PDF | On Jan 1, , E.M. Ginzler and others published Aspreva Lupus Management Study (ALMS): Maintenance Results. [abstract]. *Members of the Aspreva Lupus Manage- ment Study (ALMS) Group are listed in the Supplementary Appendix, available at The study group underwent repeat randomization in a ratio. A total of patients were randomly assigned to maintenance treatment ( to a renal response to treatment and in preventing relapse in patients with lupus (Funded by Vifor Pharma [formerly Aspreva]; ALMS number, NCT).

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An assessment of renal failure in an SLE cohort with special reference to ethnicity, over a year period. Nanagement studies have suggested that mycophenolate mofetil MMF may offer advantages over intravenous cyclophosphamide IVC for the treatment of lupus nephritis, but these therapies have not been compared in an international randomized, controlled trial.

Nephrol Dial Transplant Time since diagnosis of lupus nephritis yr; median [range] k. In the MMF group, 35 Arthritis Res Ther 8: The primary end point analysis was performed aspreca the intention-to-treat population. A meta-analysis of randomized controlled trials.

In the MMF group treatment difference 2. Although meta-analyses of smaller studies 17 — 19 have suggested that more patients respond to MMF than stusy IVC, results from the large and racially diverse population of this study indicate that these drugs in combination with prednisone have similar efficacy in short-term induction therapy.

Detailed inclusion and exclusion criteria are given in Supplemental Table 2.

Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.

Data from the ALMS study have been published in abstract form at the following congresses: It has been reported that black and Hispanic patients are at an increased risk for aggressive disease. In the initial, prospectively planned, primary efficacy analysis, interactions between treatment and these covariates were added and assessed at the 0.


The mean duration of treatment was Examination of the data did not reveal an association of region, race, body weight, or body surface area with safety outcomes of either treatment group. Usable articles Nephrology Rheumatology. The numbers of patients receiving concomitant medications were mostly similar between treatment groups.

ALMS – Wiki Journal Club

A double-blind controlled trial comparing cyclophosphamide, azathioprine and placebo in the treatment of lupus glomerulonephritis. Patients who were aged 12 to 75 yr and had a diagnosis of SLE by American College of Rheumatology criteria 33 were enrolled between July 27,and October 6, Neither of these was objectively addressed in this study because of the length of follow-up and limited health economic assessments undertaken.

Ann Intern Med Summary of results of secondary efficacy end points a. Supplementary Material [Supplemental Data] Click here manwgement view. Randomization and Interventions Patients were randomly assigned 1: Any patient who did not complete the wk induction phase for any reason or who received pulse methylprednisolone therapy for major renal or extrarenal flare was classified as a nonresponder.

Ovarian failure and strategies for fertility preservation in patients with systemic lupus erythematosus. The Euro-Lupus Nephritis Aaspreva, a randomized trial of low-dose high-dose intravenous cyclophosphamide.

These include the convenience of twice-daily oral medication MMF versus a monthly infusion IVC and the impact on women of child-bearing age as a result of the potential of IVC to cause ovarian dysfunction.

Patients in both groups received corticosteroids as well as conventional antiproteinuric and antihypertensive therapies as part of standard care. Long-term followup of a cohort of patients participating in randomized controlled studies. A more accurate method to estimate glomerular filtration rate from serum creatinine: There was no progression on the Systemic Lupus International Collaborating Clinics damage index in either patient group. Navigation menu Personal tools Create account Log in.

Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.

A systematic review and meta-analysis. J Am Soc Nephrol.


Clinical and immunologic effects of monthly administration of intravenous cyclophosphamide in severe systemic lupus erythematosus. The primary efficacy end point was stuvy in Supplemental information for this article is available online at http: Pulse intravenous corticosteroids were prohibited within 2 wk before first randomization and throughout the study.

Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: Parameters such as the duration of the induction phase and the response criteria were based on previously reported trials 1216managemeny2728 ; however, 24 wk may be too short to differentiate between the treatments, because the disease may continue to improve and AEs may continue to emerge. Nausea and vomiting were the most common gastrointestinal disorder in patients with IVC, but diarrhea predominated with MMF.

Six randomly assigned patients one in the MMF group and five in the IVC group were excluded from the safety analysis because they received no study drug. Remission, relapse, and re-remission of proliferative lupus nephritis treated with cyclophosphamide. Prospective registry-based observational cohort study of the long-term risk of malignancies in renal transplant patients treated with mangement mofetil. Among patients with active lupus nephritis, remission induction with either mycophenolate or cyclophosphamide yields similar response rates, and subgroup analyses suggest mycophenolate may yield superior results in African American and Hispanic patients.

The open-label design of this study was chosen because the AE profiles of the two study drugs would interfere with attempted blinding; the randomization of patients to treatment groups should mitigate any potential bias produced as a result of this design. The relationship between cancer and medication exposures in systemic lupus erythematosus: At the end of the week induction period, renal responses were observed in