SAkuraStar: ENSPRYNG monotherapy

Summary of adverse reactions 1

During the double-blind period, the median observation time for patients taking ENSPRYNG was approximately 2 years. The most common adverse events (incidence at least 15%) included rash, arthralgia, extremity pain, fatigue, and nausea.

Adverse reactions occurring in 4 or more patients treated with ENSPRYNG and greater incidence than placebo

ENSPRYNG Monotherapy
Patients (%)
ENSPRYNG
(n=41)
Placebo
(n=23)
Rash 17 0
Arthralgia
17 0
Pain in extremity 15 9
Fatigue
15 4
Nausea 15 9
Nasopharyngitis 12 4
Pruritus
10 0
Depression
10 0
Cellulitis 10 0
Neutropenia 10 4
Blood creatine phosphokinase increased 10 4
Fall
10 4

There were no deaths or anaphylactic reactions in the clinical trials. However, hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin-6 receptor antagonists.

 


SAkuraSky: ENSPRYNG + IST

Summary of adverse reactions 1

During the double-blind period, the median observation time for patients taking ENSPRYNG + IST was approximately 3 years. Common adverse events (incidence at least 15%) included nasopharyngitis, headache, upper respiratory infection, and gastritis.

Adverse reactions occurring in 3 or more patients treated with ENSPRYNG and greater incidence than placebo

ENSPRYNG + IST*
Patients (%)
ENSPRYNG + IST
(n=26)
Placebo + IST
(n=26)
Nasopharyngitis 31 15
Headache 27 12
Upper respiratory tract infection 19 12
Gastritis 15 0
Arthralgia 12 0
Pharyngitis 12 8

*All patients were concurrently receiving immunosuppressive therapy, which included oral corticosteroids, azathioprine, and mycophenolate mofetil.

There were no deaths or anaphylactic reactions in the clinical trials. However, hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin-6 receptor antagonists.

 


Injection-related reactions

In both studies, injection-related reactions were reported in 9% of patients treated with ENSPRYNG compared with 8% in patients receiving placebo. These reactions were predominantly mild to moderate in severity, and most occurred within 24 hours after the injection. 1

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