Multiple sclerosis and related disorders · 2026
The comparative efficacy of cladribine tablets versus alternative disease-modifying treatments for relapsing-remitting multiple sclerosis: Updated meta-regression estimates by patient subgroup.
СтатьяМетаанализСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Harty Gerard T, Jones Michelle, J Saipriya, Maheshwari Vikalp
Аннотация
BACKGROUND: A previously published meta-regression compared cladribine tablets with key disease-modifying treatments (DMTs) for patients with relapsing-remitting multiple sclerosis (RRMS). This analysis updates and extends that work by evaluating the relative efficacy of cladribine tablets versus approved DMTs in specific RRMS subgroups, including high disease activity (HDA) and sub-optimal therapy (SOT).
METHODS: Updated systematic literature reviews identified clinical trials evaluating cladribine tablets and other DMTs in RRMS. Baseline-risk-adjusted meta-regressions were conducted. Outcomes included 6-month confirmed disability progression (6 M-CDP) and annualised relapse rate (ARR).
RESULTS: Fifty-four clinical trials assessing cladribine tablets plus 19 additional DMTs contributed to the meta-regressions. Results showed significant overlap in the hazard ratio credible intervals, with no therapy statistically dominating in terms of efficacy. At the point-estimate level in the HDA population, for 6 M-CDP, cladribine tablets were predicted to be more efficacious than placebo, fingolimod, alemtuzumab, glatiramer acetate, teriflunomide, ozanimod, interferon beta-1a, ocrelizumab, dimethyl fumarate, and ponesimod; comparable estimates were observed versus ofatumumab. For ARR, cladribine tablets were predicted to be more efficacious than placebo, dimethyl fumarate, glatiramer acetate, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, and teriflunomide, as well as fingolimod, ozanimod, and ponesimod; comparable estimates were observed versus ocrelizumab.
CONCLUSIONS: Updated meta-regressions demonstrate that cladribine tablets have comparable relative efficacy to other high-efficacy therapies in HDA and SOT patient subgroups. For disability progression outcomes, cladribine tablets showed similar efficacy to ofatumumab; for relapse reduction, cladribine tablets were comparable to ocrelizumab. Cladribine tablets also consistently outperformed most platform therapies across all analyzed subgroups.
METHODS: Updated systematic literature reviews identified clinical trials evaluating cladribine tablets and other DMTs in RRMS. Baseline-risk-adjusted meta-regressions were conducted. Outcomes included 6-month confirmed disability progression (6 M-CDP) and annualised relapse rate (ARR).
RESULTS: Fifty-four clinical trials assessing cladribine tablets plus 19 additional DMTs contributed to the meta-regressions. Results showed significant overlap in the hazard ratio credible intervals, with no therapy statistically dominating in terms of efficacy. At the point-estimate level in the HDA population, for 6 M-CDP, cladribine tablets were predicted to be more efficacious than placebo, fingolimod, alemtuzumab, glatiramer acetate, teriflunomide, ozanimod, interferon beta-1a, ocrelizumab, dimethyl fumarate, and ponesimod; comparable estimates were observed versus ofatumumab. For ARR, cladribine tablets were predicted to be more efficacious than placebo, dimethyl fumarate, glatiramer acetate, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, and teriflunomide, as well as fingolimod, ozanimod, and ponesimod; comparable estimates were observed versus ocrelizumab.
CONCLUSIONS: Updated meta-regressions demonstrate that cladribine tablets have comparable relative efficacy to other high-efficacy therapies in HDA and SOT patient subgroups. For disability progression outcomes, cladribine tablets showed similar efficacy to ofatumumab; for relapse reduction, cladribine tablets were comparable to ocrelizumab. Cladribine tablets also consistently outperformed most platform therapies across all analyzed subgroups.