Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study

Abstract

Objective. To compare the efficacy and safety of mycophenolate mofetil (MMF) and intravenous cyclophosphamide (IVC) as induction treatment for lupus nephritis (LN), by race, ethnicity and geographical region.Methods. A total of 370 patients with active Class III–V LN received MMF (target dose 3.0 g/day) or IVC (0.5–1.0 g/m2/month), plus tapered prednisone, for 24 weeks. Renal function, global disease activity, immunological complement (C3 and C4) and anti-dsDNA levels are the outcomes that were assessed in this study.Results. MMF was not superior to IVC as induction treatment (primary objective). There were important pre-specified interactions between treatment and race (P = 0.047) and treatment and region (P = 0.069) (primary endpoint). MMF and IVC response rates were similar for Asians (53.2 vs 63.9%; P = 0.24) and Whites (56.0 vs 54.2%; P = 0.83), but differed in the combined Other and Black group (60.4 vs 38.5%; P = 0.03). Fewer patients in the Black (40 vs 53.9%; P = 0.39) and Hispanic (38.8 vs 60.9%; P = 0.011) groups responded to IVC. Latin American patients had lower response to IVC (32 vs 60.7%; P = 0.003). Baseline disease characteristics were not predictive of response. The incidence of adverse events (AEs) was similar across groups. Serious AEs were slightly more prevalent among Asians.Conclusions. MMF and IVC have similar efficacy overall to short-term induction therapy for LN. However, race, ethnicity and geographical region may affect treatment response; more Black and Hispanic patients responded to MMF than IVC. As these factors are inter-related, it is difficult to draw firm conclusions about their importance.Trial registration. National Institutes of Health, www.clinicaltrials.gov, registration number NCT00377637.

Three Decades of Progress in Treating Childhood-Onset Lupus Nephritis

“…Although these results substantiate other published experiences in adults (30), they merit further scrutiny in children. The recent Aspreva Lupus Management Study suggests that patients of AA and Hispanic ethnicity demonstrate a better response to MMF than CYC (31). This may account for the better-than-expected response to MMF in our primarily nonwhite patient population.…”

Mycophenolate versus Azathioprine as Maintenance Therapy for Lupus Nephritis

“…4,5 There has been mounting interest in the use of mycophenolate mofetil as induction therapy, maintenance therapy, or both for patients with lupus nephritis. [6][7][8][9][10][11][12] The Aspreva Lupus Management Study (ALMS), which examined the efficacy and safety of induction therapy with mycophenolate mofetil as compared with intravenous cyclophosphamide (plus standardized tapering of glucocorticoid therapy) in patients with active lupus nephritis (renal-biopsy active class III, IV, or V [13][14][15][16] [according to the International Society of Nephrology and Renal Pathology Society 2003 Classification of Lupus Nephritis 17 ]), showed no significant difference between the two drugs. 13 (For a description of the classes of renal biopsy used in this study, see the protocol, available with the full text of this article at NEJM.org.)…”

Predictive Factors and Long Term Outcome in Lupus Nephritis in Libya

“…That enhanced risk of developing nephritis earlier in the course of the disease [15]. The most frequently observed abnormality is proteinuria, our data shows common are Nephritis lupus nephritis then nephrotic disease and acute renal failure [16,17].…”

“…Approximately 10-30% of patients with lupus nephritis progress to End-Stage Renal Disease (ESRD), depending upon the severity of the disease, socio-economic factors, noncompliance, and the response to initial treatment [15].…”