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Well-Established
Safety Profile1,2a

8 phase 2-3 clinical trials across UC and MS, ~56,000 patients in clinical trials and post-marketing setting, and ~58,000 patient years total exposure in clinical trials and post-marketing setting 8 phase 2-3 clinical trials across UC and MS, ~56,000 patients in clinical trials and post-marketing setting, and ~58,000 patient years total exposure in clinical trials and post-marketing setting

Overall ZEPOSIA exposure in parent and extension trials (phase 1-3 MS, phase 2-3 UC) was 17,896.33 patient years (PY) and estimated to be 40,511 PY in the post-marketing setting. The cumulative number of patients exposed to ozanimod in parent and extension trials (all indications) was 4042 and estimated to be 51,736 in the post-marketing setting. Clinical trial data is current as of May 19, 2024, and post-marketing estimated data is current as of May 14, 2024.12,13

ZEPOSIA has been studied across multiple indications in 4 clinical trials, including TRUE NORTH (Ph 3); TOUCHSTONE (Ph 2); and SUNBEAM (Ph 3) and RADIANCE (Ph 3). 496 patients receiving the 0.92 mg orally once daily dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92 mg orally once daily dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis.1-4,6

In UC, from the start of the TOUCHSTONE phase 2 clinical trial (December 26, 2012) through TRUE NORTH OLE study data cutoff (June 30, 2023). In MS, from the start of the RADIANCE phase 2 clinical trial (September 18, 2012) through the DAYBREAK OLE database lock (April 7, 2023). Only includes patients receiving the 0.92 mg oral daily dose of ZEPOSIA.1,2,5,14,15

From the first patient randomized (October 18, 2012) through the DAYBREAK database lock (April 7, 2023), the maximum continuous exposure was 117.2 months. The mean exposure to ZEPOSIA 0.92 mg in the parent trials and DAYBREAK was 74.8 months.15

Moderate-to-severe UC: TRUE NORTH (NCT02435992), a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial; TRUE NORTH OLE (NCT02531126), an ongoing phase 3, multicenter, OLE trial; TOUCHSTONE (NCT01647516), a phase 2, multicenter, randomized, double-blind, placebo-controlled trial; JAPAN TRUE NORTH (NCT03915769), a phase 2/3, multicenter, randomized, double-blind, placebo-controlled, treat-through study. 2,6-8,10
Relapsing MS: SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), 2 phase 3, multicenter, randomized, double-blind, double-dummy, active treatment-controlled studies; DAYBREAK (NCT02576717), a phase 3, multicenter, OLE trial; ENLIGHTEN (NCT04140305), an ongoing phase 3b, multicenter, longitudinal, open-label, single arm study.1,3,4,9,11,15

MS=multiple sclerosis; OLE=open-label extension; Ph=phase; UC=ulcerative colitis.

Safety Comparable to Avonex in Overall Incidence of AEs, and Generally Similar Safety in Long-Term Extension Study;
10 Years* of Experience1,15-17

In Pivotal Trials: Incidence of Adverse Reactions1,16,17
SUNBEAM (1 YEAR) RADIANCE (2 YEARS)
Summary of Adverse Reactions Avonex n=445 ZEPOSIA n=448 Avonex n=440 ZEPOSIA n=434
Overall incidence of adverse reactions 75.5% 59.8% 83.0% 74.7%
Severe adverse reactions 2.2% 1.6% 4.3% 3.5%
Serious adverse reactions 2.5% 2.9% 6.4% 6.5%
SUNBEAM (1 YEAR)
Summary of Adverse Reactions Avonex n=445 ZEPOSIA n=448
Overall incidence of adverse reactions 75.5% 59.8%
Severe adverse reactions 2.2% 1.6%
Serious adverse reactions 2.5% 2.9%
RADIANCE (2 YEARS)
Summary of Adverse Reactions Avonex n=440 ZEPOSIA n=434
Overall incidence of adverse reactions 83.0% 74.7%
Severe adverse reactions 4.3% 3.5%
Serious adverse reactions 6.4% 6.5%

