Cladribine tablets for relapsing-remitting multiple sclerosis: Efficacy across patient subgroups from the phase III CLARITY study

Kottil W Rammohan, Gavin Giovannoni, Giancarlo Comi, Stuart Cook, Peter Rieckmann, Per Soelberg Sørensen, Patrick Vermersch, Anthony Hamlett, Nuwan Kurukulasuriya

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: In the phase III CLARITY study, treatment with cladribine tablets at cumulative doses of 3.5 or 5.25 mg/kg over 96 weeks led to significant reductions in annualized relapse rates (ARR) versus placebo in patients with relapsing-remitting multiple sclerosis. Further post hoc analyses of CLARITY study data were conducted to determine the efficacy of cladribine tablets across patient subgroups stratified by baseline characteristics. Methods: Relapse rates over the 96-week CLARITY study were analyzed in cohorts stratified by demographics; disease duration; treatment history and disease activity at baseline. Results: In the intent-to-treat population (n=437, 433 and 456 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively), treatment with cladribine tablets 3.5 and 5.25 mg/kg led to consistent improvements in ARR versus placebo in patients stratified by gender; age ( ≤ 40/ > 40 years); disease duration ( < 3/3-10/ > 10 years); prior disease-modifying drug treatment (treated/naive); relapses in the prior year ( ≤ 1/2/ > 3); Expanded Disability Status Scale score ( < 3.5/ > 3.5); T1 gadolinium- enhancing lesions (presence, absence); and T2 lesion volume ( ≤ median/ > median) at baseline (all Pr 0.05 for reduction in the relative risk of relapse [cladribine tablets versus placebo]). Significant effects were also observed in patients who had only one relapse in the year prior to study entry (n=306, 303 and 323 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively) and who were further stratified according to other measures of disease activity at baseline. Conclusions: Treatment with cladribine tablets provides consistent reductions in ARR compared with placebo across the spectrum of baseline demographics and disease characteristics represented in the CLARITY study.

Original languageEnglish
Pages (from-to)49-54
Number of pages6
JournalMultiple Sclerosis and Related Disorders
Volume1
Issue number1
DOIs
StatePublished - Jan 1 2012

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Cladribine
Relapsing-Remitting Multiple Sclerosis
Tablets
Recurrence
Placebos
Demography
Therapeutics
Gadolinium
History

Keywords

  • Administration
  • Cladribine
  • Disease-modiiying drug
  • Oral
  • Relapsing-remitting multiple sclerosis
  • Treatment outcome

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Cladribine tablets for relapsing-remitting multiple sclerosis : Efficacy across patient subgroups from the phase III CLARITY study. / Rammohan, Kottil W; Giovannoni, Gavin; Comi, Giancarlo; Cook, Stuart; Rieckmann, Peter; Sørensen, Per Soelberg; Vermersch, Patrick; Hamlett, Anthony; Kurukulasuriya, Nuwan.

In: Multiple Sclerosis and Related Disorders, Vol. 1, No. 1, 01.01.2012, p. 49-54.

Research output: Contribution to journalArticle

Rammohan, Kottil W ; Giovannoni, Gavin ; Comi, Giancarlo ; Cook, Stuart ; Rieckmann, Peter ; Sørensen, Per Soelberg ; Vermersch, Patrick ; Hamlett, Anthony ; Kurukulasuriya, Nuwan. / Cladribine tablets for relapsing-remitting multiple sclerosis : Efficacy across patient subgroups from the phase III CLARITY study. In: Multiple Sclerosis and Related Disorders. 2012 ; Vol. 1, No. 1. pp. 49-54.
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abstract = "Background: In the phase III CLARITY study, treatment with cladribine tablets at cumulative doses of 3.5 or 5.25 mg/kg over 96 weeks led to significant reductions in annualized relapse rates (ARR) versus placebo in patients with relapsing-remitting multiple sclerosis. Further post hoc analyses of CLARITY study data were conducted to determine the efficacy of cladribine tablets across patient subgroups stratified by baseline characteristics. Methods: Relapse rates over the 96-week CLARITY study were analyzed in cohorts stratified by demographics; disease duration; treatment history and disease activity at baseline. Results: In the intent-to-treat population (n=437, 433 and 456 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively), treatment with cladribine tablets 3.5 and 5.25 mg/kg led to consistent improvements in ARR versus placebo in patients stratified by gender; age ( ≤ 40/ > 40 years); disease duration ( < 3/3-10/ > 10 years); prior disease-modifying drug treatment (treated/naive); relapses in the prior year ( ≤ 1/2/ > 3); Expanded Disability Status Scale score ( < 3.5/ > 3.5); T1 gadolinium- enhancing lesions (presence, absence); and T2 lesion volume ( ≤ median/ > median) at baseline (all Pr 0.05 for reduction in the relative risk of relapse [cladribine tablets versus placebo]). Significant effects were also observed in patients who had only one relapse in the year prior to study entry (n=306, 303 and 323 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively) and who were further stratified according to other measures of disease activity at baseline. Conclusions: Treatment with cladribine tablets provides consistent reductions in ARR compared with placebo across the spectrum of baseline demographics and disease characteristics represented in the CLARITY study.",
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AU - Cook, Stuart

AU - Rieckmann, Peter

AU - Sørensen, Per Soelberg

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N2 - Background: In the phase III CLARITY study, treatment with cladribine tablets at cumulative doses of 3.5 or 5.25 mg/kg over 96 weeks led to significant reductions in annualized relapse rates (ARR) versus placebo in patients with relapsing-remitting multiple sclerosis. Further post hoc analyses of CLARITY study data were conducted to determine the efficacy of cladribine tablets across patient subgroups stratified by baseline characteristics. Methods: Relapse rates over the 96-week CLARITY study were analyzed in cohorts stratified by demographics; disease duration; treatment history and disease activity at baseline. Results: In the intent-to-treat population (n=437, 433 and 456 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively), treatment with cladribine tablets 3.5 and 5.25 mg/kg led to consistent improvements in ARR versus placebo in patients stratified by gender; age ( ≤ 40/ > 40 years); disease duration ( < 3/3-10/ > 10 years); prior disease-modifying drug treatment (treated/naive); relapses in the prior year ( ≤ 1/2/ > 3); Expanded Disability Status Scale score ( < 3.5/ > 3.5); T1 gadolinium- enhancing lesions (presence, absence); and T2 lesion volume ( ≤ median/ > median) at baseline (all Pr 0.05 for reduction in the relative risk of relapse [cladribine tablets versus placebo]). Significant effects were also observed in patients who had only one relapse in the year prior to study entry (n=306, 303 and 323 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively) and who were further stratified according to other measures of disease activity at baseline. Conclusions: Treatment with cladribine tablets provides consistent reductions in ARR compared with placebo across the spectrum of baseline demographics and disease characteristics represented in the CLARITY study.

AB - Background: In the phase III CLARITY study, treatment with cladribine tablets at cumulative doses of 3.5 or 5.25 mg/kg over 96 weeks led to significant reductions in annualized relapse rates (ARR) versus placebo in patients with relapsing-remitting multiple sclerosis. Further post hoc analyses of CLARITY study data were conducted to determine the efficacy of cladribine tablets across patient subgroups stratified by baseline characteristics. Methods: Relapse rates over the 96-week CLARITY study were analyzed in cohorts stratified by demographics; disease duration; treatment history and disease activity at baseline. Results: In the intent-to-treat population (n=437, 433 and 456 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively), treatment with cladribine tablets 3.5 and 5.25 mg/kg led to consistent improvements in ARR versus placebo in patients stratified by gender; age ( ≤ 40/ > 40 years); disease duration ( < 3/3-10/ > 10 years); prior disease-modifying drug treatment (treated/naive); relapses in the prior year ( ≤ 1/2/ > 3); Expanded Disability Status Scale score ( < 3.5/ > 3.5); T1 gadolinium- enhancing lesions (presence, absence); and T2 lesion volume ( ≤ median/ > median) at baseline (all Pr 0.05 for reduction in the relative risk of relapse [cladribine tablets versus placebo]). Significant effects were also observed in patients who had only one relapse in the year prior to study entry (n=306, 303 and 323 in the placebo, cladribine 3.5 and 5.25 mg/kg groups, respectively) and who were further stratified according to other measures of disease activity at baseline. Conclusions: Treatment with cladribine tablets provides consistent reductions in ARR compared with placebo across the spectrum of baseline demographics and disease characteristics represented in the CLARITY study.

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