Clinical Studies, Trial Design & Data | CD | Omvoh® (mirikizumab-mrkz)

Blue banner with hypothetical bio-failed, crohn's disease patient Morgan smiling while wearing a brown apron

The phase 3, randomized, double‑blind trial evaluated Omvoh in adult patients with moderately to severely active CD^1,2*

Co-primary endpoints¹:

Proportion of participants achieving clinical remission (CDAI)^† at Week 52
Proportion of participants achieving endoscopic response^3,a at Week 52

Crohn's disease CD-1 study design showing 12 week induction period and 40 week maintenance period. — The efficacy population in CD-1 consisted of 679 subjects who were randomized 3:1 at Week 0 to receive OMVOH 900 mg by IV infusion at Week 0, Week 4, and Week 8 followed by a dosage of 300 mg by SC injection at Week 12 and then every 4 weeks for 40 weeks, or placebo. Among the 168 patients who were randomized to placebo at baseline, 67 (40%) patients did not achieve clinical response by PRO at Week 12 and were switched to blinded Omvoh induction followed by blinded Omvoh maintenance therapy. Placebo patients who achieved clinical response by patient reported outcome at Week 12 remained on placebo until Week 52. Clinical response by PRO is defined as at least a 30% decrease in SF and/or AP and neither score worse than baseline.

At baseline, all patients had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or a biologic treatment (TNFα antagonist or integrin receptor antagonists).¹

*Moderately to severely active CD was defined by a CDAI of ≥220 and an SES-CD ≥7 (centrally read) for subjects with ileal-colonic or ≥4 for subjects with isolated ileal disease. At baseline, subjects had a median CDAI of 329 and SES-CD of 12.¹
^†Clinical remission is defined as CDAI <150.¹
^‡Endoscopic response is defined as >50% reduction from baseline in SES-CD total score, based on central reading.¹
^aCD-1 also included an active comparator arm, where patients received ~6 mg/kg ustekinumab as an IV infusion at Week 0, followed by 90 mg ustekinumab SC injections at Week 8 and every 8 weeks through the end of CD-1. 247 patients were randomized and included for efficacy analyses. Ustekinumab in CD-1 included US-licensed Stelara^® and EU-authorized ustekinumab. A scientific bridge was not established between these two sources of ustekinumab. Other company and product names are trademarks of their respective owners.^1,3
^bAmong the 168 patients who were randomized to placebo at baseline, 67 (40%) patients did not achieve clinical response by PRO at Week 12 and were switched to blinded Omvoh induction followed by blinded Omvoh maintenance therapy. Placebo patients who achieved clinical response by patient reported outcome at Week 12 remained on placebo until Week 52. Clinical response by PRO is defined as at least a 30% decrease in SF and/or AP and neither score worse than baseline.¹

AP=abdominal pain; CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; PRO=patient-reported outcomes; Q4W=every 4 weeks; SES-CD=Simple Endoscopic Score for Crohn's Disease; SC=subcutaneous; SF=stool frequency subscore; TNF=tumor necrosis factor.

Baseline and prior therapies chart for Omvoh — 511 adult patients were randomized to Omvoh and 168 patients were randomized to placebo

Baseline oral corticosteroid use was reported in 160 (31.3%) in the Omvoh group and 51 (30.4%) in the placebo group

Baseline immunomodulator use was reported in 127 (24.9%) in the Omvoh group and 51 (30.4%) in the placebo group

Prior biologic failure was reported in 243 (47.6%) in the Omvoh group and 79 (47.0%) in the placebo group

Prior anti-TNF failure was reported in 227 (44.4%) in the Omvoh group and 72 (42.9%) in the placebo group

Prior anti-integrin failure was reported in 59 (11.5%) in the Omvoh group and 21 (12.5%) in the placebo group

No failed biologics were reported in 268 (52.4%) in the Omvoh group and 89 (53.0%) in the placebo group

1 failed biologic was reported in 154 (30.1%) in the Omvoh group and 54 (32.1%) in the placebo group

≥2 failed biologics were reported in 89 (17.4%) in the Omvoh group and 25 (14.9%) in the placebo group

