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      Successful use of intravenous immunoglobulin in the treatment of resistant lupus nephritis Translated title: Imunoglobulina intravenosa eficaz no tratamento de nefrite lúpica resistente

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          Abstract

          Background: Renal involvement in systemic lupus erythematosus is a major factor of morbidity/mortality and a significant prognostic determinant. Despite the high rates of remission with current immunosuppressive therapies, management of refractory lupus nephritis is still cumbersome. In these cases, intravenous immunoglobulin may be a suitable option, regardless of the scarcity of experience with long-term use. Case report: We present the case of a 35-year-old female with a diagnosis of systemic lupus erythematosus since 1999, at the age of 23. In 2002, due to a nephrotic syndrome, a kidney biopsy was performed, which revealed WHO class IV lupus nephritis. She underwent immunosuppression with prednisolone and cyclophosphamide, with subsequent conversion to azathioprine. Proteinuria decreased to subnephrotic levels. In 2005, a nephrotic syndrome relapse occurred and kidney biopsy was repeated, with a similar result. After conversion from azathioprine to mycophenolate mofetil, proteinuria decreased to subnephrotic levels. At the end of 2006, a nephrotic syndrome relapse accompanied by arthralgia, azotaemia, leukopaenia and anaemia led to a third biopsy. The diagnosis was again the same, with no sclerotic lesions. Intravenous immunoglobulin was initiated in a protocol of monthly courses of 400mg/Kg/day during 5 consecutive days, maintaining prednisolone and mycophenolate mofetil. She achieved partial and complete remission after the third and tenth courses, respectively. The treatment scheme of immunoglobulin became quarterly from the second year until today. In 2010, she became pregnant and mycophenolic acid was replaced by azathioprine.In the last trimester of pregnancy proteinuria worsened, thus delivery was induced at the 32nd week. Nowadays the patient is in complete remission of nephritis, without extrarenal manifestations of lupus and no adverse effects of intravenous immunoglobulin. Conclusion: Intravenous immunoglobulin has been effectively used in a broad spectrum of lupus manifestations. As this case illustrates, it may be an option in the treatment of lupus nephritis resistant to conventional immunosuppressive therapy. Its long-term use appears to be safe.

          Translated abstract

          Introdução: O envolvimento renal no lupus eritematoso sistémico é um fator determinante de morbimortalidade e um importante marcador de prognóstico. Apesar das elevadas taxas de remissão alcançadas com as terapias imunossupressoras atuais, a abordagem da nefrite lúpica refratária permanece um desafio. A imunoglobulina intravenosa pode ser uma alternativa nestes casos, embora a experiência com a sua administração prolongada seja limitada. Caso clínico: Apresentamos o caso de uma doente de 35 anos de idade com lupus eritematoso sistémico diagnosticado em 1999, aos 23 anos. Em 2002, por síndrome nefrótica, realizou biópsia renal que revelou nefrite lúpica classe IV OMS. Iniciou imunossupressão com prednisolona e ciclofosfamida, com conversão posterior a azatioprina. A proteinúria diminuiu para níveis subnefróticos. Em 2005, por recidiva da síndrome nefrótica repetiu biópsia renal, que foi sobreponível à anterior. Fez conversão de azatioprina para micofenolato de mofetil e a proteinúria reduziu para valores subnefróticos. Em finais de 2006, nova recidiva de síndrome nefrótica associada a artralgia, azotemia, leucopenia e anemia condicionou uma terceira biópsia. O diagnóstico foi o mesmo, sem lesões de esclerose. Iniciou imunoglobulina intravenosa num protocolo de ciclos mensais de 400mg/Kg/dia durante 5 dias consecutivos, mantendo prednisolona e micofenolato de mofetil. Alcançou remissão parcial e completa após o terceiro e décimo ciclos, respetivamente. O esquema de imunoglobulina passou a trimestral após o primeiro ano. Em 2010 engravidou, tendo-se convertido o micofenolato de mofetil para azatioprina. No último trimestre da gravidez agravou a proteinúria e o parto foi induzido à 32ª semana. Atualmente a doente apresenta remissão completa da nefrite, ausência de manifestações extra-renais de lúpus ou de efeitos adversos da imunoglobulina intravenosa. Conclusão: A imunoglobulina intravenosa tem eficácia documentada num amplo espectro de manifestações de lúpus. Pode ser uma opção nos casos de nefrite lúpica resistente aos imunossupressores convencionais. A sua administração prolongada parece ser segura.

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          Most cited references 35

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          Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis.

          Since anecdotal series and small, prospective, controlled trials suggest that mycophenolate mofetil may be effective for treating lupus nephritis, larger trials are desirable. We conducted a 24-week randomized, open-label, noninferiority trial comparing oral mycophenolate mofetil (initial dose, 1000 mg per day, increased to 3000 mg per day) with monthly intravenous cyclophosphamide (0.5 g per square meter of body-surface area, increased to 1.0 g per square meter) as induction therapy for active lupus nephritis. A change to the alternative regimen was allowed at 12 weeks in patients who did not have an early response. The study protocol specified adjunctive care and the use and tapering of corticosteroids. The primary end point was complete remission at 24 weeks (normalization of abnormal renal measurements and maintenance of baseline normal measurements). A secondary end point was partial remission at 24 weeks. Of 140 patients recruited, 71 were randomly assigned to receive mycophenolate mofetil and 69 were randomly assigned to receive cyclophosphamide. At 12 weeks, 56 patients receiving mycophenolate mofetil and 42 receiving cyclophosphamide had satisfactory early responses. In the intention-to-treat analysis, 16 of the 71 patients (22.5 percent) receiving mycophenolate mofetil and 4 of the 69 patients receiving cyclophosphamide (5.8 percent) had complete remission, for an absolute difference of 16.7 percentage points (95 percent confidence interval, 5.6 to 27.9 percentage points; P=0.005), meeting the prespecified criteria for noninferiority and demonstrating the superiority of mycophenolate mofetil to cyclophosphamide. Partial remission occurred in 21 of the 71 patients (29.6 percent) and 17 of the 69 patients (24.6 percent), respectively (P=0.51). Three patients assigned to cyclophosphamide died, two during protocol therapy. Fewer severe infections and hospitalizations but more diarrhea occurred among those receiving mycophenolate. In this 24-week trial, mycophenolate mofetil was more effective than intravenous cyclophosphamide in inducing remission of lupus nephritis and had a more favorable safety profile. Copyright 2005 Massachusetts Medical Society.
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            Therapy of lupus nephritis. Controlled trial of prednisone and cytotoxic drugs.

            We evaluated renal function in 107 patients with active lupus nephritis who participated in long-term randomized therapeutic trials (median follow-up, seven years). For patients taking oral prednisone alone, the probability of renal failure began to increase substantially after five years of observation. Renal function was better preserved in patients who received various cytotoxic-drug therapies, but the difference was statistically significant only for intravenous cyclophosphamide plus low-dose prednisone as compared with high-dose prednisone alone (P = 0.027). The advantage of treatment with intravenous cyclophosphamide over oral prednisone alone was particularly apparent in the high-risk subgroup of patients who had chronic histologic changes on renal biopsy at study entry. Patients treated with intravenous cyclophosphamide have not experienced hemorrhagic cystitis, cancer, or a disproportionate number of major infections. We conclude that, as compared with high-dose oral prednisone alone, treatment of lupus glomerulonephritis with intravenous cyclophosphamide reduces the risk of end-stage renal failure with few serious complications.
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              Sequential therapies for proliferative lupus nephritis.

              Long-term therapy with cyclophosphamide enhances renal survival in patients with proliferative lupus nephritis; however, the beneficial effect of cyclophosphamide must be weighed against its considerable toxic effects. Fifty-nine patients with lupus nephritis (12 in World Health Organization class III, 46 in class IV, and 1 in class Vb) received induction therapy consisting of a maximum of seven monthly boluses of intravenous cyclophosphamide (0.5 to 1.0 g per square meter of body-surface area) plus corticosteroids. Subsequently, the patients were randomly assigned to one of three maintenance therapies: quarterly intravenous injections of cyclophosphamide, oral azathioprine (1 to 3 mg per kilogram of body weight per day), or oral mycophenolate mofetil (500 to 3000 mg per day) for one to three years. The base-line characteristics of the three groups were similar, with the exception that the chronicity index was 1.9 points lower in the cyclophosphamide group than in the mycophenolate mofetil group (P=0.009). During maintenance therapy, five patients died (four in the cyclophosphamide group and one in the mycophenolate mofetil group), and chronic renal failure developed in five (three in the cyclophosphamide group and one each in the azathioprine and mycophenolate mofetil groups). The 72-month event-free survival rate for the composite end point of death or chronic renal failure was higher in the mycophenolate mofetil and azathioprine groups than in the cyclophosphamide group (P=0.05 and P=0.009, respectively). The rate of relapse-free survival was higher in the mycophenolate mofetil group than in the cyclophosphamide group (P=0.02). The incidence of hospitalization, amenorrhea, infections, nausea, and vomiting was significantly lower in the mycophenolate mofetil and azathioprine groups than in the cyclophosphamide group. For patients with proliferative lupus nephritis, short-term therapy with intravenous cyclophosphamide followed by maintenance therapy with mycophenolate mofetil or azathioprine appears to be more efficacious and safer than long-term therapy with intravenous cyclophosphamide. Copyright 2004 Massachusetts Medical Society
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                nep
                Portuguese Journal of Nephrology & Hypertension
                Port J Nephrol Hypert
                Sociedade Portuguesa de Nefrologia (Lisboa )
                0872-0169
                January 2013
                : 27
                : 1
                : 41-48
                Affiliations
                [1 ] Universidade de Coimbra Portugal
                Article
                S0872-01692013000100007
                Product
                Product Information: website
                Categories
                UROLOGY & NEPHROLOGY

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