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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Baseline demographics and disease characteristics in LUCENT clinical trials
The baseline demographics and disease characteristics were similar among the mirikizumab and placebo groups in the phase 3 LUCENT studies.
Content overview
Mirikizumab phase 3 clinical trial program in ulcerative colitis
The safety and efficacy of mirikizumab in adult patients with moderate-to-severe active ulcerative colitis are being evaluated in the phase 3 studies
- LUCENT-1 and
- LUCENT-2.1
LUCENT-1 clinical trial
Study design
LUCENT-1 is a 12-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study of mirikizumab, a p19-directed anti-interleukin-23 (anti-IL-23) antibody.2
The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active UC, with a modified Mayo score of 4 to 9 points and centrally read Mayo endoscopic subscore ≥2, who had an inadequate response, loss of response, or an intolerance to
- corticosteroids,
- immunosuppressants,
- biologic therapies, or
- tofacitinib.2
A total of 1281 patients were randomized in a 3:1 ratio to receive intravenous mirikizumab 300 mg or placebo every 4 weeks. Randomization was stratified by
- biologic or tofacitinib failure status
- baseline corticosteroid use
- baseline disease activity as measured by the modified Mayo score, and
- world region.2
Baseline demographics and disease characteristics
Baseline demographics and disease characteristics were similar across treatment groups (Baseline Demographics and Disease Characteristics in the Phase 3 LUCENT-1 Clinical Trial).2
Parametera |
MIRI 300 mg |
PBO |
Age, mean years (SD) |
42.9 (13.9) |
41.3 (13.8) |
Male |
530 (61.1) |
165 (56.1) |
BMI categoryb |
||
≥18.5 to <25 kg/m2 |
451 (52.0) |
149 (50.7) |
≥25 kg/m2 |
362 (41.7) |
117 (39.8) |
Disease duration, mean years (SD) |
7.2 (6.7) |
6.9 (7.0) |
Disease extent |
||
Left-sided colitis |
544 (62.7) |
188 (64.2) |
Modified Mayo scorec category |
||
Moderate (4-6) |
404 (46.5) |
138 (47.1) |
Severe (7-9) |
463 (53.3) |
155 (52.9) |
Mayo endoscopic subscore of 3 (severe disease) |
574 (66.1) |
200 (68.3) |
Bowel urgency severity,d median (Q1, Q3) |
6.0 (5.0, 8.0) |
7.0 (5.0, 8.0) |
Fecal calprotectin, median μg/g (Q1, Q3) |
1559.0 (634.0, 3210.0) |
1471.5 (626.5, 2944.5) |
C-reactive protein, median mg/L (Q1, Q3) |
4.1 (1.5, 9.6) |
4.2 (1.2, 9.5) |
Abbreviations: BMI = body mass index; eCOA = electronic clinical outcome assessment; MIRI = mirikizumab; NRS = numeric rating scale; PBO = placebo; Q = quartile.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aData presented as n (%) unless otherwise specified.
bA total of 28 patients (9.5%) in the placebo group and 55 (6.3%) in the mirikizumab group had a BMI indicating underweight (<18.5).
cThe modified Mayo score is a sum of the Mayo stool frequency, rectal bleeding subscore, and endoscopic subscore, giving a maximum modified Mayo score of 9.
dThe urgency NRS 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 NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
Prior and baseline ulcerative colitis therapy
Baseline and Prior UC Therapy in the Phase 3 LUCENT-1 Clinical Trial shows data on prior and baseline treatment of ulcerative colitis for each treatment arm.
Parametera |
MIRI 300 mg |
PBO |
Prior UC treatment |
||
Failed treatment with a biologic or tofacitinib |
361 (41.6) |
118 (40.1) |
Failed TNF inhibitor treatment |
325 (37.4) |
97 (33.0) |
Failed vedolizumab treatment |
159 (18.3) |
59 (20.1) |
Failed tofacitinib treatment |
34 (3.9) |
6 (2.0) |
Number of failed biologic or tofacitinib therapies |
||
0 |
507 (58.4) |
176 (59.9) |
1 |
180 (20.7) |
65 (22.1) |
≥2 |
181 (20.9) |
53 (18.0) |
UC therapy at baseline |
||
Corticosteroids |
351 (40.4) |
113 (38.4) |
Immunomodulators |
211 (24.3) |
69 (23.5) |
Aminosalicylates |
646 (74.4) |
217 (73.8) |
Abbreviations: eCOA = electronic clinical outcome assessment; MIRI = mirikizumab; PBO = placebo; TNF = tumor necrosis factor; UC = ulcerative colitis.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aData are presented as n (%).
