Efficacy and safety of obinutuzumab in active lupus nephritis
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Fecha
2025
Autores
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.
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Editor
Massachusetts Medical Society
Resumen
Obinutuzumab, 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.
