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Omvoh ™ (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What were the results of the phase 3 clinical trial of mirikizumab for the treatment of Crohn's disease in adults?
A significantly greater proportion of patients in the mirikizumab group than in the placebo group achieved both co-primary endpoints in the VIVID-1 study (p<.000001).
VIVID-1 Study Design
VIVID-1 was a phase 3, multicenter, randomized, double-blind, active- and placebo-controlled, treat-through study in patients with moderate-to-severe Crohn's disease.1
Key Eligibility Criteria
Inclusion Criteria
To be eligible for the study, participants had to
- be aged 18 to 80 years
- have a diagnosis of Crohn's disease or fistulizing Crohn's disease for at least 3 months prior to study enrollment
- have moderately to severely active Crohn's disease, defined as
- an unweighted baseline daily average loose stool frequency (SF) of at least 4, and/or
- an unweighted baseline daily average abdominal pain (AP) of at least 2
- have a Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 7 in patients with ileal-colonic disease or at least 4 in patients with isolated ileal disease within 21 days before randomization, and
- have had an inadequate response, loss of response, or intolerance to at least 1 conventional corticosteroid, immunomodulator, or approved biologic therapy for Crohn's disease.1-3
Enrollment of patients with both SES-CD of at least 3 but less than 7 (or less than 4 in patients with isolated ileal disease) and the presence of at least 1 large ulcer in the ileum, colon, or both that resulted in a minimum score of 1 for the component of "ulcerated surface" was limited to approximately 10% of total enrollment.1
Exclusion Criteria
Patients who had previously received anti-interleukin-23 antibodies, except for no more than 2 doses of ustekinumab and had not failed or had an intolerance to ustekinumab, were excluded from the study.1
Treatment Arms
In this treat-through study, a total of 1152 patients were randomized 6:3:2 to either
- mirikizumab 900 mg infused intravenously (IV) every 4 weeks for 3 doses followed by 300 mg injected subcutaneously (SC) every 4 weeks through week 52
- ustekinumab 6 mg/kg infused IV for one dose followed by 90 mg injected SC every 8 weeks through week 52, or
- placebo.1
From weeks 8 through 20, all patients received their assigned treatment and matching placebo via both intravenous infusion and subcutaneous injection.1
Patients Randomized to Placebo
Patients randomized to placebo received an IV infusion every 4 weeks for 3 doses. At week 12, patients were classified as responders if they had achieved at least a 30% decrease in loose SF and/or AP, with neither score higher than baseline.1
- Placebo responders received another 3 doses of placebo infused IV every 4 weeks for 3 doses followed by placebo injected SC every 4 weeks through week 52.1
- Placebo nonresponders received mirikizumab 900 mg infused IV every 4 weeks for 3 doses followed by 300 mg injected SC every 4 weeks through week 52.1
Endpoints
Mirikizumab Compared With Placebo
The primary objective of the VIVID-1 study was to evaluate the efficacy and safety of mirikizumab with that of placebo in patients with moderately to severely active Crohn's disease. The co-primary efficacy endpoints were
- patient-reported outcomes (PRO) clinical response at week 12 and endoscopic response at week 52, and
- PRO clinical response at week 12 and clinical remission by Crohn's Disease Activity Index (CDAI) at week 52.4
The key secondary endpoints were
- endoscopic response at week 12
- CDAI clinical remission at week 12
- PRO clinical response at week 12
- endoscopic remission at week 12
- endoscopic response at week 52
- CDAI clinical remission at week 52
- composite endpoints of
- PRO clinical response at week 12 and PRO clinical remission at week 52
- PRO clinical response at week 12 and corticosteroid-free remission at week 52, and
- PRO clinical response at week 12 and endoscopic remission at week 52.4
The endpoints are defined in the Appendix.
Mirikizumab Compared With Ustekinumab
The secondary objective of the VIVID-1 study was to assess the proportion of patients who received mirikizumab and the proportion of patients who received ustekinumab who achieved
- the gated endpoints of
- endoscopic response at week 52, and
- CDAI clinical remission at week 52, and
- the non-multiplicity-adjusted endpoints of
- endoscopic remission at week 52
- corticosteroid-free CDAI clinical remission at week 52, and
- the composite of CDAI clinical remission and endoscopic response at week 52.2
The endpoints are defined in the Appendix.
