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

Kottil 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
Publication statusPublished - Jan 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; 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, 01.2012, p. 49-54.

Research output: Contribution to journalArticle

Rammohan, K, Giovannoni, G, Comi, G, Cook, S, Rieckmann, P, Sørensen, PS, Vermersch, P, Hamlett, A & Kurukulasuriya, N 2012, 'Cladribine tablets for relapsing-remitting multiple sclerosis: Efficacy across patient subgroups from the phase III CLARITY study', Multiple Sclerosis and Related Disorders, vol. 1, no. 1, pp. 49-54. https://doi.org/10.1016/j.msard.2011.08.006
Rammohan, Kottil ; 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 - Giovannoni, Gavin

AU - Comi, Giancarlo

AU - Cook, Stuart

AU - Rieckmann, Peter

AU - Sørensen, Per Soelberg

AU - Vermersch, Patrick

AU - Hamlett, Anthony

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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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