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Endopeptidase Cleavage of Anti-Glomerular Basement Membrane Antibodies in vivo in Severe Kidney Disease : An Open-Label Phase 2a Study

Uhlin, Fredrik (författare)
Linköpings universitet,Linköping University,Tallinn University of Technology,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US,Tallinn Univ Technol, Estonia
Szpirt, Wladimir (författare)
Univ Copenhagen, Dept Nephrol P, Copenhagen, Denmark,University of Copenhagen
Kronbichler, Andreas (författare)
Med Univ Innsbruck, Dept Internal Med Nephrol & Hypertensi 4, Innsbruck, Austria,Medical University of Innsbruck
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Bruchfeld, Annette (författare)
Karolinska Institutet,Linköpings universitet,Linköping University,Karolinska University Hospital,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US,Karolinska Univ Hosp, Sweden; CLINTEC Karolinska Inst, Sweden
Soveri, Inga (författare)
Uppsala University,Uppsala universitet,Njurmedicin,Uppsala Univ, Sweden
Rostaing, Lionel (författare)
EriCHU Grenoble Alpes, Dept Nephrol Hemodialysis Apheresis & Kidney Tran, Grenoble, France
Daugas, Eric (författare)
Univ Paris, Hop Bichat, Nephrol Serv, Paris, France,Paris Diderot University
Lionet, Arnaud (författare)
Lille Univ, Ctr Hosp Reg, Neohrol Serv, Lille, France,University of Lille
Kamar, Nassim (författare)
Univ Paul Sabatier, Dept Nephrol & Organ Transplantat, Toulouse, France,Université Paul Sabatier
Rafat, Cedric (författare)
Urgences Nephrolog & Transplantat Renale, Paris, France
Myslivecek, Marek (författare)
Charles Univ Prague, Dept Nephrol, Prague, Czech Republic.;Gen Univ Hosp, Dept Nephrol, Prague, Czech Republic,General University Hospital in Prague
Tesar, Vladimir (författare)
Charles Univ Prague, Dept Nephrol, Prague, Czech Republic.;Gen Univ Hosp, Dept Nephrol, Prague, Czech Republic,General University Hospital in Prague
Fernström, Anders, 1958- (författare)
Linköpings universitet,Linköping University,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US
Kjellman, Christian (författare)
Hansa Biopharma, Lund, Sweden
Elfving, Charlotte (författare)
Hansa Biopharma, Lund, Sweden
McAdoo, Stephen (författare)
Imperial Coll London, Dept Med, London, England,Imperial College London
Molne, Johan (författare)
University of Gothenburg,Univ Gothenburg, Sweden
Bajema, Ingeborg (författare)
Leiden Univ, Med Ctr, Dept Pathol, Leiden, Netherlands,Leiden University Medical Centre
Sonesson, Elisabeth (författare)
Hansa Biopharma, Lund, Sweden
Segelmark, Marten (författare)
Linköpings universitet,Linköping University,Lund University,Lunds universitet,Njurmedicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Nephrology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Avdelningen för diagnostik och specialistmedicin,Region Östergötland, Njurmedicinska kliniken US,Lund Univ, Sweden
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 (creator_code:org_t)
AMER SOC NEPHROLOGY, 2022
2022
Engelska.
Ingår i: Journal of the American Society of Nephrology. - : AMER SOC NEPHROLOGY. - 1046-6673 .- 1533-3450. ; 33:4, s. 829-838
Relaterad länk:
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http://dx.doi.org/10...
https://urn.kb.se/re...
https://doi.org/10.1...
https://lup.lub.lu.s...
https://urn.kb.se/re...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background The prognosis for kidney survival is poor in patients presenting with circulating anti-glomerular basement membrane (GBM) antibodies and severe kidney injury. It is unknown if treat-ment with an endopeptidase that cleaves circulating and kidney bound IgG can alter the prognosis.& nbsp;Methods An investigator-driven phase 2a one-arm study (EudraCT 2016-004082-39) was performed in 17 hospitals in five European countries. A single dose of 0.25 mg/kg of imlifidase was given to 15 adults with circulating anti-GBM antibodies and an eGFR < 15 ml/min per 1.73m(2). All patients received standard treatment with cyclophosphamide and corticosteroids, but plasma exchange only if autoantibodies rebounded. The primary outcomes were safety and dialysis independency at 6 months.& nbsp;Results At inclusion, ten patients were dialysis dependent and the other five had eGFR levels between 7 and 14 ml/min per 1.73m(2). The median age was 61 years (range 19-77), six were women, and six were also positive for anti-neutrophil cytoplasmic antibodies. Then 6 hours after imlifidase infusion, all patients had anti-GBM antibodies levels below the reference range of a prespecified assay. At 6 months 67% (ten out of 15) were dialysis independent. This is significantly higher compared with 18% (nine out of 50) in a historical control cohort (P < 0.001, Fisher's exact test). Eight serious adverse events (including one death) were reported, none assessed as probably or possibly related to the study drug.& nbsp;Conclusions In this pilot study, the use of imlifidase was associated with a better outcome compared with earlier publications, without major safety issues, but the findings need to be confirmed in a randomized controlled trial.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)

Nyckelord

anti-GBM disease
endopeptidases
clinical trial
glomerulonephritis
Goodpasture syndrome

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