Up To 8 Yearsb Of Continuous Exposure In Multiple Sclerosis From Phase 1 through DAYBREAK data cutoff

5 Phase 3 clinical
trials across

multiple sclerosis (MS) and ulcerative colitis (UC)1,2c

>13,000 patients

in clinical trials (Phase 1-3 MS, Phase 2-3 UC) and post-marketing setting3,4

>20,000 patient years

total exposure in clinical trials (Phase 1-3 MS, Phase 2-3 UC)
and post-marketing setting3,4

Multiple Sclerosis: Includes Phase 1, Phase 2, SUNBEAM, RADIANCE, and DAYBREAK (data cutoff: February 2, 2021).
Ulcerative Colitis: Includes TOUCHSTONE, TRUE NORTH, TRUE NORTH OLE (data cutoff: September 30, 2020).
Post-Marketing Setting: Data cutoff November 19, 2021.
Exposure for patients with MS in clinical trials: 2631 patients and 11,938 patient years. Exposure for patients with UC in clinical trials: 1158 patients and 2108 patient years. Exposure for patients in the post-marketing setting across indications: 9738 patients and 6455 patient years.

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

From first patient randomized (October 18, 2012) through the DAYBREAK data cutoff (February 2, 2021), mean (range) continuous ozanimod 0.92 mg exposure was 67.4 (6.01-98.8) months.5

ZEPOSIA has been studied across multiple indications in 5 Phase 3 clinical trials, including TRUE NORTH (NCT02435992), a multicenter, randomized, double-blind, placebo-controlled clinical trial; TRUE NORTH OLE (NCT02531126), a Phase 3, multicenter, open-label extension trial for moderate to severe ulcerative colitis; SUNBEAM (NCT02294058); RADIANCE (NCT02047734); and DAYBREAK (NCT02576717).3

Safety Comparable to Avonex in Overall Incidence of AEs, and Generally Similar Safety in Ongoing Long-Term Extension Study;
Up to 8 Years* of Exposure.1-4

In Pivotal Trials: Incidence of Adverse Reactions1-4
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 Avonex1a

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%
Abdominal pain upper 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.4
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.4

From first patient randomized (October 18, 2012) through the DAYBREAK data cutoff (February 2, 2021), mean (range) continuous ozanimod 0.92 mg exposure was 67.4 (6.01—98.8) months.5

Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control.4

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.4

Includes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased.4

Includes hypertension, essential hypertension, and orthostatic hypertension.4

IN OLE STUDY: Incidence of Adverse Events3

DAYBREAK (UP TO 5 YEARSe)

Summary Of TEAEs (DAYBREAK OLE primary endpoint) ZEPOSIA (n=881)
Any TEAE 84.7%
Severe TEAEs 6.0%
Serious TEAEs 11.7%
TEAEs leading to permanent treatment discontinuation 2.7%

TEAEs With Incidence of at Least 4% in Patients Treated With ZEPOSIA

TEAEs ZEPOSIA (n=881)
Nasopharyngitis 19.3%
Headache 15.6%
Upper respiratory tract infection 10.9%
ALC decreased 8.9%
Lymphopenia 8.7%
Back pain 8.1%
GGT increased 5.9%
Bronchitis 5.8%
Urinary tract infection 5.8%
Hypertensionf 5.4%
Respiratory tract infection 5.4%
Viral respiratory tract infection 5.0%
Depression-related TEAEsg 4.9%

TEAEs are sorted by decreasing incidence in patients treated with ZEPOSIA.

At data cutoff, mean (range) continuous ozanimod 0.92 mg exposure in DAYBREAK was 47.6 (0.43-62.7) months.8

Includes preferred terms of hypertension, essential hypertension, labile hypertension, systolic hypertension, and hypertensive crisis.3

Includes preferred terms of depression, depressed mood, and depressive symptoms.3

Demonstrated Tolerability Profile With Low Discontinuation Rates Due to Adverse Events1-4

>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 Avonex4

 

RADIANCE (2 Years)

90%

Remained on ZEPOSIA at 2 Years and 85% remained on Avonex4

LOW DISCONTINUATION RATES
DUE TO AES1-3

SUNBEAM (1 Year)

2.9%

For ZEPOSIA and 3.6% for Avonex2

 

RADIANCE (2 Years)

3.0%

For ZEPOSIA and 4.1% for Avonex3

DAYBREAK (Up to 5 Years) n=881

2.7%

For ZEPOSIA in Long-Term Extension Study4

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.1,2

► Overall Infections

In SUNBEAM and RADIANCE, the overall rate of infections with ZEPOSIA (35%) was similar to Avonex (34%).1 ZEPOSIA causes a reduction in peripheral blood lymphocyte count and may increase the risk of infection.4

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.1-3,9

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 ZEPOSIA 0.92 mg and in 0.2% of patients taking Avonex.4

ZEPOSIA Consistently Maintained ALC Near the Lower Limit of Normal1,2,6

ZEPOSIA® consistently maintained ALC near the lower limit of normal

Lymphocyte numbers can be restored to normal values by discontinuing therapy 1,2,4,7

  • After discontinuing 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 ZEPOSIA 0.92 mg and in 0.2% of patients taking Avonex.4

Get your patients
started on ZEPOSIA
PATIENT
START FORM
Enroll your patients in ZEPOSIA 360 Support
and help them get started on treatment.
GETTING STARTED VIDEO
Helpful instructions to guide you through the process of getting your patients started on ZEPOSIA.

This website is best viewed
using the horizontal display on
your tablet device.

This website is best viewed
using the vertical display on
your mobile device.