Enspryng

Indications and use

Enspryng (satralizumab) is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and young people 12 years of age and older who are anti-aquaporin 4 (AQP4) seropositive.

Enspryng is not intended for acute treatment of an NMOSD relapse.
The safety and efficacy of Enspryng in young people less than 12 years of age have not been established.
The safety and efficacy of Enspryng in adults older than 74 years of age have not been studied.

Enspryng is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus. Breastfeeding is not recommended during treatment with Enspryng as a risk to the nursing infant cannot be excluded.

Administration and dosage

The recommended loading dose is 120 mg by SC injection at Weeks 0, 2, and 4 for the first three administrations, followed by a maintenance dose of 120 mg every 4 weeks. 

The recommended injection sites are the abdomen and thigh. Injection sites should be rotated, and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Mechanism of action

Enspryng works by preventing relapses of NMOSD for aquaporin-4 antibody (AQP4-IgG) seropositive patients by targeting the interleukin-6 (IL-6) receptor, believed to play a key role in the inflammation that occurs NMOSD.

Side-effects*

Injection-related reactions (redness, itching, pain or swelling where the injection is given, rash, red or itchy skin or hives, feeling flushed, headache, throat irritation, swelling or pain, feeling short of breath, low blood pressure, fever, or chills, feeling tired or dizzy, feeling sick to your stomach or vomiting, diarrhea, fast heart rate, fluttering or pounding heart.

Headache, joint pain, stiffness, migraine, unable to sleep, swelling in your lower legs, feet or hands, rash or itching, allergies or hay fever, low levels of fibrinogen (type of blood clotting protein shown in tests), low levels of white blood cells, high levels of bilirubin.

Serious side-effect: Liver enzyme increase (yellowing of the skin and the whites of the eyes, dark coloured urine, feeling sick to your stomach, vomiting).

This is not a comprehensive list of all possible side effects of Enspryng. Please see the Enspryng product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Enspryng.)

Clinical trials

SAkuraSky was a randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of Enspryng in combination with a baseline immunosuppressant therapy (corticosteroids, azathioprine, or mycophenolate mofetil). The primary endpoint of SAkuraSky was time to first relapse, and included 83 patients, 55 of whom were AQP4-IgG seropositive. Participants received the first 3 single doses of Enspryng 120 mg or placebo by injection under the skin (subcutaneous) every 2 weeks for the first 4 weeks, and then once every 4 weeks thereafter. In total, 41 patients were randomized to receive Enspryng, and 42 were randomized to receive placebo. The risk of relapse was reduced by 79% with Enspryng, compared to placebo (in combination with baseline immunosuppressant therapy) in participants who were AQP4-IgG seropositive.

SAkuraStar was a randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ENSPRYNG monotherapy compared to placebo. The primary endpoint of the SAkuraStar study was time to first relapse and included 95 adult participants of which 64 were AQP4-IgG seropositive. Participants received the first 3 single doses of ENSPRYNG 120 mg or placebo by injection under the skin every 2 weeks for the first 4 weeks and once every 4 weeks thereafter. A total of 63 patients were randomized to receive ENSPRYNG and 32 were randomized to receive placebo. The risk of relapse was reduced by 74% with ENSPRYNG monotherapy compared to placebo.

Cost reimbursement

Coming soon

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