Pediatric Rheumatology Online Journal → July 2003 → Childhood Lupus→ Treatment → Abstract #105

TREATMENT OF PEDIATRIC SYSTEMIC LUPUS ERYTHEMATOSUS WITH TACROLIMUS

S. C. Li,¹ Y. Kimura,¹ L. Ebner-Lyons,¹ K. Lieberman.¹

¹Pediatrics, Hackensack University Medical Center, Hackensack, NJ

INTRODUCTION: Various immunosuppressive therapies have been used to treat patients with SLE. Cyclophosphamide (CYC)has been beneficial in the treatment of lupus nephritis and other SLE symptoms, but is associated with many potentially serious complications. Newer immunosuppressants include mycophenolate mofetil(MMF) and tacrolimus (FK506). Some patients appear to respond well to treatment with MMF, but others develop an adverse reaction or continue to have active disease on MMF. For these poorly responsive SLE patients, we have added FK506 to their regimens as an added immunosuppressive agent.
AIM: Our aim was to analyze the safety and efficacy of tacrolimus in this subset of pediatric SLE patients.
RESULTS: Tacrolimus, at doses ranging from 0.05-0.16 mg/kg/d, was used in combination with azathioprine and prednisone (1 pt), or MMF and prednisone (3 pts). Patients were treated for a mean of 9.7 months (range 6-14 mo). Indications for the addition of FK506 included active lupus nephritis and vasculitic skin lesions. All four pts had been previously treated with MMF (26-50 mg/kg/d) and prednisone (0.5-3.0 mg/kg/d) for a mean duration of 10 mo (range 0.4 to 19.5 mo). Two pts discontinued MMF treatment because of severe GI symptoms. Three pts had been treated with CYC (dose 6.1-19.6 g, over 12-33 mo). CYC treatment was discontinued because of limited efficacy, an adverse reaction, or concern about the effect of their cumulative CYC dose. Two pts treated with FK506 showed a reduction in SLEDAI (mean 45%), prednisone dose (mean 44%), and U_P/C (mean 90%) within 6 mo. Another pt showed a reduction in SLEDAI (30%), physician global assessment of disease activity (40%), and hematuria (55%), but required an increase in her prednisone dose (230%). There have been no serious infections, and creatinine levels and blood pressures have remained stable. One pt had hyperglycemia and hyperkalemia that responded to dose reduction of FK506.
CONCLUSION: Our data suggest that tacrolimus may be useful for long-term disease management in some pediatric patients with SLE.