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


CONCLUSIONS
Rituximab can be an effective treatment option for patients who have refractory lupus with severe or life-threatening disease with an acceptable tolerance profile.
Rheumatology Service, Hospital Regional Universitario Carlos Haya, Spain. afnebro@gmail.com
A
A
Fernández-Nebro
J L Marenco
JL
de la Fuente
L
L
Carreño
M Galindo
MG
Izquierdo
E
E
Tomero
I
I
Rúa-Figueroa
B E
BE
Hernández-Cruz
J
J
Narváez
E
E
Ucar
A
A
Olivé
A
A
Zea
M
M
Fernández-Castro
E
E
Raya-Álvarez
J M
JM
Pego-Reigosa
M
M
Freire
V M
VM
Martínez-Taboada
J
J
Pérez-Venegas
A I
AI
Sánchez-Atrio
I
I
Villa-Blanco
S
S
Manrique-Arija
F J
FJ
López-Longo
P E
PE
Carreira
R
R
Martínez-Pérez
R
R
García-Vicuña
D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001402:B-Lymphocytes / Q000276:immunology*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008137:Longitudinal Studies; D008180:Lupus Erythematosus, Systemic / Q000276:immunology* / Q000628:therapy*; D008212:Lymphocyte Depletion / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069283:Rituximab; D016896:Treatment Outcome
D058846:Antibodies, Monoclonal, Murine-Derived; D007166:Immunosuppressive Agents; D000069283:Rituximab