Multicenter longitudinal study of B-lymphocyte depletion in refractory systemic lupus erythematosus: the LESIMAB study

• Published in: Lupus Vol. 21; no. 10; pp. 1063 - 1076
• Main Authors: Fernández-Nebro, A, de la Fuente, JL Marenco, Carreño, L, Izquierdo, M Galindo, Tomero, E, Rúa-Figueroa, I, Hernández-Cruz, BE, Narváez, J, Úcar, E, Olivé, A, Zea, A, Fernández-Castro, M, Raya-Álvarez, E, Pego-Reigosa, JM, Freire, M, Martínez-Taboada, VM, Pérez-Venegas, J, Sánchez-Atrio, AI, Villa-Blanco, I, Manrique-Arija, S, López-Longo, FJ, Carreira, PE, Martínez-Pérez, R, García-Vicuña, R
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.09.2012; Sage Publications Ltd
• Subjects: Adult; Antibodies, Monoclonal, Murine-Derived - administration & dosage; Antibodies, Monoclonal, Murine-Derived - adverse effects; Antibodies, Monoclonal, Murine-Derived - therapeutic use; B-Lymphocytes - immunology; Disease; Female; Humans; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Infection; Infections; Longitudinal Studies; Lupus; Lupus Erythematosus, Systemic - immunology; Lupus Erythematosus, Systemic - therapy; Lymphocyte Depletion - adverse effects; Lymphocyte Depletion - methods; Lymphocytes; Lymphocytes B; Male; Medical prognosis; Middle Aged; Prednisone; Retrospective Studies; Rheumatology; Rituximab; Steroids; Systemic lupus erythematosus; Treatment Outcome; Spain; infection; effectiveness treatment; Systematic lupus erythematosus; safety; biological therapy; rituximab
• ISSN: 0961-2033; 1477-0962
• DOI: 10.1177/0961203312446627

Objective: This study aimed to investigate the effectiveness and safety of single and repeated courses of rituximab in patients with refractory lupus. Methods: LESIMAB is a multicenter, retrospective, longitudinal study of lupus patients who have not responded to standard therapy and have been treated with rituximab. Response rates at six months and at follow-up were defined as efficacy outcomes. Complete response was defined as a SELENA-SLEDAI score ≤ two and a SELENA-SLEDAI Flare Index of zero. Partial response was defined as a reduction in the SELENA-SLEDAI score of ≥four points with no new or worsening of symptoms. Adverse events were collected. Results: Seventy-three (62.9%) of 116 patients achieved a response at six months (complete in 22 and partial in 51). Ninety-seven (77.6%) of 128 patients achieved a response after a mean follow-up of 20.0 ± 15.2 months (complete in 50 and partial in 47). High baseline SLEDAI score, previous treatment with ≥100 mg/day prednisone, and no history of severe hematologic flare were associated with response after the first treatment course. The median time to response was 6.5 months (95% CI, 5.0–8.0). Thirty-seven patients (38.1%) relapsed after the first infusion. The flare was severe in seven cases and mild to moderate in 29 cases. Serious infection rate was 12.6/100 patient-years. A schedule of four weekly doses was associated with more serious infections. Six patients died: two of infection and four of lupus complications. Conclusion: Rituximab can be an effective treatment option for patients who have refractory lupus with severe or life-threatening disease with an acceptable tolerance profile.