2020
DOI: 10.1007/s40263-020-00749-x
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Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study

Abstract: Background Alemtuzumab efficacy versus subcutaneous interferon-β-1a (SC IFNB-1a) was demonstrated over 2 years in patients with relapsing-remitting multiple sclerosis, with continued efficacy over 7 additional years. Alemtuzumab is included as a recommended treatment for patients with highly active disease (HAD) by the American Academy of Neurology Practice Guidelines, and the label indication in Europe was recently restricted to the treatment of HAD patients. There is currently no consensus definition for HAD… Show more

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Cited by 45 publications
(35 citation statements)
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“…Long-term safety and efficacy follow-up continue in the subsequent 5-year long-Term follow-up study for multiple sclerOsis Patients who have completed the AlemtuZumab extension study (TOPAZ; NCT02255656). 43 …”
Section: Discussionmentioning
confidence: 99%
“…Long-term safety and efficacy follow-up continue in the subsequent 5-year long-Term follow-up study for multiple sclerOsis Patients who have completed the AlemtuZumab extension study (TOPAZ; NCT02255656). 43 …”
Section: Discussionmentioning
confidence: 99%
“…Details on the rater-blinded, active-controlled CARE-MS trials and subsequent extension studies have been published previously [6,7,[9][10][11][12][13]. After C 30 days of clinical stability, patients were randomized to receive either two courses of alemtuzumab 12 mg/day (given as intravenous [IV] infusions on 5 consecutive days at baseline and on 3 consecutive days 12 months later) or SC IFNB-1a 44 lg three times per week after dose titration.…”
Section: Methodsmentioning
confidence: 99%
“…Lorscheider et al 20 proposed a diagnostic definition of SPMS based on the EDSS value and preceding relapses: SPMS is present if a patient has at least a 1-point worsening from a previous EDSS ≤5. 5 (or a 0.5-point EDSS worsening from a previous EDSS ≥6.0) confirmed over ≥3 months in the absence of relapses, with a minimum EDSS score of ≥4 and a pyramidal FS score of ≥2. Transitional MS according to Kleiter et al 21 implies: MS disease duration ≥ 4 years; EDSS 3.0 to 5.0; relapse-independent increase of disability by ≥0.5 points over the previous year or ≥1 point over the previous 2 years; MRI with ≥1 cortical lesion(s) OR evidence of cortical atrophy and/or smoldering lesions; disease activity during previous 2 years with ≥1 clinical relapse or ≥1 new or enlarging T2 lesion on MRI.…”
Section: Available Evidencementioning
confidence: 99%
“…While mouse experiments reveal teratogenicity of cladribine upon intraperitoneal administration of dosages ≥5 mg/kg, 4 no signal of teratogenicity emerged from the limited pregnancy data in the oral cladribine clinical trial program with the approved dose. 5 According to the current summary of product characteristics of cladribine tablets, 11 pregnancy must be ruled out in females of childbearing age prior to the initiation of treatment with oral cladribine in years 1 and 2. Dual-method contraception (i.e.…”
Section: Available Evidencementioning
confidence: 99%
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