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Rigshospitalet - en del af Københavns Universitetshospital
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Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  3. The Multiple Sclerosis Care Unit

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Gavin Giovannoni
  • Per Soelberg Sorensen
  • Stuart Cook
  • Kottil Rammohan
  • Peter Rieckmann
  • Giancarlo Comi
  • Fernando Dangond
  • Abidemi K Adeniji
  • Patrick Vermersch
Vis graf over relationer

BACKGROUND: In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS).

OBJECTIVE: To assess the safety and efficacy of cladribine treatment in a 2-year Extension study.

METHODS: In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained.

RESULTS: A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0-1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension.

CONCLUSION: Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting.

OriginalsprogEngelsk
TidsskriftMultiple sclerosis (Houndmills, Basingstoke, England)
Vol/bind24
Udgave nummer12
Sider (fra-til)1594-1604
Antal sider11
ISSN1352-4585
DOI
StatusUdgivet - okt. 2018

ID: 56320860