^aAll participants from the mITT population who have CDAI of ≥220 and an SES-CD ≥7 (or ≥4 for isolated ileal disease) were used for the efficacy analysis.¹

Baseline Demographics and Disease Characteristics — 511 patients took Omvoh and 168 patients took placebo

The average age was 35.9 (SD 13.3) years in the Omvoh group and 34.9 (SD 12.3) in the placebo group

The number of male patients was 297 (58.1%) in the Omvoh group and 97 (57.7%) in the placebo group

The mean body mass index was 23.0 (standard deviation 5.4) in the Omvoh group and 23.7 (standard deviation 6.0) in the placebo group

The body mass index category was underweight (<18.5 kilograms per square meter) for 99 patients (19.4%) in the Omvoh group and 34 patients (20.2%) in the placebo group

The body mass index category was normal (≥18.5 and <25 kilograms per square meter) for 260 patients (50.9%) in the Omvoh group and 81 patients (48.2%) in the placebo group

The body mass index was obese (≥30 and <40 kilograms per square meter) in 47 patients (9.2%) in the Omvoh group and 29 patients (17.3%) in the placebo group

The body mass index was extreme obese (≥40 kilograms per square meter) in 5 patients (1.0%) in the Omvoh group and 2 patients (1.2%) in the placebo group

The mean duration of Crohn’s disease in years was 7.0 (standard deviation 8.0) in the Omvoh group and 7.0 (standard deviation 6.6) in the placebo group

The mean stool frequency daily average was 5.9 (standard deviation 3.1) in the Omvoh group and 6.0 (standard deviation 3.3) in the placebo group

The mean abdominal pain daily average was 2.2 (standard deviation 0.5) in the Omvoh group and 2.2 (standard deviation 0.5) in the placebo group

The mean Simple Endoscopic Score for Crohn’s Disease was 13.8 (standard deviation 6.7) in the Omvoh group and 13.2 (standard deviation 6.0) in the placebo group

The mean Crohn’s Disease Activity Index score was 337.9 (standard deviation 75.6) in the Omvoh group and 337.1 (standard deviation 73.2) in the placebo group

The median C-reactive protein (milligrams per liter) was 8.8 (Q1: 3.2, Q3: 26.1) in the Omvoh group and 7.9 (Q1: 3.1, Q3: 20.4) in the placebo group

The median fecal calprotectin (micrograms per kilogram) was 1430.0 (Q1: 493.0, Q3: 2734.0) in the Omvoh group and 1190.5 (Q1: 445.5, Q3: 2274.5) in the placebo group

The disease location was ileal in 52 patients (10.2%) in the Omvoh group and 16 patients (9.5%) in the placebo group

The disease location was colonic in 204 patients (39.9%) in the Omvoh group and 67 patients (39.9%) in the placebo group

The disease location was ileal-colonic in 255 patients (49.9%) in the Omvoh group and 85 patients (50.6%) in the placebo group

AP=abdominal pain; BMI=body mass index; CDAI=Crohn's Disease Activity Index; CRP=C-reactive protein; mITT=modified intent-to-treat; SES-CD=Simple Endoscopic Score for Crohn's Disease; SD=standard deviation; SF=stool frequency.

^aAll participants from the mITT population who have CDAI of ≥220 and an SES-CD ≥7 (or ≥4 for isolated ileal disease) were used for the efficacy analysis.¹

FOR ADULTS WITH MODERATE TO SEVERE CD¹

Strong clinical remission and endoscopic response at Week 52¹

With rapid reduction in abdominal pain observed as early as Week 6 and stool frequency at Week 12

Co-primary endpoints of clinical remission and endoscopic response chart for Omvoh — In a study of patients taking Omvoh every 4 weeks (N=511) vs patients taking Placebo + Placebo/Omvoh (N=168), 53% of patients taking Omvoh achieved clinical remission at Week 52 (co-primary endpoint; p<0.001) vs 36% taking Placebo/Omvoh, which was 1.5 times greater than Placebo; 46% of patients taking Omvoh achieved endoscopic response at Week 52 (co-primary endpoint; p<0.001) vs 23% taking Placebo + Placebo/Omvoh, which was 2 times greater than Placebo + Placebo/Omvoh.

