Hypothetical patient Milo standing with his arms crossed in front of an orange background

Omvoh safety data in adult patients across UC and CD trials

Overall, the safety profiles in adult patients with CD and in adult patients with UC treated with Omvoh are generally consistent.¹

Most Common Adverse Reactions^a, Serious Adverse Events, and Discontinuations in UC-1 and UC-2^1,2

Adverse reactions, serious adverse events and discontinuations in the UC-1 induction and UC-2 — Adverse reactions in UC-1 (induction, 12 weeks) occurring in patients treated with Omvoh 300 mg intravenously every four weeks (N=958) and placebo (N=321) were upper respiratory tract infections (n=72, 8% with Omvoh vs n=20, 6% with placebo) and arthralgia (n=20, 2% with Omvoh vs n=4, 1% with placebo), serious adverse events (n=27, 2.8% with Omvoh vs n=17, 5.3% with placebo), and discontinuation of treatment due to adverse events (n=15, 1.6% with Omvoh vs n=23, 7.2% with placebo).

Adverse reactions in UC-2 (maintenance, 40 weeks) occurring in patients treated with Omvoh 200 mg subcutaneously every four weeks (N=389) and placebo (N=192) were upper respiratory tract infections (n=53, 14% with Omvoh vs n=23, 12% with placebo), arthralgia (n=26, 7% with Omvoh vs n=8, 4% with placebo), injection site reactions (n=34, 9% with Omvoh vs n=8, 4% with placebo), rash (n=16, 4% with Omvoh vs n=2, 1% with placebo), headache (n=16, 4% with Omvoh vs n=2, 1% with placebo), and herpes viral infection (n=9, 2% with Omvoh vs n=1, 1% with placebo), serious adverse events (n=13, 3.3% with Omvoh vs n=15, 7.8% with placebo), and discontinuation of treatment due to adverse events (n=6, 1.5% with Omvoh vs n=16, 8.3% with placebo).

In UC-1, infusion-related hypersensitivity reactions were reported by 4 (0.4%) patients treated with Omvoh and 1 (0.3%) patient treated with placebo.¹

^aOccurring in ≥2% of patients and higher frequency than placebo

^bOmvoh 300 mg as an intravenous infusion at Weeks 0, 4, and 8.¹

^cOmvoh 200 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.¹

^dUpper respiratory tract infections includes related terms (eg, COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection).¹

^eInjection site reactions includes related terms (eg, erythema, hypersensitivity, pain, reaction, and urticaria at the injection site).¹

^fRash is composed of several similar terms.¹

^gHerpes viral infection includes related terms (eg, herpes zoster, herpes simplex, and oral herpes).¹

Most Common Adverse Reactions^a, Serious Adverse Events, and Discontinuations in CD-1^1,3

Adverse Reactions (Reported in at Least 5% of Patients Treated With Omvoh and at a Higher Frequency Than Placebo), Serious Adverse Events, and Discontinuations in CD-1 — Adverse reactions in CD-1 during the induction and maintenance trial over 52 weeks occurring in patients treated with Omvoh (N=715, PY=655) and placebo (N=211, PY=120): upper respiratory tract infections (n=199, 28% [EAIR=37] with Omvoh vs n=47, 22% [EAIR=47] with placebo), injection site reactions (n=69, 10% [EAIR=11] with Omvoh vs n=8, 4% [EAIR=7] with placebo), headache (n=45, 6% [EAIR=7] with Omvoh vs n=9, 4% [EAIR=8] with placebo), arthralgia (n=44, 6% [EAIR=7] with Omvoh vs n=11, 5% [EAIR=10] with placebo), elevated liver tests (n=36, 5% [EAIR=6] with Omvoh vs n=8, 4% [EAIR=7] with placebo), serious adverse events (n=73, 10% [EAIR=12] with Omvoh vs n=36, 17% [EAIR=32] with placebo), and discontinuation of treatment due to adverse events (n=36, 5% [EAIR=6] with Omvoh vs n=20, 10% [EAIR=17] with placebo).

^aReported in at Least 5% of Patients Treated With Omvoh and at a Higher Frequency Than Placebo

^bFollowing Omvoh 900 mg as an intravenous infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks. In addition, 85 placebo patients who did not achieve clinical response by PRO at Week 12 were switched to blinded induction and maintenance treatment with Omvoh. The observed data after Week 12 from these 85 patients were included in the Omvoh cohort.¹

^cEAIRs are per 100 PY. The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 patients were treated for one year. In CD-1, Omvoh and placebo-treated patients had different lengths of exposure, therefore, frequencies and EAIRs are shown to appropriately compare adverse reactions.¹

^dUpper respiratory tract infections includes related terms (eg, COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection).¹

^eInjection site reactions includes related terms (eg, erythema, hematoma, induration, pain, pruritus, and reaction at the injection site).¹

^fHeadache includes related terms (ie, headache and migraine).¹

^gElevated liver tests include related terms (eg, ALT increased, AST increased, alkaline phosphatase increased, bilirubin increased, and GGT increased).¹

AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CD=Crohn's disease; COVID-19=coronavirus 2019; EAIR=exposure-adjusted incidence rate; GGT=gamma-glutamyl transferase; IV=intravenous; PRO=patient-reported outcome; PY=patient-years; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.

Omvoh safety data in adult patients across UC and CD trials

Overall, the safety profiles of Omvoh are generally consistent in adult patients with CD and in adult patients with UC.^1-5

Select Adverse Events in UC-1 and UC-2²

Adverse events in UC-1 (Omvoh 300 mg IV Q4W), UC-2 (Omvoh 200 mg SC Q4W) and UC-3 (Omvoh 200 mg SC Q4W) — Select adverse events in UC-1 (induction, 12 weeks) occurring in patients treated with Omvoh 300 mg intravenously every four weeks (N=958) and placebo (N=321): serious infection (n=7, 0.7% with Omvoh vs n=2, 0.6% with placebo), opportunistic infection (n=5, 0.5% with Omvoh vs n=1, 0.3% with placebo), adjudicated cerebrocardiovascular events (n=1, 0.1% with Omvoh vs n=2, 0.6% with placebo), malignancies (n=2, 0.2% with Omvoh vs n=0, 0% with placebo), nonmelanoma skin cancer (NMSC) (n=0, 0% with Omvoh vs n=0, 0% with placebo), malignancies excluding NMSC (n=2, 0.2% with Omvoh vs n=0, 0% with placebo), immediate hypersensitivity reaction (n=10, 1.0% with Omvoh vs n=1, 0.3% with placebo), and hepatic events (n=15, 1.6% with Omvoh vs n=5, 1.6% with placebo).

Select adverse events in UC-2 (maintenance, 40 weeks) occurring in patients treated with Omvoh 200 mg subcutaneously every four weeks (N=389) and placebo (N=192): serious infection (n=3, 0.8% with Omvoh vs n=3, 1.6% with placebo), opportunistic infection (n=5, 1.3% with Omvoh vs n=0, 0% with placebo), adjudicated cerebrocardiovascular events (n=0, 0% with Omvoh vs n=1, 0.5% with placebo), malignancies (n=1, 0.3% with Omvoh vs n=1, 0.5% with placebo), non-melanoma skin cancer (NMSC) (n=0, 0% with Omvoh vs n=1, 0.5% with placebo), malignancies excluding NMSC (n=1, 0.3% with Omvoh vs n=0, 0% with placebo), immediate hypersensitivity reaction (n=7, 1.8% with Omvoh vs n=2, 1.0% with placebo), and hepatic events (n=12, 3.1% with Omvoh vs n=4, 2.1% with placebo).

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly continues to conduct long-term studies to evaluate the safety of Omvoh.

