Open AccessClinical and biologic effects of anti–interleukin‐10 monoclonal antibody administration in systemic lupus erythematosus
Author(s) -
Llorente Luis,
RichaudPatin Yvonne,
GarcíaPadilla Carlos,
Claret Emmanuel,
JakezOcampo Juan,
Cardiel Mario H.,
AlcocerVarela Jorge,
GrangeotKeros Liliane,
AlarcónSegovia Donato,
Wijdenes John,
Galanaud Pierre,
Emilie Dominique
Publication year - 2000
Publication title -
arthritis & rheumatism
Language(s) - English
Resource type - Journals
eISSN - 1529-0131
pISSN - 0004-3591
DOI - 10.1002/1529-0131(200008)43:8<1790::aid-anr15>3.0.co;2-2
Subject(s) - medicine , prednisone , monoclonal antibody , immunology , antibody , pathogenesis , immune system , gastroenterology , autoimmune disease , connective tissue disease , monoclonal , interleukin , lupus erythematosus , systemic disease , immunopathology , cytokine
Objective To evaluate the safety and clinical efficacy of administering an anti–interleukin‐10 (anti–IL‐10) monoclonal antibody (mAb) to systemic lupus erythematosus (SLE) patients with active and steroid‐dependent disease. In addition, we sought to assess the effects of in vivo IL‐10 neutralization on biologic markers of SLE. Methods Treatment consisted of 20 mg/day intravenous administration of an anti–IL‐10 murine mAb (B‐N10) for 21 consecutive days, with a followup period of 6 months. Six patients were studied. Results Treatment was safe and well tolerated. All patients developed antibodies against B‐N10. Cutaneous lesions and joint symptoms improved in all patients beginning during B‐N10 administration and continuing to month 6. The SLE Disease Activity Index decreased from a mean ± SEM of 8.83 ± 0.91 on day 1 to 3.67 ± 0.67 on day 21 ( P = 0.001), 1.50 ± 0.84 at month 2, and 1.33 ± 0.80 at month 6 ( P < 0.001). At the end of followup, the disease was clinically inactive in 5 of the 6 patients. Prednisone administration was decreased from a mean ± SEM of 27.9 ± 5.7 mg/day on day 1 to 9.6 ± 2.0 mg/day at month 6 ( P < 0.005). Activity of immune and endothelial cells rapidly decreased, as assessed by the early evolution of several biologic markers. Conclusion This is the first report of IL‐10 antagonist administration to humans. The study shows the involvement of IL‐10 in the pathogenesis of SLE, and indicates that the use of IL‐10 antagonists may be beneficial in the management of refractory SLE.