Predictors for multiple sclerosis relapses after switching from natalizumab to fingolimod.
BACKGROUND
Risks of natalizumab (NAT) therapy have to be weighed against disease recurrence after stopping NAT.


OBJECTIVE
The objective of this paper is to identify risk factors for recurrence of relapses after switching from NAT to fingolimod (FTY) in relapsing-remitting multiple sclerosis (RRMS).


METHODS
Patients (n = 33) were treated with NAT for ≥1 year, and then switched to FTY within 24 weeks (mean follow-up on FTY 81.1 (SD 26.5) weeks). Annual relapse rates (ARR) and Expanded Disability Status Scale scores (EDSS) were assessed. Descriptive statistics, univariate logistic regression analysis, and receiver operating characteristic curves were conducted.


RESULTS
Overall, 20 patients (61%) had relapses after discontinuation of NAT and 16 (48%) during FTY therapy. The maximum incidence of relapses occurred between weeks 13-24 post-NAT. The last EDSS during the switching period predicted relapses during subsequent FTY therapy. EDSS >3 separated most powerfully between the groups (sensitivity 64%, specificity 88%) and significantly predicted relapses (relative risk 3.27, 95% CI: 1.5-7.3). Seventy-five percent of patients with EDSS ≤ 3 remained free of relapses, compared to 18% of patients with EDSS >3.


CONCLUSIONS
There was an increase of the ARR in the first year after switching from NAT to FTY. Last EDSS during the switching period was a predictor of relapses during FTY.
St Josef-Hospital, Ruhr-University, Germany.
Robert
R
Hoepner
Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Germany.
Joachim
J
Havla
Clinical Neuroimmunology Group, Philipps-University, Germany.
Christian
C
Eienbröker
Clinical Neuroimmunology Group, Philipps-University, Germany.
Björn
B
Tackenberg
St Josef-Hospital, Ruhr-University, Germany.
Kerstin
K
Hellwig
Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Germany.
Ingrid
I
Meinl
Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, GermanyMunich Cluster for Systems Neurology (SyNergy), Germany.
Reinhard
R
Hohlfeld
St Josef-Hospital, Ruhr-University, Germany.
Ralf
R
Gold
Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Germany.
Tania
T
Kümpfel
St Josef-Hospital, Ruhr-University, Germany ingo.kleiter@rub.de.
Ingo
I
Kleiter
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000069442:Natalizumab; D011409:Propylene Glycols / Q000627:therapeutic use*; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine
EDSS; Multiple sclerosis; disease activity; fingolimod; natalizumab; predictor