) in Stockholm. Additional data presented from the Phase 3 VIVID-1 (Crohn's disease) and LUCENT-3 (UC) clinical trials showed Omvoh-treated patients experienced minimal hospitalizations and surgeries across both major types of inflammatory bowel disease (IBD).^2,3 Omvoh is the first and only IL-23p19 inhibitor to show strong and durable efficacy over four years in UC and three years in Crohn's disease, with proven reduction of disease complications. 

"Too many people with inflammatory bowel disease never achieve lasting remission, leaving them vulnerable to cumulative damage from poorly controlled inflammation that can result in emergency hospitalizations or surgery," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Omvoh is redefining what durable disease control can look like, with long-term data showing patients treated with Omvoh stayed in remission and experienced fewer serious complications over three years, underscoring its potential to alter the course of the disease." 

Long-Term Remission and Bowel Urgency Improvements in Crohn's Disease
In VIVID-2, patients who achieved an endoscopic response at one year with Omvoh in the Phase 3 VIVID-1 clinical trial experienced long-term efficacy, with the majority remaining in clinical and corticosteroid-free remission and sustaining bowel urgency improvements through three years of continuous Omvoh treatment.¹

Efficacy results at 152 weeks*
Clinical remission†	92.4 % ‌
Corticosteroid-free clinical remission‡	91.2 %
≥3-point reduction on the Urgency Numeric Rating Scale (UNRS)§	82.1 %
UNRS ≤2¶	71.7 %
* Among patients who achieved each specified outcome at Week 52 in VIVID-1 and continued treatment in the VIVID-2 extension; observed cases. These data were also evaluated using a modified non-responder imputation (mNRI), presented in the About VIVID Clinical Trial Program section below.
† Crohn's Disease Activity Index (CDAI) total score <150.
‡ CDAI score <150 with no corticosteroid use for prior 12 weeks.
§ UNRS is the patient-centric scale of 0-10 that evaluates bowel urgency severity, with 0 being no bowel urgency  and 10 being worst possible bowel urgency.
¶ Among patients with baseline UNRS ≥3.

"For people with Crohn's disease, unpredictable flares and abdominal pain can persist when remission isn't achieved or sustained. Additionally, ongoing symptoms like urgent trips to the bathroom and fatigue can continue to disrupt daily life when the disease is not adequately controlled," said Edward Barnes, M.D. MPH, Associate Professor of Medicine, University of North Carolina at Chapel Hill. "Seeing more than 90% of patients maintain steroid-free remission through three years on consistent monthly dosing, with 80% also experiencing relief from the disruptive symptoms of bowel urgency, gives providers confidence in Omvoh for outcomes that can last."

These new long-term Crohn's disease data also showed Omvoh-treated patients who achieved endoscopic response at one year experienced sustained improvement in inflammation, as measured by the continued decrease in inflammatory biomarkers (C-reactive protein and fecal calprotectin) up to three years.¹ The long-term safety profile in patients with moderately to severely active Crohn's disease was consistent with the known safety profile of Omvoh. Common adverse events reported from the end of year one through the end of year three (≥5% of Omvoh-treated patients who achieved endoscopic response at one year) included COVID-19, nasopharyngitis, and upper respiratory tract infection.¹

Consistently Low Rates of Severe Disease‑Related Complications in IBD
Complementing the three-year Crohn's disease results, additional post hoc data presented from the VIVID-1 (Crohn's disease) and LUCENT-3 (UC) clinical trials showed patients treated with Omvoh experienced consistently low rates of severe disease-related complications. In VIVID-1, Omvoh reduced Crohn's disease-related hospitalizations and/or surgeries by nearly half versus placebo in the first 12 weeks (incidence rate: 16.9 vs. 30.9 per 100 patient-years), and by nearly 70% during weeks 12 to 52 (4.5 vs. 14.0*).² In LUCENT-3, one UC-related hospitalization and no UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension (incidence rates 0.1 and 0 per 100 patient-years, respectively).³

* Placebo rates during weeks 12 to 52 only include placebo patients who were in clinical response at week 12.

Together, these findings expand the growing body of long-term data on Omvoh in IBD, building on previously disclosed two-year results in Crohn's disease and four-year results in UC. 

Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) (NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials evaluating the efficacy and safety of mirikizumab used concomitantly with an incretin-based therapy in adults with ulcerative colitis or Crohn's disease who also have obesity or are overweight with at least one weight-related comorbidity. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn's disease (NCT05509777). 

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world.

