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In PRISMS, Rebif demonstrated significant reductions in relapses while delaying disability progression in patients with a range of EDSS scores1,2

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Significant relapse reduction vs placebo at 2 years1,2

Total patient cohort EDSS
0 TO 5.0

EDSS: Expanded Disability Status Scale.

  • Post hoc analysis: at 3 months, significantly fewer patients taking Rebif 44 mcg 3 times weekly (n=184) experienced a relapse at 3 months compared with those taking placebo (n=187; 29% vs 40%, respectively; P=0.0381)

In patients with higher baseline EDSS scores, Rebif reduced relapses by more than half1,2

Higher baseline EDSS EDSS
>3.5 TO 5.0

  • The rate of serious adverse events in patients with EDSS >3.5 to 5.0 (regardless of causality) was 20% vs 11.3% for the total patient cohort (EDSS 0 to 5.0)

Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis (PRISMS) was a double-blind, placebo-controlled study conducted over 2 years. Patients were randomly assigned Rebif 44 mcg (n=184), Rebif 22 mcg (n=189), or placebo (n=187), given 3 times weekly by subcutaneous injection. Outcomes measured included relapse rate, disability, MRI, safety, and antigenicity. Neurological assessments were conducted every 3 months.

IMPORTANT SAFETY INFORMATION

Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury. Monitor liver function tests and patients for signs and symptoms of hepatic injury. Consider discontinuing Rebif if hepatic injury occurs.

Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.

Rebif demonstrated a significant delay in disability progression in patients with a range of EDSS scores1,2

Significantly longer first quartile time to sustained disability progression vs placebo ~2X
LONGER

TOTAL PATIENT COHORT (EDSS 0 TO 5.0)

Significantly longer first quartile time to sustained disability progression vs placebo ~3X
LONGER

HIGH EDSS COHORT (EDSS >3.5 TO 5.0)

  • In time to confirmed progression, a statistically significant difference was seen between Rebif 22 mcg and placebo in the total patient cohort (0 to 5.0) but was not seen in the high EDSS cohort (>3.5 to 5.0)
  • The rate of serious adverse events in patients with EDSS >3.5 to 5.0 (regardless of causality) was 20% vs 11.3% for the total patient cohort (EDSS 0 to 5.0)

PRISMS STUDY DESIGN +

PRISMS1 trial: initiated in 1994

  STUDY DESIGN TREATMENT GROUPS CLINICAL ASSESSMENTS OUTCOMES MEASURED

2 years

Double-blind, placebo-controlled study (class 1)

Rebif 44 mcg
SC tiw (n=184)

Rebif 22 mcg
SC tiw (n=189)

Placebo (n=187)

Every 3 months

–Relapse rate
(primary endpoint)

–Disability progression

–MRI outcomes

–Safety

–Antigenicity

INDICATION

Rebif is indicated for the treatment of patients with relapsing forms of MS to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability.

IMPORTANT SAFETY INFORMATION

Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.

Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury. Monitor liver function tests and patients for signs and symptoms of hepatic injury. Consider discontinuing Rebif if hepatic injury occurs.

Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.

In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.

Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.

Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.

The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.

There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

INDICATION

Rebif is indicated for the treatment of patients with relapsing forms of MS to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability.

Please see Rebif Prescribing Information and Medication Guide.

References: 1. PRISMS Study Group. Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet. 1998;352(9139):1498-1504. 2. Data on file. EMD Serono, Inc.

Rebif and MS LifeLines are registered trademarks of EMD Serono, Inc. or its affiliates. Avonex is a registered trademark of Biogen.

©2017 EMD Serono, Inc. All rights reserved. US/REB/0217/0042(1) 07/17