Proven to reduce the risk of relapse1

Efficacy demonstrated in 2 distinct clinical trials with ENSPRYNG® (satralizumab-mwge) as monotherapy or with certain immunosuppressant therapies (ISTs)


SAkuraStar: ENSPRYNG monotherapy

A randomized, double-blind, multicenter, placebo-controlled trial1

Key inclusion criteria1,3

  • 95 adult patients (18 to 74 years) with NMO (AQP4-IgG+/-) or NMOSD (AQP4-IgG+)
    • 64 AQP4-IgG(+); 31 AQP4-IgG(-)
  • ≥1 attack in the last year

Key exclusion criteria1

  • Patients were excluded if they had taken immunosuppressive therapy (IST) within an interval specified for each such therapy

 

SAkuraStar trial design1,3

 
 
 ENSPRYNG® (satralizumab) SAkuraStar double-blind period

SC=subcutaneous.
*Patients were randomized to receive ENSPRYNG 120 mg or placebo administered subcutaneously at Weeks 0, 2, and 4, and once every 4 weeks thereafter.

 

Baseline characteristics6

AQP4-IgG(+) patients

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)

ARR=annualized relapse rate; EDSS=Expanded Disability Status Scale. 

With ENSPRYNG, time to first relapse was longer in AQP4-IgG(+) patients1

Primary endpoint: time to first protocol-defined relapse1

Graph representing 82.9% of patients taking ENSPRYNG were relapse-free at week 48 compared with 55.4% of patients taking placebo. At week 96, 76.5% of patients taking ENSPRYNG were relapse-free vs 41.1% of patients taking placebo.

HR=hazard ratio. 

Patients remained relapse-free at nearly twice the rate with ENSPRYNG vs placebo1

 77% patients taking ENSPRYNG® (satralizumab) were relapse-free at 96 weeks vs 41% of patients taking placebo

SAkuraSky: ENSPRYNG + IST

A randomized, double-blind, multicenter, placebo-controlled trial1

Key inclusion criteria1,4

  • 76 adult patients with NMO (AQP4-IgG+/-) or NMOSD (AQP4-IgG+)
    • 52 AQP4-IgG(+); 24 AQP4-IgG(-)
  • ≥2 relapses in the last 2 years (≥1 relapse in last year)
  • Baseline treatment with a stable dose of immunosuppressive therapy (IST), including azathioprine, mycophenolate mofetil, or oral corticosteroids, as monotherapy for 8 weeks prior to randomization

SAkuraSky trial design1,4

 
 
 
 ENSPRYNG® (satralizumab) SAkuraSky double-blind period

SC=subcutaneous.
Patients were randomized to receive ENSPRYNG 120 mg or placebo administered subcutaneously at Weeks 0, 2, and 4, and once every 4 weeks thereafter.

 

Baseline characteristics6

AQP4-IgG(+) adult patients

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

ARR=annualized relapse rate; EDSS=Expanded Disability Status Scale.

ENSPRYNG + IST was shown to reduce relapse risk1

Primary endpoint: time to first protocol-defined relapse1

Graph representing 91.1% of patients taking ENSPRYNG were relapse-free at week 48 compared with 63.8% of patients taking placebo. At week 96, 91.1% of patients taking ENSPRYNG were relapse-free vs 56.8% of patients taking placebo.

HR=hazard ratio. 

Majority of patients remained relapse-free with ENSPRYNG + IST1

91% of patients taking ENSPRYNG® (satralizumab) were relapse-free at 96 weeks vs 57% of patients taking placebo
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Patient safety

ENSPRYNG SAFETY

Observed in 2 distinct clinical trials1

Dosing and administration

SUBCUTANEOUS INJECTION

Monthly self-administration after proper training1

Indication

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Contraindications

ENSPRYNG is contraindicated in patients with a known hypersensitivity to satralizumab or any of the inactive ingredients, an active hepatitis B infection, or active or untreated latent tuberculosis.

Warnings and Precautions

Infections
An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including ENSPRYNG. The most common infections reported in a randomized clinical trial of patients treated with ENSPRYNG who were not on other chronic immunosuppressant therapies, and that occurred more often than in patients receiving placebo, were nasopharyngitis (12%) and cellulitis (10%). The most common infections in patients who were on an additional concurrent immunosuppressant, and that occurred more often than in patients receiving placebo, were nasopharyngitis (31%), upper respiratory infection (19%), and pharyngitis (12%). Delay ENSPRYNG administration in patients with an active infection, including localized infections, until the infection is resolved.

