|Pronunciation||in eb" i liz' ue mab|
|Other names||Inebilizumab-cdon, MEDI-551|
|Main uses||Neuromyelitis optica spectrum disorder (NMOSD)|
|Side effects||Urinary tract infection, joint pain|
|Chemical and physical data|
|Molar mass||146652.90 g·mol−1|
Inebilizumab, sold under the brand name Uplizna, is a medication used to treat neuromyelitis optica spectrum disorder (NMOSD) due to antibodies against aquaporin 4. It is given by gradual injection into a vein.
Common side effects include urinary tract infection and joint pain. Other side effects may include infusion reactions and infections. Use in pregnancy may harm the baby. It is a monoclonal antibody that binds to CD19 on B lymphocytes and results in their breakdown.
Inebilizumab was approved for medical use in the United States in 2020. In the United States it costs about 137,000 USD per dose as of 2021. It is not commercially avaliable in the United Kingdom or Europe as of 2021.
NMOSD is a rare autoimmune disorder in which immune system cells and autoantibodies attack and damage the optic nerves and spinal cord. NMOSD can be 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. Clinically, the disease is manifested with attacks/relapses that result in neurological impairment such as blindness, paraplegia, sensory loss, bladder dysfunction, and peripheral pain. The disability from each attack is cumulative, making NMOSD a chronically debilitating and potentially life-threatening disease.
It is given at a dose of 300 mg, followed by a second dose of 300 mg after two weeks, and than 300 mg every 6 months.
The label for inebilizumab includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential increased risk of infection – including Progressive Multifocal Leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis.
The most common adverse reactions in the NMOSD clinical trial were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain.
Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with inebilizumab and for six months after the last dose.
Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks prior to initiation of inebilizumab.
The effectiveness of inebilizumab for the treatment of NMOSD was demonstrated in a clinical study (NCT02200770) of 230 adult participants that evaluated the efficacy and safety of intravenous inebilizumab. In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive). During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody positive participants who were treated with inebilizumab was reduced by 77% when compared to the placebo treatment group. There was no evidence of a benefit in participants who were anti-AQP4 antibody negative. The primary efficacy endpoint was the time to the onset of the first adjudicated relapse on or before study day 197 evaluated by a blinded, independent, adjudication committee, who determined whether the attack met protocol-defined criteria. The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia.
Society and culture
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