Baseline Demographics and Disease Characteristics
Overall, the baseline demographics and disease characteristics were similar among the 3 treatment groups ().2
Approximately, half of the patients in each treatment group had failed at least one biologic, and the proportion of patients who had failed more than one biologic was
|
Mirikizumab (n=579) |
Ustekinumab (n=287) |
Placebo (n=199) |
Age (years), mean (SD) |
36.0 (13.2) |
36.6 (12.7) |
36.3 (12.7) |
Male, n (%) |
332 (57.3) |
137 (47.7) |
118 (59.3) |
Weight (kg), mean (SD) |
68.0 (18.3) |
66.9 (17.6) |
69.5 (19.0) |
BMI, mean (SD) |
|||
Underweight (<18.5 kg/m2) |
109 (18.8) |
52 (18.1) |
38 (19.1) |
Normal (≥18.5 and <25 kg/m2) |
289 (49.9) |
141 (49.1) |
94 (47.2) |
Overweight (≥25 and <30 kg/m2) |
115 (19.9) |
62 (21.6) |
31 (15.6) |
Obese (≥30 and <40 kg/m2) |
60 (10.4) |
27 (9.4) |
34 (17.1) |
Race, n (%) |
|||
White |
408 (71.5) |
201 (70.3) |
144 (74.6) |
Black or African American |
10 (1.8) |
8 (2.8) |
5 (2.6) |
Asian |
148 (25.9) |
74 (25.9) |
42 (21.8) |
American Indian or Alaska Native |
2 (0.4) |
2 (0.7) |
2 (1.0) |
Multiple |
3 (0.5) |
1 (0.3) |
0 (0.0) |
Geographic region, n (%) |
|||
North America |
77 (13.3) |
37 (12.9) |
27 (13.6) |
Europe |
310 (53.5) |
155 (54.0) |
109 (54.8) |
Other |
192 (33.2) |
95 (33.1) |
63 (31.7) |
Duration of Crohn's disease (years), mean (SD) |
7.4 (8.2) |
7.2 (7.7) |
7.8 (7.4) |
Duration of Crohn's disease (years), median (IQR) |
4.6 (1.7-9.3) |
5.1 (2.2-9.0) |
5.6 (2.0-10.4) |
Baseline CDAI, mean (SD) |
323.1 (85.8) |
318.5 (93.2) |
318.9 (86.2) |
SF daily average, mean (SD) |
5.7 (3.0) |
5.7 (2.9) |
5.8 (3.2) |
AP daily average, mean (SD) |
2.1 (0.6) |
2.1 (0.6) |
2.1 (0.6) |
Baseline CDAI, median (IQR) |
318.0 (268.0-374.9) |
309.6 (247.0-379.0) |
320.3 (259.6-374.7) |
SF daily average, median (IQR) |
5.6 (4.1-6.7) |
5.4 (4.1-7.0) |
5.6 (4.1-7.1) |
AP score daily average, median (IQR) |
2.0 (2.0-2.6) |
2.0 (1.7-2.6) |
2.0 (2.0-2.4) |
SES-CD total score, mean (SD) |
13.5 (6.6) |
13.9 (6.6) |
13.1 (6.0) |
SES-CD total score, median (IQR) |
11.7 (8.5-17.5) |
12.0 (8.5-18.0) |
11.5 (8.7-17.0) |
CRP (mg/L), median (IQR) |
8.5 (2.9-5.0) |
8.9 (3.4-24.8) |
7.6 (2.9-18.8) |
FCal (μg/g), median (Q1, Q3) |
1315.0 (444.0, 2676.0) |
1489.0 (519.0, 2814.0) |
1161.0 (324.0, 2170.0) |
Disease location, n (%) |
|||
Ileum only |
65 (11.2) |
29 (10.1) |
19 (9.5) |
Colon only |
225 (38.9) |
120 (41.8) |
77 (38.7) |
Ileum and colon |
289 (49.9) |
138 (48.1) |
103 (51.8) |
Baseline corticosteroid use, n (%) |
177 (30.6) |
90 (31.4) |
58 (29.1) |
Prednisone equivalent dose, mg, median (range) |
20 (3-30) |
16 (5-100) |
15 (5-30) |
Budesonide use, n (%) |
63 (10.9) |
27 (9.4) |
23 (11.6) |
Baseline immunomodulator use, n (%) |
146 (25.2) |
87 (30.3) |
58 (29.1) |
Prior ustekinumab use, n (%) |
4 (0.7) |
1 (0.3) |
2 (1.0) |
Prior biologic failure, n (%) |
281 (48.5) |
139 (48.4) |
97 (48.7) |
Number of failed biologics, n (%) |
|||
0 |
298 (51.5) |
148 (51.6) |
102 (51.3) |
1 |
175 (30.2) |
91 (31.7) |
66 (33.2) |
2 |
82 (14.2) |
42 (14.6) |
25 (12.6) |
>2 |
24 (4.1) |
6 (2.1) |
6 (3.0) |
Abbreviations: AP = abdominal pain; BMI = body mass index; CDAI = Crohn's Disease Activity Index; CRP = C-reactive protein; FCal = fecal calprotectin; IQR = interquartile range; SES-CD = Simple Endoscopic Score for Crohn's disease; SF = stool frequency.