Hepatitis B Virus (HBV) Reactivation
Risk of HBV reactivation has been observed with other immunosuppressant therapies. Patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with ENSPRYNG. Do not administer ENSPRYNG to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+] or are negative for HBsAg and positive for HB core antibody [HBcAb+], consult liver disease experts before starting and during treatment with ENSPRYNG.

Tuberculosis
Tuberculosis has occurred in patients treated with other IL-6 receptor antagonists. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating ENSPRYNG. Consider anti-tuberculosis therapy prior to initiation of ENSPRYNG in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. Patients should be monitored for the development of signs and symptoms of tuberculosis with ENSPRYNG, even if initial tuberculosis testing is negative.

Vaccinations
Live or live-attenuated vaccines should not be given concurrently with ENSPRYNG because clinical safety has not been established. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ENSPRYNG for non-live vaccines.

Elevated Liver Enzymes
Mild and moderate elevations of liver enzymes have been observed in patients treated with ENSPRYNG at a higher incidence than in patients receiving placebo. ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for one year, and thereafter, as clinically indicated.

Decreased Neutrophil Counts
Decreases in neutrophil counts were observed in patients treated with ENSPRYNG at a higher incidence than placebo. Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy, and thereafter at regular clinically determined intervals.

Hypersensitivity Reactions
Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other IL-6 receptor antagonists.

Use in Specific Populations

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENSPRYNG during pregnancy. Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338.

There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring, with administration of ENSPRYNG at doses up to 50 mg/kg/week. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.


Lactation
No information is available on the presence of ENSPRYNG in human milk, the effects of ENSPRYNG on the breastfed infant, or the effects of ENSPRYNG on milk production. ENSPRYNG was excreted in the milk of lactating monkeys administered ENSPRYNG throughout pregnancy. Human IgG is excreted in human milk and the potential for absorption in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENSPRYNG and any potential adverse effects on the breastfed infant from ENSPRYNG or from the underlying maternal condition.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic analyses in patients with NMOSD did not show that age affected the pharmacokinetics of ENSPRYNG. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Most Common Adverse Reactions

The most common adverse reactions (≥15% in either trial) were nasopharyngitis (31%), headache (27%), upper respiratory tract infection (19%), rash (17%), arthralgia (17%), extremity pain (15%), gastritis (15%), fatigue (15%), and nausea (15%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.

    • ENSPRYNG [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.

      ENSPRYNG [prescribing information]. South San Francisco, CA: Genentech, Inc. 2022.

    • Naka T, Nishimoto N, Kishimoto T. The paradigm of IL-6: from basic science to medicine. Arthritis Res. 2002;4(suppl 3):S233-S242.

      Naka T, Nishimoto N, Kishimoto T. The paradigm of IL-6: from basic science to medicine. Arthritis Res. 2002;4(suppl 3):S233-S242.

    • Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(6):402-412.

      Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(6):402-412.

    • Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.

      Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.

    • Barros PO, Cassano T, Hygino J, et al. Prediction of disease severity in neuromyelitis optica by the levels of interleukin (IL)-6 produced during remission phase. Clin Exp Immunol. 2016;183:480-489.

      Barros PO, Cassano T, Hygino J, et al. Prediction of disease severity in neuromyelitis optica by the levels of interleukin (IL)-6 produced during remission phase. Clin Exp Immunol. 2016;183:480-489.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.

    • Uzawa A, Mori M, Kuwabara S. Role of interleukin-6 in the pathogenesis of neuromyelitis optica. Clin Exp Neuroimmunolol. 2013,4(2):167-172.

      Uzawa A, Mori M, Kuwabara S. Role of interleukin-6 in the pathogenesis of neuromyelitis optica. Clin Exp Neuroimmunolol. 2013,4(2):167-172.

    • Naka T, Nishimoto N, Kishimoto T. The paradigm of IL-6: from basic science to medicine. Arthritis Res. 2002;4(suppl 3):S233-S242.

      Naka T, Nishimoto N, Kishimoto T. The paradigm of IL-6: from basic science to medicine. Arthritis Res. 2002;4(suppl 3):S233-S242.

    • Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(6):402-412.

      Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(6):402-412.

    • Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.

      Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.

    • Data on file. Genentech, Inc. South San Francisco, CA.

      Data on file. Genentech, Inc. South San Francisco, CA.