^aClinical remission is deﬁned as CDAI <150.¹

^bFollowing Omvoh 900 mg as an IV infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg as an SC injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.¹

^cEndoscopic response is deﬁned as a >50% reduction from baseline in SES-CD total score, based on central reading.¹

^dIncludes all 168 subjects randomized to Placebo at baseline. Of those, 67 (40%) subjects did not achieve clinical response (PRO) at Week 12 and were switched to blinded induction and maintenance treatment with Omvoh at Week 12 (designated as Placebo/Omvoh). Eﬃcacy data from these 67 subjects are included here with the remaining subjects randomized to Placebo who did not receive Omvoh (designated as Placebo).¹

CD=Crohn's disease; CDAI=Crohn’s Disease Activity Index; IV=intravenous; PRO=patient-reported-outcome; Q4W=every 4 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn's Disease.

See CD-1 trial design

FOR ADULTS WITH MODERATE TO SEVERE CD¹

**Demonstrated efficacy consistently across both bio‑naive^* and bio-failed^† patients at Week 52¹**

Comparison between Omvoh 300 mg SC Q4W and the placebo in achieving clinical remission in bio-naive and bio-failed patients at week 52. — Clinical remission in bio-naive patients at Week 52 was 56% for patients taking Omvoh 300 mg subcutaneously every 4 weeks (N=268) and 45% for Placebo + Placebo/Omvoh (N=89). Clinical remission in bio-failed patients at Week 52 was 49% for patients taking Omvoh 300 mg subcutaneously every 4 weeks (N=243) and 25% for Placebo + Placebo/Omvoh (N=79). Analysis of this prespecified subgroup was not controlled for multiplicity.

Bio-failed=biologic-failed; bio-naive=biologic-naive; CD=Crohn's disease; TNF=tumor necrosis factor.

See CD-1 trial design

Comparison between Omvoh 300 mg SC Q4W and the placebo endoscopic response in bio-naive and bio-failed patients at week 52. — Endoscopic response in bio-naive patients at Week 52 was 49% for patients taking Omvoh 300 mg subcutaneously every 4 weeks (N=268) and 27% for Placebo + Placebo/Omvoh (N=89). Endoscopic response in bio-failed patients at Week 52 was 43% for patients taking Omvoh 300 mg subcutaneously every 4 weeks (N=243) and 18% for Placebo + Placebo/Omvoh (N=79). Analysis of this prespecified subgroup was not controlled for multiplicity.

^*Bio-naive is defined as without prior biologic failure which includes patients who either had not been treated with biologics or were exposed to biologics but did not experience inadequate response, loss of response, or intolerance.¹
^†Bio-failed is defined as prior biologic failure which includes loss of response, inadequate response, or intolerance to one or more biologic therapy (TNF blockers, and integrin receptor antagonist).¹

^aClinical remission by CDAI is deﬁned as CDAI <150.¹

^bFollowing Omvoh 900 mg as an IV infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg as an SC injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.¹

^cIncludes all 168 subjects randomized to Placebo at baseline. Of those, 67 (40%) subjects did not achieve clinical response (PRO) at Week 12 and were switched to blinded induction and maintenance treatment with Omvoh at Week 12 (designated as Placebo/Omvoh). Eﬃcacy data from these 67 subjects are included here with the remaining subjects randomized to Placebo who did not receive Omvoh (designated as Placebo).¹

^dEndoscopic response is deﬁned as >50% reduction from baseline in SES-CD total score, based on central reading.¹

See CD-1 trial design

OMVOH VS USTEKINUMAB HEAD-TO-HEAD COMPARISON* IN ADULTS WITH MODERATE TO SEVERE CD³

Numerically more bio-failed patients achieved clinical remission (CDAI)^† with Omvoh vs ustekinumab⁵

Clinical Remission (CDAI) of Omvoh vs ustekinumab in Bio-failed Patients at Week 52 — Clinical remission in bio-failed patients at Week 52 was 49% for patients taking Omvoh (N=243) and 42% for patients taking ustekinumab (N=123). Analysis of this prespecified endpoint was not controlled for multiplicity. Statistical significance cannot be concluded.

