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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Neurological Autoimmune Diseases

Treatments: Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT04687332

IA vs PE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

plasma exchange

Experimental group

Description:

patients were treated with plasma exchange

Treatment:

Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

immunadsorption

Experimental group

Description:

patients were treated with immunadsorption

Treatment:

Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)