Neurological Autoimmune Diseases
Conditions
Keywords
Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis
Brief summary
In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.
Detailed description
Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective controlled monocentric observational study of patients treated with either tryptophan IA or PE in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. The main outcome parameter for efficiency was clinical improvement after completion of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In total, all patients receive 5 treatments. As patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.
Interventions
OTHERApheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.
Sponsors
University Medical Center Mainz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective controlled monocentric observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* autoimmune neurological therapy refractory disease
Exclusion criteria
* Intake of Angiotensin-converting-enzyme inhibitors (ACE inhibitors) because of allergic reactions by using tryptophan adsorber * contraindication for any anticoagulation * contraindication for treatment with citrate dextrose anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in descriptive characterization of Symptoms | After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).] | Patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms. |
| Change in the Expanded Disability Status Scale (EDSS) | After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7). | In the subgroup of MS patients, disability was evaluated by EDSS. The Expanded Disability Status Scale is a scale system for the systematic recording (assessment) of disability in neurological patients suffering from multiple sclerosis. The scale is used to classify the severity of disability by symptoms, ranging from 0 (no symptoms) to a maximum of grade 10 (death from MS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of Immunglobulins | After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7). | Measurement of IgE, IgM, IgG levels and IgG subclasses. |
| Change in concentration of human cytokines | After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7). | Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28. |
Countries
Germany
Outcome results
None listed