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Abstract Details

Escalation Treatment with Methylprednisolone Versus Immunoadsorption in MS Relapse: Results of the EMMA Trial
Multiple Sclerosis
P11 - Poster Session 11 (8:00 AM-9:00 AM)
1-011
To demonstrate superior efficacy of immunoadsorption (IA) over double-dose intravenous methylprednisolone (dd-IVMP) as escalated relapse treatment in multiple sclerosis (MS).
MS relapse is treated by IVMP. If symptoms persist, escalated treatment with dd-IVMP and eventually plasma exchange or IA is recommended, in the absence of randomized trials.
Publicly funded randomized, evaluator-blinded trial, including patients with persisting ADL impairment from an acute MS relapse with duration ≤28 days, and ≥7 days after receiving 2,500-3,000mg of IVMP. Randomization (1:1) to five sessions IA or cumulative 10,000mg IVMP. Primary outcome was the EDSS on day 45, analyzed by ANCOVA using baseline EDSS and stratification criteria as covariates.
Site initiation began in December 2019. During the Covid-19 pandemic, recruitment remained far behind schedule; organizational factors at the participating centers, non-competitive public funding, off-label IA treatment outside of clinical trials, and probably decreasing relapse rates persistently hampered recruitment even after the end of the pandemic. Therefore, recruitment had to be closed prematurely in June 2024. Until last safety data cutoff in May 2024, 29 patients had been randomized (f/m 22/7; mean age 32.9+/-10.6 yrs; 48% optic neuritis; median EDSS 5.5). Of these, 15 received IA, and 14 dd-IVMP. Three SAEs had occurred in the IA arm (syncope leading to concussion; pulmonary embolism with cough; anaphylactic reaction); all resolved without sequelae, and none of three dropouts was related to an SAE. Treatment response will be evaluated after database lock in Q1/2025, and results will be reported at the meeting.

IA or dd-IVMP are feasible options in MS relapse with insufficient response to a first course of IVMP. Safety was consistent with known risks; treatment response will be reported, while the trial is clearly underpowered. In addition to clinical factors, insufficient public funding has contributed to premature termination of another investigator-initiated trial.
Authors/Disclosures
Florian Then Bergh, MD (University of Leipzig, Klinik u. Poliklinik fuer Neurologie)
PRESENTER 		Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Actelion. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Fresenius. Dr. Then Bergh has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Then Bergh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Takeda. The institution of Dr. Then Bergh has received research support from Actelion. The institution of Dr. Then Bergh has received research support from Novartis. The institution of Dr. Then Bergh has received research support from DFG (German Science Fund). The institution of Dr. Then Bergh has received research support from Fresenius. The institution of Dr. Then Bergh has received research support from Diamed. Dr. Then Bergh has received personal compensation in the range of $10,000-$49,999 for serving as a Member of the Institutional Ethics Board with University of Leipzig, Medical Faculty.
Nicole Köppe-Bauernfeind Mrs. Köppe-Bauernfeind has nothing to disclose.
Clemens Goedel, MD (University Hospital Leipzig) Dr. Goedel has nothing to disclose.
Achim Berthele (School of Medicine, Technical University Munich, Klinikum rechts der Isar, Dept.) Achim Berthele has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Achim Berthele has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuraxpharm. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sabofi. Achim Berthele has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Achim Berthele has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Argenx. Achim Berthele has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Achim Berthele has received publishing royalties from a publication relating to health care.
Clemens Warnke (Klinik Fuer Neurologie, University of Duesseldorf) The institution of Clemens Warnke has received research support from Novartis. The institution of Clemens Warnke has received research support from Alexion. The institution of Clemens Warnke has received research support from Sanofi-Genzyme. The institution of Clemens Warnke has received research support from Biogen. The institution of Clemens Warnke has received research support from Roche.
Muriel Stoppe Muriel Stoppe has nothing to disclose.
Claudius Küchle Dr. Küchle has nothing to disclose.
Martin R. Späth, MD Dr. Späth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fresenius Medical Care. Dr. Späth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SERB. The institution of Dr. Späth has received research support from Dr. Werner Jackstädt-Stiftung.
Annegret Franke, PhD Dr. Franke has nothing to disclose.