Adverse Reactions With an Incidence of at Least 2% in Patients Treated With ZEPOSIA and at Least 1% Greater Than Avonex1,16,17a

SUNBEAM AND RADIANCE: POOLED DATA

Adverse Reactions Avonex n=885 ZEPOSIA n=882
Upper respiratory infectionb 23% 26%
Hepatic transaminase elevationc 5% 10%
Orthostatic hypotension 3% 4%
Urinary tract infection 3% 4%
Back pain 3% 4%
Hypertensiond 2% 4%
Upper abdominal pain 1% 2%

Adverse reactions are sorted by decreasing incidence in patients treated with ZEPOSIA. For adverse reactions pertaining to liver function tests, increases were transient and generally resolved without discontinuation.
Elevations of 3-fold the ULN or greater occurred in 5.5% of patients taking ZEPOSIA and in 3.1% of patients taking Avonex. The majority (79%) continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2 to 4 weeks.1,16

From the first patient randomized (October 18, 2012) through the DAYBREAK database lock (April 7, 2023), the maximum continuous exposure was 117.2 months. The mean exposure to ZEPOSIA 0.92 mg oral daily dose in the parent trials and DAYBREAK was 74.8 months.1,15

Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control.1

Includes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis.1

Includes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased.1

Includes hypertension, essential hypertension, and orthostatic hypertension.1

AE=adverse event; ULN=upper limit of normal.

DAYBREAK OLE: Incidence of Adverse Events15

Summary of TEAEs (PRIMARY ENDPOINT) ZEPOSIA (n=2494) IR/1000 PY
Any TEAE 89.0% 650.8
Severe TEAEs 9.6% 19.8
Serious TEAEs 15.3% 32.4
TEAEs leading to permanent treatment discontinuation 3.9% 7.7

TEAEs in ≥5% of Patients Treated With ZEPOSIA15

TEAEs ZEPOSIA (N=2494) IR/1000 PY
Nasopharyngitis 21.3% 49.6
Headache 17.1% 38.3
COVID-19 16.5% 33.5
Upper respiratory tract infection 12.4% 26.7
Lymphopeniae 10.3% 22.2
Back pain 9.6% 20.1
ALC decreasede 9.4% 20.0
Hypertensionf 9.2% 19.3
GGT increased 8.0% 16.7
Urinary tract infection 6.8% 13.9
Respiratory tract infection 6.6% 13.6
Arthralgia 6.5% 13.3
Bronchitis 6.3% 12.9
Depression-related TEAEsg 5.9% 12.0
Viral respiratory tract infection 5.8% 11.9
ALT increased 5.1% 10.2

Similar safety patterns were seen in the continuous once-daily oral ZEPOSIA 0.92 mg (n=881) population1,15

ALC reductions are an expected pharmacodynamic effect related to the mechanism of ozanimod; although investigators were not required to report ALC reductions as TEAEs, lymphopenia and ALC decreases were reported as TEAEs according to investigator determination.15

Includes preferred terms of hypertension, essential hypertension, labile hypertension, and systolic hypertension.15

Includes preferred terms of depression, depressed mood, and depressive symptoms.15

ALC=absolute lymphocyte count; ALT=alanine aminotransferase; GGT=gamma-glutamyl transferase; TEAE=treatment emergent adverse event.

