Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing–remitting multiple sclerosis

Siddiqui, Mohammad Khubeb; Khurana, Inderpreet Singh; Budhia, Sangeeta; Hettle, Robert; Harty, Gerard; Wong, Schiffon L.

doi:10.1080/03007995.2017.1407303

Cited by 69 publications

(89 citation statements)

References 56 publications

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“…However, their inclusion would have been complicated and most likely given unreliable results, as there are no direct randomised comparisons between cladribine tablets, fingolimod and natalizumab. However, cladribine tablets have demonstrated a comparable efficacy with other DMDs for highly active disease in recent indirect comparison analyses [50][51][52]. Thus, speculatively, the inclusion of treatment effects could have even increased the affordability of cladribine tablets.…”

Section: Discussionmentioning

confidence: 99%

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Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

et al. 2019

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Introduction:Cost assessment modelling (CAM) of treatments in highly active relapsing multiple sclerosis was conducted. Methods: The CAM was developed using the R programming language. The PICOSTEPS health technology assessment framework was applied in the CAM. Modelled patients were 280 adults with highly active relapsing multiple sclerosis eligible for disease-modifying treatment. Intervention was cladribine tablets, a new and reimbursed oral treatment for highly active

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Section: Discussionmentioning

confidence: 99%

“…In systematic reviews, indirect comparisons, health economic analyses and models, systematic reporting is especially important [21,50]. PICO is commonly applied in, e.g., evidence synthesis and Finnish current care treatment guidelines.…”

Section: Discussionmentioning

confidence: 99%

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

et al. 2019

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“…In the absence of such a trial, network meta-analyses (NMAs) can be used to compare treatments using both direct comparisons of interventions within clinical trials and indirect comparisons based on a common comparator, often placebo (Li et al, 2011). Several such NMAs have compared the different DMTs for RMS (Fogarty et al, 2016;Huisman et al, 2017;Institute for Clinical and Economic Review, 2017;Tolley et al, 2015;Tramacere et al, 2015;Tsivgoulis et al, 2015;Siddiqui et al, 2017;Melendez-Torres et al, 2017). However, these NMAs have used differing methodologies, have not used all available data by combining hazard ratio and count data, (Watkins, 2018) and did not consider the trade-off between efficacy and safety with surface under the cumulative ranking curve (SUCRA) values.…”

Section: Introductionmentioning

confidence: 99%

Systematic review and network meta-analysis comparing ocrelizumab with other treatments for relapsing multiple sclerosis

McCool

Wilson

Arber

et al. 2019

Multiple Sclerosis and Related Disorders

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Background: Ocrelizumab was approved for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) by the US Food and Drug Administration in March 2017 and by the European Medicines Agency in January 2018. These approvals were based on two pivotal randomized controlled trials (RCTs), OPERA I and OPERA II, comparing ocrelizumab 600 mg with an active comparator, interferon β-1a 44 μg (Rebif), and the first trial with positive results in patients with PPMS, which compared ocrelizumab with placebo. However, direct evidence of the efficacy and safety of ocrelizumab in RMS compared with other disease-modifying therapies (DMTs) approved for RMS is not available from RCTs. In the absence of such RCTs, network meta-analyses (NMAs) were conducted to compare indirectly the relative efficacy and safety of ocrelizumab with all other approved DMTs for the treatment of RMS. Methods: Systematic literature searches were conducted in MEDLINE, Embase, the Cochrane Library, trial registers, relevant conference websites and health technology assessment agency websites. Eligible RCTs evaluated approved treatments for multiple sclerosis (MS) in which more than 75% of patients had a relapsing form of MS. NMAs were conducted for four efficacy and three safety outcomes, and treatment hierarchies were generated for each outcome using surface under the cumulative ranking curve (SUCRA) values. Results: Results suggest that ocrelizumab has superior efficacy to 10 of the 17 treatments in the 12-week confirmed disability progression network and 12 of the 17 treatments in the annualized relapse rate network (both including placebo). The efficacy of ocrelizumab was comparable with the other treatments in both networks. In the serious adverse events and discontinuation due to adverse events networks, ocrelizumab demonstrated a safety profile comparable with all other treatments (including placebo). SUCRA values consistently ranked ocrelizumab among the most effective or tolerable treatments across all outcomes. Conclusions: Results suggest that ocrelizumab has an efficacy superior to or comparable with all other currently approved DMTs across all endpoints analyzed, and a similar safety profile, indicating it offers a valuable package for the treatment of patients with RMS.

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“…Compared with alemtuzumab, cladribine was a less cost-effective option. 7 An extended analysis of data from the CLARITY trial also revealed that use of cladribine had a significant positive impact on quality of life indices. 8 …”

Section: Evidencementioning

confidence: 99%

“…However, this was not statistically significant. 7 On assessment of cost-effectiveness, cladribine was found to be more cost effective and cheaper than daclizumab, fingolimod and natalizumab in the relevant subgroups with severe disease. Compared with alemtuzumab, cladribine was a less cost-effective option.…”

Section: Evidencementioning

confidence: 99%

Cladribine tablets and multiple sclerosis: NICE technology appraisal

Gaber¹,

Shippen²

2018

Prog Neurol Psychiatry

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Cladribine is the first disease modifying treatment (DMT) for relapsing remitting multiple sclerosis (RRMS) that progressed straight to a positive final recommendation in the NICE appraisal process. The final recommendations were published in December 2017.1 An agreement between NHS England and Merck, the manufacturer of cladribine (Mavenclad), will allow MS patients who are suffering from highly active or rapidly evolving RRMS to access the drug. Here, the authors discuss the clinical and economic considerations for cladribine usage.

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Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing–remitting multiple sclerosis

Abstract: In this first NMA to consider cladribine tablets, ocrelizumab and daclizumab for treatment of RRMS, cladribine tablets are a comparatively effective and safe alternative to other DMTs in both active RRMS and HRA + DAT populations.

Cited by 69 publications

References 56 publications

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

Systematic review and network meta-analysis comparing ocrelizumab with other treatments for relapsing multiple sclerosis

Cladribine tablets and multiple sclerosis: NICE technology appraisal

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