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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Risk for sustained amenorrhea in patients with systemic lupus erythematosus receiving intermittent pulse cyclophosphamide therapy. Outcome, Measurements, and Follow-up The objective of this study was to test whether MMF was superior to IVC in the primary end point, namely the proportion of patients responding to treatment. A maximum MMF dosage of 2.
Although most patients in both treatment groups experienced clinical improvement, the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis. Mycophenolate mofetil vs cyclophosphamide therapy for patients with diffuse proliferative lupus nephritis. Patients in both groups received corticosteroids as well as conventional antiproteinuric and antihypertensive therapies as part of standard care.
Summary of results of secondary efficacy end points a. Summary of reasons for premature withdrawal from treatment intention-to-treat population. Cardiovascular risk factors and the long-term outcome of lupus nephritis. Am J Transplant 5: New approaches for systemic lupus erythematosus.
In the sensitivity analysis, the number of patients achieving the primary efficacy end point was not statistically significantly different between treatment groups, irrespective of adjustment for covariates. The reasons for withdrawal before 24 wk in both groups are described in Table 2.
Controlled trial of pulse methylprednisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis. Long-term study of mycophenolate mofetil as continuous induction and maintenance treatment for diffuse proliferative lupus nephritis.
Results did not differ between treatment groups for any secondary renal or nonrenal efficacy end points.
Newer drugs for the treatment of lupus nephritis. Update on the treatment of lupus nephritis. Clin J Am Soc Nephrol 2: IVC was given in monthly pulses of 0. Prospective registry-based observational cohort study of the long-term risk of malignancies in renal transplant patients treated with mycophenolate mofetil.
Ovarian failure and strategies for fertility preservation in patients with systemic lupus erythematosus. The Euro-Lupus Nephritis Trial, a randomized trial of low-dose high-dose intravenous cyclophosphamide.
ALMS – Wiki Journal Club
Of patients screened, were randomly assigned Majagement 1. Notes Published online ahead of print. 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.
Reasons for early withdrawal and hence nonresponse included AEs leading to withdrawal, intolerance of either therapy, or requirement to receive prohibited treatments.
Randomization and Interventions Patients were randomly assigned 1: Supplementary Material [Supplemental Data] Click here to view. The h urine collections were obtained at baseline and every 4 wk thereafter until completion of the wk induction phase.
Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.
The response rates asprevq similar between patients with renal biopsy class III or IV and those with renal biopsy class V, irrespective of treatment. The primary efficacy end point was achieved in The numbers of patients receiving concomitant medications were mostly similar between treatment groups.
Mycophenolate mofetil in induction and maintenance therapy of severe lupus nephritis: Overall, the mean dosage of prednisone did not differ between groups Focal proliferative class III and diffuse proliferative class IV lupus nephritis are mediated by immune and inflammatory mechanisms responsive to immunosuppression and antiinflammatory therapy, and preferred therapy has generally been with a combination of prednisone plus cyclophosphamide based upon a landmark study from the NIH.
During the study, any drugs affecting the angiotensin system were taken at stable dosage.
A post hoc subgroup analysis indicated that African American and Hispanic patients had a more favorable response to MMF over cyclophosphamide. An independent Data and Safety Monitoring Board, comprising two physicians and one biostatistician, was convened every 3 mo to review study data on an ongoing basis. Waldman M, Appel GB: J Am Soc Nephrol.