LUCENT-2 clinical trial
LUCENT-2 is a 40-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled, maintenance study that evaluated the safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, conducted in adult patients with moderate-to-severe ulcerative colitis who completed the LUCENT-1 study.2
Mirikizumab responders in LUCENT-1 study
A total of 544 patients who received mirikizumab in LUCENT-1 and achieved a clinical response were rerandomized in a 2:1 ratio to receive subcutaneous mirikizumab 200 mg or placebo every 4 weeks for 40 weeks. Randomization was stratified by
- biologic failure status
- induction remission status
- baseline corticosteroid use, and
- geographic region (North America/Europe/other).2
Baseline demographics and disease characteristics
Baseline demographics and disease characteristics were similar across treatment groups (Baseline Demographics and Disease Characteristics in the Phase 3 LUCENT-2 Clinical Trial).2
Parameterb |
MIRI Induction Respondersc |
|
MIRI 200 mg SC |
PBO SC |
|
Age, mean years (SD) |
43.4 (14.2) |
41.2 (12.8) |
Male |
214 (58.6) |
104 (58.1) |
BMI category |
||
≥18.5 to <25 kg/m2 |
196 (53.7) |
97 (54.2) |
≥25 kg/m2 |
143 (39.2) |
74 (41.3) |
Disease duration, mean years (SD) |
6.9 (7.1) |
6.7 (5.6) |
Disease extent |
||
Left-sided colitis |
234 (64.1) |
119 (66.5) |
Modified Mayo score category |
||
Moderate (4-6) |
181 (49.6) |
77 (43.0) |
Severe (7-9) |
184 (50.4) |
102 (57.0) |
Mayo endoscopic subscore of 3 (severe disease) |
235 (64.4) |
106 (59.2) |
Bowel urgencyd severity, mean (SD) |
6.0 (2.2) |
6.2 (1.9) |
Fecal calprotectin, median μg/g (Q1, Q3) |
1482.0 (558.0, 3045.0) |
1750.0 (754.0, 3519.0) |
C-reactive protein, median mg/L (Q1, Q3) |
3.8 (1.4, 8.7) |
3.0 (1.0, 7.7) |
Abbreviations: BMI = body mass index; eCOA = electronic clinical outcome assessment; MIRI = mirikizumab; NRS = numeric rating scale; PBO = placebo; Q = quartile; SC = subcutaneous.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aRefers to induction baseline (week 0 of LUCENT-1).
bData presented as n (%) unless otherwise specified.
cDefined as patients who received 12-week mirikizumab induction therapy and achieved 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
dThe Urgency NRS 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 NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
Prior baseline ulcerative colitis therapy
Baseline and Prior UC Therapy in the Phase 3 LUCENT-2 Clinical Trial shows data on prior and baseline treatment of ulcerative colitis for induction responders in the LUCENT-2 clinical trial.
Parameterb |
MIRI Induction Respondersc |
|
MIRI 200 mg SC |
PBO SC |
|
Prior UC treatment |
||
Failed treatment with a biologic or tofacitinib |
128 (35.1) |
64 (35.8) |
Failed TNF inhibitor treatment |
112 (30.7) |
58 (32.4) |
Failed vedolizumab treatment |
47 (12.9) |
23 (12.8) |
Failed tofacitinib treatment |
8 (2.2) |
8 (4.5) |
Number of failed biologic or tofacitinib therapies |
||
0 |
237 (64.9) |
115 (64.2) |
1 |
77 (21.1) |
35 (19.6) |
≥2 |
51 (14.0) |
29 (16.2) |
UC therapy at baseline |
||
Corticosteroids |
135 (37.0) |
68 (38.0) |
Immunomodulators |
78 (21.4) |
39 (21.8) |
Aminosalicylates |
278 (76.2) |
134 (74.9) |
Abbreviations: eCOA = electronic clinical outcome assessment; MIRI = mirikizumab; PBO = placebo; SC = subcutaneous; TNF = tumor necrosis factor; UC = ulcerative colitis.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aRefers to induction baseline (week 0 of LUCENT-1).
