Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies

被引：20

作者：

De Stefano, Nicola ^{[1
,2
]}

Sormani, Maria Pia ^{[3
,4
]}

Giovannoni, Gavin ^{[5
]}

Rammohan, Kottil ^{[6
]}

Leist, Thomas ^{[7
]}

Coyle, Patricia K. ^{[8
]}

Dangond, Fernando ^{[9
]}

Keller, Birgit ^{[10
]}

Alexandri, Nektaria ^{[10
]}

Galazka, Andrew ^{[10
]}

机构：

[1] Univ Siena, Dept Med Surg & Neurosci, Viale Bracci 2, I-53100 Siena, Italy

[2] Univ Siena, Dept Neurol & Behav Sci, Siena, Italy

[3] Univ Genoa, Dept Hlth Sci, Genoa, Italy

[4] Osped Policlin San Martino IRCCS, Genoa, Italy

[5] Queen Mary Univ London, Barts & London Sch Med & Dent, Blizard Inst, London, England

[6] Univ Miami, Sch Med, Dept Neurol, MS Res Ctr, Miami, FL USA

[7] Jefferson Univ, Comprehens MS Ctr, Div Clin Neuroimmunol, Philadelphia, PA USA

[8] SUNY Stony Brook, Dept Neurol, Stony Brook, NY 11794 USA

[9] EMD Serono Res & Dev Inst Inc, Billerica, MA USA

[10] Merck KGaA, Darmstadt, Germany

来源：

MULTIPLE SCLEROSIS JOURNAL | 2022年 / 28卷 / 01期

关键词：

Relapsing-remitting multiple sclerosis; relapses; hospitalisation; steroids; cladribine tablets; disease-modifying therapy; QUALITY-OF-LIFE; TRIAL;

D O I：

10.1177/13524585211010294

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background: In the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study of patients with relapsing-remitting multiple sclerosis, treatment with cladribine tablets 3.5 mg/kg (CladT) significantly reduced the annualised relapse rate (ARR) versus placebo; this effect was sustained in CLARITY Extension, without further treatment. Objective: To assess the frequency and severity of relapses in patients treated with CladT versus placebo in CLARITY over 2 years and evaluate the durability of effect in patients who received no further treatment for 2 years in CLARITY Extension. Methods: In this post hoc analysis, ARRs were calculated for qualifying and all relapses, and qualifying and all severe relapses (i.e. requiring steroid treatment or leading to hospitalisation) in patients treated with CladT (n = 433) and placebo (n = 437) in CLARITY, and those from the CladT group who received placebo in CLARITY Extension (n = 98). Results: At Month 6, Year 1 and Year 2, patients receiving CladT had a significantly lower risk of qualifying or all relapses (all p < 0.0001), and qualifying or all severe relapses (all p < 0.005), compared with placebo. This effect was sustained in CLARITY Extension without further treatment. Conclusion: The results show durable efficacy of cladribine tablets 3.5 mg/kg for reducing frequency and severity of relapses in patients with relapsing-remitting multiple sclerosis. CLARITY: NCT00213135; CLARITY Extension: NCT00641537

引用

页码：111 / 120

页数：10

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