Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Aspreva Lupus Management Study (ALMS): Maintenance Results.
Ginzler4, Ellen M., Appel1, Gerald B., Dooley7, Mary Anne, Isenberg5, David A., Jayne3, David, Wofsy6, David, Solomons8, Neil
Columbia University, New York
Renal Unit, Addenbrooke's Hospital, Cambridge, United Kingdom
SUNY-Downstate Medical Center, Brooklyn, NY
University College London, London, United Kingdom
University of California, San Francisco, San Francisco, CA
University of North Carolina at Chapel Hill, Chapel Hill, NC
Vifor Pharma (formerly Aspreva Pharmaceuticals), BC, Canada
Vifor Pharma, UK, Bagshot, Surrey, United Kingdom
The 36-month, maintenance phase of the ALMS study (NCT00377637) compared the efficacy and safety of mycophenolate mofetil (MMF) with azathioprine (AZA) in patients with active lupus nephritis (LN) achieving partial or complete response during the 6-month induction phase.
Patients were re-randomized 1:1 to a double-blind comparison of either oral MMF (2 g/day) plus placebo or oral AZA (2 mg/kg/d) plus placebo. Patients were permitted to receive corticosteroids (CS; maximum dose: 10 mg/d prednisone or equivalent). The primary efficacy outcome measure was time to treatment failure (death, end-stage renal disease [ESRD], sustained doubling of serum creatinine, renal flare [proteinuric or nephritic], and/or requirement for rescue CS). Key secondary parameters included time to event for each individual component of treatment failure: complete renal remission; combined renal and extra-renal remission; major extra-renal flare (British Isles Lupus Assessment Group score category A in 1 extra-renal system or 3 systems with concurrent category B scores); and adverse events (AEs).
Of 227 patients randomized (intent-to-treat population), 127 completed (MMF, 73/116 [62.9%]; AZA, 54/111 [48.6%]). Demographic and disease characteristics were similar across groups at baseline. MMF was superior (log-rank test) to AZA in time to treatment failure (primary endpoint, P=0.003). MMF was superior to AZA (log-rank test) with respect to the following components of treatment failure: time to renal flare (P=0.027) and time to rescue therapy for LN (P=0.017). All other elements of the primary efficacy parameter showed numerical benefit in favor of MMF: time to ESRD (P=0.069) and time to sustained doubling of serum creatinine (P=0.073). MMF was superior to AZA with respect to the key secondary endpoint: time to first confirmed or suspected renal flare (P=0.012). Times to combined renal and extra-renal remission, and major extra-renal flare did not differ between the 2 groups (P=0.416 and P=0.936, respectively). The superiority of MMF over AZA was consistent regardless of induction treatment (MMF or cyclophosphamide [IVC]), race, or geographic region. The incidence of AEs was similar between MMF and AZA groups; the most common AEs in both groups were infections/infestations and gastrointestinal disorders. Numerically fewer patients treated with MMF than AZA reported at least 1 serious AE (27/115 [23.5%] vs 37/111 [33.3%]. One death (AZA group, unrelated to treatment) occurred during the study.
MMF was superior to AZA in maintaining renal response and preventing relapse in patients with active LN who responded to induction therapy with CS and either MMF or IVC.
To cite this abstract, please use the following information:
Ginzler, Ellen M., Appel, Gerald B., Dooley, Mary Anne, Isenberg, David A., Jayne, David, Wofsy, David, et al; Aspreva Lupus Management Study (ALMS): Maintenance Results. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2085