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A Multicenter, Non-Interventional Study to Evaluate the Disease Activity in Multiple Sclerosis after Withdrawal of Natalizumab in Portugal

2019-09Journal article Open access
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dc.contributor.authorLadeira, F
dc.contributor.authorBraz, L
dc.contributor.authorSalgado, P
dc.contributor.authorVaz, S
dc.contributor.authorLeitão, L
dc.contributor.authorFélix, C
dc.contributor.authorCorreia, AS
dc.contributor.authorMartins da Silva, A
dc.contributor.authorSalgado, V
dc.contributor.authorFerreira, F
dc.contributor.authorVale, J
dc.contributor.authorSá, MJ
dc.contributor.authorCapela, C
dc.date.accessioned2022-08-22T15:41:20Z
dc.date.available2022-08-22T15:41:20Z
dc.date.issued2019-09
dc.description.abstractObjectives: Natalizumab (NTZ) is very effective for treatment of relapsing-remitting multiple sclerosis (RRMS), its use is mainly limited by safety issues. Discontinuation of NTZ is associated with recurrence of disease activity (reactivation and rebound). The best strategy for subsequent therapy and the predictive factors for recurrence in such patients are areas of active research. We aimed to evaluate predictors of reactivation in a multicentric study. Patients and methods: Multicentric retrospective observational study in five portuguese MS referral centers. Demographic, clinical and imagiological data were collected in the year prior, during and in the year following NTZ discontinuation. Predictors of reactivation and rebound after NTZ suspension were studied using a multivariate Cox model. Results: Sixty-nine patients were included. They were mainly non-naïve patients (97%), with a mean age of 29.1 ± 8.3 years at diagnosis, and a mean age of 37.2 ± 10.3 years at NTZ initiation. The mean annualized relapse rate (ARR) previous, during and after NTZ was 1.6 ± 1.2, 0.2 ± 0.5 and 0.6 ± 1.0, respectively. The median EDSS before, during and after NTZ was 3.5 (IQR 3.3), 3.5 (IQR 3.5) and 4.0 (IQR 3.8), respectively. The median number of infusions was 26.0 (IQR 12.5) and the main reason to NTZ discontinuation was progressive multifocal leukoencephalopathy (PML) risk (70%). After NTZ suspension, reactivation was observed in 25 (36%) patients after a median time of 20.0 (IQR 29.0) weeks. Reactivation predictors in our sample included NTZ suspension for reasons other than PML (adjusted HR = 0.228, 95% CI [0.084- 0.616], p = 0.004), ARR before NTZ (adjusted HR = 1.914 95% [CI 1.330-2.754], p < 0.001) and a longer disease duration at time of NTZ initiation (adjusted HR = 1.154, 95% CI [1.020-1.306], p = 0.023). Rebound occurred in 5 (7%) patients after a median time of 20 (IQR 34.5) weeks. Conclusion: Significant predictors of disease reactivation in our cohort were discontinuation of NTZ for reasons other than PML risk, higher disease activity before NTZ treatment, and longer disease duration. Our study provides valuable data of portuguese patients after NTZ withdrawal.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationClin Neurol Neurosurg. 2019 Sep;184:105390.pt_PT
dc.identifier.doi10.1016/j.clineuro.2019.105390.pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4226
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherElsevierpt_PT
dc.subjectHSAC NEUpt_PT
dc.subjectAdultpt_PT
dc.subjectFemalept_PT
dc.subjectMalept_PT
dc.subjectHumanspt_PT
dc.subjectCohort Studiespt_PT
dc.subjectDisease Progression*pt_PT
dc.subjectFollow-Up Studiespt_PT
dc.subjectImmunologic Factors / adverse effectspt_PT
dc.subjectImmunologic Factors / therapeutic usept_PT
dc.subjectMultiple Sclerosis, Relapsing-Remitting / diagnosis*pt_PT
dc.subjectMultiple Sclerosis, Relapsing-Remitting / drug therapypt_PT
dc.subjectMultiple Sclerosis, Relapsing-Remitting / epidemiologypt_PT
dc.subjectNatalizumab / adverse effectspt_PT
dc.subjectNatalizumab / therapeutic use*pt_PT
dc.subjectRetrospective Studiespt_PT
dc.subjectPortugal / epidemiologypt_PT
dc.subjectYoung Adultpt_PT
dc.subjectWithholding Treatment / trends*pt_PT
dc.titleA Multicenter, Non-Interventional Study to Evaluate the Disease Activity in Multiple Sclerosis after Withdrawal of Natalizumab in Portugalpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.startPage105390pt_PT
oaire.citation.titleClinical Neurology and Neurosurgerypt_PT
oaire.citation.volume184pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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