Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

Conditions

Multiple Sclerosis, Clinically Isolated Syndrome

Keywords

Immunoadsorption, Plasmapheresis

Brief summary

This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.

Ioannis Vardakas, Johannes Dorst, André Huss, Benjamin Mayer, Pia Eichele et al. (9 authors)

Multiple Sclerosis Journal - Experimental Translational and Clinical2025-04-012 citations

10.1177/20552173251321797

Serum neurofilament light chain and glial fibrillary acidic protein for predicting response to apheresis in steroid‐refractory multiple sclerosis relapses

Ioannis Vardakas, Johannes Dorst, André Huss, Benjamin Mayer, Tanja Fangerau et al. (8 authors)

European Journal of Neurology2024-05-036 citations

10.1111/ene.16323

Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial.

Dorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H.

2019-11-1434 citations

10.1016/j.eclinm.2019.10.017

Interventions

PROCEDUREImmunoadsorption

PROCEDUREPlasmapheresis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

* relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy) * informed consent * age ≥ 12 years old

Exclusion criteria

* clinical or laboratory signs of infection * intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Design outcomes

Primary

Measure	Time frame
Multiple Sclerosis Functional Composite (MSFC)	4 weeks

Secondary

Measure	Time frame	Description
EuroQol (EQ5D-5L)	2 and 4 weeks	—
Response Rate	4 weeks	defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
Vision	4 weeks	defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
Visually Evoked Potentials (VEP; P100 latency)	4 weeks	—
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)	4 weeks	—
Expanded Disability Status Scale (EDSS)	2 and 4 weeks	—
Verbaler Lern- und Merkfähigkeitstest (VLMT) score	4 weeks	—
MSFC	2 weeks	—
Thickness of Ganglion Cell Layer (GCL) in OCT	4 weeks	—
Symbol Digit Modalities Test (SDMT) score	4 weeks	—
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)	4 weeks	—

Countries

Germany

Outcome results

None listed