SAkuraStar: ENSPRYNG monotherapy

Trial design 1

  • Multicenter, double-blind, placebo-controlled trial
  • 95 adult patients were randomized 2:1 to ENSPRYNG or placebo
    • 64 AQP4-IgG(+)
    • 31 AQP4-IgG(-)
  • ENSPRYNG 120 mg or placebo administered subcutaneously at Weeks 0, 2, and 4, and once every 4 weeks thereafter

As ENSPRYNG is indicated for AQP4-IgG(+) patients, reported results reflect that population.

Baseline Characteristics for AQP4-IgG(+) Patients 1,5 ENSPRYNG
(n=41)
Placebo
(n=23)
Mean age in years (SD)
(Range) 
46.0 (12.0)
(22-70)
40.1 (11.5)
(20-56)
Gender distribution, n (%) female
31 (75.6)
22 (95.7)
ARR in previous 2 years
0.91 (0.5)
1.02 (0.51)
Mean EDSS score
4.02 (1.5)
3.43 (1.55)
Prior treatment, n (%):
B-cell-depleting therapy
5 (12.2)
4 (17.4)
Immunosuppressants/other
36 (87.8)
19 (82.6)

 

ENSPRYNG as monotherapy reduced relapse risk vs placebo in AQP4-IgG(+) patients 1

Efficacy Endpoints for Monotherapy 1,5
ENSPRYNG
(n=41)
Placebo
(n=23)
Risk reduction (primary endpoint)
74%
(HR: 0.26; 95% CI: 0.11, 0.63; P=0.0014)
Proportion of relapse-free patients at 48 weeks
82.9%
(95% CI: 67.5, 91.5)
55.4%
(95% CI: 33.0, 73.1)
Proportion of relapse-free patients at 96 weeks
76.5%
(95% CI: 59.2, 87.2)
41.1%
(95% CI: 20.8, 60.4)

Time to first protocol-defined relapse with ENSPRYNG monotherapy 1,5

82.9% and 76.5% of patients treated with ENSPRYNG were relapse-free at 48 and 96 weeks, respectively 1,5


SAkuraSky: ENSPRYNG + IST

Trial design 1

  • Randomized, multicenter, double-blind, placebo-controlled trial
  • ENSPRYNG with concurrent oral corticosteroids, azathioprine, or mycophenolate mofetil
  • 76 adult patients were randomized to receive ENSPRYNG or placebo
    • 52 AQP4-IgG(+)
    • 24 AQP4-IgG(-)
  • ENSPRYNG 120 mg or placebo administered subcutaneously at Weeks 0, 2, and 4, and once every 4 weeks thereafter

As ENSPRYNG is indicated for AQP4-IgG(+) adults, reported results reflect that population.

Baseline Characteristics for AQP4-IgG(+) Adult Patients 1,5
ENSPRYNG + IST
(n=26)
Placebo + IST
(n=26)
Mean age in years (SD)
(Range)
45.6 (14.7)
(21-73)
45.6 (10.5)
(23-65)
Gender distribution, n (%) female
26 (100) 26 (100)
ARR in previous 2 years
1.38 (0.52) 1.33 (0.45)
Mean EDSS score
4.21 (1.54) 3.72 (1.49)
Immunosuppressive therapy, n (%):
Oral corticosteroids (OCs)
14 (53.8)
13 (50)
Azathioprine (AZA)
11 (42.3)
11 (42.3)
Mycophenolate mofetil (MMF)
1 (3.8)
2 (7.7)
AZA + OCs
0
0
MMF + OCs
0 0

 

ENSPRYNG + IST reduced relapse risk vs IST alone in AQP4-IgG(+) patients 1

Efficacy Endpoints for ENSPRYNG + IST 1,5
ENSPRYNG + IST
(n=26)
Placebo + IST
(n=26)
Risk reduction (primary endpoint)
78%
(HR: 0.22; 95% CI: 0.06, 0.82; P=0.0143)
Proportion of relapse-free patients at 48 weeks
91.1%
(95% CI: 68.4, 97.7)
63.8%
(95% CI: 40.1, 80.2)
Proportion of relapse-free patients at 96 weeks
91.1%
(95% CI: 68.4, 97.7)
56.8%
(95% CI: 32.1, 75.4)

Time to first protocol-defined relapse with ENSPRYNG + IST 1,5

91.1% of patients treated with ENSPRYNG + IST were relapse-free at both 48 and 96 weeks 1,5

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