Furie, R.A.Rovin, B.H.Garg, J.P.Santiago, M.B.Aroca Martínez, G.Zuta Santillán, A.E.Álvarez, D.Navarro Sandoval, C.Lila, A.M.Tumlin, J.A.Saxena, A.Irazoque Palazuelos, F.Raghu, H.Yoo, B.Hassan, I.Martins, E.Sehgal, H.Kirchner, P.Ross Terres, J.Omachi, T.A.Schindler, T.Pendergraft, W.F.Malvar, A.2025-02-102025-02-10202500284793 (Impreso)15334406 (Electrónico)https://hdl.handle.net/20.500.12442/16252Obinutuzumab, 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.pdfengAttribution-NonCommercial-NoDerivs 3.0 United Statesinfo:eu-repo/semantics/closedAccessinfo:eu-repo/semantics/articleDOI: 10.1056/NEJMoa2410965https://www.nejm.org/doi/full/10.1056/NEJMoa2410965