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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plasma exchange | Experimental | patients were treated with plasma exchange |
|
| immunadsorption | Experimental | patients were treated with immunadsorption |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) | Other | 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik | Mainz | Rhineland-Palatinate | 55130 | Germany |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D020275 | Guillain-Barre Syndrome |
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
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prospective controlled monocentric observational study
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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). |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D011129 | Polyradiculoneuropathy |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000094025 | Post-Infectious Disorders |