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| |  Alemtuzumab Treatment Benefits Continue Into Fourth Year of Follow-Up for Patients With Relapsing-Remitting MS: Presented at ECTRIMS By Chris Berrie DÜSSELDORF, Germany -- September 14, 2009 -- The benefits of 2 or 3 annual cycles of alemtuzumab treatment continue into the fourth year of follow-up for patients with relapsing-remitting multiple sclerosis (RRMS), researchers stated here at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This follow-up analysis of a randomised, rater-blinded, phase 2 study was presented here on on September 11 on behalf of the Campath in Multiple Sclerosis (CAMMS223) Study Group by principal investigator Alasdair Coles, MD, Neuroimmunology, Addenbrookes Hospital, Cambridge, United Kingdom. In the original CAMMS223 trial of patients with early, active RRMS, 2 dose levels of annual alemtuzumab were compared with 3-times weekly subcutaneous interferon (IFN) beta-1a at 44 mcg. Alemtuzumab dosing was 12/24 mg intravenous daily for 5 days at month 0, and 3 days at month 12, with 21% of patients receiving a further 3 days at month 24. IFN beta-1a was provided through month 36. Of the original patients, 158 completed a month-48 study visit: 58 of 64 patients from the alemtuzumab 12-mg/24-mg treatment group, and 36 patients from the IFN-beta-1a treatment group. The aim was to evaluate the efficacy durability of alemtuzumab versus IFN beta-1a at 4 years. The coprimary efficacy endpoints of MS relapse rate and time to sustained accumulation of disability (SAD) were used, with SAD defined as an increase in Expanded Disability Status Scale (EDSS) score that was sustained for 6 months or more. There was a significant 72% reduction in risk of relapse in the combined alemtuzumab-treatment groups compared with the IFN-beta-1a-treated group (P < .0001). Similarly, the annual relapse rate for alemtuzumab-treated patients was significantly lower than that for patients treated with IFN beta-1a: 0.10 (95% confidence interval [CI], 0.08-0.12) versus 0.34 (95% CI, 0.28-0.41), respectively. There was a significant 73% reduction in risk for SAD with alemtuzumab compared with IFN beta-1a (P < .0001). In fact, the percentage of alemtuzumab patients experiencing SAD by 4 years was as seen at 3 years; however, with IFN beta-1a, there was an increase from 26.2% at 3 years to 32.0% at 4 years. Improvements in EDSS scores for the alemtuzumab-treated group continued from the 3-year analysis, showing a further improvement of -0.43, while the IFN-beta-1a-treated group saw EDSS increase: +0.25. This benefit was also significant (P < .001). As these patients could take nonstudy drugs at this stage, sensitivity analyses were carried out by censoring patients who had indeed taken nonstudy drugs. The results were still in favour of alemtuzumab, indicating that the other drugs did not contribute to these differences between treatment groups. Safety concerns remain, however, for secondary autoimmune disorders. Although effectively managed with conventional therapies, the safety analysis saw thyroid disorders associated with alemtuzumab treatment, with 13% and 9.3% of alemtuzumab-treated patients experiencing hyperthyroidism and hypothyroidism, respectively. These disorders were not seen with IFN-beta-1a treatment. Considering that alemtuzumab kills off the lymphocytes, which then grow back, Dr. Coles concluded that, “the new immune system that reconstitutes is radically different from the one that was there before -- and that seems to be a stable change.” Funding for this study was provided by Genzyme. [Presentation title: Alemtuzumab Treatment Benefit Is Durable: Primary Efficacy Outcomes of CAMMS223 at 4 years. Abstract P890]
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