bData presented as n (%).
cDefined as patients who received 12-week mirikizumab induction therapy and achieved 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
Mirikizumab nonresponders in LUCENT-1
A total of 272 patients who received mirikizumab or placebo in LUCENT-1 and did not achieve clinical response were entered into an open-label extended induction treatment arm. Patients received an additional three doses of 300-mg intravenous mirikizumab every 4 weeks for 12 weeks. Patients who achieved clinical response at week 12 (representing week 24 of the overall 52-week period) of LUCENT-2 were then eligible to continue on to open-label 200-mg subcutaneous mirikizumab every 4 weeks through week 40 of LUCENT-2.2
Baseline demographics and disease characteristics
Baseline Demographics and Disease Characteristics in the Phase 3 LUCENT-2 Clinical Trial for the Mirikizumab Induction Nonresponders shows data on baseline demographics and disease characteristics for induction nonresponders in LUCENT-2.
Parameterb |
MIRI Induction Nonrespondersc |
OL MIRI 300 mg IV |
|
Age, mean years (SD) |
44.0 (14.2) |
Male |
182 (66.9) |
BMI category |
|
≥18.5 to <25 kg/m2 |
134 (49.3) |
≥25 kg/m2 |
122 (44.8) |
Disease duration, mean years (SD) |
7.62 (6.8) |
Disease extent |
|
Left-sided colitis |
154 (56.6) |
Modified Mayo score category |
|
Moderate (4-6) |
117 (43.0) |
Severe (7-9) |
154 (56.6) |
Mayo endoscopic subscore of 3 (severe disease) |
197 (72.4) |
Bowel urgencyd severity, mean (SD) |
6.2 (2.2) |
Fecal calprotectin, median μg/g (Q1, Q3) |
1546.0 (650.0, 2912.0) |
C-reactive protein, median mg/L (Q1, Q3) |
5.5 (2.5, 13.6) |
Abbreviations: BMI = body mass index; eCOA = electronic clinical outcome assessment; IV = intravenous; MIRI = mirikizumab; NRS = numeric rating scale; OL = open label; Q = quartile.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aRefers to induction baseline (week 0 of LUCENT-1).
bData presented as n (%) unless otherwise specified.
cDefined as patients who received 12-week mirikizumab induction therapy and did not achieve 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
dThe Urgency NRS 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 NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
Prior and baseline ulcerative colitis therapy
Baseline and Prior UC Therapy in the Phase 3 LUCENT-2 Clinical Trial for the Mirikizumab Induction Nonresponders shows data on prior and baseline treatment of ulcerative colitis for induction nonresponders in the LUCENT-2 clinical trial.
Parameterb |
MIRI Induction Nonrespondersc |
OL MIRI 300 mg IV |
|
Prior UC treatment |
|
Failed treatment with a biologic or tofacitinib |
147 (54.0) |
Failed TNF inhibitor treatment |
135 (49.6) |
Failed vedolizumab treatment |
81 (29.8) |
Failed tofacitinib treatment |
18 (6.6) |
Number of failed biologic or tofacitinib therapies |
|
0 |
125 (46.0) |
1 |
56 (20.6) |
≥2 |
91 (33.5) |
UC therapy at baseline |
|
Corticosteroids |
118 (43.4) |
Immunomodulators |
77 (28.3) |
Aminosalicylates |
202 (74.3) |
Abbreviations: eCOA = electronic clinical outcome assessment; IV = intravenous; MIRI = mirikizumab; OL = open label; TNF = tumor necrosis factor; UC = ulcerative colitis.
Note: Data are from the modified intent-to-treat population which excludes patients impacted by the eCOA transcription error in Poland and Turkey.
aRefers to induction baseline (week 0 of LUCENT-1).
bData presented as n (%).
cDefined as patients who received 12-week mirikizumab induction therapy and did not achieve 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
References
1US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed August 20, 2021. https://clinicaltrials.gov/
2D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 30 May 2023