North Valley Neurology & Sleep © All Rights Reserved.
Looking After Your Health
3815 E. Bell Rd. #2400
Phoenix, AZ 85032
Phone: (602) 482-2116
FAX: (602) 482-9563
We are moving to our new office!
Effective
June 1, 2010
3815 E. Bell Rd. #2400
Phoenix, AZ 85032
Effective
June 1, 2010
3815 E. Bell Rd. #2400
Phoenix, AZ 85032
Phone:
(602) 482-2116 Fax:
(602) 4829563
(602) 482-2116 Fax:
(602) 4829563
Cladribine
Oral short-course treatment with cladribine, at 2 dosing levels, demonstrated efficacy compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS), according to results from the Cladribine Tablets Treating MS Orally (CLARITY) trial, and a 96-week extension trial is now planned.
"The 2-year extension of the CLARITY study will provide important information on the safety, tolerability, and benefit/risk profile of up to 4 years of cladribine use," Peter Rieckmann, MD, from the Multiple Sclerosis Program at the University of British Columbia, in Vancouver, and colleagues note.
The latest findings from the CLARITY trial were presented here at the Consortium of Multiple Sclerosis Centers (CMSC) 23rd Annual Meeting and previously at the American Academy of Neurology meeting held April 25–May 2, 2009, in Seattle, Washington. If approved, cladribine will represent the first oral treatment for RRMS.
The new phase 3b extension study will enroll patients who completed 96 weeks in the CLARITY study evaluating cladribine vs placebo and follow them for over 2 additional years. Patients previously treated with cladribine will be randomized in a ratio of 2:1 to 4- or 5-day courses per year in consecutive months of once-daily cladribine tablets or to placebo. Patients previously randomized to placebo in the first 96 weeks of the CLARITY study will receive a 5-day course for 2 consecutive months per year of once-daily cladribine tablets.
The primary end point will be safety, including assessment of hematologic and hepatic function.
Oral Therapy
The CLARITY study included patients diagnosed with RRMS with at least 1 relapse within the past 12 months and no more than 1 prior failed disease-modifying treatment given at least 3 months prior to study entry. Patients had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5. Rescue therapy with interferon beta-1a was allowed after week 24.
For the main analysis, 1326 patients were randomized equally to receive placebo or 1 of 2 doses of cladribine tablets: either 4 courses, for a total dose of 3.5 mg/kg, or 5 courses, for a total dose of 5.25 mg/kg, over the 96-week study period. For each course, patients received 1 to 2 tablets according to body weight for 4 or 5 consecutive days per month.
The annualized rate of relapse was reduced with cladribine compared with placebo; patients treated with the low-dose regimen of cladribine tablets experienced a 58% relative reduction in annualized relapse rates with respect to placebo (0.14 vs 0.33 for the placebo group; P < .001). Patients in the high-dose regimen group experienced a 55% relative reduction in annualized relapse rates compared with placebo (0.15 vs 0.33; P < .001).
The proportion of patients who remained relapse-free, a secondary end point, was significantly higher with=2 0cladribine than with placebo. Over the 2-year period of the study, 80% of the patients treated with the low-dose regimen of cladribine tablets and 79% of the patients treated with the high-dose regimen experienced no clinical relapse, compared with 61% of the patients from the placebo group (P < .001 for both dose regimens vs placebo).
"The 2-year extension of the CLARITY study will provide important information on the safety, tolerability, and benefit/risk profile of up to 4 years of cladribine use," Peter Rieckmann, MD, from the Multiple Sclerosis Program at the University of British Columbia, in Vancouver, and colleagues note.
The latest findings from the CLARITY trial were presented here at the Consortium of Multiple Sclerosis Centers (CMSC) 23rd Annual Meeting and previously at the American Academy of Neurology meeting held April 25–May 2, 2009, in Seattle, Washington. If approved, cladribine will represent the first oral treatment for RRMS.
The new phase 3b extension study will enroll patients who completed 96 weeks in the CLARITY study evaluating cladribine vs placebo and follow them for over 2 additional years. Patients previously treated with cladribine will be randomized in a ratio of 2:1 to 4- or 5-day courses per year in consecutive months of once-daily cladribine tablets or to placebo. Patients previously randomized to placebo in the first 96 weeks of the CLARITY study will receive a 5-day course for 2 consecutive months per year of once-daily cladribine tablets.
The primary end point will be safety, including assessment of hematologic and hepatic function.
Oral Therapy
The CLARITY study included patients diagnosed with RRMS with at least 1 relapse within the past 12 months and no more than 1 prior failed disease-modifying treatment given at least 3 months prior to study entry. Patients had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5. Rescue therapy with interferon beta-1a was allowed after week 24.
For the main analysis, 1326 patients were randomized equally to receive placebo or 1 of 2 doses of cladribine tablets: either 4 courses, for a total dose of 3.5 mg/kg, or 5 courses, for a total dose of 5.25 mg/kg, over the 96-week study period. For each course, patients received 1 to 2 tablets according to body weight for 4 or 5 consecutive days per month.
The annualized rate of relapse was reduced with cladribine compared with placebo; patients treated with the low-dose regimen of cladribine tablets experienced a 58% relative reduction in annualized relapse rates with respect to placebo (0.14 vs 0.33 for the placebo group; P < .001). Patients in the high-dose regimen group experienced a 55% relative reduction in annualized relapse rates compared with placebo (0.15 vs 0.33; P < .001).
The proportion of patients who remained relapse-free, a secondary end point, was significantly higher with=2 0cladribine than with placebo. Over the 2-year period of the study, 80% of the patients treated with the low-dose regimen of cladribine tablets and 79% of the patients treated with the high-dose regimen experienced no clinical relapse, compared with 61% of the patients from the placebo group (P < .001 for both dose regimens vs placebo).