In the total population: Clinical remission (CDAI) at Week 52 Omvoh (N=511) 53% vs ustekinumab (N=247) 47%⁵

In bio-naived patients: Clinical remission (CDAI) at Week 52 Omvoh (N=268) 56% vs ustekinumab (N=124) 52%⁵

Ustekinumab in CD-1 included US-licensed Stelara^® and EU-authorized ustekinumab. A scientific bridge was not established between these two sources of ustekinumab. Other company and product names are trademarks of their respective owners.

*This was a phase 3, randomized, double-blind trial that included Omvoh, placebo, and active control (ustekinumab) arms.

^†Clinical remission by CDAI is defined as CDAI <150.¹

^aBio-failed is defined as prior biologic failure which includes loss of response, inadequate response, or intolerance to one or more biologic therapy (TNF blockers, and integrin receptor antagonists).¹

^bFollowing Omvoh 900 mg as an IV infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg SC injections at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.¹

^cFollowing ustekinumab ~6 mg/kg as an IV infusion at Week 0, patients received ustekinumab 90 mg SC injections at Week 8 and every 8 weeks through the end of CD-1.¹

^dBio-naive is defined as without prior biologic failure which includes patients who either had not been treated with biologics or were exposed to biologics but did not experience inadequate response, loss of response, or intolerance.¹

Bio-failed=biologic-failed; CD=Crohn’s disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; SC=subcutaneous; TNF=tumor necrosis factor.

See CD-1 trial design

Bowel urgency, a disruptive symptom, in adults with moderate to severe CD^6,7

In a survey,

48%

of patients with CD^* reported wearing a diaper, pad, or other protection at least once a week due to concern or anticipated bowel urgency-related accidents, despite received advanced therapies^6†

*Data from an international cross-sectional survey with 762 CD patients ≥18 years of age. Of those, 472 CD patients were receiving advanced therapies.⁶
^†Advanced therapy=biologic or novel oral therapy.⁶

FOR ADULTS WITH MODERATE TO SEVERE CD¹

Bowel Urgency Reduction Data at Week 52⁸

Patients Achieving Clinical Response (PRO) at Week 12 and UNRS ≤2 at Week 52 — 489 patients took Omvoh and 161 took Placebo + Placebo/Omvoh. 39% of patients who took Omvoh achieved UNRS (0-2) at Week 52 vs 27% with Placebo + Placebo/Omvoh.

Analysis of this prespecified endpoint was not controlled for multiplicity. Statistical significance cannot be concluded.

Reduction in bowel urgency was defined as UNRS weekly average score of (0-2).⁸

^aBowel urgency severity was assessed during CD-1 with an Urgency Numeric Rating Scale (UNRS) of 0 to 10. This 11-point scale ranges from 0 (no urgency) to 10 (worst possible urgency). Patients with a baseline UNRS weekly average score ≥3 were included in this analysis.^8,9

^bFollowing Omvoh 900 mg as an IV infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg as a SC injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.¹

^cIncludes subjects that did not achieve clinical response (PRO) at Week 12 and were switched to blinded induction and maintenance treatment with Omvoh at Week 12 (designated as Placebo/Omvoh). Efficacy data from these subjects are included here with the remaining subjects randomized to Placebo who did not receive Omvoh (designated as Placebo).¹

CD=Crohn’s disease; IV=intravenous; NRI=nonresponder imputation; PRO=patient-reported outcome; SC=subcutaneous; UNRS=Urgency Numeric Rating Scale.

See CD-1 trial design

How did the Omvoh clinical trials measure bowel urgency?^1,9-11

No urgency

Worst Possible Urgency

No urgency

Worst Possible Urgency

Averaged over the past week

The Urgency Numeric Rating Scale (UNRS). No urgency is rated as 0 and worst possible urgency is rated as 10. The daily reported scores are averaged over one week.

