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  • Legendre, C. M. (author)

Terminal Complement Inhibitor Eculizumab in Atypical Hemolytic-Uremic Syndrome

  • Article/chapterEnglish2013

Publisher, publication year, extent ...

  • 2013
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:7c05d973-6f33-4d20-8559-2aa0701cc0bc
  • https://lup.lub.lu.se/record/3921110URI
  • https://doi.org/10.1056/NEJMoa1208981DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:127002132URI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • Background Atypical hemolytic-uremic syndrome is a genetic, life-threatening, chronic disease of complement-mediated thrombotic microangiopathy. Plasma exchange or infusion may transiently maintain normal levels of hematologic measures but does not treat the underlying systemic disease. Methods We conducted two prospective phase 2 trials in which patients with atypical hemolytic-uremic syndrome who were 12 years of age or older received eculizumab for 26 weeks and during long-term extension phases. Patients with low platelet counts and renal damage (in trial 1) and those with renal damage but no decrease in the platelet count of more than 25% for at least 8 weeks during plasma exchange or infusion (in trial 2) were recruited. The primary end points included a change in the platelet count (in trial 1) and thrombotic microangiopathy event-free status (no decrease in the platelet count of >25%, no plasma exchange or infusion, and no initiation of dialysis) (in trial 2). Results A total of 37 patients (17 in trial 1 and 20 in trial 2) received eculizumab for a median of 64 and 62 weeks, respectively. Eculizumab resulted in increases in the platelet count; in trial 1, the mean increase in the count from baseline to week 26 was 73x10(9) per liter (P<0.001). In trial 2, 80% of the patients had thrombotic microangiopathy event-free status. Eculizumab was associated with significant improvement in all secondary end points, with continuous, time-dependent increases in the estimated glomerular filtration rate (GFR). In trial 1, dialysis was discontinued in 4 of 5 patients. Earlier intervention with eculizumab was associated with significantly greater improvement in the estimated GFR. Eculizumab was also associated with improvement in health-related quality of life. No cumulative toxicity of therapy or serious infection-related adverse events, including meningococcal infections, were observed through the extension period. Conclusions Eculizumab inhibited complement-mediated thrombotic microangiopathy and was associated with significant time-dependent improvement in renal function in patients with atypical hemolytic-uremic syndrome.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Licht, C. (author)
  • Muus, P. (author)
  • Greenbaum, L. A. (author)
  • Babu, S. (author)
  • Bedrosian, C. (author)
  • Bingham, C. (author)
  • Cohen, D. J. (author)
  • Delmas, Y. (author)
  • Douglas, K. (author)
  • Eitner, F. (author)
  • Feldkamp, T. (author)
  • Fouque, D. (author)
  • Furman, R. R. (author)
  • Gaber, O. (author)
  • Herthelius, M.Karolinska Institutet (author)
  • Hourmant, M. (author)
  • Karpman, DianaLund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Pediatrisk nefrologi,Forskargrupper vid Lunds universitet,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Pediatric Nephrology,Lund University Research Groups(Swepub:lu)pedi-dka (author)
  • Lebranchu, Y. (author)
  • Mariat, C. (author)
  • Menne, J. (author)
  • Moulin, B. (author)
  • Nuernberger, J. (author)
  • Ogawa, M. (author)
  • Remuzzi, G. (author)
  • Richard, T. (author)
  • Sberro-Soussan, R. (author)
  • Severino, B. (author)
  • Sheerin, N. S. (author)
  • Trivelli, A. (author)
  • Zimmerhackl, L. B. (author)
  • Goodship, T. (author)
  • Loirat, C. (author)
  • Karolinska InstitutetPediatrik, Lund (creator_code:org_t)

Related titles

  • In:New England Journal of Medicine368:23, s. 2169-21810028-47931533-4406

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