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 endpoints, including NEDA and brain volume change, are exploratory1,2
- The clinical and radiological efficacy endpoints that comprise NEDA-3 have been studied individually in 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 years1
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.