Summary of Efficacy
Primary Efficacy of Mirikizumab Compared With Placebo in the VIVID-1 Study
A significantly greater proportion of patients in the mirikizumab group than in the placebo group achieved the co-primary endpoints regardless of biologic failure status (p<.001). In addition, the mirikizumab group met all key secondary endpoints compared with placebo (p<.01, ).3,4
Endpointa |
Mirikizumab (n=579) |
Placebo (n=199) |
Co-primary endpoints |
||
Week 12 PRO clinical response and week 52 endoscopic response |
220 (38.0)b |
18 (9.0) |
Not biologic failed |
117 (39.3)b |
12 (11.8) |
Biologic failed |
103 (36.7)b |
6 (6.2) |
Week 12 PRO clinical response and week 52 CDAI clinical remission |
263 (45.4)b |
39 (19.6) |
Not biologic failed |
141 (47.3)c |
27 (26.5) |
Biologic failed |
122 (43.4)b |
12 (12.4) |
Key secondary endpoints |
||
Week 12 |
||
Endoscopic response |
188 (32.5)b |
25 (12.6) |
CDAI clinical remission |
218 (37.7)d |
50 (25.1) |
PRO clinical response |
409 (70.6)e |
103 (51.8) |
Endoscopic remission |
102 (17.6)c |
14 (7.0) |
Week 52 |
||
Endoscopic responsef |
280 (48.4)b |
18 (9.0) |
CDAI clinical remissionf |
313 (54.1)b |
39 (19.6) |
Composite endpoints |
||
Week 12 PRO clinical response and week 52 PRO clinical remission |
263 (45.4)b |
39 (19.6) |
Week 12 PRO clinical response and week 52 CS-free remission |
253 (43.7)b |
37 (18.6) |
Week 12 PRO clinical response and week 52 endoscopic remission |
136 (23.5)b |
8 (4.0) |
Abbreviations: CDAI = Crohn's Disease Activity Index; CS = corticosteroid; PRO = patient-reported outcome.
Note: The analysis used nonresponder imputation.
aData are presented as n (%).
bp<.000001 vs placebo.
cp<.001 vs placebo.
dp<.01 vs placebo.
ep<.00001 vs placebo.
fThe treat-through result reflects the week 52 endpoint regardless of response status at week 12.
Efficacy of Mirikizumab Compared With Ustekinumab in the VIVID-1 Study
Mirikizumab was noninferior to ustekinumab for CDAI clinical remission and was superior to ustekinumab in achieving the composite of CDAI clinical remission and endoscopic response (p<.05) at week 52.1
The proportions of patients who achieved endoscopic response, CDAI corticosteroid-free clinical remission, and endoscopic remission were similar among the mirikizumab and ustekinumab treatment groups.1
Compared with ustekinumab, although not significant, a greater proportion of patients in the mirikizumab group who had previously failed a biologic for the treatment of Crohn's disease achieved the clinical and endoscopic endpoints.1
Endpointa |
Mirikizumab |
Ustekinumab |
Placebo |
CDAI clinical remission |
313/579 (54.1)b |
139/287 (48.4) |
39/199 (19.6) |
Not biologic failed |
169/298 (56.7)b |
81/148 (54.7) |
27/102 (26.5) |
Biologic failed |
144/281 (51.2)b |
58/139 (41.7) |
12/97 (12.4) |
Endoscopic response |
280/579 (48.4)b |
133/287 (46.3) |
18/199 (9.0) |
Not biologic failed |
154/298 (51.7)b |
78/148 (52.7) |
12/102 (11.8) |
Biologic failed |
126/281 (44.8)b |
55/139 (39.6) |
6/97 (6.2) |
CS-free CDAI remission |
300/579 (51.8)b |
131/287 (45.6) |
37/199 (18.6) |
Not biologic failed |
164/298 (55.0)b |
76/148 (51.4) |
25/102 (24.5) |
Biologic failed |
136/281 (48.4)b |
55/139 (39.6) |
12/97 (12.4) |
Endoscopic remission SES-CD ≤4c |
165/579 (28.5)b |
80/287 (27.9) |
8/199 (4.0) |
Composite of clinical remission by CDAI and endoscopic response |
80/287 (27.9) |
12/199 (6.0) |
Abbreviations: CDAI = Crohn's Disease Activity Index; CS = corticosteroid; SES-CD = Simple Endoscopic Score for Crohn's Disease.
