Evidence map›Paper›PMID 31654272›Full record

ArticleNeurology and therapy2019

Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study).

Annette F Okai, Lilyana Amezcua, Regina R Berkovich, Angel R Chinea, Keith R Edwards, Brian Steingo, Aljoeson Walker, Alan K Jacobs, Nadia Daizadeh, Mitzi J Williams and 1 more

5 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00530348 phase3completednot on this map

A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2007 to 2011Enrolled581ConditionsMultiple Sclerosis, Relapsing-RemittingArmsAlemtuzumab, Interferon beta-1a
NCT00548405 phase3completednot on this map

A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2007 to 2011Enrolled840ConditionsMultiple Sclerosis, Relapsing-RemittingArmsAlemtuzumab 12 mg, Alemtuzumab 24 mg, Interferon beta-1a
NCT00930553 phase3completednot on this map

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2009 to 2016Enrolled1,314ConditionsMultiple Sclerosis, Relapsing-RemittingArmsalemtuzumab
NCT02255656 phase4completednot on this map

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2015 to 2020Enrolled1,062ConditionsRelapsing Remitting Multiple SclerosisArmsalemtuzumab GZ402673
NCT04550455 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets

TypeinterventionalSponsorKeith Edwards, M.D.Ran2020 to 2025Enrolled30ConditionsMultiple SclerosisArmsCladribine Tablets
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Annette F OkaiMultiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA. afokai@gmail.com.
Lilyana AmezcuaKeck School of Medicine of University of Southern California, Los Angeles, CA, USA.
Regina R BerkovichKeck School of Medicine of University of Southern California, Los Angeles, CA, USA.
Angel R ChineaSan Juan Multiple Sclerosis Center, Guaynabo, PR, USA.
Keith R EdwardsMS Center of Northeastern New York, Latham, NY, USA.
Brian SteingoFort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA.
Aljoeson WalkerMedical University of South Carolina, Charleston, SC, USA.
Alan K JacobsSanofi, Cambridge, MA, USA.
Nadia DaizadehSanofi, Cambridge, MA, USA.
Mitzi J WilliamsMultiple Sclerosis Center of Atlanta, Mableton, GA, USA.
CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators
Multiple Sclerosis Center of Atlanta · USSanofi (United States) · USUniversity of Southern California · USMedical University of South Carolina · USMultiple Sclerosis Center Of Northeastern New York · USMultiple Sclerosis Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultiple sclerosis (MS) patients of African descent have increased risk for disease progression and may be less responsive to disease-modifying therapy.

methodsPatients in the CARE-MS studies received alemtuzumab 12 mg/day [initial alemtuzumab treatment (IAT); baseline: 5 days; 12 months later: 3 days] or subcutaneous interferon beta-1a (SC IFNB-1a) 3 ×/week. Core study outcomes were compared between treatment groups. In the extension study CAMMS03409, SC IFNB-1a-treated patients switched to alemtuzumab [delayed alemtuzumab treatment (DAT)]. Data from IAT and DAT arms were pooled to assess outcomes through 6 years post alemtuzumab initiation; IAT patients had an additional 2 years of follow-up in TOPAZ.

resultsOf 1200 CARE-MS patients, 43 (4%) were of African descent (35 IAT; 8 DAT) and received alemtuzumab in the 2-year core and/or 6-year extension; 29 (67%) remained on study at the time of analysis (24 IAT patients completed year 8 post alemtuzumab; 5 DAT patients completed year 6 post alemtuzumab). In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a. Alemtuzumab remained efficacious at year 6 (pooled IAT/DAT) and at year 8 (IAT only) post alemtuzumab (ARR: 0.15 and 0.30; improved EDSS: 17% and 25%; CDI: 47% and 55%; BVL: - 1.14% and - 0.70%, respectively). No safety signals were unique to this population.

conclusionsAlemtuzumab was efficacious in a small cohort of relapsing-remitting MS patients of African descent over 8 years. Safety was consistent with the overall CARE-MS population, although the small sample size may have prevented the detection of known low-frequency adverse events. CLINICALTRIALS. GOV REGISTRATION NUMBERS: CARE-MS I, II, extension, TOPAZ: NCT00530348, NCT00548405, NCT00930553, NCT02255656.

fundingSanofi (Cambridge, MA, USA) and Bayer HealthCare Pharmaceuticals (Leverkusen, Germany).

Indexed as

African descentAlemtuzumabDisease-modifying therapyMultiple sclerosis

Identifiers

PMID31654272
PMCPMC6858901
OpenAlexW2981781094

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.