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Efficacy and safety of obinutuzumab in active lupus nephritis

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dc.contributor.authorFurie, R.A.
dc.contributor.authorRovin, B.H.
dc.contributor.authorGarg, J.P.
dc.contributor.authorSantiago, M.B.
dc.contributor.authorAroca Martínez, G.
dc.contributor.authorZuta Santillán, A.E.
dc.contributor.authorÁlvarez, D.
dc.contributor.authorNavarro Sandoval, C.
dc.contributor.authorLila, A.M.
dc.contributor.authorTumlin, J.A.
dc.contributor.authorSaxena, A.
dc.contributor.authorIrazoque Palazuelos, F.
dc.contributor.authorRaghu, H.
dc.contributor.authorYoo, B.
dc.contributor.authorHassan, I.
dc.contributor.authorMartins, E.
dc.contributor.authorSehgal, H.
dc.contributor.authorKirchner, P.
dc.contributor.authorRoss Terres, J.
dc.contributor.authorOmachi, T.A.
dc.contributor.authorSchindler, T.
dc.contributor.authorPendergraft, W.F.
dc.contributor.authorMalvar, A.
dc.date.accessioned2025-02-10T19:26:03Z
dc.date.available2025-02-10T19:26:03Z
dc.date.issued2025
dc.description.abstractObinutuzumab, a humanized type II anti-CD20 monoclonal antibody, provided sig nificantly better renal responses than placebo in a phase 2 trial involving patients with lupus nephritis receiving standard therapy. METHODS In a phase 3, randomized, controlled trial, we assigned adults with biopsy-proven active lupus nephritis in a 1:1 ratio to receive obinutuzumab in one of two dose schedules (1000 mg on day 1 and at weeks 2, 24, 26, and 52, with or without a dose at week 50) or placebo. All patients received standard therapy with mycophen olate mofetil, along with oral prednisone at a target dose of 7.5 mg per day by week 12 and 5 mg per day by week 24. The primary end point was a complete renal response at week 76, defined by a urinary protein-to-creatinine ratio of less than 0.5 (with protein and creatinine both measured in milligrams), an estimated glo merular filtration rate of at least 85% of the baseline value, and no intercurrent event (i.e., rescue therapy, treatment failure, death, or early trial withdrawal). Key secondary end points at week 76 included a complete renal response with a pred nisone dose of 7.5 mg per day or lower between weeks 64 and 76 and a urinary protein-to-creatinine ratio lower than 0.8 without an intercurrent event.eng
dc.format.mimetypepdf
dc.identifier.doiDOI: 10.1056/NEJMoa2410965
dc.identifier.issn00284793 (Impreso)
dc.identifier.issn15334406 (Electrónico)
dc.identifier.urihttps://hdl.handle.net/20.500.12442/16252
dc.identifier.urlhttps://www.nejm.org/doi/full/10.1056/NEJMoa2410965
dc.language.isoeng
dc.publisherMassachusetts Medical Societyeng
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United Stateseng
dc.rights.accessrightsinfo:eu-repo/semantics/closedAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/
dc.sourceThe New England Journal of Medicine (NEJM)eng
dc.sourceN Engl J Medeng
dc.sourceVol. 392,  No. 6 (2025)spa
dc.titleEfficacy and safety of obinutuzumab in active lupus nephritiseng
dc.type.driverinfo:eu-repo/semantics/article
dc.type.spaArtículo científico
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