Notes: The efficacy analyses for mirikizumab compared with ustekinumab included the multiplicity-adjusted secondary endpoints at week 52 of clinical remission by CDAI (noninferiority test with 10% margin) and endoscopic response (superiority test), and the nonmultiplicity-adjusted secondary endpoints at week 52 of endoscopic remission, CS-free CDAI remission, and the composite of CDAI clinical remission and endoscopic response. Missing data were imputed as nonresponse. Patients who switched to mirikizumab were subsequently treated as nonresponders.
aData are presented as n/N (%).
bp<.0001 vs placebo.
cDefined as 1) SES-CD total score ≤4, 2) ≥2-point reduction in SES-CD total score from baseline, and 3) no SES-CD score >1.
dp<.05 vs ustekinumab.
shows the change from baseline in fecal calprotectin and C-reactive protein (CRP) at weeks 12 and 52 of VIVID-1.
The least-squares mean (LSM) change from baseline in fecal calprotectin was significantly greater in the mirikizumab group compared with
- the placebo group as early as week 4 and was sustained through week 52 (p<.0001), and
- the ustekinumab group at week 28 (p<.05) and was sustained through week 52 (p<.001).1
The LSM change from baseline in CRP was significantly greater in the mirikizumab group compared with
- the placebo group as early as week 4 and was sustained through week 52 (p<.0001), and
- the ustekinumab group at weeks 16 (p<.01), 44 (p<.01), and 52 (p<.05).1
Parametera |
Mirikizumab (n=579) |
Ustekinumab (n=287) |
Placebo (n=199) |
Change from baseline in FCP |
|||
12 weeks |
-1.05 |
-0.94 |
-0.09b |
52 weeks |
-1.41 |
-0.96c |
-0.19b |
Change from baseline in CRP |
|||
12 weeks |
-0.73 |
-0.69 |
0.12b |
52 weeks |
-0.93 |
-0.75d |
-0.08b |
Abbreviations: CRP = C-reactive protein; FCP = fecal calprotectin; LSM = least-squares mean.
aData are presented as LSM of log-transformed values. For participants in the placebo group who switched to mirikizumab at week 12, the baseline values were carried forward to derive the change from baseline at week 52.
bp<.0001 vs mirikizumab.
cp<.001 vs mirikizumab.
dp<.05 vs mirikizumab.
