Comparative safety of high-efficacy disease-modifying therapies in relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis

Śladowska, Katarzyna; Kawalec, Paweł; Holko, Przemysław; Osiecka, Oktawia

doi:10.1007/s10072-022-06197-3

Cited by 14 publications

(7 citation statements)

References 67 publications

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“…A recent (2022) network meta-analysis [ 27 ] found generally similar rates of AE and SAE between CladT 3.5 mg/kg and other high-efficacy DMTs, except for a higher rate of AE for CladT vs. ozanimod (odds ratio [OR] 1.8 [95% CI 1.1–2,8] or placebo (OR 1.5 [1.1–2.1]); SAEs were more frequent for CladT vs. ocrelizumab (OR 2.9 [1.0–4.7]), with no other significant differences between CladT and other DMTs. There were no differences between CladT and other high-efficacy DMTs for AE leading to treatment discontinuation in this analysis.…”

Section: Overview Of Adverse Eventsmentioning

confidence: 99%

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Clavelou¹,

Castelnovo

Pourcher

et al. 2023

Neurol Ther

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Section: Overview Of Adverse Eventsmentioning

confidence: 99%

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Clavelou¹,

Castelnovo

Pourcher

et al. 2023

Neurol Ther

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“…Cladribine offers the chance of an easy posology, which is compatible with family planning, and has shown superior efficacy compared to other oral treatments [ 30 , 31 ]. Lastly, alemtuzumab induction therapy can be of interest in certain patients with high activity after the discontinuation of NTZ [ 32 , 33 ] but with a notable risk of serious adverse events, including secondary autoimmunity, which requires considerable monitoring [ 34 , 35 ].…”

Section: Discussionmentioning

confidence: 99%

Natalizumab continuation versus switching to ocrelizumab after PML risk stratification in RRMS patients: a natural experiment

et al. 2023

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Background Natalizumab (NTZ) and ocrelizumab (OCR) can be used for the treatment of relapsing–remitting multiple sclerosis (RRMS). In patients treated with NTZ, screening for JC virus (JCV) is mandatory, and a positive serology usually requires a change in treatment after 2 years. In this study, JCV serology was used as a natural experiment to pseudo-randomize patients into NTZ continuation or OCR. Methods An observational analysis of patients who had received NTZ for at least 2 years and were either changed to OCR or maintained on NTZ, depending on JCV serology status, was performed. A stratification moment (STRm) was established when patients were pseudo-randomized to either arm (NTZ continuation if JCV negativity, or change to OCR if JCV positivity). Primary endpoints include time to first relapse and presence of relapses after STRm and OCR initiation. Secondary endpoints include clinical and radiological outcomes after 1 year. Results Of the 67 patients included, 40 continued on NTZ (60%) and 27 were changed to OCR (40%). Baseline characteristics were similar. Time to first relapse was not significantly different. Ten patients in the JCV + OCR arm presented a relapse after STRm (37%), four during the washout period, and 13 patients in the JCV-NTZ arm (32.5%, p = 0.701). No differences in secondary endpoints were detected in the first year after STRm. Conclusions The JCV status can be used as a natural experiment to compare treatment arms with a low selection bias. In our study, switching to OCR versus NTZ continuation led to similar disease activity outcomes.

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“…[6][7][8] Also, recent studies and meta-analysis have demonstrated that NTZ is still highly effective and viable immunotherapy for RRMS in comparison to other high-efficacy DMTs. [21][22][23] Previous registry-based studies, including one Finnish study, have indicated that initiating treatment with a high-efficacy DMT in RRMS may reduce long-term disability progression and relapses compared to moderate-efficacy DMTs. [24][25][26][27] In the restricted cohort of our study, we did not identify a statistically significant difference in disability progression as measured with EDSS change between 22 treatment-naive patients and 82 patients who had previously used another DMT.…”

Section: Discussionmentioning

confidence: 99%

“… 6 – 8 Also, recent studies and meta-analysis have demonstrated that NTZ is still highly effective and viable immunotherapy for RRMS in comparison to other high-efficacy DMTs. 21 – 23 …”

Section: Discussionmentioning

confidence: 99%

Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients

Verkkoniemi-Ahola,

Hartikainen,

Hassi

et al. 2023

Multiple Sclerosis Journal - Experimental, Translational and Cl

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Objectives The primary objective was to evaluate long-term treatment persistence and safety of natalizumab in Finnish multiple sclerosis patients. The secondary objectives were to assess patient characteristics, use of natalizumab-related safety protocol, and treatment persistence in patients with different anti-John Cunningham virus antibody statuses (John Cunningham virus status). Materials & Methods All adult multiple sclerosis patients in the Finnish multiple sclerosis register who started natalizumab between 1/2006 and 12/2018 were included in this study and followed retrospectively until treatment discontinuation or end of follow-up (12/2019). Results In total, 850 patients were included. Median duration of natalizumab treatment was 7.8 years in John Cunningham virus negative ( n = 229) and 2.1 years in John Cunningham virus positive patients ( n = 115; p < 0.001). The most common cause for treatment discontinuation was John Cunningham virus positivity. After natalizumab discontinuation, patients who had a washout duration of less than 6 weeks had fewer relapses during the first 6 months ( p = 0.012) and 12 months ( p = 0.005) compared with patients who had a washout duration of over 6 weeks. During the median follow-up of 3.6 years, 76% of patients remained stable or improved on their Expanded Disability Status Scale. Conclusions Treatment persistence was very high among John Cunningham virus negative patients. The study supports long-term effectiveness of natalizumab and a washout duration of less than 6 weeks after discontinuation.

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Comparative safety of high-efficacy disease-modifying therapies in relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis

Cited by 14 publications

References 67 publications

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Natalizumab continuation versus switching to ocrelizumab after PML risk stratification in RRMS patients: a natural experiment

Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients

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