Efficacy and safety results in patients switched from glatiramer acetate (GA) to VUMERITY from EVOLVE-MS-1 study1

A post hoc analysis of 166 patients with MS switched from GA to VUMERITY

(See full analysis below)

Limitations

  • The reported analysis is limited in that efficacy and safety outcomes could be less conclusively assessed relative to baseline, due to the open-label study design relying on retrospective data collection of events before therapy
  • The study is not designed or intended to be comparative
  • Efficacy endpoint NEDA-3 is exploratory2
  • The clinical and radiological efficacy endpoints that comprise NEDA-3 have been proven in studies of DMF and VUMERITY, but not with NEDA-3 named as a specific primary or secondary trial endpoint

aNEDA-3 was based on the Kaplan-Meier product limit method using relapse, MRI, and EDSS data, as well as on the number of evaluable patients for NEDA-3.

74% reduction in ARR after switching from GA to VUMERITY with up to 2 years of treatment1

Adjusted ARR on VUMERITY compared with 12 months before initiation

78.4%

estimated proportion of relapse-free patients

Demonstrated clinical efficacy with 85% of patients
with no confirmed disability progression1

In patients switched from GA to VUMERITY after 2 years

Study was funded by Biogen.

96% of patients switched from GA to VUMERITY were free from Gd+ lesions at 2 years

Patients free from Gd+ lesions

75% reduction in Gd+ lesions from baseline in patients switched from GA to VUMERITY after 2 years1

Gd+ lesion count

70%

REDUCTION in mean number of new or enlarging T2 lesions from Year 1 to Year 2

Study was funded by Biogen.

NEDA-3 was achieved by just under half of patients switched from GA to VUMERITY after 2 years of treatment1

NEDA-3 was defined as:

  • No relapses
  • No 12-week sustained CDP
  • No new or enlarging T2 hyperintense lesions
  • No new Gd+ lesions

Study was funded by Biogen.

No discontinuations due to GI AEs in patients switched from GA to VUMERITY1

Safety summary

AEs, n (%) GA/DRF
(n=166)
AEs, n (%) GA/DRF
(n=166)
Any AE 154 (92.8) Infections 83 (50.0)
Mild 52 (31.3) Serious infections 2 (1.2)
Moderate 88 (53.0) Opportunistic 3 (1.8)
Severe 14 (8.4) Oral candidiasis 2 (1.2)
GI AEs (occurring in ≥ 5%
of patients in any group)
58 (34.9) Candida infection 0
Vulvovaginal candidiasis 1 (0.6)
Diarrhea 25 (15.1) Esophageal candidiasis 0
Nausea 20 (12.0) COVID-19 infection 0
Constipation 6 (3.6) AEs leading to treatment discontinuation 19 (11.4)
Upper abdominal pain 6 (3.6) GI AEs leading to treatment discontinuation 0
Vomiting 4 (2.4) SAEsb 20 (12.0)
    Death 0
AEs, n (%) GA/DRF
(n=166)
Any AE 154 (92.8)
Mild 52 (31.3)
Moderate 88 (53.0)
Severe 14 (8.4)
GI AEs (occurring in ≥ 5%
of patients in any group)
58 (34.9)
Diarrhea 25 (15.1)
Nausea 20 (12.0)
Constipation 6 (3.6)
Upper abdominal pain 6 (3.6)
Vomiting 4 (2.4)
AEs, n (%) GA/DRF
(n=166)
Infections 83 (50.0)
Serious infections 2 (1.2)
Opportunistic 3 (1.8)
Oral candidiasis 2 (1.2)
Candida infection 0
Vulvovaginal candidiasis 1 (0.6)
Esophageal candidiasis 0
COVID-19 infection 0
AEs leading to treatment discontinuation 19 (11.4)
GI AEs leading to treatment discontinuation 0
SAEsb 20 (12.0)
Death 0

bSAEs in the GA/DRF group included MS relapse, n=7; and 1 patient each with uterine leiomyoma; fallopian tube cyst; abortion spontaneous; cardiac failure; diffuse large B-cell lymphoma; sepsis; cellulitis; suicidal ideation; pelvic prolapse; sciatica; cholelithiasis; chorioretinopathy; bipolar I disorder.

No unexpected safety concerns were identified with up to 2 years of treatment in patients switched from GA to VUMERITY

Study was funded by Biogen.

75% of participants were women, average age 44 years1

Baseline patient characteristics in EVOLVE-MS-1 patients who
most recently received GA before initiating DRF

  GA/DRF
(n=166)
  GA/DRF
(n=166)
Mean (SD) age, y   44.0 (10.4) Treatment duration of most recent prior DMT, years (IQR) GA, 1.76
(0.82-3.55)
Female, n (%) 124 (75)
Race, n (%)   Mean (SD) time since diagnosis, y  8.2 (7.2)
White 151 (91) Mean (SD) number of relapses in previous year 0.6 (0.7)
Black or African American 13 (8) Mean (SD) EDSS score 2.6 (1.5)
Other 2 (1) Mean (SD) number of Gd+ lesions 0.7 (2.5)
Mean (SD) BMI, kg/m2 28.8 (6.5) Gd+ lesion-free, n (%) 128 (77)
US region, n (%) 117 (71)    
  GA/DRF
(n=166)
Mean (SD) age, y   44.0 (10.4)
Female, n (%) 124 (75)
Race, n (%)  
White 151 (91)
Black or African American 13 (8)
Other 2 (1)
Mean (SD) BMI, kg/m2 28.8 (6.5)
US region, n (%) 117 (71)
  GA/DRF
(n=166)
Treatment duration of most recent prior DMT, years (IQR) GA, 1.76
(0.82-3.55)
Mean (SD) time since diagnosis, y  8.2 (7.2)
Mean (SD) number of relapses in previous year 0.6 (0.7)
Mean (SD) EDSS score 2.6 (1.5)
Mean (SD) number of Gd+ lesions 0.7 (2.5)
Gd+ lesion-free, n (%) 128 (77)

Study was funded by Biogen.