Summary of Safety
Primary Safety of Mirikizumab Compared With Placebo in the VIVID-1 Study
In the VIVID-1 study, mirikizumab demonstrated an acceptable safety profile which was consistent with that of patients with moderate-to-severe Crohn's disease ().3
Eventa |
Mirikizumab (n=630) |
Placebob (n=211) |
At least 1 TEAE |
495 (78.6) [201.9] |
154 (73.0) [291.8] |
Most commonly reported TEAEsc |
||
COVID-19 |
104 (16.5) [19.3] |
29 (13.7) [26.4] |
Anemia |
42 (6.7) [7.4] |
14 (6.6) [12.2] |
Arthralgia |
41 (6.5) [7.2] |
11 (5.2) [9.6] |
Headache |
41 (6.5) [7.2] |
9 (4.3) [7.8] |
Upper respiratory tract infection |
38 (6.0) [6.7] |
9 (4.3) [7.8] |
Nasopharyngitis |
36 (5.7) [6.3] |
9 (4.3) [7.7] |
Diarrhea |
35 (5.6) [6.1] |
10 (4.7) [8.6] |
AEs of interest |
||
Infections (all) |
261 (41.4) [59.7] |
73 (34.6) [81.3] |
Serious infections |
14 (2.2) [2.4] |
6 (2.8) [5.1] |
Opportunistic infectionsd |
7 (1.1) [1.2] |
0 (0.0) [0] |
Injection-site reaction |
66 (10.5) [15.3] |
8 (3.8) [10.4] |
Cerebrocardiovascular events |
3 (0.5) [0.5] |
2 (0.9) [1.7] |
Major adverse cardiovascular event |
0 (0.0) [0] |
1 (0.5) [0.8] |
Malignancies |
2 (0.3)e [0.3] |
1 (0.5)f [0.8] |
Suicide/self-injuryg |
2 (0.3) [0.3] |
0 (0.0) [0] |
Hepatic event |
39 (6.2) [6.8] |
9 (4.3) [7.8] |
Serious adverse event |
65 (10.3) [11.5] |
36 (17.1) [32.5] |
MACEh |
0 |
2 (0.9) [1.7] |
VTE |
0 |
1 (0.5) [0.8] |
Hepatic laboratory findings |
||
ALT ≥3× ULN |
12 (1.9) [2.0] |
0 |
ALT ≥5× ULN |
3 (0.5) [0.5] |
0 |
AST ≥3× ULN |
9 (1.4) [1.5] |
2 (1.0) [1.7] |
AST ≥5× ULN |
2 (0.3) [0.3] |
0 |
ALP ≥2× ULN |
7 (1.1) [1.2] |
2 (1.0) [1.7] |
Discontinuation due to AE |
32 (5.1) [5.4] |
20 (9.5) [17.1] |
Death |
0i |
1 (0.5)j [0.8] |
Abbreviations: AE = adverse event; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; COVID-19 = coronavirus disease-19; EAIR = exposure-adjusted incidence rate; MACE = major adverse cardiovascular event; PYE = patient-years of exposure; TEAE = treatment-emergent adverse event; ULN = upper limit of normal; VTE = venous thrombotic event.
Note: The safety population includes all patients who received at least one dose of study drug.
aData are presented as n (%) [EAIR].
bFor patients randomized to placebo, only the exposure period to placebo is included.
cIncludes AEs that occurred in at least 5% of patients who received mirikizumab.
dThe opportunistic infections included mostly herpes zoster with one Candida infection.
eIncludes one basal cell carcinoma and one breast cancer.
fBasal cell carcinoma.
gBoth events were suicidal ideation. One patient had a prior history of suicide attempt and the other patient had a history of anxiety.
hAdjudicated and confirmed events.
iOne additional 23-year-old male patient who was a nonresponder to placebo and switched to mirikizumab after week 12 died from worsening of Crohn's disease.
jA 35-year-old male patient died from pulmonary embolism.
Safety of Mirikizumab Compared With Ustekinumab in the VIVID-1 Study
In VIVID-1, the proportion of patients who experienced at least one treatment-emergent adverse event (TEAE) was similar among the mirikizumab (78.6%) and ustekinumab (77.3%) treatment groups. The most commonly reported TEAEs were
- coronavirus disease-19
- anemia
- arthralgia
- headache
- upper respiratory tract infection
- nasopharyngitis, and
- diarrhea.2
The proportion of patients who experienced a serious adverse event was similar among the mirikizumab (10.3%) and ustekinumab (10.7%) treatment groups and was lower than in the placebo group (17.1%).1,2
Eventa |
Mirikizumab (n=630) |
Ustekinumab (n=309) |
Placebob (n=211) |
At least 1 TEAE |
495 (78.6) |
239 (77.3) |
154 (73.0) |
Common TEAEsc |
|||
COVID-19 |
104 (16.5) |
47 (15.2) |
29 (13.7) |
Anemia |
42 (6.7) |
15 (4.9) |
14 (6.6) |
Arthralgia |
41 (6.5) |
8 (2.6) |
11 (5.2) |
Headache |
41 (6.5) |
15 (4.9) |
9 (4.3) |
Upper respiratory tract infection |
38 (6.0) |
