{
  "abstract": "Objectives Obinutuzumab (OBZ), a humanized type II anti-CD20 monoclonal antibody, has proved effective in lupus nephritis (LN) in randomized clinical trials, when adding to standard therapy. Despite OBZ is still not approved to be used in LN, the availability for other indications is paving its use in patients who are refractory LN. We present preliminary real-world data on its off-label use in refractory LN.Methods Patients fulfilling EULAR-2019 SLE classification criteria with biopsy-proven, refractory LN were included. All of them were treated of-label with OBZ and were follow up for at least 3 months. Clinical, serological characteristics as well as concomitant treatments were collected. Efficacy was assessed using EULAR response criteria and complete renal response (CRR). Adverse effects, with special focus on serious infection were recorded.Results Five female patients were included (mean age 49.1 ± 11.3 years). Four had proliferative LN (class III or IV) and one had membranous LN (class V). Median duration of LN: 33.5 (29.2-47.6) months. Median follow up: 7.8 (6.7-10) months.Median baseline SLEDAI-2k: 22 (p25-p50)(12-24); SLICC/ACR/DI: 1 (1-2); Previous therapy: all of them had received mycophenolate mophetil or equivalent (MMF/Na) and 4/5 two or more immunosuppressant; 3/5 rituximab and 4/5 belimumab. Concomitant therapy: 5/5 hydroxychloroquine, 4/5 MMF/Na, 5/5 prednisone (mean baseline dose 15 mg/day (10-15). All of them also received antiproteinuric drugs.A dramatic reduction of proteinuria was noted after starting OBZ, from a mean of 2.2 g/24h at baseline to 1.18 g/24h at 3 months and 0.35 g/24h at 6 months. Serum creatinine remained stable or improved. All of the patients reached EULAR objetives at 3 and 6 months. CRR was achieved in 2/5 at 3 months and in 3/3 at 6 months. Improvements in SLEDAI-2k, proteinuria, GFR, anti-DNA, complements and prednisone dosages are displayed in figure 1. Two serious infection were reported as well as a non-severe herpes zoster. No other significant adverse events were reported.Abstract PO:11:282 Figure 1Conclusions - Preliminary real word data suggest a rapid and remarkable efficacy of OBZ in refractory LN, including post-rituximab failure.- Infection risk warrants close monitoring.",
  "authors": [
    {
      "affiliations": [
        "University Hospital of Gran Canaria Doctor Negrin, Las Palmas GC, Spain"
      ],
      "name": "Iñigo Rua-Figueroa"
    },
    {
      "affiliations": [
        "La Paz University Hospital, Madrid, Spain"
      ],
      "name": "Angel Robles"
    },
    {
      "affiliations": [
        "Bellvitge University Hospital, Barcelona, Spain"
      ],
      "name": "Paola Vidal"
    },
    {
      "affiliations": [
        "General Hospital of Valencia, Valencia, Spain"
      ],
      "name": "Jorge Juan Fragío Gil"
    },
    {
      "affiliations": [
        "Research Unit of the University Hospital of Gran Canaria Doctor Negrin, Las Palmas GC, Spain"
      ],
      "name": "Jesús González-Martín"
    },
    {
      "affiliations": [
        "Infanta Leonor University Hospital, Madrid, Spain"
      ],
      "name": "Ana Pareja"
    }
  ],
  "title": "PO:11:282 Remarkable efficacy of obinutuzumab in refractory lupus nephritis: preliminary, real world data from a multicenter register",
  "uid": "056a6615-eddf-5760-a95f-720e9433dc1f"
}