Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses

Ramo-Tello, Cristina; Tintoré, Mar; Ramió-Torrentà, Luís; Brieva, Luís; Sáiz, Albert; Cano, Antonio; Carmona, Olga; Hervás, José Vicente; Grau-López, Laia

doi:10.1177/1352458515590648

Cited by 6 publications

(1 citation statement)

References 8 publications

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“…Furthermore, the number of relapses within 2 years prior to fingolimod initiation was also an independent predictor for being relapse-free. These results are consistent with the previous findings, which demonstrated that a better clinical outcome was most influenced by immunomodulatory treatment and lower EDSS score change during the relapse [13, 14]. Of note, Hoepner et al identified an EDSS score >3 as a predictive factor for relapse; however, these observations were based on a different patient population comprising patients switching from natalizumab to fingolimod [15].…”

Section: Discussionsupporting

confidence: 91%

Real-World Outcomes in Fingolimod-Treated Patients with Multiple Sclerosis in the Czech Republic: Results from the 12-Month GOLEMS Study

Tichá

Kodým²,

Počíková³

et al. 2016

Clin Drug Investig

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Background and ObjectiveOnce-daily oral fingolimod is approved in the EU as escalation treatment for adult patients with highly active relapsing multiple sclerosis (MS). The efficacy and safety profiles of fingolimod have been well established in a large clinical development programme and several papers reflecting the experience with fingolimod in real-world settings have been published to date. The GOLEMS study was designed to evaluate the efficacy, safety and tolerability of fingolimod and the impact of fingolimod treatment on disability progression and work capability in patients with MS in routine clinical practice in the Czech Republic.MethodsGOLEMS was a national, multicentre, non-interventional, single-arm study conducted to analyse the outcomes of a minimum of 12 months of fingolimod therapy on primary and secondary endpoints. The primary endpoint was to assess the proportion of relapse-free patients and severity of MS relapses in patients treated with fingolimod for 12 months. Secondary endpoints included assessment of changes in disability progression evaluated by the Expanded Disability Status Scale (EDSS) score and work capability assessment measured through voluntary completion of the WPAI-GH questionnaire. The predictive factors for relapse-free status during fingolimod treatment were also analysed.ResultsOf the 240 enrolled patients, 219 completed the 12-month treatment period at the time of final analysis. In the efficacy set (N = 237), the proportion of relapse-free patients increased from 47 patients (19.6 %; 95 % confidence interval [CI] 14.8–25.2) in the year before fingolimod initiation to 152 patients (64.1 %; 95 % CI 58.0–70.2) after 1 year of fingolimod treatment. Of the 85 patients who experienced at least one relapse after 1 year of fingolimod treatment, 53 (62.4 %; 95 % CI 51.7–71.9) reported only one relapse, while 25 (29.4 %; 95 % CI 20.8–39.8) and seven (8.2 %; 95 % CI 4.0–16.0) patients had ≥2 relapses, respectively. No significant changes were observed in EDSS scores over the 12-month treatment period compared with baseline. The absolute number of relapses during 2 years before initiation of fingolimod treatment and baseline EDSS scores were identified as significant independent predictors for ‘being relapse-free’ during the 12-month fingolimod treatment period. No trend was established in work capability or number of missed days at work due to the large proportion of missing data. Of 240 enrolled patients, 27 (11.3 %) patients discontinued the study at or before the 12-month visit, 16 (6.7 %) discontinued because of adverse events related to study drug. Only six (2.5 %) patients reported serious adverse events related to the study drug.ConclusionThe results confirm the favourable safety and efficacy profile of fingolimod under real-world conditions, consistent with phase III trials.

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Section: Discussionsupporting

confidence: 91%

Real-World Outcomes in Fingolimod-Treated Patients with Multiple Sclerosis in the Czech Republic: Results from the 12-Month GOLEMS Study

Tichá

Kodým²,

Počíková³

et al. 2016

Clin Drug Investig

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Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis

Tramacere,

Virgili,

Perduca

et al. 2023

Cochrane Database of Systematic Reviews

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Corticosteroids in the management of acute multiple sclerosis exacerbations

et al. 2017

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Multiple sclerosis (MS) is an autoimmune, inflammatory demyelinating disease of the central nervous system characterized in the majority of the patients by a relapsing-remitting disease course. For decades high-dosage corticosteroids (CS) are considered the cornerstone in the management of acute MS relapses. However, many unanswered questions remain when it comes to the exact modalities of CS administration. In this review on behalf of the Belgian Study Group for MS we define the efficacy of CS in reducing MS-related morbidity and examine whether the effect is different according to type of CS, route of administration, cumulative dosage, timing of initiation and disease course. We also review the use of CS in combination with other MS treatments and during pregnancy and lactation. Furthermore, we delineate the relevant adverse events due to a pulse CS regimen and present a decision tree that can be used when treating MS relapses in clinical practice.

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Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses

Cited by 6 publications

References 8 publications

Real-World Outcomes in Fingolimod-Treated Patients with Multiple Sclerosis in the Czech Republic: Results from the 12-Month GOLEMS Study

Real-World Outcomes in Fingolimod-Treated Patients with Multiple Sclerosis in the Czech Republic: Results from the 12-Month GOLEMS Study

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis

Corticosteroids in the management of acute multiple sclerosis exacerbations

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