P3.022 - Patients with Active RRMS and an Inadequate Response to Prior Therapy Demonstrate Durable Improvements in Relapse and Disability Following Treatment with Alemtuzumab: 5-Year Follow-Up of the CARE-MS II Study
Coles AJ et al.
OBJECTIVE:To examine 5-year clinical efficacy and safety in CARE-MS II alemtuzumab-treated patients.
BACKGROUND: In CARE-MS II (NCT00548405), active relapsing-remitting MS (RRMS) patients with an inadequate response (≥1 relapse) to prior therapy at baseline, alemtuzumab showed superior efficacy versus SC IFNB-1a over 2 years. Efficacy was durable through 4 years.
DESIGN/METHODS: In the CARE-MS II core study, alemtuzumab patients received 2 annual treatment courses at Months 0 and 12. Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or radiological activity. Endpoints included annualized relapse rate (ARR), 6-month sustained accumulation of disability (SAD)/confirmed disability progression (≥1-point EDSS increase [≥1.5-point if baseline EDSS=0] confirmed at 6 months), 6-month sustained reduction in disability (SRD; ≥1-point EDSS decrease [baseline score ≥2.0]), and no evidence of clinical disease activity (absence of relapse and 6-month SAD).
RESULTS: 393 (93%) alemtuzumab-treated patients completing CARE-MS II enrolled in extension. Through 5 years, 91% remained on study, 60% received no alemtuzumab since the initial 2 courses, and 8% received another disease-modifying therapy. Low ARR (0.21) was maintained over Years 3-5. Through Years 0-5, 76% of patients were free from 6-month SAD, 77% had stable or improved EDSS, and 43% achieved 6-month SRD. More than half of patients (52%) had no evidence of clinical disease activity over Years 3-5. Incidences of infusion-associated reactions and infections during extension decreased versus core study; serious adverse event (AE) incidence was low. Thyroid AE incidence peaked at Year 3, declining thereafter.
CONCLUSIONS: Alemtuzumab demonstrated durable improvements in clinical efficacy over 5 years despite most patients not receiving alemtuzumab for 4 years. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for RRMS patients.
P3.053 - Durable Efficacy of Alemtuzumab Over 10 Years: Long-Term Follow-Up of Patients with RRMS from the CAMMS223 Study
OBJECTIVE:Evaluate 10-year efficacy and safety in treatment-naive patients who received alemtuzumab 12 mg in phase 2 CAMMS223, and enrolled in the ongoing CARE-MS extension study.
BACKGROUND: In CAMMS223, in patients with active relapsing-remitting MS (RRMS), alemtuzumab showed superior efficacy versus SC IFNB-1a. During 3 randomized studies, efficacy was durable through 5 years, with most patients not receiving retreatment for 4 years.
DESIGN/METHODS: In the CAMMS223 core study (NCT00050778), patients were randomized to receive 2 annual courses of alemtuzumab with a possible third course based on T-cell counts. Patients could enter the extension (NCT00930553) for additional follow-up and as-needed retreatment. Endpoints included annualized relapse rate (ARR) and 6-month sustained accumulation of disability (SAD)/confirmed disability progression (≥1-point Expanded Disability Status Scale [EDSS] increase [≥1.5-point if baseline EDSS=0]).
RESULTS: Of 108 alemtuzumab 12-mg-treated patients in CAMMS223, 60 entered the extension; based on rising T-cell counts, 39 received a third course (25 after Year 3). 57 (95%) of extension patients were followed through Year 10; of these, 12% and 10% received 4 or 5 alemtuzumab courses, respectively. Through Year 10, low ARR was maintained (0.07), 76% were free from 6-month SAD, and 78% had stable or ≥1-point improved EDSS versus baseline. Serious adverse event (AE) incidence was low. Incidence of infusion-associated reactions decreased after first treatment course (98%). Annual incidence of infections decreased after Year 1 (55%). Incidence of thyroid AEs peaked in Year 3 (17%) and declined thereafter.
CONCLUSIONS: Alemtuzumab demonstrated durable clinical efficacy through Year 10 despite most patients receiving ≤3 treatment courses. Safety findings were consistent with those of other alemtuzumab clinical trials. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for patients with RRMS.
You asked for the ten year data and there you have it the 10 year data. More of the same compared to that already published by Tuohy et al. but as you can see it is not simply two doses and that's it, as many people need another dose. So is it really pulsed immune reconstitution therapy (PIRT) as suggested by profG or pulsed immune ablation therapy (PIAT), where by the pathogenic cells are wiped away for years and if and when they regenerate they need another dose of medicine.
However what you want to know is what is the number of converters to secondary progression?