ENSPRYNG

ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive. It is not known if ENSPRYNG is safe and effective in children.

Most common adverse events with ENSPRYNG (satralizumab-mwge) 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%).

Eculizumab (Soliris, Elizaria), satralizumab (Enspryng) and inebilizumab (Uplizna) have been approved by the U.S. Food and Drug Administration (FDA) for relapses in adults. Rituximab (Rituxan) also has been shown in clinical trials to be effective in reducing NMO relapses.

NMOSD versus MS MS usually affects one at a time. NMOSD usually affects only the optic nerve and spinal cord although there may be lesions in specific areas of the brain (such as the brainstem). MS typically affects multiple areas of the brain as well as the spinal cord and optic nerve.

NMOSD is rare. Estimates vary but suggest that roughly 15,000 people in the U.S. have it. Numbers are rising as doctors become better able to diagnose NMOSD.

Medication suggestions are Baclofen, Tizanidine, Gabapentin. Tonic Spasms this is a painful spasm of the muscles that lasts seconds to minutes but frequently. Often, it’s controlled by Carbamazepine at low doses.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare and disabling neurological disorder, marked by recurrent attacks of the central nervous system. NMO has a high female predominance and disproportionately affects racial and ethnic groups who are under- and unemployed in the USA.

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The average life expectancy for patients with NMO is approximately 5 years following the initial attack if left untreated; however, with treatment, outcomes are substantially improved. Conversely, MS generally does not affect life expectancy, highlighting the distinctions between these two autoimmune disorders.

A total of 71 patients (mean age: 39 ± 14 years) were enrolled in the study. The female:male ratio≈11:1. Among these patients, 32 patients were classified as having REO-NMOSD. The mean age of onset was 25.5 ± 6.7 years in the REO-NMOSD group and 50.8 ± 8.1 years in the RLO-NMOSD group.

Satralizumab is a humanized immunoglobulin G2 monoclonal antibody that has been developed for the treatment of NMOSD and was approved for first time use in Canada in June of 2020 as monotherapy or as combination therapy in adults and children 12 years or older who are positive for AQP4-IgG autoantibodies (13, 14).

Treatment efficacy The mean duration of treatment with rituximab was 5 years, 1 month (range: 3 years to 9 years and 3 months). The patients received between 2 and 11 cycles of rituximab (mean 5). In the study, 8 (61.54%) of 13 patients were completely relapse free after starting treatment with rituximab.

Neuromyelitis optica is a rare but serious disease that affects the central nervous system. There is no cure but there medicines and treatments may inhibit future disease flares. Many healthcare providers including physical and occupational therapists, and social workers can help you deal with your disease.

Relapses are common. Preventing recurrent attacks is a key to averting disability. Neuromyelitis optica flare-ups might be reversible, but they can be severe enough to cause permanent visual loss and problems with walking.

In NMOSD, pain has a prevalence of over 80%, and pain syndromes include neuropathic, nociceptive, and mixed pain, which can emerge in acute relapse or become chronic during the disease course. The impact of pain in MOGAD has only recently received increased attention, with an estimated prevalence of over 70%.

While the precise mechanism through which ENSPRYNG exerts therapeutic effects in NMOSD is unknown, it is presumed to involve inhibition of IL-6-mediated signaling via binding through soluble and membrane-bound IL-6 receptors.

Enspryng is a monoclonal antibody. Enspryng is used to treat neuromyelitis optica spectrum disorders (NMOSD) in adult patients, who test positive for an antibody called AQP4-IgG (aquaporin-4 immunoglobulin G), also known as NMO-IgG (neuromyelitis optica immunoglobulin G).

ENSPRYNG is taken as a subcutaneous injection under the skin. During the first 4 weeks, you will have 3 starting doses (injections) of ENSPRYNG. You will receive 1 prefilled syringe (120 mg of ENSPRYNG) 2 weeks apart for each dose. After the starting doses, ongoing doses will be taken every 4 weeks.

Blurry vision or blindness in one or both eyes.Weakness or paralysis in the legs or arms.Painful spasms.Numbness or loss of sensation throughout the body.Persistent nausea.Uncontrollable vomiting.Persistent hiccups.Bladder or bowel dysfunction.

NMO is also called neuromyelitis optica spectrum disorder (NMOSD) and Devic disease. It occurs when the body’s immune system reacts against its own cells. This happens mainly in the optic nerves that connect the retina of the eye with the brain and in the spinal cord.

Rituximab targets the CD20 antigen on B-cells and leads to profound B-cell depletion, principally over an antibody-dependent cell cytotoxicity mechanism and decreases attack frequency and severity in patients with NMO; however, it does not remove attacks, even when modifying treatment to achieve B-cell depletion.

Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing central nervous system disease associated with aquaporin-4 antibodies. Common presentations include longitudinally extensive myelitis, severe optic neuritis, and area postrema syndrome.

Satralizumab-mwge is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of the part of the immune system that may damage certain areas of the nervous system in people with NMOSD.

Genentech: Enspryng® (satralizumab-mwge) – Information for Patients.

ENSPRYNG (satralizumab-mwge) is intended for patient self-administration by subcutaneous injection under the guidance of a healthcare provider. After proper training in subcutaneous injection technique, a patient or their caregiver may administer ENSPRYNG if it’s determined to be appropriate.

Since 2019, eculizumab, inebilizumab, and satralizumab have received FDA approval for the treatment of aquaporin-4 IgG positive (AQP4+) NMOSD after showing efficacy in reducing attack frequency. However, little is known regarding the adoption of these therapies into practice or barriers to their use.

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist used to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

The FDA approved ENSPRYNG based on evidence from two clinical trials (Trial 1/ NCT02073279 and Trial 2/NCT02028884) of 116 patients with NMOSD who were AQP4 antibody positive.

DateArticleAug 14, 2020Approval FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum DisorderMay 21, 2020New Longer-Term Data Reinforce Safety of Genentech’s Satralizumab in Adults and Adolescents With Neuromyelitis Optica Spectrum Disorder (NMOSD)

On June 27, 2019, eculizumab, or Soliris, became the first FDA approved treatment for anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) in adults.