dc.contributor.author | Singer, Barry A | |
dc.contributor.author | Alroughani, Raed | |
dc.contributor.author | Brassat, David | |
dc.contributor.author | Broadley, Simon | |
dc.contributor.author | Hartung, Hans-Peter | |
dc.contributor.author | Havrdova, Eva | |
dc.contributor.author | Kim, Ho Jin | |
dc.contributor.author | Oreja-Guevara, Celia | |
dc.contributor.author | Pozzilli, Carlo | |
dc.contributor.author | Selmaj, Krzysztof W | |
dc.contributor.author | Vermersch, Patrick | |
dc.contributor.author | Wray, Sibyl | |
dc.contributor.author | Margolin, David H | |
dc.contributor.author | Chung, Luke | |
dc.contributor.author | Daizadeh, Nadia | |
dc.contributor.author | Chirieac, Madalina | |
dc.contributor.author | Coles, Alasdair J | |
dc.date.accessioned | 2021-05-18T06:09:17Z | |
dc.date.available | 2021-05-18T06:09:17Z | |
dc.date.issued | 2018 | |
dc.identifier.issn | 0028-3878 | |
dc.identifier.uri | http://hdl.handle.net/10072/404487 | |
dc.description.abstract | Objective: Evaluate efficacy/safety of alemtuzumab over 7 years (y) in relapsing-remitting MS (RRMS) patients from CARE-MS II.
Background: In CARE-MS II (NCT00548405), alemtuzumab (12mg/day, baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 y in patients with inadequate response to prior therapy. Durable efficacy was observed in a 4-y extension (NCT00930553; 93% enrolled, 86% completed), in which patients could receive alemtuzumab retreatment as-needed for relapse/MRI activity or receive other disease-modifying therapies (DMTs) per investigator’s discretion. Patients completing the extension could enroll in TOPAZ (n=336), a 5-y study (NCT02255656), for further evaluation.
Design/Methods: In TOPAZ, patients can receive alemtuzumab retreatment (≥12 months apart) or other DMTs at any time (both per investigator’s discretion). MRI scans are performed annually. Assessments: annualized relapse rate (ARR); 6-month confirmed disability worsening (CDW); 6-month confirmed disability improvement (CDI); no evidence of disease activity (NEDA); AEs.
Results: 317 patients (94%) completed TOPAZ Y1 (Y7 after initiating alemtuzumab). ARR remained low (Y7: 0.14); 51% were relapse-free in Y3–7. The percentage of patients with stable/improved EDSS scores versus baseline remained high (Y7: 73%). At Y7, 69% were 6-month CDW-free, and 44% achieved 6-month CDI. The majority of patients achieved NEDA each year (Y7: 60%). 47% received no additional treatment (alemtuzumab or other DMT) after the initial 2 courses. Overall AE incidence, infusion-associated reactions, and infections decreased over time. Thyroid AE incidence peaked in Y3 (17%) and then declined.
Conclusions: Alemtuzumab efficacy was maintained for 7 y in CARE-MS II patients, despite 47% receiving no additional treatment since the initial 2 courses. 44% of patients also showed improvement in disability. Alemtuzumab safety profile remained consistent; overall AE incidence decreased over time. Alemtuzumab may provide a unique treatment approach for patients, offering durable efficacy in the absence of continuous treatment. | |
dc.language | English | |
dc.publisher | Lippincott Williams & Wilkins | |
dc.publisher.uri | https://n.neurology.org/content/90/15_Supplement/P6.369.abstract | |
dc.relation.ispartofconferencename | 70th Annual Meeting of the American Academy of Neurology (AAN) | |
dc.relation.ispartofconferencetitle | Neurology | |
dc.relation.ispartofdatefrom | 2018-04-21 | |
dc.relation.ispartofdateto | 2018-04-27 | |
dc.relation.ispartoflocation | Los Angeles, CA, USA | |
dc.relation.ispartofissue | 15 Supplement | |
dc.relation.ispartofvolume | 90 | |
dc.subject.fieldofresearch | Clinical sciences | |
dc.subject.fieldofresearch | Neurosciences | |
dc.subject.fieldofresearch | Cognitive and computational psychology | |
dc.subject.fieldofresearchcode | 3202 | |
dc.subject.fieldofresearchcode | 3209 | |
dc.subject.fieldofresearchcode | 5204 | |
dc.subject.keywords | Science & Technology | |
dc.subject.keywords | Life Sciences & Biomedicine | |
dc.subject.keywords | Clinical Neurology | |
dc.subject.keywords | Neurology | |
dc.title | Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study) | |
dc.type | Conference output | |
dc.type.description | E3 - Conferences (Extract Paper) | |
dcterms.bibliographicCitation | Singer, BA; Alroughani, R; Brassat, D; Broadley, S; Hartung, H-P; Havrdova, E; Kim, HJ; Oreja-Guevara, C; Pozzilli, C; Selmaj, KW; Vermersch, P; Wray, S; Margolin, DH; Chung, L; Daizadeh, N; Chirieac, M; Coles, AJ, Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study), Neurology, 2018, 90 | |
dc.date.updated | 2021-05-18T05:59:40Z | |
gro.hasfulltext | No Full Text | |
gro.griffith.author | Broadley, Simon | |