Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease
Eli Lilly announced breakthrough results from two Phase 3 studies demonstrating the long-term effectiveness of mirikizumab in treating inflammatory bowel diseases. The drug showed remarkable success in maintaining remission for patients with ulcerative colitis and Crohn's disease.
After three years, over 80% of ulcerative colitis patients maintained remission and symptom relief. For Crohn's disease patients, more than 50% sustained endoscopic remission for up to five years. Mirikizumab, the first IL23p19 antagonist to report such long-term data, demonstrated a consistent safety profile across both conditions.
The drug is already FDA-approved for ulcerative colitis treatment and is under review for Crohn's disease. These findings were presented at the American College of Gastroenterology Annual Meeting 2024.
Eli Lilly ha annunciato risultati straordinari da due studi di Fase 3 che dimostrano l'efficacia a lungo termine di mirikizumab nel trattamento delle malattie infiammatorie intestinali. Il farmaco ha mostrato un notevole successo nel mantenere la remissione per i pazienti affetti da colite ulcerosa e morbo di Crohn.
Dopo tre anni, oltre l'80% dei pazienti con colite ulcerosa ha mantenuto la remissione e il sollievo dai sintomi. Per i pazienti con morbo di Crohn, più del 50% ha sostenuto la remissione endoscopica per un periodo fino a cinque anni. Mirikizumab, il primo antagonista dell'IL23p19 a riportare dati così a lungo termine, ha dimostrato un profilo di sicurezza coerente in entrambe le condizioni.
Il farmaco è già approvato dalla FDA per il trattamento della colite ulcerosa ed è attualmente in fase di revisione per il morbo di Crohn. Questi risultati sono stati presentati alla Riunione Annuale 2024 del Collegio Americano di Gastroenterologia.
Eli Lilly anunció resultados innovadores de dos estudios de Fase 3 que demuestran la eficacia a largo plazo de mirikizumab en el tratamiento de enfermedades inflamatorias intestinales. El medicamento mostró un éxito notable en el mantenimiento de la remisión en pacientes con colitis ulcerosa y enfermedad de Crohn.
Después de tres años, más del 80% de los pacientes con colitis ulcerosa mantuvieron la remisión y el alivio de síntomas. Para los pacientes con enfermedad de Crohn, más del 50% mantuvo la remisión endoscópica durante hasta cinco años. Mirikizumab, el primer antagonista del IL23p19 en reportar datos a largo plazo, demostró un perfil de seguridad consistente en ambas condiciones.
El medicamento ya está aprobado por la FDA para el tratamiento de la colitis ulcerosa y se encuentra en revisión para la enfermedad de Crohn. Estos hallazgos se presentaron en la Reunión Anual 2024 de la Colegiada Americana de Gastroenterología.
엘리 릴리는 염증성 장 질환 치료에 있어 미리키주맙의 장기적인 효과를 입증하는 3상 연구 두 건의 혁신적인 결과를 발표했습니다. 이 약물은 궤양성 대장염 및 크론병 환자에서 관해를 유지하는 데 매우 성공적이었습니다.
3년 후, 궤양성 대장염 환자의 80% 이상이 관해와 증상 완화를 유지했습니다. 크론병 환자 중 50% 이상이 최대 5년 동안 내시경 관해를 지속했습니다. 미리키주맙은 이러한 장기 데이터를 보고한 최초의 IL23p19 길항제로, 두 가지 조건 모두에서 일관된 안전성 프로필을 입증했습니다.
이 약물은 이미 궤양성 대장염 치료를 위해 FDA 승인을 받았으며 크론병에 대해서는 심사를 받고 있습니다. 이러한 발견은 2024년 미국 위장병학회 연례 회의에서 발표되었습니다.
Eli Lilly a annoncé des résultats révolutionnaires de deux études de Phase 3 démontrant l'efficacité à long terme de mirikizumab dans le traitement des maladies inflammatoires de l'intestin. Le médicament a montré un succès remarquable dans le maintien de la rémission chez les patients atteints de colite ulcéreuse et de maladie de Crohn.
Après trois ans, plus de 80 % des patients atteints de colite ulcéreuse ont maintenu leur rémission et le soulagement des symptômes. Pour les patients atteints de la maladie de Crohn, plus de 50 % ont maintenu une rémission endoscopique pendant jusqu'à cinq ans. Mirikizumab, le premier antagoniste de l'IL23p19 à rapporter de telles données à long terme, a démontré un profil de sécurité cohérent dans les deux conditions.
Le médicament est déjà approuvé par la FDA pour le traitement de la colite ulcéreuse et est actuellement examiné pour la maladie de Crohn. Ces résultats ont été présentés lors de la Réunion Annuelle 2024 du Collège Américain de Gastroentérologie.
Eli Lilly gab bahnbrechende Ergebnisse aus zwei Phase-3-Studien bekannt, die die Langzeitwirksamkeit von mirikizumab bei der Behandlung von entzündlichen Darmerkrankungen demonstrieren. Das Medikament zeigte bemerkenswerte Erfolge bei der Aufrechterhaltung der Remission bei Patienten mit Colitis ulcerosa und Morbus Crohn.
Nach drei Jahren hielten über 80 % der Patienten mit Colitis ulcerosa die Remission und die Symptomlinderung aufrecht. Bei Morbus-Crohn-Patienten erreichten mehr als 50 % eine endoskopische Remission von bis zu fünf Jahren. Mirikizumab, der erste IL23p19-Antagonist, der solche Langzeitdaten berichtete, wies ein konsistentes Sicherheitsprofil für beide Bedingungen auf.
Das Medikament ist bereits von der FDA für die Behandlung der Colitis ulcerosa zugelassen und wird derzeit für Morbus Crohn überprüft. Diese Ergebnisse wurden auf dem Jahrestreffen der American College of Gastroenterology 2024 vorgestellt.
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At three years, over
Mirikizumab also helped over
Mirikizumab is an interleukin-23p19 (IL23p19) antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of UC and Crohn's disease. Inflammation from UC and Crohn's disease can lead to disruptive symptoms, including bowel urgency, that can result in decreased health-related quality of life and potentially irreversible complications for patients if left untreated. Mirikizumab is approved in
"Mirikizumab is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn's disease," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "This achievement reflects our commitment to help people with immune system conditions sustain long-standing remission and relieve disease burden."
Long-Term Data in Adults with UC
In LUCENT-3, mirikizumab helped patients with moderately to severely active UC achieve long-term outcomes, including histologic-endoscopic mucosal remission, defined as mucosal healing. Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among those who achieved clinical remission with mirikizumab at one year in the LUCENT-2 study, the following results were achieved based upon observed case analysis after an additional two years of treatment (up to three years total):
81% of patients maintained long-term clinical remission82% achieved long-term endoscopic remission72% had mucosal healing79% achieved corticosteroid-free clinical remission- Patients demonstrated a sustained clinically meaningful improvement in symptom score reduction for bowel urgency (-4.72)
These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Ulcerative Colitis Program section below.
Among patients receiving mirikizumab in the LUCENT-3 study,
Long-Term Data in Adults with Crohn's Disease
New data from patients in the Phase 2 program who enrolled into the VIVID-2 long-term extension study showed that patients with moderately to severely active Crohn's disease treated with mirikizumab maintained high rates of clinical and endoscopic remission over time. The following results were achieved based upon observed case analysis after an additional three years of treatment (up to five years total):
96% of patients had clinical response as measured by the Crohn's Disease Activity Index (CDAI)87% were in clinical remission as measured by CDAI76% had endoscopic response54% of patients were in endoscopic remission
These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Crohn's Disease Program section below.
"Despite continued advances, people living with ulcerative colitis and Crohn's disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency, and provide lasting results over time," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "These multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients."
Among these patients who enrolled into the VIVID-2 long-term extension study,
Omvoh® (mirikizumab-mrkz) was approved by the FDA in October 2023 as the first IL23p19 antagonist for the treatment of moderately to severely active UC in adults and is also approved in 44 countries around the world. Lilly submitted marketing applications for mirikizumab in Crohn's disease around the globe, including in the
Additionally, Lilly has a combination study in UC with mirikizumab and eltrekibart, a humanized monoclonal antibody that binds to the seven ligands that signal through the CXCR1 and CXCR2 chemokine receptors involved in neutrophil movement to sites of inflammation (NCT06598943). There are also ongoing studies in both UC (NCT05611671) and Crohn's disease (NCT06226883) with MORF-057, a selective oral small molecule alpha-4/beta-7 integrin inhibitor that may improve outcomes and expand treatment options for people with IBD.
Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work.
About the Mirikizumab Ulcerative Colitis Program
Mirikizumab was studied in two, Phase 3 clinical trials which evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. The induction LUCENT-1 and maintenance LUCENT-2 studies were randomized, double-blind, and placebo-controlled and included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib). Additionally,
LUCENT-3, the ongoing long-term Phase 3 extension of LUCENT-1 and LUCENT-2 evaluated the efficacy and safety of mirikizumab in patients with UC for up to three years. Using a modified non-responder imputation analysis to handle discontinuation and missing data, among Week 52 mirikizumab remitters,
About the Mirikizumab Crohn's Disease Program
VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Week 0-12, then 300 mg subcutaneously every four weeks from Weeks 12-52. In this study,
SERENITY, the Phase 2, multi-center, randomized, parallel-arm, double-blind, placebo-controlled trial was designed to assess the safety and efficacy of mirikizumab in patients with moderately to severely active Crohn's disease. At baseline, participants were randomized with a 2:1:1:2 allocation across four treatment arms (placebo, mirikizumab 200 mg, mirikizumab 600 mg and mirikizumab 1000 mg). The primary endpoint was endoscopic response as determined by the proportion of participants achieving at least
VIVID-2, the ongoing long-term Phase 3 extension of SERENITY and the VIVID-1 study, evaluated the efficacy and safety of mirikizumab in patients with Crohn's disease for up to five years. Using a modified non-responder imputation analysis to handle discontinuation and missing data,
Indications and Usage for Omvoh® (mirikizumab-mrkz) (in
Omvoh® is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
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 patient 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 (≥
During induction, Omvoh is available as a single dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility. During maintenance, Omvoh is available as a one-time use prefilled pen or syringe with 100 mg/mL for subcutaneous injections. See Prescribing Information for dosing information.
MR HCP ISI 31JUL2024
Please click for Prescribing Information and Medication Guide for Omvoh. Please click for Instructions for Use included with the device.
About Omvoh®
Omvoh® (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis 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 ulcerative colitis. Treatment of ulcerative colitis with Omvoh starts with 300-mg IV infusions, once every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous injections every four weeks during maintenance treatment.
Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.
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
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 mirikizumab as a potential treatment for people with moderately to severely active ulcerative colitis and Crohn's disease and the timeline for future readouts, presentations, and other milestones relating to mirikizumab and its clinical trials, 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 mirikizumab will prove to be a safe and effective treatment for Crohn's disease, that mirikizumab will receive regulatory approval, or that Lilly will execute its strategy as expected. 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.
Refer to: Cathy Buck; cathy.buck@lilly.com; +1-317-982-1153 (Lilly media)
Joe Fletcher; jfletcher@lilly.com; 317-296-2884; (Lilly investors)
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