^aIn UC-1, infections were reported by 145 (15%) patients treated with Omvoh 300 mg and 45 (14%) patients treated with placebo. Serious infections were reported by less than 1% in both groups. Serious infections in the Omvoh group included intestinal sepsis, listeria sepsis, and pneumonia. In UC-2, through Week 40, infections were reported by 93 (24%) patients treated with Omvoh 200 mg and 44 (23%) patients treated with placebo. A case of COVID-19 pneumonia was reported as a serious infection in the Omvoh group.¹

^bIn UC-1, 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 UC-2, 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 UC-1 and UC-2 were mild to moderate.²

^cIn UC-1, there were no instances of MACE. In UC-2, one instance of MACE (ischemic stroke) occurred in the placebo group.²

^dDuring UC-1, colon adenocarcinoma occurred in 2 patients in the Omvoh group. During UC-2, nonmelanoma skin cancer (basal cell carcinoma) occurred in 1 patient in the placebo group and gastric cancer in 1 patient in the Omvoh group.²

^eDuring UC-1, no serious hypersensitivity or anaphylactic reactions occurred. During UC-2, one case of anaphylaxis occurred in the placebo group.²

Select Adverse Events in UC (Long-term)³

CD-1 and -2 Select Adverse Events — Select adverse events in UC (up to 3 years of exposure to Omvoh) (N=339, PY=986.3): serious infection (n=10 [EAIR=1.0]), opportunistic infection (n=9 [EAIR=0.9]), adjudicated cerebrocardiovascular events (n=5 [EAIR=0.5]), MACE (n=1 [EAIR=0.1]), malignancies (n=1 [EAIR=0.1]), non-melanoma skin cancer (NMSC) (n=0 [EAIR=0]), malignancies excluding NMSC (n=1 [EAIR=0.1]), immediate hypersensitivity reaction (n=10 [EAIR=1.0]) , and hepatic events (n=22 [EAIR=2.3]).

^aEAIRs are per 100 PY. The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 patients were treated for one year.¹

CD=Crohn's disease; COVID-19=coronavirus 2019; EAIR=exposure-adjusted incidence rate; IV=intravenous; MACE=major adverse cardiac event; NMSC=nonmelanoma skin cancer; PRO=patient-reported outcome;PY=patient-years; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.

Select Adverse Events in CD-1^1,3

^aFollowing Omvoh 900 mg as an intravenous infusion at Week 0, Week 4, and Week 8, patients received Omvoh 300 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks. In addition, 85 placebo patients who did not achieve clinical response by PRO at Week 12 were switched to blinded induction and maintenance treatment with Omvoh. The observed data after Week 12 from these 85 patients were included in the Omvoh cohort.¹

^bEAIRs are per 100 PY. The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 patients were treated for one year.¹

^cIn CD-1 through Week 52, infections were reported by 282 (39%, 58 per 100 PY) patients treated with Omvoh and 73 (35%, 81 per 100 PY) patients treated with placebo. Serious infections in the Omvoh group included abscess (including abdominal abscess, anal abscess, gluteal abscess, and perineal abscess), cellulitis, pneumonia, and sepsis.¹

Select Adverse Events in CD (Long-term)⁵

^aEAIRs are per 100 PY. The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 patients were treated for one year.¹

Initiate your patients on Omvoh

SEE DOSING

Initiate your patients on Omvoh

SEE DOSING

References:

Omvoh. Prescribing Information. 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
Data on File. DOF-MR-US-0071. Lilly USA, LLC.
Data on File. DOF-MR-US-0089. Lilly USA, LLC.
Data on File. DOF-MR-US-0069. Lilly USA, LLC.

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.

Omvoh safety data in adult patients across UC and CD trials

Overall, the safety profiles in adult patients with CD and in adult patients with UC treated with Omvoh are generally consistent.1

Omvoh safety data in adult patients across UC and CD trials

Initiate your patients on Omvoh

Initiate your patients on Omvoh

IMPORTANT SAFETY INFORMATION for Omvoh (mirikizumab-mrkz)

Warning:

INDICATIONS

Overall, the safety profiles in adult patients with CD and in adult patients with UC treated with Omvoh are generally consistent.¹