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 language | English |
|---|---|
| Pages (from-to) | 49-54 |
| Number of pages | 6 |
| Journal | Multiple Sclerosis and Related Disorders |
| Volume | 1 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 2012 |
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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 journal › Article
}
TY - JOUR
T1 - Cladribine tablets for relapsing-remitting multiple sclerosis
T2 - Efficacy across patient subgroups from the phase III CLARITY study
AU - Rammohan, Kottil
AU - Giovannoni, Gavin
AU - Comi, Giancarlo
AU - Cook, Stuart
AU - Rieckmann, Peter
AU - Sørensen, Per Soelberg
AU - Vermersch, Patrick
AU - Hamlett, Anthony
AU - Kurukulasuriya, Nuwan
PY - 2012/1
Y1 - 2012/1
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.
KW - Administration
KW - Cladribine
KW - Disease-modiiying drug
KW - Oral
KW - Relapsing-remitting multiple sclerosis
KW - Treatment outcome
UR - http://www.scopus.com/inward/record.url?scp=80054696992&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80054696992&partnerID=8YFLogxK
U2 - 10.1016/j.msard.2011.08.006
DO - 10.1016/j.msard.2011.08.006
M3 - Article
AN - SCOPUS:80054696992
VL - 1
SP - 49
EP - 54
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
SN - 2211-0348
IS - 1
ER -