Le post qui suit résume les très bonnes données sur l'extension à 5 ans des personnes atteintes de
Voici les résultats de l'étude d'extension de cinq ans portant sur l'alemtuzumab. Si vous avez la
Nous avons soutenu le paradigme de traitement consistant à inverser la pyramide (première ligne de haute efficacité) depuis un certain temps déjà. L'étude CARE-MS 1 est justement celle-ci, c'est-à-dire 68,5 % des sujets n'ont eu besoin que de deux cycles de traitement au cours de l'année 1 et 2, la majorité d'entre eux étant NEDA (sans nouveau symptômes visibles) au cours des années 3,4 et 5. La mesure importante est la perte de volume cérébral, une mesure des dommages aux organes terminaux, qui était inférieure ou égale à 0,2 % par année. Ce niveau de perte de volume cérébral est ce que vous voyez chez les gens normaux.
Les résultats de l'étude d'extension de CARE-MS 2 ne sont pas moins impressionnants. Ces sujets avaient tous échoué à des traitements antérieurs et, par conséquent, avaient eu une maladie de plus longue durée et étaient tous passés à l'alemtuzumab avec des
Les contre-indications de l'alemtuzumab sont bien définies; ~45-50 % des sujets développeront une auto-immunité secondaire au fil du temps. La maladie thyroïdienne
[paragraphe sur le système de santé anglais et la SEP]
[article qu'ils citent en VO]
Havrdova et al. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Aug 23.
OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348).
METHODS: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point
RESULTS: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0-5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2-4, remaining low in year 5 (years 1-5: -0.59%, -0.25%, -0.19%, -0.15%, and -0.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined.
CONCLUSIONS: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses.
Coles et al. Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings. Neurology. 2017 Aug 23.
OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy.
METHODS: In the 2-year Comparison of Alemtuzumab and
RESULTS: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter.
CONCLUSIONS: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment.