The comparative effectiveness of fingolimod, natalizumab, and ocrelizumab in relapsing-remitting multiple sclerosis

Boz, Cavit; Özakbaş, Serkan; Terzı, Murat; Karabudak, Rana; Sevim, Serhan; Türkoğlu, Recai; Soysal, Aysun; Balcı, Belgin Petek; Efendı, Hüsnü; Turan, Ömer Faruk; Yüceyar, Nur; Yetkin, Mehmet Fatih; Karahan, Serap Zengin; Demirkıran, Meltem; Güler, Sibel; Ağan, Kadriye; Kıylıoğlu, Nefati; Baba, Cavid; Tuncer, Aslı; Köseoğlu, Mesrure

doi:10.1007/s10072-023-06608-z

Cited by 7 publications

(5 citation statements)

References 28 publications

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“…There was no significant difference between MR activity and gender, age at disease onset and other sub-parameters. Compared to other studies, the positive effect on radiologic activation in this study was slightly higher than expected [6,10,11,15]. EDSS scores were slightly lower than in other studies (2.08 ± 0.2) and the proportion of patients with no increase in EDSS scores was similar (76.4%) [7,12].…”

Section: Discussioncontrasting

confidence: 74%

“…The following are examples of data on countries, case numbers and follow-up periods from a selection of studies: UK 209, 12 months; Poland 253, 42 months; Germany 4229, 7 years; Spain 804, 26.4 months; Italy 414, 22.7 months; Hungary 570, up to 5 years; Czech Republic 237, 3.5 years [6][7][8][9][10][11][12][13]. In our country, there are multicenter studies evaluating the 5-year effect on cognition, comparing natalizumab (NTZ) and ocrelizumab treatment in the first and second year, and reporting two-year efficacy and safety results [14][15][16].…”

Section: Discussionmentioning

confidence: 99%

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Fingolimod real life experience in non-naive multiple sclerosis patients

Sarıdaş,

Koç,

Özkaya

et al. 2024

The European Research Journal

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Objectives: Fingolimod is approved in Turkey or the treatment of cases of multiple sclerosis (MS) which cannot be controlled with first-line treatments. There is limited information about its efficacy and safety in clinical practice in Turkey. The aim of this study was to evaluate the efficacy and safety of fingolimod treatment in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by the Multiple Sclerosis specialists of Bursa Uludağ University Department of Neurology. Methods: This is a single-center observational study evaluating 142 patients using fingolimod who were followed up for at least 12 months in our center between April 2015 and October 2022. Efficacy results were evaluated in terms of mean number of attacks, annualized relapse rate, relapse-free patient rate, disease progression, clinical and radiological disease activity, and no evidence of disease activity (NEDA-3). The safety outcomes are the rates of treatment-related severe adverse events and patients' continuation rates. Results: Over 12 months of treatment with fingolimod, the average number of attacks decreased by 94.6%, the annual relapse rate decreased by 87%, and most patients did not relapse (83.1%). Alongside this, in 76.4% of cases, there was no disability progression and in 83.3% of cases, magnetic resonance imaging (MRI) activation was not observed. Excluding replacement due to ineffectiveness, 89.4% of patients continued fingolimod therapy. Cardiac events, treatment-related infections and a decreased lymphocyte count were observed as side effects. Conclusion: In our center, switching from first-line treatments to fingolimod was effective in reducing disease activity in patients with multiple sclerosis.

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Section: Discussioncontrasting

confidence: 74%

Section: Discussionmentioning

confidence: 99%

Fingolimod real life experience in non-naive multiple sclerosis patients

Sarıdaş,

Koç,

Özkaya

et al. 2024

The European Research Journal

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“…Treatment guidelines 27 and findings from NMAs 11 – 17 and real-world evidence studies 19 – 26 suggest that the currently available mAbs offer a therapeutic advantage over oral therapies and, therefore, warrant consideration as a distinct group of DMTs for patients with RMS. However, some jurisdictions, payers, and guidelines do not currently differentiate DMTs by their relative efficacy.…”

Section: Discussionmentioning

confidence: 99%

“…11 , 18 Propensity score (PS) analyses and other studies using real-world data have also provided evidence supporting the superiority of mAb therapies over oral therapies. 19 – 26 This distinction is reflected in treatment guidelines published by the Association of British Neurologists, which identify mAbs as high-efficacy therapies and suggest their use for treating patients with frequent clinical relapses. 27 …”

Section: Introductionmentioning

confidence: 99%

Comparative efficacy of ofatumumab versus oral therapies for relapsing multiple sclerosis patients using propensity score analyses and simulated treatment comparisons

