The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2
Omvoh helped patients achieve sustained clinical remission and reduced bowel urgency severity1
50% of patients achieved clinical remission at week 52 with Omvoh1
43% of patients taking Omvoh achieved bowel urgency remission at week 521,3,4
Well tolerated with similar adverse events and discontinuation rates comparable to placebo through 52 weeks1
Dr. Peter Irving discusses how patients achieved clinical remission with Omvoh in the LUCENT trialWATCH NOW
If you look at the efficacy data from the LUCENT trials, Omvoh demonstrated superiority compared to placebo on all primary and key secondary endpoints.
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“I plan, map out where bathrooms are, and always carry an emergency bag of supplies. But I want another option for my ulcerative colitis symptoms so I’m not always wondering what if bowel urgency strikes and I can’t make it?”*
*Hypothetical patient
“I plan, map out where bathrooms are, and always carry an emergency bag of supplies. But I want another option for my ulcerative colitis symptoms so I’m not always wondering what if bowel urgency strikes and I can’t make it?”*
*Hypothetical patient
Mia has moderately to severely active UC and is still experiencing ulcerative colitis symptoms
Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway1
Inflamation due to over activation of the IL-23 pathway plays a critical role in the pathogenesis of UC1
Omvoh spares the IL-21 pathway, preserving the protective role of IL-12 in immune responses1,4
Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials1,3
At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC1
aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.1
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.1
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.
41% of patients in LUCENT-1 and 35% of patients in LUCENT-2 had failed at least one prior biologic1-4
Bio-naive=biologic-naive; IV=intravenous; SC=subcutaneous; TNF=tumor necrosis factor.
TNF=tumor necrosis factor.
Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials
At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC
aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.
64% of patients taking Omvoh achieved clinical response after 12 weeks of induction dosing
aClinical response at Week 12 was defined as ≥2-point and ≥30% decrease in the MMS from baseline; RB=0 or 1, or a ≥1-point decrease from baseline.1
ES=endoscopic subscore; IV=intravenous; MMS=Modified Mayo Score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore.
24% of patients taking Omvoh achieved clinical remission after 12 weeks of induction dosing1
bClinical remission at Week 12 was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1ES=endoscopic subscore; IV=intravenous; MMS=Modified Mayo Score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore.
* The data presented are from a post hoc analysis and were not type I error controlled. Therefore treatment differences between Omvoh and placebo cannot be regarded as statistically significant.2
aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.
64% of patients maintained clinical remission through 1 year of continuous treatment with Omvoh1
aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.
aCorticosteroid-free clinical remission without surgery was defined as clinical remission at Week 40 in LUCENT-2; symptomatic remission at Week 28; no corticosteroid use for ≥12 weeks prior to Week 40. Denominator includes all patients irrespective of baseline corticosteroid use status.1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1Week 52/1 year is defined as the 12-week induction study (LUCENT-1) plus the 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment
.Bio-failed=biologic-failed; bio-naive=biologic-naive; Q4W=every 4 weeks; SC=subcutaneous.
aEndoscopic remission was defined as ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; SC=subcutaneous.
aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.
47% of patients (n=72/153) on advanced therapy reported wearing a diaper, pad,or other protection at least once a weekdue to worry or anticipation of a bowel urgency accident.2
According to the European Crohn’s and Colitis Organisation (ECCO), bowel urgency is a symptom of active disease and should be addressed in medical examinations of patients with UC.3
Despite the ECCO recommendations, the definition of clinical remission in UC clinical trials does not include bowel urgency.1,4
Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).4
aSymptomatic remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0.4,5
bSymptomatic remission was measured as a gated secondary endpoint at Weeks 4 and 12, therefore statistical significance is shown for these time points only.5
IV=intravenous; LSM=least squares mean; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore; UC=ulcerative colitis; UNRS=Urgency Numeric Rating Scale.
43% of patients taking Omvoh achieved bowel urgency remission at Week 525
Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).5*
*Patients included in this analysis had a UNRS score of ≥3 at baseline in LUCENT-1.5
aBowel urgency remission: Patients rating bowel urgency severity as 0 or 1 on UNRS (0-10).4,5
Q4W=every 4 weeks; SC=subcutaneous; UNRS=Urgency Numeric Rating Scale.
65% of patients achieved clinically meaningful improvement in bowel urgency severity with Omvoh8*
Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).5*
*Clinically meaningful improvement in bowel uregency severity was defined as ≥3-point decrease from baseline in UNRS among patients with UNRS ≥3 at baseline.8
The data presented are from a post hoc analysis and were not type error controlled. Therefore treatment differences between Omvoh and placebo cannot be regarded as statistically significant. Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis; UNRS=Urgency Numeric Rating Scale.
Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials
At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC
aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.
aOccurring in ≥3% of patients in any treatment group during induction or maintenance; listed by decreasing frequency in the Omvoh arm during maintenance.1
bThe most frequent events were injection site pain, injection site reaction, and injection site erythema. These symptoms were usually reported as non-serious, mild, and transient in nature.2
IV=intravenous; SC=subcutaneous.
In the maintenance study (LUCENT-2), injection-site reactions were reported by 9% of patients taking Omvoh compared to 4% of patients taking placebo.1,2
The most frequently reported reactions were:
1 patient (0.3%) taking Omvoh discontinued treatment due to injection-site hypersensitivity.2,3
aIn the induction trial, 1 case of herpes zoster infection was reported in the placebo group, and 1 case of esophageal candidiasis, 2 of cytomegalovirus colitis, 1 of herpes zoster infection, and 1 of intestinal tuberculosis were reported in the Omvoh group; cytomegalovirus colitis was severe in 1 patient. In the maintenance trial, 1 case of oral candidiasis and 4 cases of herpes zoster infection were reported in the Omvoh group. Herpes zoster infection was severe in 1 patient. Other opportunistic infections during both the induction and maintenance trials were mild to moderate, and none resulted in discontinuation of Omvoh. In the open-label extension trial, 3 cases of herpes zoster infection, 1 case of esophageal candidiasis, and 1 case of oral candidiasis were reported in patients taking Omvoh.1
bNo instances of major adverse cardiovascular events (MACE) during induction; 1 instance of MACE (ischemic stroke) in the placebo group during maintenance; 1 instance of MACE reported during LUCENT-3, determined by the investigator as not related to Omvoh.1,2
cIn the Omvoh group during the induction trial, both cancers were colon adenocarcinoma. During the maintenance trial, nonmelanoma skin cancer (basal cell carcinoma) occurred in 1 patient in the placebo group and gastric cancer in 1 patient in the Omvoh group.1
dNo serious hypersensitivity or anaphylactic reactions occurred during the induction trial. One case of anaphylaxis occurred in the placebo group during the maintenance trial. In the open-label extension trial, 1 case of allergic sinusitis, 1 case of eczema, 1 case of injection site hypersensitivity, and 1 case of injection site urticaria were reported in patients taking Omvoh.1
AE=adverse event; IV=intravenous; SC=subcutaneous.
aIn the induction trial, 1 case of herpes zoster infection was reported in the placebo group, and 1 case of esophageal candidiasis, 2 of cytomegalovirus colitis, 1 of herpes zoster infection, and 1 of intestinal tuberculosis were reported in the Omvoh group; cytomegalovirus colitis was severe in 1 patient. In the maintenance trial, 1 case of oral candidiasis and 4 cases of herpes zoster infection were reported in the Omvoh group. Herpes zoster infection was severe in 1 patient. Other opportunistic infections during both the induction and maintenance trials were mild to moderate, and none resulted in discontinuation of Omvoh. In the open-label extension trial, 3 cases of herpes zoster infection, 1 case of esophageal candidiasis, and 1 case of oral candidiasis were reported in patients taking Omvoh.1
bNo instances of major adverse cardiovascular events (MACE) during induction; 1 instance of MACE (ischemic stroke) in the placebo group during maintenance; 1 instance of MACE reported during LUCENT-3, determined by the investigator as not related to Omvoh.1,2
cIn the Omvoh group during the induction trial, both cancers were colon adenocarcinoma. During the maintenance trial, nonmelanoma skin cancer (basal cell carcinoma) occurred in 1 patient in the placebo group and gastric cancer in 1 patient in the Omvoh group.1
dNo serious hypersensitivity or anaphylactic reactions occurred during the induction trial. One case of anaphylaxis occurred in the placebo group during the maintenance trial. In the open-label extension trial, 1 case of allergic sinusitis, 1 case of eczema, 1 case of injection site hypersensitivity, and 1 case of injection site urticaria were reported in patients taking Omvoh.1
Omvoh dosing begins with 3 induction doses via infusion every 4 weeks and transitions to self-injections for maintenance1
300 mg (IV)a at Weeks 0, 4, and 8b
200 mg (SC) via 2 consecutive injections every 4 weeks starting at Week 12
a For at least 30 minutes.
IV=intravenous; SC=subcutaneous.
From latest articles to infographics, we’ve got you covered. Explore what’s new and stay in the loop!
Learn more about how Omvoh can help your UC patients with their most burdensome symptom
Learn more about how Omvoh can help your UC patients with their most burdensome symptom