Bowel urgency is defined as the sudden or immediate need to have a bowel movement^1,9,10
Patients reported the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency) over the past 24 hours using the 11-point Urgency Numeric Rating Scale (UNRS), which is a valid and reliable measure of urgency^9-11
The UNRS scores recorded in a daily diary by the patients were averaged over one week¹⁰

Fatigue, a disruptive symptom of CD could be impacting your patients^6,7

About

86.4%

of patients with CD reported fatigue as a prevalent symptom, and fatigue was ranked as having the greatest impact on patients’ lives^12*

*Data from a cross-sectional survey study with 403 patients ≥18 years of age with CD.¹²

Improvement in one of the most disruptive symptoms reported by patients with CD^1,12,13

See CD-1 trial design

Improvement of Fatigue Was Measured Using the FACIT- Fatigue Scale — Patients taking Omvoh experienced clinically meaningful improvement in fatigue as early as Week 12.

^aAssessed by change from baseline in FACIT-Fatigue. The LS mean change from baseline was 6.2 for patients taking Omvoh (N=508) vs 2.9 for Placebo (N=168). The LS mean values adjusted for baseline FACIT-Fatigue and other covariates reported. At baseline, mean FACIT-Fatigue values were similar across treatment groups and ranged from 31.9-30.9.¹

^bThe eﬀect of Omvoh to improve fatigue after 12 weeks has not been established.

CD=Crohn's disease; FACIT-Fatigue=Functional Assessment of Chronic Illness Therapy-Fatigue; LS mean=least-squares mean.

Long-term Data

Long-term extension study (CD-2): trial design

CD-2 is an ongoing phase 3 open-label long-term extension study evaluating the long-term efficacy and safety of Omvoh up to 3 years in adults with moderately-to-severely active CD. The primary objective is to evaluate the long-term effect of Omvoh in clinical remission by CDAI^* and endoscopic response^† at Week 52 in CD-2. Participants who completed Week 52 of CD-1 and, in the investigator's opinion, would derive clinical benefit from treatment with Omvoh were enrolled in CD-2. The first interim analysis included participants who completed Week 52 of CD-2 (totaling 104 weeks of continuous treatment). Safety was assessed from the first dose in CD-2 through Week 52.²

*Clinical remission by CDAI is defined as CDAI <150.
^†Endoscopic response is defined as >50% reduction from baseline in SES-CD total score, based on central reading.

CD=Crohn’s disease; CDAI=Crohn's Disease Activity Index; SES-CD=Simple Endoscopic Score for Crohn’s disease.

FOR ADULTS WITH MODERATE TO SEVERE CD¹

**About 90% of patients taking Omvoh maintained clinical remission* and endoscopic response^† through 2 years,^† respectively¹⁴**

mNRI analyses showed 89% of patients maintained clinical remission (N=156) and 82% of patients maintained endoscopic response (N=223) at 2 years.¹⁴

clinical remission maintenance - 93% of patients maintained clinical remission (CDAI) at week 104, observed data — Analysis of a pre-specified endpoint among 126 patients who achieved both clinical remission (CDAI) and endoscopic response at Week 52 and who took Omvoh 300 mg subcutaneously every 4 weeks in CD-2, 93% maintained clinical remission at Week 104, observed data.

Edoscopic response maintenance - 87% of patients maintained endoscopic response at week 104, observed data — Analysis of a pre-specified endpoint of 199 patients who achieved endoscopic response at Week 52 and who took Omvoh 300 mg subcutaneously every 4 weeks, 87% maintained endoscopic response at Week 104, observed data.

Open-label extension studies may have selection bias as patients who cannot tolerate treatment or do not respond may drop out of the study prior to the extension.

mNRI analysis imputes the missing values, but patients that discontinue treatment are considered nonresponders.¹⁴

^*Clinical remission by CDAI is defined as CDAI <150.¹
^†Endoscopic response is defined as >50% reduction from baseline in SES-CD total score, based on central reading.¹
^‡Week 104.

CD=Crohn’s disease; CDAI=Crohn’s Disease Activity Index; mITT=modified intent-to-treat; mNRI=modified magnetic resonance imaging; Q4W=every 4 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease.

See CD-2 trial design

FOR ADULTS WITH MODERATE TO SEVERE CD¹

Bowel Urgency Reduction through 2 Years^15,16

UNRS Scores Change from Baseline through 2 years

During CD-1 (52 Weeks), 511 patients took Omvoh with a least square mean change from baseline of -3.45 at Week 52 and 168 patients took Placebo (Weeks 0-12) and Placebo or Placebo/Omvoh (Weeks 12-52) with a least square mean change from baseline of -2.44 at Week 52. During CD-2 (52 Weeks), 223 patients took Omvoh with a least square mean change from baseline of -4.6 at Week 104.

The baseline median UNRS scores were 7.0 for Omvoh patients and 7.1 for Placebo patients.¹

Analysis through week 52 was not controlled for multiplicity. Statistical significance cannot be concluded.

Data after Week 52 only include patients who achieved endoscopic responsed at Week 52 and continued Omvoh 300mg subcutaneous (SC) injection dosing through Week 104.

^aBowel urgency severity was assessed using an Urgency Numeric Rating Scale (UNRS) ranging from 0 (no urgency) to 10 (worst possible urgency).^1,2,9
^bFollowing Omvoh 900 mg as an intravenous infusion at Week 0, Week 4, and Week 8, participants received Omvoh 300 mg as a SC injection at Week 12 and every 4 weeks (Q4W) thereafter.¹
^cIncludes all 168 subjects randomized to Placebo at baseline. Of those, 67 (40%) subjects did not achieve clinical response (PRO) at Week 12 and were switched to blinded induction and maintenance treatment with Omvoh at Week 12 (designated as Placebo/Omvoh). Efficacy data from these 67 subjects are included here with the remaining subjects randomized to Placebo who did not receive Omvoh (designated as Placebo).¹
^dEndoscopic response is defined as >50% reduction from baseline in SES-CD total score, based on central reading. CD-2 has limitations.^1,2,9

CD=Crohn’s disease; LSM=least-square mean; mBOCF=modified baseline observation carried forward; SES-CD=Simple Endoscopic Score for Crohn’s Disease; UNRS=Urgency Numeric Rating Scale

See CD-2 trial design

Hypothetical female Omvoh patient holding a serving tray and standing in front of a green line

Safety Data Across UC and CD Trials

SEE THE DATA

Safety Data Across UC and CD Trials

SEE THE DATA

References:

Omvoh. Prescribing Information. Lilly USA, LLC.
Data on File. DOF-MR-US-0065. Lilly USA, LLC.
Data on File. DOF-MR-US-0058. Lilly USA, LLC.
Data on File. DOF-MR-US-0077. Lilly USA, LLC.
Data on File. DOF-MR-US-0087. Lilly USA, LLC.
Schreiber S, Hunter Gibble TH, Panaccione R, et al. Patient and health care professional perceptions of the experience and impact of symptoms of moderate-to-severe Crohn’s disease in US and Europe: results from the cross-sectional CONFIDE study. Dig Dis Sci. 2024;69(7):2333-2344 (Incl Suppl Mat). doi:10.1007/s10620-024-08434-5
Rubin DT, Sninsky C, Siegmund B, et al. International perspectives on management of inﬂammatory bowel disease: opinion diﬀerences and similarities between patients and physicians from the IBD GAPPS survey. Inﬂamm Bowel Dis. 2021;27(12):1942-1953. doi:10.1093/ibd/izab006
Data on File. DOF-MR-US-0085. Lilly USA, LLC.
Dubinsky MC, Delbecque L, Hunter T, et al. Validation of the bowel urgency numeric rating scale in patients with Crohn's disease: results from a mixed methods study. Qual Life Res. 2023;32(12):3403-3415. doi:10.1007/s11136-023-03494-y
Dubinsky MC, Irving PM, Panaccione R, et al. Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient- reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022;6(1):31. doi:10.1186/s41687-022-00439-w
Dubinsky MC, Shan M, Delbecque L, et al. Psychometric evaluation of the Urgency NRS as a new patient-reported outcome measure for patients with ulcerative colitis. J Patient Rep Outcomes. 2022;6(1):114. doi:10.1186/s41687-022-00522-2
Varma A, Weinstein J, Seabury J, et al. Patient-reported impact of symptoms in Crohn's disease. Am J Gastroenterol. 2022;117(12):2033-2045. doi:10.14309/ajg.0000000000001954
Data on File. DOF-MR-US-0076. Lilly USA, LLC.
Data on File. DOF-MR-US-0066. Lilly USA, LLC.
Data on File. DOF-MR-US-0063. Lilly USA, LLC.
Data on File. DOF-MR-US-0064. Lilly USA, LLC.

IMPORTANT SAFETY INFORMATION for Omvoh (mirikizumab-mrkz)

Warning:

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 300mg/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

Please see Prescribing Information and Medication Guide for Omvoh. Please see Instructions for Use included with the device.

INDICATIONS

Ulcerative Colitis
Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Crohn's Disease
Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.

The phase 3, randomized, double‑blind trial evaluated Omvoh in adult patients with moderately to severely active CD1,2*

Collapse accordion CD-1 Study Design1,3a

Collapse accordion Baseline and Prior Therapies1,4,a

Collapse accordion Baseline Demographics and Disease Characteristics4,a

Strong clinical remission and endoscopic response at Week 521

Collapse accordion Co-primary Endpoints1

Demonstrated efficacy consistently across both bio‑naive* and bio-failed† patients at Week 521

Collapse accordion Clinical Remission (CDAI)a in Bio‑naive and Bio‑failed Patients at Week 521

Collapse accordion Endoscopic Responsed in Bio-naive and Bio-failed Patients at Week 521

Numerically more bio-failed patients achieved clinical remission (CDAI)† with Omvoh vs ustekinumab5

Collapse accordion Clinical Remission (CDAI) of Omvoh vs ustekinumab in Bio-faileda Patients at Week 525

Bowel urgency, a disruptive symptom, in adults with moderate to severe CD6,7

In a survey,

48%

Bowel Urgency Reduction Data at Week 528

Collapse accordion Percentage of Patients Achieving UNRS (0-2)a at Week 528

How did the Omvoh clinical trials measure bowel urgency?1,9-11

Collapse accordion The Urgency Numeric Rating Scale (UNRS)

Fatigue, a disruptive symptom of CD could be impacting your patients6,7

About

86.4%

Improvement in one of the most disruptive symptoms reported by patients with CD1,12,13

Collapse accordion Improvement of Fatigue Was Measured Using the FACIT-Fatigue Scale1

Long-term Data

Long-term extension study (CD-2): trial design

About 90% of patients taking Omvoh maintained clinical remission* and endoscopic response† through 2 years,† respectively14

Collapse accordion Clinical Remission Maintenance2,14

Collapse accordion Endoscopic Response Maintenance2,14

Bowel Urgency Reduction through 2 Years15,16

Collapse accordion UNRS Scores Change from Baseline through 2 years1-3,a

Safety Data Across UC and CD Trials

Safety Data Across UC and CD Trials

IMPORTANT SAFETY INFORMATION for Omvoh (mirikizumab-mrkz)

Warning:

INDICATIONS

The phase 3, randomized, double‑blind trial evaluated Omvoh in adult patients with moderately to severely active CD^1,2*

Strong clinical remission and endoscopic response at Week 52¹

**Demonstrated efficacy consistently across both bio‑naive^* and bio-failed^† patients at Week 52¹**

Numerically more bio-failed patients achieved clinical remission (CDAI)^† with Omvoh vs ustekinumab⁵

Bowel urgency, a disruptive symptom, in adults with moderate to severe CD^6,7

Bowel Urgency Reduction Data at Week 52⁸

How did the Omvoh clinical trials measure bowel urgency?^1,9-11

Fatigue, a disruptive symptom of CD could be impacting your patients^6,7

Improvement in one of the most disruptive symptoms reported by patients with CD^1,12,13

**About 90% of patients taking Omvoh maintained clinical remission* and endoscopic response^† through 2 years,^† respectively¹⁴**

Bowel Urgency Reduction through 2 Years^15,16