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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurological Autoimmune Diseases
• Intervention / Treatment: Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55130
      • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: plasma exchange; patients were treated with plasma exchange	Other: Apheresis 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.; Other Names: IA treatment: using single-use tryptophane adsorber TR 350 in combination with the OP-0,5W plasma separator (Asahi Kasei Medical, Tokyo, Japan) and the tubing system PA-420; PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250
EXPERIMENTAL: immunadsorption; patients were treated with immunadsorption	Other: Apheresis 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.; Other Names: IA treatment: using single-use tryptophane adsorber TR 350 in combination with the OP-0,5W plasma separator (Asahi Kasei Medical, Tokyo, Japan) and the tubing system PA-420; PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University Medical Center Mainz

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): September 15, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: multiple sclerosis; autoimmune encephalitis; chronic inflammatory demyelinating polyneuropathy; Plasma exchange (PE); immunoadsorption (IA); neuromyelitis optica,; acute inflammatory demyelinating polyradiculoneuropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: IA vs PE

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No