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Dr. Cohen:
Hi. My name is Erica Cohen. I’m a gastroenterologist at Capital Digestive CareSM in Chevy Chase, Maryland, and my focus is on management of Crohn’s disease and ulcerative colitis.
0:17-0:42
Dr. Cohen:
In my clinical practice, treatment decisions are guided by the patient’s needs at every stage of their journey. For patients with moderate to severe ulcerative colitis, or UC, achieving and maintaining long-term remission is a key treatment goal.
In this video, we’ll review Omvoh’s 4-year clinical data in UC and explore how Omvoh may be able to help patients reach their long-term treatment goals.
0:43-1:20
Dr. Cohen:
Let’s start by reviewing Omvoh’s indications and contraindications.
Omvoh is an interleukin-23 antagonist indicated for adults with moderately to severely active ulcerative colitis, or UC, or moderately to severely active Crohn’s disease, or CD.1
It is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
This is not the complete Important Safety Information for Omvoh, so please see additional Important Safety Information at the end of this video.
1:21-1:29
Dr. Cohen:
Omvoh’s efficacy and safety were evaluated in adults with moderately to severely active UC in the LUCENT trials.
1:30-1:59
Dr. Cohen:
LUCENT-1 was a double-blind, placebo-controlled induction study. Omvoh responders entered LUCENT-2 for maintenance and were re-randomized to Omvoh or placebo.
LUCENT-3 is the open-label extension trial in which adult patients who completed LUCENT-2 on Omvoh were assessed for long-term efficacy and those patients who received at least one dose of Omvoh from the LUCENT trial program were assessed for long-term safety.
2:00-2:09
Dr. Cohen:
The LUCENT trials included adult patients who had been treated with a prior biologic treatment and those who were bio-naive.
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Dr. Cohen:
By Week 12 in LUCENT-1, patients on Omvoh showed meaningful improvements compared to placebo with 65% achieving clinical response and 24% achieving clinical remission.
2:23-2:42
In LUCENT-2, improvements in clinical outcomes continued for those patients who achieved clinical response on Omvoh at Week 12.
At Week 52, 51% of patients on Omvoh achieved clinical remission, and 50% of patients on Omvoh were in corticosteroid-free remission.
2:43-3:02
Dr. Cohen:
Omvoh also demonstrated endoscopic improvement and histologic-endoscopic mucosal improvement, or HEMI, at Week 52 with 58% and 43% of patients achieving endoscopic improvement and HEMI, respectively.
3:03-3:30
Dr. Cohen:
Looking at subgroup data, bio-failed patients reached clinical and endoscopic goals with Omvoh at Week 52.
Specifically, 45% of bio-failed patients achieved clinical remission, and 50% achieved endoscopic improvement with Omvoh.
In UC, Omvoh showed consistent efficacy regardless of biologic exposure.
3:31-3:52
Dr. Cohen:
Omvoh also reduced bowel urgency severity, one of patients’ most disruptive symptoms.
At Week 52, 39% of patients achieved bowel urgency improvement with Omvoh as measured by a weekly average score of 0 to 1 on the Urgency Numeric Rating Scale, or UNRS.
3:53-4:11
Dr. Cohen:
We’ve explored how Omvoh can support patients in the earlier stages of treatment through Week 52.
Let’s look at the long-term results from LUCENT-3.
Among those patients who achieved clinical remission at Week 52 with Omvoh, 79% of them maintained it at 4 years.
4:12-4:39
Dr. Cohen:
Patients taking Omvoh also achieved long-term results at 4 years across the key secondary endpoints, including bowel urgency improvement, corticosteroid-free remission, endoscopic improvement, and HEMI.
Please note that open-label extension studies have limitations, including no placebo comparison and patients remaining in the extension study may have better outcomes than patients who left the study.
4:40-4:55
Dr. Cohen:
Looking at the safety profile of Omvoh, the most common adverse reactions included upper respiratory tract infections, arthralgia, injection site reactions, rash, headache, and herpes viral infections.
04:56-5:10
Dr. Cohen:
Additionally, no new safety signals were identified during 4 years of treatment with Omvoh as you can see from the table on select adverse events reported in the LUCENT trials.
5:11-5:26
Dr. Cohen:
It’s been a pleasure sharing Omvoh’s 4-year long-term data in UC. It’s exciting to know that wherever your patients are in their treatment journey, Omvoh may be able to help—not just for short-term relief but for a chance at sustained, long-term remission.
5:27-5:41
Dr. Cohen:
Visit Lilly Play to watch additional videos on Omvoh or visit omvoh.lilly.com/hcp for more information.
Please continue watching for additional Important Safety Information.
5:42-10:16
Narrator:
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.
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