Evidence map›Paper›PMID 35365179›Full record

Trial reportArthritis research & therapy2022

Alemtuzumab for refractory primary systemic vasculitis-a randomised controlled dose ranging clinical trial of efficacy and safety (ALEVIATE).

Seerapani Gopaluni, Rona Smith, Donna Goymer, Hugh Cahill, Elizabeth Broadhurst, Elizabeth Wallin, Mark McClure, Afzal Chaudhry, David Jayne

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01405807 (Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT01405807 phase4unknown statusnot on this map

Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy

TypeinterventionalSponsorCambridge University Hospitals NHS Foundation TrustRan2011 to 2014Enrolled24ConditionsVasculitis, Microscopic Polyangiitis, Granulomatosis With Polyangiitis, Wegener'sArmsAlemtuzumab
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. [Diagnosis and treatment of ANCA-associated vasculitis : SHORT VERSION of the S3 guideline of the German Society for Rheumatology and Clinical Immunology e. V. (DGRh) and German Society for Internal Medicine e. V. (DGIM), German Society for Nephrology e. V. (DGfN), German Society for Otorhinolaryngology and Head and Neck Surgery e. V. (DGHNO-KHC), German Ophthalmological Society e. V. (DOG), German Society for Neurology e. V. (DGN), German Society for Pneumology and Respiratory Medicine e. V. (DGP), German Society for Pathology e. V. (DGP), German Radiological Society, Society for Medical Radiology e. V. (DRG), Federal Association of German Pathologists, Federal Kidney Association e. V., German Rheumatism League Federal Association e. V.]Zeitschrift fur Rheumatologie · 2025
    Guideline
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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

9 authors at 2 institutions in 1 country.

Seerapani GopaluniUniversity of Cambridge, Box 118, Addenbrooke's Hospital, Hills Road, Cambridge, CB20QQ, UK. drpanigopaluni@gmail.com.
Rona SmithUniversity of Cambridge, Box 118, Addenbrooke's Hospital, Hills Road, Cambridge, CB20QQ, UK.
Donna GoymerCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Hugh CahillCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Elizabeth BroadhurstCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Elizabeth WallinCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Mark McClureUniversity of Cambridge, Box 118, Addenbrooke's Hospital, Hills Road, Cambridge, CB20QQ, UK.
Afzal ChaudhryCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
David JayneUniversity of Cambridge, Box 118, Addenbrooke's Hospital, Hills Road, Cambridge, CB20QQ, UK.
Cambridge University Hospitals NHS Foundation Trust · GBAddenbrooke's Hospital · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundPrimary systemic vasculitis (PSV) is a heterogeneous group of autoimmune conditions. There is an unmet need for alternative therapies that lead to sustained remission in patients with refractory disease. Alemtuzumab, an anti-CD52 antibody, depletes lymphocytes for prolonged periods and, in retrospective studies, has induced sustained, treatment-free remissions in patients with refractory/relapsing vasculitis but has raised safety concerns of infection and secondary autoimmunity. This phase IIb clinical trial aimed to assess the efficacy and safety of alemtuzumab, at two different doses, in inducing remission in refractory vasculitis patients.

methodsThe ALEVIATE trial was a randomised, prospective, open-label, dose ranging clinical trial. Patients with refractory ANCA-associated vasculitis (AAV) or Behçet's disease (BD) were randomised to receive either 60 mg or 30 mg alemtuzumab. Treatments were administered at baseline and 6 months or earlier where clinically appropriate. A maximum of three treatments were allowed within the 12-month study period.

resultsTwenty-three patients received at least one dose of alemtuzumab. Twelve had AAV, and 11 a diagnosis of BD. The median age was 40 years (range 28-44), with a prior disease duration of 61 months (42-103). Sixteen (70%) achieved either complete (6/23, 26%) or partial (10/23, 44%) response at 6 months. Eight (35%) maintained remission to the end of the trial without relapse. Ten severe adverse events were observed in 7 (30%) patients; 4 were related to alemtuzumab. There were no differences in clinical endpoints between the 60 and 30 mg alemtuzumab treatment groups.

conclusionIn a selected group of refractory vasculitis patients, alemtuzumab led to remission in two thirds of patients at 6 months. Remission was maintained to 12 months in a third of the patients, and the safety profile was acceptable.

trial registrationClinicalTrials.gov identifier: NCT01405807, EudraCT Number: 2009-017087-17. Registered on April 07, 2011.

Indexed as

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAdultAlemtuzumabHumansProspective StudiesRemission InductionRetrospective StudiesTreatment OutcomeAlemtuzumabAlemtuzumabANCABehçet’s diseaseClinical trialLymphocytesT cellsVasculitis

Identifiers

PMID35365179
PMCPMC8972754
OpenAlexW4220683627

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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.