Image from the chest up of hypothetical patient Milo

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active ulcerative colitis (UC)¹

Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials¹

Omvoh induction (UC-1) and maintenance (UC-2) study designs. UC-1 was a blinded induction study with 1279 patients randomized 3 to 1 to receive Omvoh 300 mg intravenously every 4 weeks or placebo intravenously every 4 weeks at Weeks 0, 4, and 8. The primary endpoint was clinical remission at Week 12. UC-2 was a blinded maintenance study with 581 patients who had achieved clinical response with Omvoh induction treatment in UC-1 and were re-randomized 2 to 1 to receive Omvoh 200 mg subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. The primary endpoint was clinical remission at Week 40 (Week 52 of Omvoh treatment).

At baseline of UC-1, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment (TNF blocker, vedolizumab), or tofacitinib¹
In UC-2, patients who were on concomitant UC therapies during UC-1 were required to continue on stable doses of oral aminosalicylates and immunomodulator agents. Corticosteroid tapering was required for patients who were receiving oral corticosteroids at baseline and achieved clinical response in UC-1¹

^aPatients with an mMS of 5 to 9 at baseline of UC-1 were included in the efficacy analyses of UC-1 (N=1062) and UC-2 (N=506).¹

IV=intravenous; mMS=modified Mayo score; Q4W=every 4 weeks; SC=subcutaneous; TNF=tumor necrosis factor.

SEE EFFICACY DATA

UC-1 AND UC-2 PATIENT POPULATION

The Omvoh trials included adult patients who had been treated with a prior biologic and those who were bio-naive¹

Baseline and Prior Therapies²

In the induction study (UC-1), 795 adult patients took Omvoh intravenously and 267 patients took placebo
Baseline corticosteroid use was reported in 331 patients (41.6%) in the Omvoh group and 100 patients (37.5%) in the placebo group
Baseline aminosalicylate use was reported in 594 patients (74.7%) in the Omvoh group and 199 patients (74.5%) in the placebo group
Baseline immunomodulator use was reported in 194 patients (24.4%) in the Omvoh group and 62 patients (23.2%) in the placebo group

Prior UC Therapy

450 (56.6%) of patients in the Omvoh group and 155 (58.1%) of patients in the placebo group were biologic- and JAKi-naive
Prior biologic or tofacitinib failure was reported in 331 patients (41.6%) in the Omvoh group and 107 patients (40.1%) in the placebo group
Prior anti-tumor necrosis factor failure was reported in 298 patients (37.5%) in the Omvoh group and 87 patients (32.6%) in the placebo group
Prior vedolizumab failure was reported in 149 patients (18.7%) in the Omvoh group and 52 patients (19.5%) in the placebo group
Prior tofacitinib failure was reported in 33 patients (4.2%) in the Omvoh group and 4 patients (1.5%) in the placebo group
In the maintenance study (UC-2), 337 patients took Omvoh subcutaneously and 169 patients took placebo
Baseline corticosteroid use was reported in 128 patients (38.0%) in the Omvoh group and 65 patients (38.5%) in the placebo group
Baseline aminosalicylate use was reported in 259 patients (76.9%) in the Omvoh group and 126 patients (74.6%) in the placebo group
Baseline immunomodulator use was reported in 69 patients (20.5%) in the Omvoh group and 38 patients (22.5%) in the placebo group

Prior UC Therapy

208 (61.7%) of patients in the Omvoh group and 109 (64.5%) of patients in the placebo group were biologic- and JAKi-naive
Prior biologic or tofacitinib failure was reported in 121 patients (35.9%) in the Omvoh group and 59 patients (34.9%) in the placebo group
Prior anti-tumor necrosis factor failure was reported in 106 patients (31.5%) in the Omvoh group and 53 patients (31.4%) in the placebo group
Prior vedolizumab failure was reported in 44 patients (13.1%) in the Omvoh group and 23 patients (13.6%) in the placebo group
Prior tofacitinib failure was reported in 8 patients (2.4%) in the Omvoh group and 7 patients (4.1%) in the placebo group

Baseline Demographics and Disease Characteristics²

In the induction study (UC-1), 795 adult patients took Omvoh intravenously and 267 patients took placebo
The mean age in years was 42.9 (standard deviation 13.9) in the Omvoh group and 41.4 (standard deviation 13.8) in the placebo group
The number of male patients was 488 (61.4%) in the Omvoh group and 147 (55.1%) in the placebo group
The body mass index category was normal (greater than or equal to 18.5 and less than 25 kilograms per square meter) for 417 patients (52.5%) in the Omvoh group and 132 patients (49.4%) in the placebo group
The body mass index category was overweight, obese, or extremely obese (greater than or equal to 25 kilograms per square meter) in 326 patients (41.0%) in the Omvoh group and 108 patients (40.4%) in the placebo group
The mean duration of ulcerative colitis in years was 7.1 (standard deviation 6.7) in the Omvoh group and 6.9 (standard deviation 7.0) in the placebo group
The disease location was left-side colitis in 500 patients (62.9%) in the Omvoh group and 169 patients (63.5%) in the placebo group
The median baseline modified Mayo score was 7.0 in the Omvoh group and 7.0 in the placebo group
The baseline modified Mayo score category was severe (7-9) in 463 patients (58.2%) in the Omvoh group and 155 patients (58.1%) in the placebo group
The median fecal calprotectin was 1621.5 micrograms per gram (Q1 641.0, Q3 3287.0) in the Omvoh group and 1508.0 micrograms per gram (Q1 684.0, Q3 3317.0) in the placebo group
The median Urgency Numeric Rating Scale score was 7.0 (Q1 5.0, Q3 8.0) in the Omvoh group and 7.0 (Q1 5.0, Q3 8.0) in the placebo group
The median C-reactive protein was 4.3 milligrams per liter (Q1 1.6, Q3 10.3) in the Omvoh group and 4.2 milligrams per liter (Q1 1.2, Q3 10.2) in the placebo group
In the maintenance study (UC-2), 337 patients took Omvoh subcutaneously and 169 patients took placebo
The mean age in years was 43.4 (standard deviation 14.5) in the Omvoh group and 40.9 (standard deviation 12.2) in the placebo group
The number of male patients was 199 (59.1%) in the Omvoh group and 97 (57.4%) in the placebo group
The body mass index category was normal (greater than or equal to 18.5 and less than 25 kilograms per square meter) in 179 patients (53.1%) in the Omvoh group and 95 patients (56.2%) in the placebo group
The body mass index category was overweight, obese, or extremely obese (greater than or equal to 25 kilograms per square meter) in 133 patients (39.5%) in the Omvoh group and 67 patients (39.6%) in the placebo group
The mean duration of ulcerative colitis in years was 6.9 (standard deviation 7.2) in the Omvoh group and 6.8 (standard deviation 5.5) in the placebo group
The disease location was left-side colitis in 215 patients (63.8%) in the Omvoh group and 114 patients (67.5%) in the placebo group
The median baseline modified Mayo score category was 7.0 in the Omvoh group and 7.0 in the placebo group
The baseline modified Mayo score category was severe (7-9) in 184 patients (54.6%) in the Omvoh group and 102 patients (60.4%) in the placebo group
The median Urgency Numeric Rating Scale score was 6.0 (Q1 5.0, Q3 8.0) in the Omvoh group and 7.0 (Q1 5.0, Q3 8.0) in the placebo group
The median fecal calprotectin was 1515.5 micrograms per gram (Q1 592.5, Q3 3064.5) in the Omvoh group and 1789.5 micrograms per gram (Q1 797.5, Q3 3818.0) in the placebo group
The median C-reactive protein was 3.9 milligrams per liter (Q1 1.6, Q3 8.8) in the Omvoh group and 3.3 milligrams per liter (Q1 1.1, Q3 8.4) in the placebo group

^aDisease activity was assessed based on mMS, which ranges from 0 to 9 and has 3 subscores that are each scored from 0 (normal) to 3 (most severe): SF, RB, and findings on centrally read ES.¹

^bThe Urgency Numeric Rating Scale (UNRS) is a patient-reported measure of the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point UNRS ranging from 0 (no urgency) to 10 (worst possibly urgency).³

Bio-naive=biologic-naive; BMI=body mass index; ES=endoscopic subscore; IV=intravenous; JAKi=Janus kinase inhibitor; mMS=modified Mayo score; Q1=first quartile; Q3=third quartile; RB=rectal bleeding subscore; SC=subcutaneous; SD=standard deviation; SF=stool frequency subscore; TNF=tumor necrosis factor; UNRS=Urgency Numeric Rating Scale.

Early clinical improvement and rapid symptom relief

Nearly 2 in 3 patients taking Omvoh achieved clinical response at Week 12¹

65% of patients taking Omvoh achieved clinical response after 12 weeks of induction dosing, and nearly 1 in 4 achieved clinical remission¹

Clinical Response^a (Secondary Endpoint) and Clinical Remission^b (Primary Endpoint) at Week 12¹

Omvoh clinical response (secondary endpoint) and clinical remission (primary endpoint) compared to the placebo at week 12.

795 patients took Omvoh 300 mg intravenously every 4 weeks and 267 patients took placebo. 65% of patients taking Omvoh had clinical response at Week 12 vs 43% with placebo (p less than 0.001). 24% of patients taking Omvoh reached clinical remission at Week 12 vs 15% with placebo (p less than 0.001).

^aClinical response is defined as a decrease in the mMS of ≥2 points with ≥30% decrease from baseline, and either a decrease of ≥1 point in RB from baseline or RB=0 or 1.¹
^bClinical remission based on mMS is defined as: SF=0 or 1, RB=0, and centrally read ES=0 or 1 (excluding friability).¹

ES=endoscopic subscore; IV=intravenous; mMS=modified Mayo score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore.

SEE EFFICACY DATA

Omvoh provided rapid relief of UC symptoms as early as Week 3^4,5

Stool Frequency Subscore Change From Baseline (MMRM) Through Week 12^1,4

Omvoh 300 mg IV Q4W LSM change from baseline in stool frequency subscore (-1.13) over 12 weeks compared to the placebo (-0.78).

795 patients took Omvoh 300 mg intravenously every 4 weeks and 267 patients took placebo. At Week 3, the mean change in stool frequency subscore from baseline was -0.57 in patients taking Omvoh and -0.38 in patients taking placebo. At Week 12, the mean change in stool frequency subscore from baseline in patients taking Omvoh was -1.13 vs -0.78 in patients taking placebo.

Rectal Bleeding Subscore Change From Baseline (MMRM) Through Week 12^1,5

Omvoh 300 mg IV Q4W LSM change from baseline in rectal bleeding subscore (-1.08) over 12 weeks compared to the placebo (-0.80).

795 patients took Omvoh 300 mg intravenously every 4 weeks and 267 patients took placebo. At Week 3, the mean change in rectal bleeding subscore from baseline was -0.64 in patients taking Omvoh and -0.46 in patients taking placebo. At Week 12, the mean change in rectal bleeding subscore from baseline in patients taking Omvoh was -1.08 vs -0.80 in patients taking placebo.

Prespecified analysis not controlled for multiplicity.

The SF subscore is a patient-reported measure. This item reports the number of stools in a 24-hour period, relative to the normal number of stools for that patient in the same period. The normal reference was collected at baseline/screening of the UC-1 trial. The SF subscore was calculated by averaging and rounding the 4-point daily SF subscore over 3 days. Possible values are: (0) Normal number of stools for subject; (1) 1 to 2 stools more than normal; (2) 3 to 4 stools more than normal; (3) 5 or more stools than normal.⁶

The RB subscore is a patient-reported measure. This item reports the most severe amount of blood passed per rectum for a given day, on a 4-point scale. The patient recorded this in a daily electronic diary. RB subscore was calculated by averaging and rounding the 4-point daily RB subscore over 3 days. Possible values are: (0) No blood seen; (1) Streaks of blood with stool less than half of the time; (2) Obvious blood (more than just streaks) or streaks of blood with stool most of the time; (3) Blood alone passed.⁶

ES=endoscopic subscore; IV=intravenous; LSM=least squares mean; MMRM=mixed model repeated measures; mMS=modified Mayo score; Q4W=every 4 weeks; RB=rectal bleeding; SF=stool frequency; UC=ulcerative colitis.

SEE EFFICACY DATA

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH AT WEEK 12¹

51% of patients taking Omvoh were in clinical remission at Week 52¹

Primary Endpoint: Patients Achieving Clinical Remission^a at Week 52¹

Primary endpoint: patients achieving clinical remission at week 52 on Omvoh 200 mg SC Q4W (51%) compared to the placebo (27%).

337 patients took Omvoh 200 mg subcutaneously every 4 weeks and 169 patients took placebo. 51% of patients taking Omvoh achieved clinical remission at Week 52 compared with 27% of patients taking placebo (p less than 0.001).

^aClinical remission based on mMS is defined as: SF=0 or 1, RB=0, and centrally read ES=0 or 1 (excluding friability).¹

Bio-Naive Patients^b

achieved clinical remission at Week 52

53%

Omvoh 200 mg SC Q4W (N=208)

33%

Placebo (N=109)

Bio-Failed Patients^b

achieved clinical remission at Week 52

45%

Omvoh 200 mg SC Q4W (N=121)

15%

Placebo (N=59)

In the bio-naive subgroup, 208 patients took Omvoh 200 mg subcutaneously every 4 weeks and 109 took placebo. 53% of the patients taking Omvoh achieved clinical remission at Week 52 compared with 33% of patients taking placebo. In the bio-failed subgroup, 121 patients took Omvoh 200 mg subcutaneously every 4 weeks and 59 took placebo. 45% of patients taking Omvoh achieved clinical remission at Week 52 compared with 15% taking placebo. Prespecified subgroup analysis not controlled for multiplicity.

Prespecified subgroup analysis not controlled for multiplicity.

^bBio-failed is defined as prior biologic or JAKi failure, which includes loss of response, inadequate response, or intolerance to one or more biologic therapy (TNF blocker or vedolizumab), or tofacitinib. Bio-naive includes biologic-naive and JAKI-naive.¹

50% of patients (N=169/337) were in corticosteroid-free remission with Omvoh vs 27% (N=45/169) with placebo (secondary endpoint, p<0.001).^1,7

Post hoc analysis

99%

(N=169/171) of patients who achieved clinical remission at 1 year of treatment with Omvoh were corticosteroid-free for at least the previous 12 weeks.

Week 52/1 year is defined as the 12-week induction study (UC-1) plus the 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.¹

Corticosteroid-free clinical remission is defined as clinical remission at Week 40 in UC-2 and no corticosteroid use for ≥12 weeks prior to Week 40.¹

Primary endpoint was clinical remission at Week 52.¹

SEE EFFICACY DATA

AMONG PATIENTS WHO ACHIEVED CLINICAL REMISSION WITH OMVOH AT WEEK 12¹

66% of patients maintained clinical remission through 1 year of continuous treatment with Omvoh¹

Secondary Endpoint: Maintenance of Clinical Remission^a at Week 52¹

Secondary endpoint: maintenance of clinical remission at week 52 on Omvoh 200 mg SC Q4W (66%) compared to the placebo (40%).

128 adult patients took Omvoh 200 mg subcutaneously every 4 weeks and 62 patients took placebo. 66% of patients taking Omvoh maintained clinical remission at Week 52 vs 40% of patients taking placebo (p less than 0.01).

Week 52 is defined as the 12-week induction study (UC-1) plus the 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.¹

^aClinical remission based on mMS is defined as: SF=0 or 1, RB=0, and centrally read ES=0 or 1 (excluding friability).¹

Bio-Naive Patients^b

maintained clinical remission at Week 52

66%

Omvoh 200 mg SC Q4W (N=91)

48%

Placebo (N=48)

Bio-Failed Patients^b

maintained clinical remission at Week 52

65%

Omvoh 200 mg SC Q4W (N=34)

14%

Placebo (N=14)

In the bio-naive subgroup, 91 patients took Omvoh 200 mg subcutaneously every 4 weeks and 48 patients took placebo. 66% of patients taking Omvoh maintained clinical remission at Week 52 vs 48% of patients taking placebo. In the bio-failed subgroup, 34 patients took Omvoh 200 mg subcutaneously every 4 weeks and 14 patients took placebo. 65% of patients taking Omvoh maintained clinical remission at Week 52 vs 14% taking placebo. Prespecified subgroup analysis not controlled for multiplicity.

Prespecified subgroup analysis not controlled for multiplicity.

SEE EFFICACY DATA

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH AT WEEK 12¹

Omvoh demonstrated endoscopic improvement and histologic‑endoscopic mucosal improvement (HEMI) at Week 52¹

Secondary Endpoint: Patients Achieving Endoscopic Improvement^a at Week 52¹

Secondary endpoint: patients achieving endoscopic improvement at week 52 on Omvoh 200 mg SC Q4W (58%) compared to the placebo (30%).

337 patients took Omvoh 200 mg subcutaneously every 4 weeks and 169 patients took placebo. 58% of patients taking Omvoh achieved endoscopic improvement at Week 52 vs 30% of patients taking placebo (p less than 0.001).

^aEndoscopic improvement is defined as centrally read ES=0 or 1 (excluding friability).¹

Secondary Endpoint: Patients Achieving HEMI^b at Week 52

337 patients took Omvoh 200 mg subcutaneously every 4 weeks and 169 patients took placebo. 43% of patients taking Omvoh achieved HEMI at Week 52 vs 22% taking placebo (p less than 0.001).

Week 52 is defined as the 12-week induction study (UC-1) plus the 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.¹

UC-2 was not designed to evaluate the relationship of HEMI at Week 40 to disease progression and long-term outcomes.

^bHistologic-endoscopic mucosal improvement is defined as achieving both endoscopic improvement (centrally read endoscopy subscore of 0 or 1, excluding friability) and histologic improvement (no neutrophils in crypts or lamina propria, no crypt destruction, and no erosions, ulcerations, or granulation tissue based on the Geboes scoring system [Geboes score ≤2B.0]).^1,8

SEE EFFICACY DATA

Efficacy data in bio‑naive and JAKi- or bio-failed patients¹

Bio-naive and Bio-failed Patients Achieved Endoscopic Improvement^a at Week 52¹

Bio-Naive Patients^b

achieved endoscopic improvement at Week 52

62%

Omvoh 200 mg SC Q4W (N=208)

35%

Placebo (N=109)

Bio-Failed Patients^b

achieved endoscopic improvement at Week 52

50%

Omvoh 200 mg SC Q4W (N=121)

20%

Placebo (N=59)

Prespecified subgroup analysis not controlled for multiplicity.

^aEndoscopic improvement is defined as centrally read ES=0 or 1 (excluding friability).¹

Bio-naive and Bio-failed Patients Achieved HEMI^c at Week 52¹

Bio-Naive Patients^b

achieved HEMI at Week 52

47%

Omvoh 200 mg SC Q4W (N=208)

27%

Placebo (N=109)

Bio-Failed Patients^b

achieved HEMI at Week 52

36%

Omvoh 200 mg SC Q4W (N=121)

14%

Placebo (N=59)

Prespecified subgroup analysis not controlled for multiplicity.

Week 52 is defined as the 12-week induction study (UC-1) plus the 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.¹

UC-2 was not designed to evaluate the relationship of HEMI at Week 40 to disease progression and long-term outcomes.¹

Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; HEMI=histologic-endoscopic mucosal improvement; JAKi=Janus kinase inhibitor; mMS=modified Mayo score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore; TNF=tumor necrosis factor.

SEE EFFICACY DATA

Bowel urgency is one of the most disruptive symptoms for patients with moderately to severely active ulcerative colitis (UC)^{9, 20}

Patients are concerned they may not make it to the bathroom on time.¹⁰

Bowel urgency’s impact:

72%

of patients (n=468/650) reported a negative impact on their life due to bowel urgency¹¹

Patients may not speak up about urgency’s impact^12:

62%

of patients (n=23/37)¹² who were not comfortable discussing bowel urgency with their doctors stated that the reason was that they were too embarrassed

In a survey,

47%

of patients (n=72/153) on advanced therapy reported wearing a diaper, pad, or other protection at least once a week due to concern or anticipation of a bowel urgency accident¹⁰

Advanced therapy=biologic or novel oral therapy; UC=ulcerative colitis.

Research findings from an online quantitative cross-sectional survey of patients with moderate to severe UC in the US in July 2021 (N=200).

How did the Omvoh clinical trials measure bowel urgency?^1,3,13

The Urgency Numeric Rating Scale (UNRS)

No urgency

Worst Possible Urgency

No urgency

Worst Possible Urgency

Averaged over the past week

Bowel urgency is defined as the sudden or immediate need to have a bowel movement³
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^3,13
The UNRS scores recorded in a daily diary by the patients were averaged over a week³

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH AT WEEK 12 AND HAD BASELINE WEEKLY AVERAGE UNRS ≥3¹

Omvoh reduced bowel urgency, one of patients' most disruptive symptoms^1,19

39% of patients taking Omvoh achieved bowel urgency improvement* vs 23% placebo at Week 52 (p<0.001). Bowel urgency improvement was also observed in a greater proportion of Omvoh patients compared to placebo at Week 12.¹

Patients Who Achieved at Least a 3-Point Reduction in the UNRS Score at Week 52¹⁴

Patients achieved bowel urgency improvement (UNRS=0 to 1) at week 52 on Omvoh 200 mg SC Q4W (39%) compared to the placebo (23%).

There were 307 patients who received Omvoh and 160 patients who received placebo who were included in the analysis. 61% of patients taking Omvoh had at least a 3-point reduction in bowel urgency at Week 52 vs 41% taking placebo.

*Bowel urgency improvement was evaluated at Week 12 in UC-1 and at Week 40 in UC-2 in patients with a baseline UNRS weekly average score of ≥3 and defined as a weekly average score of 0 to 1.¹

Weekly average UNRS scores were calculated and considered missing if the scores were available for <4 days in a given week.

The median baseline UNRS scores were 7 (UC-1) and 6.5 (UC-2).²

Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis; UNRS=Urgency Numeric Rating Scale.

SEE EFFICACY DATA

Long-term Data

Long-term extension trial design (UC‑3)

The efficacy and safety of Omvoh were studied in the UC-1, -2 and -3 clinical trials. UC-3 is a Phase 3, single arm, open-label extension trial evaluating the long-term efficacy of Omvoh in adult patients with moderately to severely active UC who had completed UC-2 on Omvoh, and the long-term safety in adult patients who received at least one dose of Omvoh in the UC trial program. The interim analysis of UC-3 included patients who received Omvoh during UC-1 and completed UC-2 on blinded Omvoh 200 mg SC Q4W (with 152 weeks of continuous therapy).^8,15,16

AMONG PATIENTS WHO ACHIEVED CLINICAL REMISSION* WITH OMVOH AT WEEK 52¹⁷

Omvoh maintained long-term clinical remission^* at 3 years (Week 152)¹⁷

post hoc analysis 81% of patients using Omvoh 200 mg SC Q4W maintained clinical remission at 3 years (Week 152) observed data. — Post hoc analysis: 81% of patients taking Omvoh 200 mg subcutaneously every 4 weeks (N=127) maintained clinical remission at 3 years, observed data.

In an mNRI analysis of 168 patients, 71% of patients maintained clinical remission at 3 years (Week 152).¹⁷

mNRI analysis method uses statistical modeling that imputes the missing values, but patients that discontinue treatment are considered non-responders.

UC-3 is an open-label extension study that has limitations (eg, no placebo comparison, patients remaining in the extension study may have better outcomes than patients who left the study).¹⁶

Data are from a post hoc analysis of the mITT population in the long-term extension study. Descriptive analysis was based on observed data, and NRI and mNRI were also conducted.

*Clinical remission was defined as SF=0 or 1; RB=0; ES=0 or 1 (excluding friability).¹

ES=endoscopic subscore; mITT=modified intent-to-treat; mNRI=modified nonresponder imputation; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore; UC=ulcerative colitis.

SEE PIVOTAL TRIAL DATA

AMONG PATIENTS WHO ACHIEVED CLINICAL REMISSION* WITH OMVOH AT WEEK 52¹⁸

Patients taking Omvoh achieved long-term results across secondary outcomes at 3 years (Week 152)¹⁸

Patients Achieving Long-term Results at 3 Years (Week 152), Observed Data¹⁸

post hoc analysis: Omvoh 200 mg SC Q4W patient long term results for bowel urgency, corticosteroid free clinical remission, endoscopic improvement and HEMI observed data.

Post hoc analysis: The percentage of patients who took Omvoh 200 mg subcutaneously every 4 weeks and achieved the following secondary outcomes at Week 152: bowel urgency improvement; UNRS=0 to 1 (69%, N=119), corticosteroid-free clinical remission (80%, N=127), endoscopic improvement (81%, N=144), histologic-endoscopic mucosal improvement (73%, N=139), observed data.

In an mNRI analysis of 158 patients, 60% of patients achieved bowel urgency improvement at 3 years (Week 152). In an mNRI analysis of 168 patients, 70% of patients achieved corticosteroid‑free clinical remission, 72% achieved endoscopic improvement, and 65% achieved HEMI at 3 years (Week 152).¹⁸

mNRI analysis method uses statistical modeling that imputes the missing values, but patients that discontinue treatment are considered non-responders.

UC-3 is an open-label extension study that has limitations (eg, no placebo comparison, patients remaining in the extension study may have better outcomes than patients who left the study).¹⁶

Data are from a post hoc analysis of the mITT population in the long-term extension study. Descriptive analysis were based on observed data, and NRI and mNRI were also conducted.

The relationship between HEMI and disease progression and long-term outcomes is not known.

*Clinical remission was defined as SF=0 or 1; RB=0; ES=0 or 1 (excluding friability).¹

^aBowel urgency improvement: UNRS=0 to 1.¹

^bCorticosteroid-free clinical remission is defined as clinical remission at Week 152 with no corticosteroid use for ≥12 weeks prior to Week 152.¹

^cEndoscopic improvement is defined as ES=0 or 1 (excluding friability).¹

^dHEMI is defined as achieving both endoscopic improvement (centrally read ES=0 or 1, excluding friability) and histologic improvement (no neutrophils in crypts or lamina propria, no crypt destruction, and no erosions, ulcerations, or granulation tissue based on the Geboes scoring system [Geboes score ≤2B.0]).¹

mITT=modified intent-to-treat; ES=endoscopic subscore; HEMI=histologic-endoscopic mucosal improvement; mNRI=modified nonresponder imputation; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore; UNRS=Urgency Numeric Rating Scale.

SEE PIVOTAL TRIAL DATA

hypothetical patient Mona smiling and standing with her arms crossed

See the safety profile across trials

EXPLORE THE SAFETY DATA

See the safety profile across trials

EXPLORE THE SAFETY DATA

References:

Omvoh (mirikizumab-mrkz). Prescribing Information. Lilly USA, LLC.
Data on File. DOF-MR-US-0011. Lilly USA, LLC.
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
Data on File. DOF-MR-US-0013. Lilly USA, LLC.
Data on File. DOF-MR-US-0012. Lilly USA, LLC.
US Food and Drug Administration. Ulcerative colitis: clinical trial endpoints guidance for industry. Draft guidance. Federal Register. 2016;7-18.
Data on File. DOF-MR-US-0019. Lilly USA, LLC.
D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940
Carpio D, López-Sanromán A, Calvet X, et al. Perception of disease burden and treatment satisfaction in patients with ulcerative colitis from outpatient clinics in Spain: UC-LIFE survey. Eur J Gastroenterol Hepatol. 2016;28(9):1056-1064. doi:10.1097/MEG.0000000000000658
Schreiber S, Travis S, Potts Bleakman A, et al. Communicating needs and features of IBD experiences (CONFIDE) survey: burden and impact of bowel urgency on patients with moderate to severe ulcerative colitis. Gastroenterology. 2022;162:S79-S112. doi:10.1093/ibd/izac015.127
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
Rubin D, Panaccione R, Potts Bleakman A, et al. Communicating needs and features of IBD experiences (CONFIDE) survey: patient and health care professional perspectives on experience of ulcerative colitis symptoms. Poster presented at: Advances in Inflammatory Bowel Diseases (AIBD); December 9-11, 2021; Orlando, FL. aibd2021.01d0092
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/s41 687-022-00522-2
Data on File. DOF-MR-US-0059. Lilly USA, LLC.
A study to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT 3). ClinicalTrials.gov identifier: NCT03519945. Updated July 22, 2024. Accessed August 9, 2024. Available from: https://clinicaltrials.gov/study/NCT03519945
Sands BE, D'Haens G, Clemow DB, 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. Inflamm Bowel Dis. Published online October 25, 2024;Epub:izae253 (Incl Suppl Mat). doi:10.1093/ibd/izae253
Data on file. DOF-MR-US-0049. Lilly USA, LLC.
Data on file. DOF-MR-US-0052. Lilly USA, LLC.
Dubinsky M, Bleakman AP, Panaccione R. Bowel urgency in ulcerative colitis: current perspectives and future directions. Am J Gastroenterol. 2023;118:1940-1953. /doi.org/10.14309/ajg.0000000000002404
Simon Travis, Alison Potts Bleakman, Marla C Dubinsky, Stefan Schreiber, Remo Panaccione, Toshifumi Hibi, Theresa Hunter Gibble, Cem Kayhan, Christian Atkinson, Christophe Sapin, Eoin J Flynn, David T Rubin, The Communicating Needs and Features of IBD Experiences (CONFIDE) Study: US and European Patient and Health Care Professional Perceptions of the Experience and Impact of Symptoms of Moderate-to-Severe Ulcerative Colitis, Inflammatory Bowel Diseases, Volume 30, Issue 6, June 2024, Pages 939–949, https://doi.org/10.1093/ibd/izad142

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.

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active ulcerative colitis (UC)1

Post hoc analysis

Post hoc analysis

Bowel urgency’s impact:

72%

Patients may not speak up about urgency’s impact12:

62%

In a survey,

47%

See the safety profile across trials

See the safety profile across trials

IMPORTANT SAFETY INFORMATION for Omvoh (mirikizumab-mrkz)

Warning:

INDICATIONS

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active ulcerative colitis (UC)¹

Patients may not speak up about urgency’s impact^12: