Satralizumab, is a humanized monoclonal antibody medication that is used for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease.
It is a humanized IgG2 monoclonal antibody that binds to soluble and membrane-bound human ((interleukin-6 (IL-6) )) receptors and prevents IL-6-mediated signal transmission through these receptors.
Brand name Enspryng.
Route of administration is subcutaneous.
Side effects include the common cold, headache, upper respiratory tract infection, gastritis, rash, joint pain, extremity pain, fatigue and nausea.
Satralizumab regulates inflammation by inhibiting the interleukin-6 (IL-6) receptor, a key mediator of the immune response.
Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 or AQP4 antibody-positive.
With NMOSD, the body’s immune system mistakenly attacks healthy cells and proteins in the body, most often those in the optic nerves and spinal cord.
Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss.
Approximately 50% of people with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks.
NMOSD is thought to impact approximately 4,000 to 8,000 Americans.
NMOSD is associated with antibodies that bind to a protein called aquaporin-4 (AQP4): Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system.
Contraindications: Live-attenuated or live vaccines is not recommended during treatment.
Side effects: common cold, headache, upper respiratory tract infection, inflammation of the lining of the stomach, rash, joint pain, extremity pain, fatigue and nausea.
Associated with an increased risk of infection, including serious and potentially fatal infections, such as potential reactivation of hepatitis B and tuberculosis.
It may elevate liver enzymes, decreased neutrophil counts and cause hypersensitivity reactions.
IL-6 is a pleiotropic cytokine that is produced by a large number of cell types and is involved in a variety of inflammatory processes.
Patients with NMO and NMOSD have elevated levels of IL-6 in cerebro-spinal fluid and serum during periods of active disease.
The pro-inflammatory processes involved in NMOSD involve IL-6, and autoantibodies against aquaporin-4 (AQP4), and the permeability of the blood-brain barrier to mediators of inflammation.
Treatment with satralizumab reduced the number of NMOSD relapses by 74% in participants who were anti-AQP4 positive compared to treatment with a placebo.
In a study of satralizumab as an adjuvant to immunosuppressant treatment for NMOSD, treatment in combination with satralizumab reduced the rate of relapses in participants who were anti-AQP4 positive by four-fifths compared to immunosuppressant treatment alone.
No evidence of a benefit in participants who were anti-AQP4 antibody negative in either trial.