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Narrator:
Indications: Ulcerative Colitis. Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis, or UC, in adults.
Crohn’s Disease. Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active Crohn's disease, or CD, in adults.
0:32-1:18
Narrator:
Select important safety information for Omvoh.
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.
Additional Important Safety Information will be covered later in this video.
1:19-1:23
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1:24-1:49
Dr. Nichols:
Hi, I’m Dr. Matthew Nichols, gastroenterologist and director of the IBD Center with South Denver GI.
In my practice, I frequently see adult patients with moderately to severely active ulcerative colitis, or UC. When I’m creating a treatment plan with these patients, I take into consideration how treatments may work over time.
This is one reason why I’m always interested in long-term data.
1:50-1:57
Dr. Nichols:
You've seen the LUCENT-1 and 2 data in a previous video. If you’d like to review those results, please continue watching for additional information.
1:58-2:07
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2:08-2:17
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2:18-2:32
Dr. Nichols:
Today, I’m pleased to share the first interim analysis from LUCENT-3, an open-label, long-term extension study. LUCENT-3 looked at patients with moderate to severe UC who were continuously treated with Omvoh for 2 years.
2:33-3:03
Dr. Nichols:
The LUCENT clinical trials cover induction, maintenance, and a long-term, open label extension study.
Let’s take a moment to look over the trial designs.
The pivotal induction and maintenance studies were randomized, double-blind, and placebo controlled. They included a 12-week induction and then maintenance for an additional 40 weeks, for 52 total weeks of treatment. Primary endpoints were clinical remission at both Week 12 and Week 52.
3:04-3:19
Dr. Nichols:
In this video, let’s discuss how Omvoh was studied in an open-label, long-term extension study.
Let’s take a moment to look over the trial designs.
The long-term efficacy of Omvoh was assessed in participants who completed LUCENT-2 on Omvoh and continued into the open-label LUCENT-3 trial.
3:20-3:27
Dr. Nichols:
Safety, on the other hand, included the experience of all adult patients who received at least one dose of Omvoh during the clinical trials.
3:28-4:13
Dr. Nichols:
Per a post hoc analysis, among patients who achieved clinical response with Omvoh at 1 year, 63% of patients taking Omvoh had achieved long-term clinical remission at 2 years.
When assessing long-term data, it’s important to note the limitations of the LUCENT-3 trial , such as the lack of a placebo comparison arm and that patients remaining in the extension study may have had a better outcome than patients who left the study.
There may be missing data as patients are followed over time. One of the ways to address this is by using a variety of statistical methods, one of which is mNRI.
I think it’s helpful to see what the clinical trial has shown for patients on Omvoh; however, statistical conclusions cannot be drawn because these two-year data come from a post hoc analysis.conclusions cannot be drawn because these two-year data come from a post hoc analysis.
4:14-4:56
Dr. Nichols:
Looking at additional data from the LUCENT-3 post hoc analysis, 54% of patients achieved bowel urgency improvement, marked by a weekly average urgency numeric rating score of 0 to 1.
61% of patients were in corticosteroid-free clinical remission.
To me, reducing mucosal inflammation is the most important long-term goal, and at two years, this shows 66% of patients had achieved endoscopic improvement, with 52% reaching histologic and endoscopic mucosal improvement, or HEMI.
These data support the idea that patients who respond well initially to their treatment may continue to maintain improvements for up to two years.
4:57-5:05
Dr. Nichols:
Looking at the safety data, no new safety signals were identified during 2 years of treatment with Omvoh.
5:06-5:36
Dr. Nichols:
I’ve found the LUCENT-3 interim analysis to show encouraging data on the potential for long-term clinical remission for patients who have been on Omvoh treatment for two years. This is further supported by data on symptoms like bowel urgency, and objective measures like endoscopic improvement.
I’m hopeful to see the lasting difference Omvoh could make for my patients.
For your adult patients with moderately to severely active UC who have inadequate response to their current treatment, make the urgent change with Omvoh.
5:37-5:47
Dr. Nichols:
For more information, visit Lilly Play and omvoh.lilly.com/hcp
Please continue watching for additional important safety information.
5:48-6:29
Narrator:
Additional Important Safety Information. 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.
6:30-7:11
Narrator:
Tuberculosis. Evaluate patients for tuberculosis, or 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.
7:12-8:02
Narrator:
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.
8:03-8:30
Narrator:
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.
8:31-9:50
Narrator:
Adverse reactions. Most common adverse reactions associated with Omvoh — greater than or equal to 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 — greater than or equal to 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 per 15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg per mL solution or a 200 mg per 2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.
Please see Prescribing Information and Medication Guide for Omvoh. Please see Instructions for Use included with the device.
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