IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

Conditions
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Neurological Autoimmune Diseases

Intervention / Treatment
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* Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective controlled monocentric observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: plasma exchange<br>patients were treated with plasma exchange | Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)<br>* 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.<br>* Other names: PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250;|
| Experimental: immunadsorption<br>patients were treated with immunadsorption | Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)<br>* 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.<br>* Other names: PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in descriptive characterization of Symptoms | 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. | After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).] | 
| Change in the Expanded Disability Status Scale (EDSS) | 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). | After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of Immunglobulins | Measurement of IgE, IgM, IgG levels and IgG subclasses. | After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7). | 
| Change in concentration of human cytokines | Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28. | After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis