Dana Horakova, MD, PhD; Aaron Boster, MD; Tjalf Ziemssen, MD; Antonio Bertolotto, MD; Susan Goelz; Isabel Firmino, MD; Steven Cavalier, MD, FAAN; Karthinathan Thangavelu, PhD; Mark Freedman, MD, FAAN Patients Who Received Alemtuzumab in CARE-MS I or II Show a Low Rate of Conversion From Relapsing-Remitting MS to
Secondary Progressive MS Through 6 Years
Objective: To determine the rate of conversion from relapsing-remitting MS (RRMS) to secondary progressive MS
(SPMS) through 6 years among CARE-MS I and II alemtuzumab-treated patients.
Background: Delaying conversion to
SPMS is an important treatment goal in MS. In an MSBase patient cohort (17,356 MS patients; median baseline disease
duration 3.8 years; median 5.8-year follow-up), 18% of all patients converted to SPMS using a recently developed SPMS
definition based on EDSS scores and relapses. In the CARE-MS studies, EDSS scores were stable/improved with
alemtuzumab over 6 years in >75% of patients with active RRMS who were treatment-naive (CARE-MS I; NCT00530348)
or had inadequate response (≥1 relapse) to prior therapy (CARE-MS II; NCT00548405), in the absence of continuous
treatment (extension study: NCT00930553). Design/Methods: Patients with active RRMS received 2 courses of
alemtuzumab 12 mg (baseline: 5 consecutive days; 12 months later: 3 consecutive days) in CARE-MS I or II, and in the
extension as-needed alemtuzumab for relapse or MRI activity, or another disease-modifying therapy (DMT) per
investigator discretion. The definition of SPMS onset was as published by Lorscheider et al. (Brain 2016;139:2395-405).
Results: Median disease duration at baseline was 1.7 years in CARE-MS I and 3.8 years in CARE-MS II (2.8 pooled).
325/376 (86%) and 344/435 (79%) alemtuzumab-treated patients, respectively, remained on study through Year 6
(669/811 [82%] pooled). Many patients (CARE-MS I: 63%; CARE-MS II: 50%) received no additional treatment in the
extension (either alemtuzumab or other DMT).
Among alemtuzumab-treated CARE-MS I or II patients, the SPMS
definition was met by 4 (1.1%) and 16 (3.7%) patients, respectively, through 6 years (20 [2.5%] pooled).
Utilizing an objective definition of SPMS based on the EDSS and relapse data, a very low proportion of alemtuzumab treated
patients from the CARE-MS studies progressed to SPMS.
Study Supported By:
Sanofi and Bayer HealthCare Pharmaceuticals.
This week its AAN (American Academy of Neurology) Week Prof G and NDG are in Sunny Boston, to learn the latest info in Neurology. If you have been through the abstracts and if something catches your eye, then let us know.
I've pulled out a few an maybe NDG will do a summary.
Anyway, you ask what is the long-term effect for alemtuzumab
So 6 + 1.7 years from CARE-MS I (no previous DMT) into MS 4 people had converted to SPMS and 6 + 3.8 years into MS 16 people in CARE-MS II (Previous use of beta interferon/Copaxone) had converted. Notably 63% in CMS1 and 50% in CMS2 did not get further treatment. As NEDA rates were below 45% in the trials, I guess some of the failures were lost in the 18% of people lost to follow up.
So if NDG does to the poster (Take a copy of the poster for me or send the IQ code)
So the quesion we want to know what would be the convertion rate in the modern era that low, I doubt it.
Were the people developing SPSS those people requiring extra doses?
Labels: AAN2017, Alemtuzumab