Multiple Sclerosis: Switching from Natalizumab to Other High-Efficacy Treatments to Mitigate Progressive Multifocal Leukoencephalopathy Risk

Hartung, Hans‐Peter; Mareś, Jan; Meuth, Sven G.; Berger, Thomas

doi:10.1007/s13311-021-01102-w

Cited by 3 publications

(2 citation statements)

References 33 publications

(28 reference statements)

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“…While both ofatumumab and natalizumab show a good safety profile overall, natalizumab, similarly to ocrelizumab, requires IV administration every 4 weeks, 52 and is associated with the risk of progressive multifocal leukoencephalopathy, which is the main reason patients discontinue the drug. 53 Since rituximab is an off-label MS therapy that requires IV administration every 6 months, 54 it is most likely not prescribed extensively. Alemtuzumab is not indicated as a first-line treatment by the European Medicines Agency.…”

Section: Discussionmentioning

confidence: 99%

Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis – real-world evidence from Germany

Papukchieva,

Stratil,

Kahn

et al. 2024

Ther Adv Neurol Disord

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Background: While evidence highlights the effectiveness of initiating disease-modifying therapy with a high-efficacy medication for multiple sclerosis (MS) patients with poor prognostic factors, it remains unclear whether this approach has been adopted by a broad range of MS providers in Germany yet. Objective: To assess the adoption of the early highly effective treatment (EHT) compared to the treat-to-target treatment approach with the option of escalating treatment efficacy over time in Germany based on real-world evidence data. Design: Patient-level pharmacy dispensing data from the Permea platform were analysed from 2020 to 2022. Methods: In total, 29,529 therapy beginners (>18 years) were included to analyse shifts in treatment approaches over time and switching behaviour. Medication classification adhered to the German Society of Neurology guidelines and designated fumarates, glatiramer acetate, teriflunomide and interferons as low-efficacy category 1 medications; cladribine and S1P-modulators as medium-efficacy category 2 medications; and alemtuzumab, natalizumab, ocrelizumab, ofatumumab and rituximab (off-label) as high-efficacy category 3 medications. Results: Our results show that 70.0% of patients redeemed their first prescription for category 1 medication, 16.3% for category 2 and 13.7% for category 3 medications. The proportion of prescriptions filled shifted from 2020 to 2022 with a decrease of 14.7% for category 1 drugs and an increase of 12.5% for category 3 drugs. 93.2% of patients stayed on their initially prescribed medication category. 3.2% of category 1 and 3.7% of category 2 therapy beginners escalated to category 3 medication. 3.4% of category 3 medication users de-escalated their treatment to category 1 or category 2. Conclusion: While most individuals started their treatment according to the treat-to-target approach and remained on their initially prescribed medication category, there has been a steadily increasing shift towards the EHT approach since 2020. These insights demonstrate that, while not officially recommended by German guidelines, MS providers increasingly adopt the EHT approach.

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Section: Discussionmentioning

confidence: 99%

Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis – real-world evidence from Germany

Papukchieva,

Stratil,

Kahn

et al. 2024

Ther Adv Neurol Disord

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“…Furthermore, in 33 patients of this study, we have switched the Natalizumab treatment to other DMTs. The major cause for switch from Natalizumab was attributable to high JCV index, associated with the risk of PML [33] . In the context on switching from Natalizumab, Ocrelizumab [34] , Rituximab and Fingolimod [35] can be administered.…”

Section: Discussionmentioning

confidence: 99%

The first study of real-world efficacy and safety of Natalizumab (Tysabri®) in Iran

Shahrbaf,

Samimi,

Karimi

et al. 2024

Trends Immunother.

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Objectives: Natalizumab is an injectable DMT (disease-modifying therapy) which used for RRMS (relapsing-remitting multiple sclerosis) since 2006. The drug has been available in Iran since 2014. Introduction: This study was aimed to evaluate the real-world effectiveness of Natalizumab in a referral center in Tehran, Iran. This study is the first real world analysis of efficacy and safety of Natalizumab in our country. Methods: In this retrospective study, patients with RRMS were investigated in a high-volume center in Tehran from 2019 to 2021. MS (Multiple Sclerosis) patients under treatment with Natalizumab who have received at least 3 infusions of the drug and had completed follow-up data, have been evaluated for safety and efficacy of Natalizumab. Results: 100 patients were included in the final analysis. The mean follow-up time was 20 months (6–33 months). The median EDSS (Expanded Disability Status Scale) score of patients reached to 2 from 2.5 after the treatment course (P < 0.0001). The annualized relapse rate (ARR) decreased from 0.81 (95% CI: 0.73–0.87) to 0.023 (95% CI 0.009–0.061). The median JCV (John Cunningham virus) index remained unchanged before treatment 0.85 (IQR: 0.21–2.41) compare to after the treatment 0.85 (IQR: 0.21–2.31). The number of patients with active brain and cervical MRI (Magnetic Resonance Imaging) lesions decreased significantly (P = 0.001). NEDA-3 (No evidence of disease activity) was improved from 9% to 87% after the treatment with Natalizumab. No serious adverse events except than one progressive multifocal encephalopathy (PML) case have been found. The main reasons of switching from Natalizumab to the other DMDs (Disease Modifying Drugs) were positive JC index, starting phase, noncompliance, pregnancy, MRI activity and seroconversion after starting the drug. Conclusion: Natalizumab is a safe and effective choice in RRMS patients for reducing relapse rate, disability score, active MRI lesion, and improving the NEDA (No evidence of disease activity).

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Switching from natalizumab to an anti-CD20 monoclonal antibody in relapsing remitting multiple sclerosis: A systematic review

Brown,

Muston,

Massey

2024

Multiple Sclerosis and Related Disorders

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Multiple Sclerosis: Switching from Natalizumab to Other High-Efficacy Treatments to Mitigate Progressive Multifocal Leukoencephalopathy Risk

Cited by 3 publications

References 33 publications

Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis – real-world evidence from Germany

Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis – real-world evidence from Germany

The first study of real-world efficacy and safety of Natalizumab (Tysabri®) in Iran

Switching from natalizumab to an anti-CD20 monoclonal antibody in relapsing remitting multiple sclerosis: A systematic review

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