2-YEAR STUDY
vs PLACEBO
1-YEAR STUDY
vs AVONEX
1-YEAR STUDY
vs COPAXONE
2-Year
STUDY vs
PLACEBO
1-Year
STUDY vs
AVONEX
1-Year
STUDY vs
COPAXONE
SIGNIFICANTLY LOWER ARR IN ADULT PATIENTS WITH RRMS
TREATED WITH GILENYA vs PLACEBO1,2
SIGNIFICANTLY LOWER
ARR IN ADULT PATIENTS
WITH RRMS
TREATED WITH
GILENYA vs PLACEBO1,2

FREEDOMS was a 2-year, placebo-controlled study in adult patients with RRMS. At baseline, patients had ≥1 relapse during the prior year or ≥2 relapses during the prior 2 years, were 18 to 55 years of age, and had an EDSS score of 0.0 to 5.5 (median baseline score was 2.0).

More adults were relapse-free
70% free of relapses with GILENYA 0.5 mg (n=425) vs 46% with placebo (n=418); (P<0.001)

MRI evaluations were performed at screening and at 2 years for the total population.
*Confirmed at 24 months, where 3-month confirmed disability progression was defined as an increase of 1 point in the EDSS score from baseline (or half of a point increase if the baseline EDSS score was equal to 5.5) sustained for 3 months.
See full FREEDOMS study design below
SIGNIFICANTLY LOWER ARR
IN ADULT PATIENTS WITH
RRMS TREATED WITH
GILENYA vs AVONEX1,3

TRANSFORMS was a 1-year, active-controlled study vs Avonex (interferon beta-1a) injection in adult patients with RRMS. At baseline, patients had ≥1 relapse during the prior year or ≥2 relapses during the prior 2 years, were 18 to 55 years of age, and had an EDSS score of 0.0 to 5.5 (median baseline score was 2.0).

More adults were relapse-free
83% free of relapses with GILENYA 0.5 mg (n=429) vs 70% with Avonex (n=431); (P<0.001)

MRI evaluations were performed at screening and at 1 year for the total population.
*Confirmed at 12 months, where 3-month confirmed disability progression was defined as an increase of 1 point in the EDSS score from baseline (or half of a point increase if the baseline EDSS score was equal to 5.5) sustained for 3 months.
See full TRANSFORMS study design below
SIGNIFICANTLY LOWER
ARR IN ADULT PATIENTS
WITH
RRMS TREATED WITH
GILENYA vs COPAXONE4
ASSESS
ASSESS was a 1-year, active-controlled, randomized, double-blind, phase IIIb study vs Copaxone (glatiramer acetate injection) 20 mg in adult patients with RRMS. At baseline, patients had ≥1 relapse during the prior year or ≥2 relapses during the prior 2 years, were 18 to 65 years of age, and had an EDSS score of 0.0 to 6.0 (median baseline score was 2.5).

First and only DMT proven superior in ARR vs both Avonex and Copaxone in adult patients with RRMS
See full ASSESS study design below
RELATIVE ARR
REDUCTIONS IN ADULT
PATIENTS
ACROSS
SUBGROUPS BY AGE2,3,5
In pooled results of the GILENYA arms of FREEDOMS and TRANSFORMS, GILENYA demonstrated a consistent and/or significant reduction in ARR vs comparator in subgroups defined by age.
- Both studies were randomized, double-blind, parallel, placebo- or active-controlled, and designed to demonstrate the efficacy and safety of GILENYA using number of relapses as the primary end point for each study

LIMITATIONS
Relative reduction percentages observed from a pooled, post hoc analysis of clinical trial data are shown. The figures above present effects in various subgroups, each of which is formed based on a baseline characteristic. The P values that are shown do not take into account the number of comparisons made, and may not reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be overinterpreted.
*Patients in FREEDOMS and TRANSFORMS were between 18 and 55 years of age and included patients with baseline EDSS 0.0 to 5.5.
See full FREEDOMS and TRANSFORMS study designs below

Download the GILENYA START FORM to get your patients started now.
STUDY DESIGNS
1,2
A 2-year, randomized, double-blind, placebo-controlled phase Ill study of 1,272 adults with RRMS
Patients were randomly assigned to receive GILENYA at a once-daily dose of 0.5 mg (n=425) or 1.25 mg (n=429) or matching placebo once daily (n=418) for 2 years
-
Patient baseline characteristics
Between 18 and 55 years of age
A diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years
A score of 0.0 to 5.5 on the EDSS. Median score at baseline was 2.0
Primary end point: ARR
Key secondary end point: time to 3-month confirmed disability progression as measured by at least a 1-point increase from baseline in EDSS (0.5-point increase for patients with baseline EDSS of 5.5) sustained for 3 months*
Additional secondary end points included number of Gd+ T1 lesions and number of new or newly enlarged lesions on T2-weighted MRI scans
The FDA-approved dose of GILENYA is 0.5 mg orally once daily. Doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefits
81.2% (345/425) of patients assigned to GILENYA 0.5 mg completed the study on GILENYA 0.5 mg at 2 years while 18.8% (80/425) discontinued GILENYA
*The analysis of a key secondary end point includes the same intent-to-treat population as the primary end point(s), as well as logistic regression adjusting for certain baseline characteristics of the sample.
1,3
A 1-year, randomized, double-blind, double-dummy, active-controlled (IFNβ-1a IM), phase Ill study of 1,292 adults with RRMS
Patients were randomly assigned to receive GILENYA at a once-daily dose of 0.5 mg (n=431) or 1.25 mg (n=426) or IFNβ-1a IM injection at a weekly dose of 30 μg (n=435) for 1 year
-
Patient baseline characteristics
Between 18 and 55 years of age
A diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses during the previous 2 years
A score of 0.0 to 5.5 on the EDSS. Median score at baseline was 2.0
Previous therapy with either any type of interferon-beta or glatiramer acetate was not a criterion for exclusion
Primary end point: the primary objective was to demonstrate that GILENYA was superior to Avonex in terms of ARR in patients with RRMS treated for up to 12 months
Two key secondary end points: number of new or newly enlarged hyperintense lesions on T2-weighted MRI scans at 1 year and the time to 3-month confirmed disability progression as measured by at least a 1-point increase from baseline in EDSS (0.5-point increase for patients with baseline EDSS of 5.5) sustained for 3 months*
The FDA-approved dose of GILENYA is 0.5 mg orally once daily. Doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefits
89.7% (385/429) of patients who received GILENYA 0.5 mg completed the study on GILENYA 0.5 mg at 1 year while 10.3% (44/429) discontinued GILENYA
*The analysis of a key secondary end point includes the same intent-to-treat population as the primary end point(s), as well as logistic regression adjusting for certain baseline characteristics of the sample.
ASSESS 4
A 1-year, randomized, dose-blind, rater-blind, active-controlled (glatiramer acetate injection) SQ phase lllb study in adults with RRMS. Patients randomly assigned to receive once-daily GILENYA 0.25 mg and 0.5 mg vs once-daily subcutaneous injections of Copaxone 20 mg. At baseline, patients with RRMS between 18 and 65 years of age (median 39) had ≥1 documented relapse during the previous year or ≥2 documented relapses during the previous 2 years, and had a score of 0.0 to 6.0 on the EDSS (median score at baseline was 2.5). The primary end point was ARR.
ARR=annualized relapse rate; CI=confidence interval; EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; HR=hazard ratio; IFN=interferon; IM=intramuscular; MRI=magnetic resonance imaging; MS=multiple sclerosis; RRMS=relapsing-remitting multiple sclerosis; SQ=subcutaneous.
Avonex is a registered trademark of Biogen.
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
References: 1. Gilenya [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2019. 2. Kappos L, Radue E-W, O'Connor P, et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.N Engl J Med. 2010;362(5):387-401. 3. Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010.362(5):402-415. 4. Data on file. Data Analysis Report: Study CFTY720D2312. Novartis Pharmaceuticals Corp; July 2015. 5. Data on file. Summary of Clinical Efficacy in Multiple Sclerosis. Novartis Pharmaceuticals Corp; November 2009.
References: 1. Gilenya [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2019. 2. Kappos L, Radue E-W, O'Connor P, et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.N Engl J Med. 2010;362(5):387-401. 3. Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010.362(5):402-415. 4. Data on file. Data Analysis Report: Study CFTY720D2312. Novartis Pharmaceuticals Corp; July 2015. 5. Data on file. Summary of Clinical Efficacy in Multiple Sclerosis. Novartis Pharmaceuticals Corp; November 2009.