About the VIVID Clinical Trial Program
VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn's disease. Patients randomized to Omvoh received Omvoh 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks.⁴

Participants who completed VIVID-1, including the Week 52 endoscopy, were eligible for VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of Omvoh in clinical remission by CDAI and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). Safety is being assessed from the first dose in VIVID-2.¹

Using a modified non-responder imputation method, among Omvoh endoscopic responders at year one, 82.8% of patients maintained CDAI clinical remission through three years, 81.1% maintained corticosteroid-free clinical remission, 72.7% maintained clinically meaningful improvement in bowel urgency and 64.0% of patients maintained bowel urgency remission.¹

About the LUCENT Clinical Trial Program
Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed biologic or Janus kinase inhibitors (JAKi). The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1.⁵ LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total).

About Omvoh 
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.⁶

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Indications and Usage for Omvoh® (mirikizumab-mrkz) (in the United States)
Omvoh is an interleukin-23 antagonist indicated for adults with:

• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease

Important Safety Information for Omvoh (mirikizumab-mrkz)

CONTRAINDICATIONS

Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.

Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.

Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.

ADVERSE REACTIONS
Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.

MR HCP ISI CD APP

Click to access provided Prescribing Information and Medication Guide. See Instructions for Use provided with the device.

About Lilly 
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References
¹Laharie D, et al. P0563 Mirikizumab demonstrated sustained and durable long-term efficacy and favorable safety in week 52 endoscopic responders with Crohn's disease: 3-year VIVID-2 open-label extension interim results. Journal of Crohn's and Colitis. 2026;20(Suppl 1):jjaf231.744. https://doi.org/10.1093/ecco-jcc/jjaf231.744
²Sands B, et al. Mirikizumab treatment reduces Crohn's disease–related surgery and hospitalization rates: analyses from VIVID-1. Journal of Crohn's and Colitis. 2026;20(Suppl 1):jjaf231.042. https://doi.org/10.1093/ecco-jcc/jjaf231.042
³Magro F, et al. Mirikizumab treatment decreases ulcerative colitis–related surgery and hospitalisation rates: 4-year LUCENT studies results. Journal of Crohn's and Colitis. 2026;20(Suppl 1):jjaf231.1300. https://doi.org/10.1093/ecco-jcc/jjaf231.1300
⁴Ferrante M, et al. 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. The Lancet. 2024;404(10470):2423-2436.
⁵Sands, B, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024;izae253, https://doi.org/10.1093/ibd/izae253
⁶Omvoh. Prescribing Information. Lilly USA, LLC.

Refer to:	Kelly Hoffman; kelly.hoffman@lilly.com; 765-736-2555 (Lilly media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

 

 

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SOURCE Eli Lilly and Company

FAQ

What were Omvoh (LLY) Crohn's disease remission rates at three years in VIVID-2?

Omvoh achieved high long‑term remission: 92.4% clinical remission and 91.2% corticosteroid‑free remission at Week 152 among patients who were responders at Year 1. According to the company, these figures reflect observed‑case outcomes in the VIVID‑2 extension.

How much did Omvoh reduce Crohn's‑related hospitalizations and surgeries in the trials?

Omvoh lowered early Crohn's complications: ~50% reduction in weeks 0–12 and ~70% reduction in weeks 12–52 versus placebo. According to the company, these are incidence rates per 100 patient‑years from post hoc analyses.

What symptom improvements did Omvoh show for bowel urgency at three years (LLY)?

Omvoh improved bowel urgency: 82.1% had ≥3‑point UNRS reduction and 71.7% reached UNRS ≤2 at Week 152 among Year‑1 responders. According to the company, these are observed‑case results from the VIVID program.

What safety signals were reported for Omvoh through three years in Crohn's disease?

Long‑term safety was consistent with prior data; common events ≥5% included COVID‑19, nasopharyngitis, and upper respiratory infection. According to the company, no new safety patterns emerged through three years in VIVID‑2.

Is Omvoh approved for Crohn's disease and in how many countries (LLY)?

Yes. Omvoh has regulatory approvals for moderate‑to‑severe Crohn's disease and ulcerative colitis and is approved in 47 countries. According to the company, approvals cover adult indications in both major IBD types.

Does Omvoh use simple dosing and how long was durability shown (LLY)?

Omvoh uses consistent monthly dosing with demonstrated durability: three years in Crohn's disease and four years in ulcerative colitis in the VIVID/LUCENT programs. According to the company, this supports long‑term disease control with IL‑23p19 inhibition.