Drug Trials Snapshots: OMVOH
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the WINREVAIR Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
OMVOH (mirikizumab-mrkz)
ahm-VOH
Eli Lilly and Company
Approval date: October 26, 2023
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
OMVOH is an antibody that prevents signaling of the human IL-23 cytokine used to treat adults with moderately to severely active ulcerative colitis (UC).
How is this drug used?
OMVOH is an infusion that is administered in a healthcare facility by a healthcare provider directly into the vein (intravenous [IV] infusion) over 30 minutes every four weeks for the first three doses (Weeks 0, 4, and 8). After the first three doses of IV infusions, OMVOH is administered as an injection under the skin (subcutaneous [SC] injection) starting at Week 12, and every four weeks thereafter.
The healthcare provider will decide how many treatment cycles will be given.
Who participated in the clinical trials?
The FDA approved OMVOH based on evidence from two clinical trials of 1,062 patients with moderately to severely active UC. The trials were conducted at 383 sites from 35 countries in Eastern Europe (Czech Republic, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia), Western Europe (Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom), Asia (China, India, Japan, South Korea, Malaysia, Taiwan), North America (Canada, United States of America), Central and South America (Argentina, Mexico), and rest of the world (Australia, Israel, Russian Federation, Serbia, Turkey, Ukraine).
Approximately 13% (135) of the patients were from the United States. In addition, 36% (385) were from Europe, 24% (253) were from Asia, 16% (165) were from North America that included patients from the United States and Canada, 2% (18) were from Central and South America, and 23% (241) were from the rest of the world.
How were the trials designed?
The safety and efficacy of OMVOH were evaluated in two randomized, double-blind, placebo-controlled clinical trials that enrolled patients with moderately to severely active UC.
The first study (UC-1) was 12 weeks in duration and the primary endpoint was clinical remission at Week 12. UC-1 compared OMVOH 300 mg IV every four weeks for 12 weeks to placebo. Patients who responded to OMVOH during UC-1 were subsequently enrolled in a second study (UC-2) that was 40 weeks in duration. UC-2 compared OMVOH 200 mg SC every four weeks to placebo, and the primary endpoint was clinical remission at Week 40 (a total of 52 weeks of treatment).
How were the trials designed?
UC-1 was a multicenter, randomized, double-blind, parallel-arm, placebo-controlled trial designed to evaluate the safety and efficacy of OMVOH, compared with placebo, over a 12-week induction period. The trial population included patients with moderately to severely active UC who had an inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine, azathioprine), biologic therapy (tumor necrosis factor [TNF] blocker, vedolizumab), or tofacitinib. A total of 1,062 patients from 35 countries were randomized with a 3:1 ratio to receive blinded OMVOH 300 mg IV or placebo every four weeks at Weeks 0, 4, and 8. The primary efficacy endpoint was the proportion of patients in clinical remission at Week 12.
UC-2 was a multicenter, randomized, double-blind, parallel-arm, placebo-controlled study designed to evaluate the safety and efficacy of OMVOH, compared with placebo, in achieving remission of UC at Week 40 in patients who completed the 12-week induction trial UC-1. A total of 544 subjects entered UC-2 and were randomized with a 2:1 ratio to receive blinded OMVOH 300 mg SC or placebo every four weeks. The primary efficacy endpoint was the proportion of patients in clinical remission at Week 40.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes the percentage of male and female patients enrolled in the clinical trials that evaluated the efficacy of OMVOH.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trials that evaluated the efficacy of OMVOH.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Review
* Other: Race not reported (10 patients) or multiple races (3 patients)
Figure 3 summarizes the percentage of patients by age enrolled in the clinical trials that evaluated the efficacy of OMVOH.
Figure 3. Baseline Demographics by Age
Source: Adapted from FDA Review
Figure 4 summarizes the percentage of patients by ethnicity in the clinical trials that evaluated the efficacy of OMVOH.
Figure 4. Baseline Demographics by Ethnicity
Source: Adapted from FDA Review
Who participated in the trials?
