Hypogammaglobulinemia, Multiple Sclerosis
Conditions
Keywords
Rituximab, Varicella Zoster, Hypogammaglobulinemia
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSerum immunoglobulin titer
Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times
Sponsors
Mazandaran University of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosis of multiple sclerosis compatible with 2017 McDonald criteria 2. history of treatment with ritximab at least for 18 month 3. written informed consent
Exclusion criteria
1. history of IVIG intake in 3 past month 2. history of plasmapheresis in 3 past month 3. unknown vaccination history 4. any indication for concurrent use of immunomodulator or immunosuppressor drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypogammaglobinemia | every 6 month until 18 month | serum IgG concentration lower than g/L, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of hypogammaglobinemia | every 6 month until 18 month | serum IgG concentration: mild (at risk) 5- 6.9 g/L, moderate 3- 4.9 g/L and severe \< 3 g/L |
| immunization response to VZV vaccination | every 6 month until 18 month | change of VZV antibody titre |
| Rate of infection | during 18 month of fallow up | number of all infection events |
| type of infection | During 18 month of study | infections in different organs |
| severity of infection events | During 18 month of study | need for hospitalization, oral or intravenous antibiotic therapy |
Countries
Iran
Contacts
Primary ContactAthena Sharifi Razavi
Outcome results
None listed