B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients . In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders. Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.
This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.
Study Type
OBSERVATIONAL
Enrollment
170
Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times
Bu Ali Sina hospital
Sari, Iran
RECRUITINGRate of hypogammaglobinemia
serum IgG concentration lower than g/L,
Time frame: every 6 month until 18 month
severity of hypogammaglobinemia
serum IgG concentration: mild (at risk) 5- 6.9 g/L, moderate 3- 4.9 g/L and severe \< 3 g/L
Time frame: every 6 month until 18 month
immunization response to VZV vaccination
change of VZV antibody titre
Time frame: every 6 month until 18 month
Rate of infection
number of all infection events
Time frame: during 18 month of fallow up
type of infection
infections in different organs
Time frame: During 18 month of study
severity of infection events
need for hospitalization, oral or intravenous antibiotic therapy
Time frame: During 18 month of study
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