Dataset Information

Therapeutic plasma exchange in steroid-refractory multiple sclerosis relapses. A retrospective two-center study.

ABSTRACT:

Background

Therapeutic plasma exchange (TPE) is frequently used in glucocorticosteroid (GCS)-refractory multiple sclerosis (MS) relapses. Data regarding predictors of treatment response are scarce. The objective of this study was to analyze predictive factors for response to TPE in GCS-refractory MS patients.

Methods

A total of 118 MS patients in two tertiary MS centers were analyzed. Primary outcome was TPE response defined as marked, mild, or no improvement. Secondary outcome was change in expanded disability status scale (?EDSS). ?EDSS and relapse activity within 6?months after TPE were studied.

Results

Marked or mild improvement was observed in 78.8% of patients. ?EDSS correlated significantly inversely with time from relapse to start of TPE (??=?-0.239, p?=?0.001), age (??=?0.182, p?=?0.009) and disease duration (??=?-0.167, p?=?0.017). In multivariate analysis, TPE response was predicted by diagnosis of relapsing MS [odds ratio (OR): 3.1], gadolinum-enhancement on magnetic resonance imaging (OR 3.2), age (OR 0.5 per 5?years older) and time from relapse onset to TPE (OR 0.7 per 7?days longer).

Conclusion

Patients with longer disease duration and higher EDSS pre and post-TPE were more likely to show further disability progression or relapses within 6?months after TPE. No sustained effects were observed during the follow-up period.

SUBMITTER: Blechinger S

PROVIDER: S-EPMC7844455 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Therapeutic plasma exchange in steroid-refractory multiple sclerosis relapses. A retrospective two-center study.

Blechinger Stephan S Ehler Johannes J Bsteh Gabriel G Winkelmann Alexander A Leutmezer Fritz F Meister Stefanie S Santer Agnes A Hecker Michael M Berger Thomas T Rommer Paulus P Zettl Uwe Klaus UK

Therapeutic advances in neurological disorders 20210127

<h4>Background</h4>Therapeutic plasma exchange (TPE) is frequently used in glucocorticosteroid (GCS)-refractory multiple sclerosis (MS) relapses. Data regarding predictors of treatment response are scarce. The objective of this study was to analyze predictive factors for response to TPE in GCS-refractory MS patients.<h4>Methods</h4>A total of 118 MS patients in two tertiary MS centers were analyzed. Primary outcome was TPE response defined as marked, mild, or no improvement. Secondary outcome wa ...[more]

PMID: 33552236

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Project description:ObjectiveIntravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse; however, this fails to improve symptoms in up to one quarter of patients. Immunoadsorption is an accepted treatment for refractory relapses, but prospective comparator-controlled studies are missing.MethodsIn this observational study, patients with steroid-refractory acute multiple sclerosis relapses receiving either six courses of tryptophan-immunoadsorption or double-dose methylprednisolone therapy were analysed. Outcomes were evaluated at discharge and three months later. Immune profiling of blood lymphocytes and proteomic analysis were performed by multi-parameter flow cytometry and Olink analysis, respectively (NCT04450030).Results42 patients were enrolled (methylprednisolone: 26 patients; immunoadsorption: 16 patients). For determination of the primary outcome, treatment response was stratified according to relative function system score changes ("full/best" vs. "average" vs. "worse/none"). Upon discharge, the adjusted odds ratio for any treatment response ("full/best" + "average" vs. "worse/none") was 10.697 favouring immunoadsorption (p = 0.005 compared to methylprednisolone). At follow-up, the adjusted odds ratio for the best treatment response ("full/best" vs. "average" + "worse/none") was 103.236 favouring IA patients (p = 0.001 compared to methylprednisolone). Similar results were observed regarding evoked potentials and quality of life outcomes, as well as serum neurofilament light-chain levels. Flow cytometry revealed a profound reduction of B cell subsets following immunoadsorption, which was closely correlated to clinical outcomes, whereas methylprednisolone had a minimal effect on B cell populations. Immunoadsorption treatment skewed the blood cytokine network, reduced levels of B cell-related cytokines and reduced immunoglobulin levels as well as levels of certain coagulation factors.InterpretationImmunoadsorption demonstrated favourable outcomes compared to double-dose methylprednisolone. Outcome differences were significant at discharge and follow-up. Further analyses identified modulation of B cell function as a potential mechanism of action for immunoadsorption, as reduction of B cell subsets correlated with clinical improvement.

Project description:Background:Plasma exchange (PE) constitutes the standard therapy for steroid-refractory relapse in multiple sclerosis and clinically isolated syndrome. Immunoadsorption (IA) is an alternative method of apheresis which selectively removes immunoglobulines (Ig) while preserving other plasma proteins. Although IA is regarded as a well-tolerated, low-risk procedure, high-level evidence for its efficacy is lacking. Therefore, we sought to investigate whether IA is superior to PE in patients with acute relapse of multiple sclerosis or clinically isolated syndrome who had insufficiently responded to high-dose intravenous methylprednisolone (MP). Methods:Patients with acute relapse of multiple sclerosis or clinically isolated syndrome and without complete clinical remission of symptoms after at least one cycle of high-dose intravenous MP therapy were enrolled to our randomised, controlled, parallel-group, monocentric trial. Eligible patients were aged at least 12 years and had no clinical or laboratory signs of systemic infection. Eligible patients were randomly assigned (1:1) to receive either IA or PE. Patients in both groups received 5 treatments on 5 consecutive days. In the IA group, the 2.0-fold individual total plasma volume was processed on day 1, and the 2.5-fold on days 2-5. In the PE group, 2 liters of plasma (corresponding to the 0.69?±?0.12-fold individual total plasma volume) were removed each day and substituted by 5% human albumin solution. Patients were followed up directly after last apheresis as well as 2 and 4 weeks after last treatment. The primary endpoint was change of the Multiple Sclerosis Functional Composite (MSFC) after 4 weeks compared to baseline. Analyses of primary outcome and safety measures were done in all patients who received at least one treatment (intention-to-treat-population). The trial is registered with ClinicalTrials.gov, number NCT02671682. Findings:Between January 21, 2016, and October 26, 2018, 63 patients were screened for eligibility, and 61 patients were randomly assigned to receive IA (n?=?31) or PE (n?=?30). All randomised patients were included in the intention-to-treat-analysis. For the primary outcome, the median improvement of MSFC after 4 weeks compared to baseline was 0.385 (IQR 0.200-0.675; p?<?0.001) in the IA group and 0.265 (IQR 0.100-0.408; p?<?0.001) in the PE group. Improvement in the IA group was significantly larger (p?=?0.034) compared to PE. Response rates after 4 weeks were 86.7% in the IA group and 76.7% in the PE group. One deep venous thrombosis occurred in each group. Interpretation:Both IA and PE were safe in patients with steroid-refractory relapse and resulted in significant improvements of the primary outcome MSFC after 4 weeks compared to baseline. IA patients showed significantly larger improvements of MSFC compared to PE patients after 4 weeks. The results indicate a potential superiority of IA compared to PE in treatment of steroid-refractory relapse in multiple sclerosis and clinically isolated syndrome, which has to be confirmed by future studies. Funding:Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.

Dataset Information

Therapeutic plasma exchange in steroid-refractory multiple sclerosis relapses. A retrospective two-center study.

Background

Methods

Results

Conclusion

Publications

Therapeutic plasma exchange in steroid-refractory multiple sclerosis relapses. A retrospective two-center study.

Similar Datasets

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