Demonstrated Tolerability Profile With Low Discontinuation Rates Due to Adverse Events1,15-17

≥90% of Patients Stayed on Therapy Through Completion
of Pivotal Trials

SUNBEAM (1 Year)

94%

Remained on ZEPOSIA at 1 Year and 92% remained on Avonex1

 

RADIANCE (2 Years)

90%

Remained on ZEPOSIA at 2 Years and 85% remained on Avonex1

LOW DISCONTINUATION RATES
DUE TO AEs15-17

SUNBEAM (1 Year)

2.9%

For ZEPOSIA and 3.6% for Avonex16

 

RADIANCE (2 Years)

3.0%

For ZEPOSIA and 4.1% for Avonex17

DAYBREAK (Up to 7 Years) n=2494

3.9%

For ZEPOSIA in Long-Term Extension Study15

Rates of Serious Infections
and Malignancies Consistent
vs Avonex

The rate of serious infections at 1 year for ZEPOSIA was 1.1% vs 0.7% for Avonex, and the rate at 2 years for ZEPOSIA
was 0.9% vs 0.9% for Avonex. The rate of malignancies at 1 year for ZEPOSIA was 0.2% vs 0% for Avonex, and the rate at 2 years for ZEPOSIA was 0.9% vs 0.5% for Avonex.16,17

► Overall Infections

In SUNBEAM and RADIANCE, the overall rate of infections with ZEPOSIA (35%) was similar to Avonex (34%). ZEPOSIA causes a reduction in peripheral blood lymphocyte count and may increase the risk of infection.1

Controlled Lymphocyte Reductions

ALC was consistently maintained near the lower limit of normal across both pivotal trials, and the mean ALC for both SUNBEAM and RADIANCE was ≈0.8 × 109/L.16-18

VIEW ALC DATA

Herpetic Infections

In active-controlled MS trials, herpes zoster was reported as an adverse reaction in 0.6% of patients treated with once-daily oral ZEPOSIA 0.92 mg and in 0.2% of patients taking Avonex.1

ZEPOSIA Consistently Maintained ALC Near the Lower Limit of Normal16-18

ZEPOSIA® consistently maintained ALC near the lower limit of normal

Lymphocyte numbers can be restored to normal values by discontinuing therapy1,16,17,19

  • After discontinuing daily oral ZEPOSIA 0.92 mg, the median time for peripheral blood lymphocytes to return to the normal range was 30 days, with approximately 90% of patients in the normal range within 3 months
  • Mean ALC was approximately 0.8 x 109 cells/L for both SUNBEAM and RADIANCE (at 1 year and 2 years, respectively)
  • ZEPOSIA causes a mean reduction in peripheral blood lymphocyte count to approximately 45% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues; ZEPOSIA may therefore increase the susceptibility to infections, some serious in nature

BL=baseline; LLN=lower limit of normal.

Herpetic Infections

In active-controlled MS trials, herpes zoster was reported as an adverse reaction in 0.6% of patients treated with once-daily oral ZEPOSIA 0.92 mg and in 0.2% of patients taking Avonex.1

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IMPORTANT SAFETY INFORMATION
Contraindications:
  • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
  • Patients with severe untreated sleep apnea
  • Patients taking a monoamine oxidase (MAO) inhibitor
Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA.
  • Herpes zoster and herpes simplex were seen in clinical trials of ZEPOSIA. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA.
  • Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with S1P receptor modulators. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
  • In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects.
  • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA.
Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability.

PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants, duration of use). Based on data from patients with MS, longer treatment duration increases the risk of PML in patients treated with S1P receptor modulators, and the majority of PML cases have occurred in patients treated with S1P receptor modulators for at least 18 months. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued.

Immune reconstitution inflammatory syndrome (IRIS) has been reported in MS patients treated with S1P receptor modulators who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.

Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals:
  • with significant QT prolongation
  • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
  • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
  • with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block
Liver Injury: Clinically significant liver injury, including acute liver failure requiring transplant, has occurred in patients treated with ZEPOSIA in the postmarketing setting. Signs of liver injury, including elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose. Obtain transaminase and bilirubin levels, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Obtain transaminase levels and total bilirubin levels periodically during treatment and until two months after ZEPOSIA discontinuation. Patients should be monitored for signs and symptoms of any hepatic injury. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes promptly checked, and ZEPOSIA should be interrupted. Treatment should not be resumed if a plausible alternative etiology for the signs and symptoms cannot be established, because these patients are at risk for severe drug-induced liver injury.
Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com.
Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately.
Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated.
Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Obtain a baseline evaluation of the fundus, including a macula, near the start of treatment with ZEPOSIA. Perform an examination of the fundus, including the macula, periodically while on therapy and any time there is a change in vision. Continuation of ZEPOSIA therapy in patients with macular edema has not been evaluated. Macular edema over an extended period of time (i.e. 6 months) can lead to permanent visual loss. Consider discontinuing ZEPOSIA if macular edema develops. The risk of recurrence after rechallenge has not been evaluated.

Patients with a history of uveitis and patients with a history of diabetes mellitus are at increased risk of macular edema during ZEPOSIA therapy.

Cutaneous Malignancies: The risk of cutaneous malignancies (including basal cell carcinoma, squamous cell carcinoma, and melanoma) is increased in patients treated with S1P receptor modulators. Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer. Providers and patients are advised to monitor for suspicious skin lesions. If a suspicious skin lesion is observed, it should be promptly evaluated. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUV-A photochemotherapy is not recommended in patients taking ZEPOSIA.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued.
Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation.
Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation. After stopping ZEPOSIA in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS).
Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days, with approximately 80% to 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA.
Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.

In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache.