Riley,

Drudge,

Nelson

et al. 2024

Ther Adv Neurol Disord

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Background: Evidence from network meta-analyses (NMAs) and real-world propensity score (PS) analyses suggest monoclonal antibodies (mAbs) offer a therapeutic advantage over currently available oral therapies and, therefore, warrant consideration as a distinct group of high-efficacy disease-modifying therapies (DMTs) for patients with relapsing multiple sclerosis (RMS). This is counter to the current perception of these therapies by some stakeholders, including payers. Objectives: A multifaceted indirect treatment comparison (ITC) approach was undertaken to clarify the relative efficacy of mAbs and oral therapies. Design: Two ITC methods that use individual patient data (IPD) to adjust for between-trial differences, PS analyses and simulated treatment comparisons (STCs), were used to compare the mAb ofatumumab versus the oral therapies cladribine, fingolimod, and ozanimod. Data sources and methods: As IPD were available for trials of ofatumumab and fingolimod, PS analyses were conducted. Given summary-level data were available for cladribine, fingolimod, and ozanimod trials, STCs were conducted between ofatumumab and each of these oral therapies. Three efficacy outcomes were compared: annualized relapse rate (ARR), 3-month confirmed disability progression (3mCDP), and 6-month CDP (6mCDP). Results: The PS analyses demonstrated ofatumumab was statistically superior to fingolimod for ARR and time to 3mCDP but not time to 6mCDP. In STCs, ofatumumab was statistically superior in reducing ARR and decreasing the proportion of patients with 3mCDP compared with cladribine, fingolimod, and ozanimod and in decreasing the proportion with 6mCP compared with fingolimod and ozanimod. These findings were largely consistent with recently published NMAs that identified mAb therapies as the most efficacious DMTs for RMS. Conclusion: Complementary ITC methods showed ofatumumab was superior to cladribine, fingolimod, and ozanimod in lowering relapse rates and delaying disability progression among patients with RMS. Our study supports the therapeutic superiority of mAbs over currently available oral DMTs for RMS and the delineation of mAbs as high-efficacy therapies.

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“…Natalizumab acts as an integrin receptor antagonist which has relapse control capacity comparable to those of primarily immunosuppressant drugs (Boz et al, 2023) and the adoption of natalizumab therapy early in disease leads to better disability prognosis when compared to an escalation approach (Iaffaldano et al, 2021). Its main action mechanism is blockage of lymphocyte migration into the CNS by competitive antagonizing of the very-long antigen 4 (VLA-4) region of the α4 integrin present in endothelial cells constituting the BBB, impeding B, T and natural killer (NK) cells in ltration without immunosuppression (Khoy et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

A case study: ADEM-like lesions as a first clinical event in highly active multiple sclerosis

Costa,

Raposo-Vedovi,

Fernandes

et al. 2024

Preprint

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Introduction: Multiple sclerosis is an autoimmune cause of neurological disability. Among its risk factors, it may be related to viral triggers. The advent of COVID-19 raises concern as a novel cause of CNS autoimmunity, which may be a response to virus antigens. In this context, we present a case of highly active multiple sclerosis onset two weeks after SARS-CoV2 mRNA vaccination. Case description: A young woman had lower limb paresthesia which quickly evolved into tetraplegia. She had oligoclonal bands on CSF, with cervical myelitis and a brain MRI suggestive of acute disseminated encephalomyelitis. The highest EDSS observed was 9.5 and sustained remission was only achieved after natalizumab treatment was initiated, reaching EDSS 1.5. Discussion: Case evaluation involved the use of plasma biomarkers. While neurodegeneration biomarkers NfL, GFAP, Tau and UCHL1 decreased, the subject appeared to have sustained inflammatory activity with increased CRP, CD-14, TLR4, IL-1β and IL-17A even after remission. Neuroprotective cytokine TGFβ content was also lower. The existence of blackhole-like lesions at first MRI evaluation and individual risk factors in the form of TNF (rs1800629), SOD2 (rs4880) and FCGR2A (rs1801274) gene variants suggest previous subclinical disease, being impossible to define vaccination as a causative factor. Furthermore, review of previously reported cases of MS onset after a SARS-CoV2 vaccine showed a total of 28 cases, with a mean EDSS of 2.44 at the time of worst disability and highly heterogenous exposition intervals. The highest reported EDSS was 3.5. At least 17 subjects achieved remission. Conclusions: Atypical presentations of MS at onset present a challenge which may benefit from precision assays. SARS-CoV2 vaccination appears as a confounder in this case, its relationship with MS activation seeming to be a rare event with low morbidity. The authors understand this case study illustrates how, in an epidemiological standpoint, vaccination benefits still outweigh the risks perceived.

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The comparative effectiveness of fingolimod, natalizumab, and ocrelizumab in relapsing-remitting multiple sclerosis

Cited by 7 publications

References 28 publications

Fingolimod real life experience in non-naive multiple sclerosis patients

Fingolimod real life experience in non-naive multiple sclerosis patients

Comparative efficacy of ofatumumab versus oral therapies for relapsing multiple sclerosis patients using propensity score analyses and simulated treatment comparisons

A case study: ADEM-like lesions as a first clinical event in highly active multiple sclerosis

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