Neuromyelitis Optica Spectrum Disorder Clinical Trial
Official title:
Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders
The purpose of this study is to compare annual relapse rate, expanded disability status scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica spectrum disorder during a one year follow up through a randomized clinical trial.
Neuromyelitis Optica Spectrum Disorder (NMO-SD) is a recurrent inflammatory demyelinating
disease affecting the central nervous system. The disease is clinically recognized by optic
neuritis and transverse myelitis and is associated with high risk of mortality. Each attack
worsens patients' disability. This means that after 5 years of the disease onset, half of
patients need to use wheelchair and approximately 50% of them become blind.
Considering that the disease can be disabling for patients, the maintenance treatment should
be applied in addition to treatment of acute attacks, in order to prevent future recurrences.
Acute attacks are usually treated with high doses of intravenous corticosteroids.
Plasmapheresis is also used when patients fail to response to corticosteroids. B lymphocyte
inhibitors are used as the maintenance therapy in these patients. First line therapeutic
medications include azathioprine and rituximab which are being recommended for long term
therapy and second line medications include methotrexate and mycophenolate mofetil.
Azathioprine is an immune-modulatory agent which is available in the oral form and don't
require hospitalization to be administered, however, because of side effects such as bone
marrow suppression and hepatotoxicity, periodic check of blood cells and liver enzymes are
needed. Rituximab is a cluster of differentiation antigen 20 inhibitor which leads to
decreased B lymphocytes and antibody in patients. This medication is only available in the
injectable form and needs hospitalization to be administered. Close monitory is needed during
the administration considering severe side effects such as allergic reactions and respiratory
distress. However, laboratory tests are not needed in patients taking rituximab although it
is more expensive than azathioprine. No clinical trial has been performed previously to
compare clinical efficacy of these two drugs in NMO-SD patients. Therefore, we aimed to
compare their efficacy through a randomized clinical trial.
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