Use in Specific Populations: Hepatic Impairment: Dosage adjustment in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) is required, and use of ZEPOSIA in patients with severe hepatic impairment (Child-Pugh class C) is not recommended.
For additional safety information, please see the full Prescribing Information and Medication Guide.
INDICATIONS
ZEPOSIA® (ozanimod) is indicated for the treatment of:
  1. Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  2. Moderately to severely active ulcerative colitis (UC) in adults.
References:
  1. Zeposia. Prescribing Information. Bristol-Myers Squibb Company; 2024.
  2. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020 and Suppl 1-26.
  3. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31.
  4. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: final analysis of the DAYBREAK open-label extension study. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P090.
2084-US-2500094 04/25
References:
  1. Zeposia. Prescribing Information. Bristol-Myers Squibb Company; 2024.
  2. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020 and Suppl 1-26.
  3. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31.
  4. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: final analysis of the DAYBREAK open-label extension study. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P090.
References:
  1. Zeposia. Prescribing Information. Bristol-Myers Squibb Company; 2024.
  2. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: final analysis of the DAYBREAK open-label extension study. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P090.
  3. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1-3 trials. Presented at: 8th Joint ACTRIMS-ECTRIMS Meeting; September 11–13, 2020; MSVirtual2020. Presentation P0217.
  4. Cree BAC, Selmaj KW, Steinman L, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: up to 5 years of follow-up in the DAYBREAK open-label extension trial. Mult Scler. 2022;28(12):1944-1962.
  5. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11): 1009-1020 and Suppl 1-26.
  6. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31.
  7. Centonze D, Hartung HP, Montalbán X, et al. Long-term efficacy of ozanimod in disease-modifying treatment-naive vs experienced patients with relapsing multiple sclerosis. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P092.
  8. DeLuca J, Cohen JA, Cree BAC, et al. Effects of ozanimod on cognitive processing speed: updated findings from the phase 3 SUNBEAM and DAYBREAK extension trials. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P353.
  9. Polman CH, Rudick RA. The multiple sclerosis functional composite: a clinically meaningful measure of disability. Neurology. 2010;74(suppl 3):S8-S15.
References:
  1. Zeposia. Prescribing Information. Bristol-Myers Squibb Company; 2024.
  2. Efficacy and safety study of ozanimod in ulcerative colitis (Touchstone). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT01647516. Updated May 19, 2021. Accessed July 26, 2023.
  3. Study of ozanimod (RPC1063) in relapsing multiple sclerosis (MS) (SUNBEAM). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02294058. Updated November 25, 2020. Accessed July 26, 2023.
  4. Efficacy and safety study of ozanimod in relapsing multiple sclerosis (RADIANCE). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02047734. Updated February 11, 2021. Accessed July 26, 2023.
  5. Efficacy and safety study of ozanimod (RPC1063) in relapsing multiple sclerosis patients (RADIANCE). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT01628393. Updated November 2, 2021. Accessed September 6, 2023.
  6. Sandborn WJ, Feagan BG, D’Haens G, et al; True North Study Group. Ozanimod as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2021;385(14):1280-1291.
  7. Safety and efficacy trial of RPC1063 for moderate to severe ulcerative colitis. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02435992. Updated September 1, 2021. Accessed July 26, 2023.
  8. An extension study of RPC1063 as therapy for moderate to severe ulcerative colitis. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02531126. Updated September 18, 2023. Accessed September 25, 2023.
  9. A multi-site, open-label extension trial of oral RPC1063 in relapsing multiple sclerosis. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02576717. Updated March 13, 2023. Accessed July 26, 2023.
  10. Nakase H, Fujii T, Hisamatsu T, et al. Ozanimod as induction and maintenance therapy for ulcerative colitis: a randomized, double-blind, placebo-controlled study in Japan (J-True North). Poster presented at Digestive Disease Week (DDW) 2024; Washington, DC; May 18-21,2024. Poster Su1795.
  11. Study describing cognitive processing speed changes in relapsing multiple sclerosis subjects treated with ozanimod (RPC-1063) (ENLIGHTEN). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT0414035. Updated November 15, 2023. Accessed June 18, 2024.
  12. Data on File. BMS-REF-OZA-0076. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  13. Data on File. BMS-REF-OZA-0077. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  14. Siegel CA, Danese S, Rubin DT, et al. Safety of long-term ozanimod treatment for up to 4 years in patients with moderately to severely active ulcerative colitis: an interim analysis of the True North open-label extension. Oral presentation at: European Crohn's and Colitis Organisation (ECCO) 2024; Stockholm, Sweden; February 21–24, 2024.
  15. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: final analysis of the DAYBREAK open-label extension study. Poster presented at: ACTRIMS 2024 Forum; February 29–March 2, 2024; West Palm Beach, FL. Poster P090.
  16. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020 and Suppl 1-26.
  17. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31.
  18. Lymphocytopenia. National Heart, Lung, and Blood Institute (NHLBI). www.nhlbi.nih.gov/health-topics/lymphocytopenia. Accessed June 7, 2022.
  19. Steinman L, Comi G, Bar-Or A, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: results from the DAYBREAK open-label extension study. Poster presented at: 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 11–13, 2019; Stockholm, Sweden. Poster P1031.
References:
  1. Zeposia. Prescribing Information. Bristol-Myers Squibb Company; 2024.
  2. Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016;173(11):1778-1792.
  3. Spiegel S, Milstien S. The outs and the ins of sphingosine-1-phosphate in immunity. Nat Rev Immunol. 2011;11(6):403-415.
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Reference:
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  4. Naismith RT, Zivadinov R, Morrow SA, et al. Safety and efficacy of ozanimod over 1 year in patients with early relapsing multiple sclerosis: an interim analysis of the ENLIGHTEN study. Presented at the 9th Joint ECTRIMS-ACTRIMS Meeting; October 11–13, 2023; Milan, Italy. Poster P690.
  5. Zivadinov R, Naismith RT, Morrow SA, et al. Brain volume changes over 1 year in ozanimod-treated patients with early relapsing multiple sclerosis: an interim analysis of the ENLIGHTEN study. Presented at the 9th Joint ECTRIMS-ACTRIMS Meeting; October 11–13, 2023; Milan, Italy. Poster P1311.
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  8. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1-3 trials. Presented at: 8th Joint ACTRIMS-ECTRIMS Meeting; September 11–13, 2020; MSVirtual2020. Presentation P0217.
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