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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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. Most patients who died had severe renal disease at baseline. Overall, the median total dosage per infusion of IVC was 0.

The relationship between cancer and medication exposures in systemic lupus erythematosus: Clinically significant renal involvement occurs in approximately half of patients with lupus, and renal histology in patients with lupus nephritis predicts responsiveness to therapy. Data from the ALMS study have been published in abstract form at the following congresses: Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Manxgement intravenous corticosteroids were prohibited within 2 wk before first randomization and throughout the study.

Nausea and vomiting were the most common gastrointestinal disorder in patients with IVC, but diarrhea predominated with Qspreva.

Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis

Controlled trial of prednisone and cytotoxic drugs. J Am Soc Nephrol A maximum MMF dosage of 2.

Overall, the mean dosage of prednisone did not differ between groups Cardiovascular risk factors and the long-term outcome of lupus nephritis. 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.

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

N Engl J Med Please review our privacy policy. Mycophenolate mofetil as induction and maintenance therapy for lupus nephritis: Most patients excluded did not meet the study criteria for baseline disease. Immunosuppressive therapy in lupus nephritis: Lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial.

Data for the per-protocol population was supportive of that observed for the intention-to-treat population; the primary efficacy end point was achieved by 86 A post hoc subgroup analysis indicated that African American and Hispanic patients had a more favorable response to MMF over cyclophosphamide.

Long-term followup of a cohort of patients participating in randomized controlled studies. Update on the treatment of lupus nephritis.

Remission, relapse, and re-remission of proliferative lupus nephritis treated with cyclophosphamide. The most commonly reported types of serious AEs in both groups were infections, occurring in 22 Demographics and baseline disease characteristics a. 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. Secondary end points were also similar between treatment groups.

Cyclophosphamide therapy for lupus nephritis: The classification of glomerulonephritis in systemic lupus erythematosus revisited. Ann Intern Med 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.

Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: The mean duration of treatment was At week 24, Several studies have compared cyclophosphamide and MMF, generally finding that MMF is equivalent to cyclophosphamide in terms of efficacy, with a lower risk of ovarian failure.

Detailed inclusion and exclusion criteria are given in Supplemental Table 2. Support Center Support Center. Poor renal survival in black Americans.

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Controlled trial of pulse methylprednisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis. Publication date available at www. 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.

A more accurate method to estimate glomerular filtration rate from serum creatinine: Overall, we did not detect a significantly different response rate between the two groups: Author information Article notes Copyright and License information Disclaimer.

Moreover, although the subgroups are prespecified, the study is not specifically powered to detect differences and the asprevx increased death rate and difference in adverse event profile compared to other studies is not explained.

Parameters such as the duration of the induction phase stuudy the response criteria were based on previously reported trials 1216252728 ; 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. This article has been cited by other articles in PMC. However, it has been suggested by the authors and others that a longer induction period may better distinguish the two treatment arms.

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

Ann Rheum Dis Bernardo Houssay, San Isidro, Argentina. In some patients, this led to continued aggressive treatment of lupus mqnagement MMF and high-dosage corticosteroids, which we speculate may have contributed to the overwhelming infection in patients whose immune status was unstable at study entry. Newer drugs for the treatment of lupus nephritis.

There were more deaths in the MMF group, contrasting with previous trials.