Table 1. Baseline Demographics in Efficacy Population
Demographic |
OMVOH N=1062 n (%) |
Sex |
|
Male |
635 (60) |
Female |
427 (40) |
Age, years |
|
<65 |
981 (92) |
≥65 |
81 (8) |
Race |
|
White |
757 (71) |
Asian |
269 (26) |
Black or African American |
11 (1) |
American Indian or Alaska Native |
12 (1) |
Other |
13 (1) |
Ethnicity |
|
Hispanic or Latino |
35 (3) |
Not Hispanic or Latino |
786 (74) |
Not reported or unknown |
241 (23) |
Country |
|
United States |
135 (13) |
Outside the United States |
927 (87) |
Source: Adapted from FDA Review
What are the benefits of this drug?
OMVOH was better than placebo at helping to get UC under control (induce clinical remission) and keep UC under control (maintain clinical remission). It may help reduce or stop the need to take corticosteroid medicines. It also may help improve the way the lining of the large intestine looks to a healthcare provider during a colonoscopy procedure.
What are the benefits of this drug (results of trials used to assess efficacy)?
Efficacy results for the primary analysis of clinical remission are presented in Table 2 (UC-1 at Week 12) and Table 3 (UC-2 at Week 40).
For the primary endpoint of clinical remission at Week 12 in UC-1, patients who received OMVOH 300 mg IV had a statistically significant higher rate of clinical remission than patients who received placebo.
For the primary endpoint of clinical remission at Week 40 in UC-2, patients who received OMVOH 200 mg SC had a statistically significant higher rate of clinical remission than patients who received placebo.
Table 2. Clinical Remission at Week 12, UC-1
Parameter |
OMVOH 300 mg IV Q4W N=795 |
Placebo N=267 |
Clinical remission at Week 12, n (%) |
187 (23.5) |
37 (13.9) |
Treatment difference, (95% CI) |
9.9 (4.8, 15.0) |
|
P-value |
0.00057 |
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; IV, intravenous; N, number of subjects in treatment group; Q4W, once every four weeks
Table 3. Clinical Remission at Week 40, UC-2
Parameter |
OMVOH 200 mg SC Q4W N=337 |
Placebo N=169 |
Clinical remission at Week 40, n (%) |
170 (50.4) |
44 (26.0) |
Treatment difference, (95% CI) |
22.7 (14.3, 31.0) |
|
P-value |
<0.001 |
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; N, number of subjects in treatment group; Q4W, once every four weeks; SC, subcutaneous
Were there any differences in how well the drug worked in clinical trials among sex, race, and age ?
- Sex: OMVOH was similarly effective in males and females.
- Race: OMVOH worked similarly in White and Asian patients. The number of patients of races other than White and Asian was limited; therefore, differences in response among other races could not be determined.
- Age: There was an insufficient number of patients older than 65 years of age to determine whether OMVOH worked differently in older adults.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Subgroup analyses were conducted to assess the potential for differences in the treatment effect for various demographics. Table 4 and Table 5 summarize efficacy results by age, sex, race, and ethnicity for UC-1 and UC-2, respectively. Overall, the treatment effect of OMVOH compared to placebo appeared consistent across demographic subgroups of sex. However, there was an insufficient number of patients of races other than White and Asian, Hispanic or Latino ethnicity, and older than 65 years of age to determine whether OMVOH worked differently in other races, ethnicities, or older adults, respectively.
Table 4. Clinical Remission at Week 12 by Sex, Age, Race, and Ethnicity, UC-1
Group |
OMVOH 300 mg IV Q4W n/N (%) |
Placebo n/N (%) |
Difference % (95% CI) |
Sex |
|
|
|
Male |
93/488 (19) |
19/147 (13) |
6 (0, 123) |
Female |
94/307 (31) |
18/120 (15) |
16 (7, 24) |
Age |
|
|
|
<65 |
179/731 (24) |
34/250 (14) |
11 (6, 16) |
≥65 |
8/64 (13) |
3/17 (18) |
-5 (-25, 15) |
Race |
|
|
|
White |
123/558 (22) |
26/199 (13) |
9 (3, 15) |
Asian |
59/207 (29) |
8/62 (13) |
16 (5, 26) |
Others1 |
5/30 (17) |
3/6 (50) |
-33 (-75, 9) |
Ethnicity |
|
|
|
Hispanic or Latino |
5/25 (20) |
1/10 (10) |
10 (-14, 34) |
Not Hispanic or Latino |
143/581 (25) |
31/205 (15) |
10 (4, 16) |
Source: Adapted from FDA Review
1 Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Multiracial people
Abbreviation: N, number of subjects in the subgroup; Q4W, once every 4 weeks; IV, intravenous; CI, confidence interval
Table 5. Clinical Remission at Week 40 by Sex, Age, Race, and Ethnicity, UC-2
Group |
OMVOH 200 mg SC Q4W n/N (%) |
Placebo n/N (%) |
Difference % (95% CI) |
Sex |
|
|
|
Male |
104/199 (52) |
24/97 (25) |
28 (17, 39) |
Female |
66/138 (48) |
20/72 (28) |
20 (7, 33) |
Age |
|
|
|
<65 |
155/307 (50) |
40/162 (25) |
26 (17, 35) |
≥65 |
15/30 (50) |
4/7 (57) |
-7 (-48, 34) |
Race |
|
|
|
White |
124/240 (52) |
31/117 (26) |
25 (15, 35) |
Asian |
39/86 (45) |
13/49 (27) |
19 (3, 35) |
Others1 |
7/11 (64) |
0/3 (0) |
64 (35, 92) |
Ethnicity |
|
|
|
Hispanic or Latino |
6/15 (40) |
0/1 (0) |
40 (15, 65) |
Not Hispanic or Latino |
132/254 (52) |
35/128 (27) |
25 (15, 35) |
Source: Adapted from FDA Review
1 Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Multiracial people
Abbreviation: N, number of subjects in the subgroup; Q4W, once every 4 weeks; IV, intravenous; CI, confidence interval
What are the possible side effects?
OMVOH may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. OMVOH may also increase the risk of serious infections and liver injury.
The most common side effects in patients treated with OMVOH include upper respiratory infections, joint pain, rash, injection site reaction, headache, and herpes viral infections.
What are the possible side effects (results of trials used to assess safety)?
A summary of adverse reactions reported during UC-1 is provided in Table 6, and UC-2 provided in Table 7.
Table 6. Adverse Reactions1 by Week 12, UC-1
Adverse Reactions |
OMVOH 300 mg IV Q4W2 N=958 n (%) |
Placebo N=321 n (%) |
Upper respiratory tract infections3 |
72 (8) |
20 (6) |
Arthralgia |
20 (2) |
4 (1) |
Source: OMVOH Prescribing Information
1 Reported in at least 2% of subjects and at a higher frequency than placebo
2 OMVOH 300 mg as an IV infusion at Weeks 0, 4, and 8
3 Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection)
Abbreviations: IV, intravenous; N, number of subjects in treatment group; Q4W, once every four weeks
Table 7. Adverse Reactions1 by Week 40, UC-2
Adverse Reactions |
OMVOH 200 mg SC Q4W2 N=389 n (%) |
Placebo N=192 n (%) |
Upper respiratory tract infections3 |
53 (14) |
23 (12) |
Injection site reactions4 |
34 (9) |
8 (4) |
Arthralgia |
26 (7) |
8 (4) |
Rash5 |
16 (4) |
2 (1) |
Headache |
16 (4) |
2 (1) |
Herpes viral infection6 |
9 (2) |
1 (1) |
Source: OMVOH Prescribing Information
1 Reported in at least 2% of subjects and at a higher frequency than placebo
2 OMVOH 200 mg as a SC injection at Week 12 and every four weeks thereafter for up to an additional 40 weeks
3 Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection)
4 Injection site reactions includes related terms (e.g., erythema, hypersensitivity, pain, reaction, and urticaria at the injection site)
5 Rash is composed of several similar terms
6 Herpes viral infection includes related terms (e.g., herpes zoster, herpes simplex, and oral herpes)
Abbreviations: N, number of subjects in treatment group; Q4W, once every four weeks; SC, subcutaneous
Were there any differences in side effects among sex, race, and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The occurrence of side effects was similar in White and Asian patients. The number of patients of races other than White and Asian was limited; therefore, differences in side effects other races could not be determined.
- Age: The number of patients older than 65 was insufficient to determine any differences in side effects in adults older than 65.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Subgroup analyses were conducted to assess the potential for differences in the side effects for various demographics. Overall, the reported side effects of OMVOH compared to placebo appeared consistent between demographic subgroups of sex, and in White and Asian patients. There was an insufficient number of patients older than 65 years of age, races other than White and Asian, and Hispanic or Latino ethnicity to determine any differences in side effects in adults older than 65, races other than White and Asian, and patients of Hispanic or Latino ethnicity.
Table 8. Adverse Events by Week 12 by Sex, Age, Race, and Ethnicity, UC-1
Characteristic |
OMVOH 300 mg IV Q4W1 |
Placebo |
Risk Difference % (95% CI) |
Sex |
|
|
|
Female |
182/367 (49.6) |
66/140 (47.1) |
2.4 (7.3, 12.2) |
Male |
246/591 (41.6) |
83/181 (45.9) |
4.2 (12.5, 4.0) |
Age group, years |
|
|
|
<65 |
394/881 (44.7) |
137/301 (45.5) |
0.8 (7.3, 5.7) |
≥65 |
34/77 (44.2) |
12/20 (60.0) |
-15.8 (40.0, 8.3) |
Race |
|
|
|
White |
315/704 (44.7) |
109/246 (44.3) |
0.4 (6.8, 7.6) |
Asian |
96/223 (43.0) |
36/68 (52.9) |
9.9 (23.4, 3.6) |
American Indian or Alaska Native |
7/10 (70.0) |
0/2 (0) |
70.0 (41.6, 98.4) |
Black or African American |
5/10 (50.0) |
1/2 (50.0) |
0 (75.9, 75.9) |
Native Hawaiian or other Pacific Islander |
0/1 (0) |
0/0 (NA) |
NA |
Ethnicity |
|
|
|
Hispanic or Latino |
14/32 (43.8) |
5/12 (41.7) |
2.1 (30.7, 34.8) |
Not Hispanic or Latino |
303/711 (42.6) |
112/248 (45.2) |
2.5 (9.7, 4.6) |
Not reported |
111/215 (51.6) |
32/61 (52.5) |
0.8 (15.0, 13.4) |
Source: Adapted from FDA Review
1 OMVOH 300 mg as an IV infusion at Weeks 0, 4, and 8
Abbreviations: CI, confidence interval; IV, intravenous; N, number of subjects; NA, not applicable; Q4W, once every four weeks
Table 9. Adverse Events by Week 40 by Sex, Age, Race, and Ethnicity, UC-2
Characteristic |
OMVOH Responders to OMVOH 200 mg SC Q4W1 |
OMVOH Responders to Placebo |
Risk Difference % (95% CI) |
Sex |
|
|
|
Female |
6/160 (3.8) |
7/78 (9.0) |
5.2 (12.2, 1.8) |
Male |
7/229 (3.1) |
8/114 (7.0) |
4.0 (9.2, 1.2) |
Age group, years |
|
|
|
<65 |
10/357 (2.8) |
15/181 (8.3) |
5.5 (9.9, 1.1) |
≥65 |
3/32 (9.4) |
0/11 (0) |
9.4 (0.7, 19.5) |
Race |
|
|
|
White |
10/285 (3.5) |
12/138 (8.7) |
5.2 (10.4, 0.0) |
Asian |
3/93 (3.2) |
3/51 (5.9) |
2.7 (10.0, 4.7) |
Black or African American |
0/6 (0) |
0/0 (NA) |
NA |
American Indian or Alaska Native |
0/3 (0) |
0/1 (0) |
0 (0, 0) |
Ethnicity |
|
|
|
Hispanic or Latino |
0/17 (0) |
0/3 (0) |
0 (0, 0) |
Not Hispanic or Latino |
10/292 (3.4) |
11/145 (7.6) |
4.2 (8.9, 0.6) |
Not reported |
3/80 (3.8) |
4/44 (9.1) |
5.3 (14.8, 4.1) |
Source: Adapted from FDA Review
1 OMVOH 200 mg as a SC injection at Week 12 and every four weeks thereafter for 40 weeks.
Abbreviations: CI, confidence interval; N, number of subjects; NA, not applicable; Q4W, once every four weeks; SC, subcutaneous
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
PRESCRIBING INFORMATION