ASPREVA LUPUS MANAGEMENT STUDY PDF
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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At week 24, Of patients screened, were randomly assigned Figure 1.
In both treatment groups, the most common types of AE were infections Kupus, relapse, and re-remission of proliferative lupus nephritis treated with sapreva. Controlled trial of prednisone and cytotoxic drugs.
A meta-analysis of randomized controlled trials. 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.
Secondary end points included complete renal remission, systemic disease activity and damage, and safety.
Oral MMF was given twice daily, titrated from 0. Articles from Journal of the American Society of Manxgement Exposure The median dosage was calculated for patients in the MMF group as 2. Recent 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.
A double-blind controlled trial comparing cyclophosphamide, azathioprine and placebo in the treatment of lupus glomerulonephritis.
Received Oct 1; Accepted Dec 5. This is overall a very well done study and the largest multi-center randomized controlled trial to date comparing MMF vs.
Update on the treatment of lupus nephritis. In this induction phase of ALMS, one of the largest and most racially diverse studies of treatments for LN to date, the efficacy and tolerability of oral MMF during 6 mo did not differ from those of IVC, the current standard treatment; however, other measures of clinical effectiveness are important to clinicians and patients and may influence prescribing decisions.
Patients in both groups received corticosteroids as well as conventional antiproteinuric and antihypertensive therapies as part of standard care. The induction phase was defined as 24 wk, because wk response can predict disease outcome 2527 and minimize the risks for long-term AEs of IVC.
Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.
Cardiovascular risk factors and the long-term outcome of managemeht nephritis. There were more deaths in the MMF group, contrasting with previous trials. IVC was given in monthly pulses of 0. Michael Neuwelt, MD, Inc.
There was no progression on the Systemic Lupus International Collaborating Clinics damage index in either patient group. Systematic review and meta-analysis of randomised trials and cohort studies of mycophenolate mofetil in lupus nephritis.
Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
For patients in the IVC group and for patients in each of the self-reported racial groups, the median number of doses was 6. J Am Soc Nephrol.
For both treatments, the most common AEs were infections and gastrointestinal disorders, occurring in approximately two thirds of patients. At the end of the week induction period, renal responses were observed in However, it has been suggested by the authors and others that a longer induction period may better distinguish the two treatment arms.
Randomization and Interventions Patients were randomly assigned 1: The response rates were similar between patients with renal biopsy class III or IV and those with renal biopsy class V, irrespective of treatment. In the safety population, 51 The corresponding mean number of doses of IVC was 5.
Pulse intravenous corticosteroids were prohibited within 2 wk before first randomization and throughout the study. New approaches for systemic lupus erythematosus. Neither of aepreva was objectively addressed in this study because of the length of follow-up and limited health economic assessments undertaken.
Overall, we did not detect a significantly different response rate between the two groups: