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Fingolimod after natalizumab and the risk of short-term relapse.
Neurology. 2014 Apr 08; 82(14):1204-11.Neur

Abstract

OBJECTIVE

To determine early risk of relapse after switch from natalizumab to fingolimod; to compare the switch experience to that in patients switching from interferon-β/glatiramer acetate (IFN-β/GA) and those previously treatment naive; and to determine predictors of time to first relapse on fingolimod.

METHODS

Data were obtained from the MSBase Registry. Relapse rates (RRs) for each patient group were compared using adjusted negative binomial regression. Survival analyses coupled with adjusted Cox regression were used to model predictors of time to first relapse on fingolimod.

RESULTS

A total of 536 patients (natalizumab-fingolimod [n = 89]; IFN-β/GA-fingolimod [n = 350]; naive-fingolimod [n = 97]) were followed up for a median 10 months. In the natalizumab-fingolimod group, there was a small increase in RR on fingolimod (annualized RR [ARR] 0.38) relative to natalizumab (ARR 0.26; p = 0.002). RRs were generally low across all patient groups in the first 9 months on fingolimod (RR 0.001-0.13). However, 30% of patients with disease activity on natalizumab relapsed within the first 6 months on fingolimod. Independent predictors of time to first relapse on fingolimod were the number of relapses in the prior 6 months (hazard ratio [HR] 1.59 per relapse; p = 0.002) and a gap in treatment of 2-4 months compared to no gap (HR 2.10; p = 0.041).

CONCLUSIONS

RRs after switch to fingolimod were low in all patient groups. The strongest predictor of relapse on fingolimod was prior relapse activity. Based on our data, we recommend a maximum 2-month treatment gap for switches to fingolimod to decrease the hazard of relapse.

CLASSIFICATION OF EVIDENCE

This study provides Class IV evidence that RRs are not higher in patients with multiple sclerosis switching to fingolimod from natalizumab compared to those patients switching to fingolimod from other therapies.

Authors+Show Affiliations

From the Department of Medicine (V.G.J., T.K., H.B.), Melbourne Brain Centre (RMH), The University of Melbourne; Department of Neurology (V.G.J., V.L., T.K., H.B.), Royal Melbourne Hospital, Australia; Hospital Universitario Virgen Macarena (G.I.), Seville, Spain; Liverpool Hospital (S.H.), New South Wales, Australia; Amiri Hospital (R.A.), Kuwait City, Kuwait; John Hunter Hospital (J.L.-S.), Newcastle, Australia; MS Center (A.L.), Department of Neuroscience and Imaging, University "G. d'Annunzio," Chieti, Italy; Hôpital Notre Dame (P.D., M.G.), Montreal, Canada; Brain and Mind Research Institute (M.B.), Sydney, Australia; Neuro Rive-Sud (F.G.), Hôpital Charles LeMoyne, Quebec, Canada; Department of Basic Medical Sciences (M.T.), Neuroscience and Sense Organs, University of Bari, Italy; Flinders University and Medical Centre (M.S.), Adelaide, Australia; Ospedale di Macerata (G.G.), Italy; Geelong Hospital (C.S.), Australia; Karadeniz Technical University (C.B.), Trabzon, Turkey; AORN San Giuseppe Moscati (D.L.A.S.), Avellino, Italy; Groene Hart Ziekenhuis (F.V.), Gouda, the Netherlands; Department of Neurology (J.H., H.B.), Eastern Health Victoria; Monash University (J.H., H.B.), Melbourne; and Melbourne EpiCentre (D.L.), The University of Melbourne and Melbourne Health, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24610329

Citation

Jokubaitis, Vilija G., et al. "Fingolimod After Natalizumab and the Risk of Short-term Relapse." Neurology, vol. 82, no. 14, 2014, pp. 1204-11.
Jokubaitis VG, Li V, Kalincik T, et al. Fingolimod after natalizumab and the risk of short-term relapse. Neurology. 2014;82(14):1204-11.
Jokubaitis, V. G., Li, V., Kalincik, T., Izquierdo, G., Hodgkinson, S., Alroughani, R., Lechner-Scott, J., Lugaresi, A., Duquette, P., Girard, M., Barnett, M., Grand'Maison, F., Trojano, M., Slee, M., Giuliani, G., Shaw, C., Boz, C., Spitaleri, D. L., Verheul, F., ... Butzkueven, H. (2014). Fingolimod after natalizumab and the risk of short-term relapse. Neurology, 82(14), 1204-11. https://doi.org/10.1212/WNL.0000000000000283
Jokubaitis VG, et al. Fingolimod After Natalizumab and the Risk of Short-term Relapse. Neurology. 2014 Apr 8;82(14):1204-11. PubMed PMID: 24610329.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fingolimod after natalizumab and the risk of short-term relapse. AU - Jokubaitis,Vilija G, AU - Li,Vivien, AU - Kalincik,Tomas, AU - Izquierdo,Guillermo, AU - Hodgkinson,Suzanne, AU - Alroughani,Raed, AU - Lechner-Scott,Jeannette, AU - Lugaresi,Alessandra, AU - Duquette,Pierre, AU - Girard,Marc, AU - Barnett,Michael, AU - Grand'Maison,Francois, AU - Trojano,Maria, AU - Slee,Mark, AU - Giuliani,Giorgio, AU - Shaw,Cameron, AU - Boz,Cavit, AU - Spitaleri,Daniele L A, AU - Verheul,Freek, AU - Haartsen,Jodi, AU - Liew,Danny, AU - Butzkueven,Helmut, AU - ,, Y1 - 2014/03/07/ PY - 2014/3/11/entrez PY - 2014/3/13/pubmed PY - 2014/6/19/medline SP - 1204 EP - 11 JF - Neurology JO - Neurology VL - 82 IS - 14 N2 - OBJECTIVE: To determine early risk of relapse after switch from natalizumab to fingolimod; to compare the switch experience to that in patients switching from interferon-β/glatiramer acetate (IFN-β/GA) and those previously treatment naive; and to determine predictors of time to first relapse on fingolimod. METHODS: Data were obtained from the MSBase Registry. Relapse rates (RRs) for each patient group were compared using adjusted negative binomial regression. Survival analyses coupled with adjusted Cox regression were used to model predictors of time to first relapse on fingolimod. RESULTS: A total of 536 patients (natalizumab-fingolimod [n = 89]; IFN-β/GA-fingolimod [n = 350]; naive-fingolimod [n = 97]) were followed up for a median 10 months. In the natalizumab-fingolimod group, there was a small increase in RR on fingolimod (annualized RR [ARR] 0.38) relative to natalizumab (ARR 0.26; p = 0.002). RRs were generally low across all patient groups in the first 9 months on fingolimod (RR 0.001-0.13). However, 30% of patients with disease activity on natalizumab relapsed within the first 6 months on fingolimod. Independent predictors of time to first relapse on fingolimod were the number of relapses in the prior 6 months (hazard ratio [HR] 1.59 per relapse; p = 0.002) and a gap in treatment of 2-4 months compared to no gap (HR 2.10; p = 0.041). CONCLUSIONS: RRs after switch to fingolimod were low in all patient groups. The strongest predictor of relapse on fingolimod was prior relapse activity. Based on our data, we recommend a maximum 2-month treatment gap for switches to fingolimod to decrease the hazard of relapse. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that RRs are not higher in patients with multiple sclerosis switching to fingolimod from natalizumab compared to those patients switching to fingolimod from other therapies. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/24610329/Fingolimod_after_natalizumab_and_the_risk_of_short_term_relapse_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=24610329 DB - PRIME DP - Unbound Medicine ER -