22 (7.1) |
9 (4.3) |
Nasopharyngitis |
36 (5.7) |
19 (6.1) |
9 (4.3) |
Diarrhea |
35 (5.6) |
12 (3.9) |
10 (4.7) |
Serious adverse event |
65 (10.3) |
33 (10.7) |
36 (17.1) |
Opportunistic infectiond |
7 (1.1) |
1 (0.3) |
0 |
Serious infection |
14 (2.2) |
9 (2.9) |
6 (2.8) |
Malignancy |
2 (0.3)e |
0 |
1 (0.5)f |
MACEg |
0 |
2 (0.6) |
2 (0.9) |
VTE |
0 |
0 |
1 (0.5)h |
Hepatic laboratory findings |
|||
ALT ≥3× ULN |
12 (1.9) |
6 (2.0) |
0 |
ALT ≥5× ULN |
3 (0.5) |
1 (0.3) |
0 |
AST ≥3× ULN |
9 (1.4) |
7 (2.3) |
2 (1.0) |
AST≥5× ULN |
2 (0.3) |
4 (1.3) |
0 |
ALT/AST ≥3× ULN and TB≥2× ULN |
1 (0.2) |
0 |
0 |
ALP ≥2× ULN and bilirubin ≥2× ULN |
0 |
0 |
0 |
ALP ≥2× ULN |
7 (1.1) |
0 |
2 (1.0) |
Death |
0i |
1 (0.3)j |
1 (0.5)k |
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; COVID-19 = coronavirus disease-19; MACE = major adverse cardiovascular event; TB = total bilirubin; TEAE = treatment-emergent adverse event; ULN = upper limit of normal; VTE = venous thrombotic event.
Note: The safety population includes all patients who received at least one dose of study drug.
aData are presented as n (%).
bFor patients who were randomized to placebo, only the exposure period to placebo is included.
cReported in 5% of patients.
dThe opportunistic infections included mostly herpes zoster with one Candida infection.
eIncludes one basal cell carcinoma and one breast cancer.
fBasal cell carcinoma.
gAdjudicated and confirmed events.
hPulmonary embolism.
iOne additional 23-year-old male patient who was a nonresponder to placebo and switched to mirikizumab after week 12 died from worsening of Crohn's disease.
jA 63-year-old female patient died from sepsis.
kA 35-year-old male patient died from pulmonary embolism.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Jairath V, Sands BE, Bossuyt P, et al. Efficacy of mirikizumab in comparison to ustekinumab in patients with moderate-to-severe Crohn's disease: results from the phase 3 VIVID 1 study. Poster presented at: 19th Congress of the European Crohn’s and Colitis Organisation (ECCO); February 21-24, 2024; Stockholm, Sweden.
2Jairath V, Sands BE, Bossuyt P, et al; VIVID Study Group. Efficacy of mirikizumab in comparison to ustekinumab in patients with moderate to severe Crohn's disease: results from the phase 3 VIVID 1 study. J Crohns Colitis. 2024;18(suppl 1):i62-i64. European Crohn’s and Colitis Organisation abstract OP35. https://doi.org/10.1093/ecco-jcc/jjad212.0035
3Ferrante M, Danese S, Chen M, et al; VIVID Study Group. Primary efficacy and safety of mirikizumab in moderate to severe Crohn's disease: results of the treat-through VIVID 1 study. Poster presented at: 19th Congress of the European Crohn’s and Colitis Organisation (ECCO); February 21-24, 2024; Stockholm, Sweden.
4Ferrante M, Danese S, Chen M, et al; VIVID Study Group. Primary efficacy and safety of mirikizumab in moderate to severe Crohn's disease: results of the treat-through VIVID 1 study. J Crohns Colitis. 2024;18(suppl 1):i7-i9. European Crohn’s and Colitis Organisation abstract OP05. https://doi.org/10.1093/ecco-jcc/jjad212.0005
Appendix
Clinical response by PRO |
At least a 30% decrease in stool frequency and/or abdominal pain with neither score worse than baseline. |
Clinical remission by CDAI |
CDAI total score less than 150. |
Clinical remission by PRO |
Stool frequency of 4 or less and not worse than baseline (per Bristol Stool Scale Category 6 or 7) and abdominal pain of 0 or 1 and no worse than baseline. |
Endoscopic response |
At least a 50% reduction from baseline in SES-CD total score. |
Endoscopic remission |
SES-CD total score of 4 or less and at least a 2-point reduction from baseline, and no subscore greater than 1 in any individual variable. |
Abbreviations: CDAI = Crohn's Disease Activity Index; PRO = patient-reported outcome; SES-CD = Simple Endoscopic Score for Crohn's Disease.
Date of Last Review: February 26, 2024