PMID- 19933596 OWN - NLM STAT- MEDLINE DCOM- 20101105 LR - 20220419 IS - 1462-0332 (Electronic) IS - 1462-0324 (Print) IS - 1462-0324 (Linking) VI - 49 IP - 1 DP - 2010 Jan TI - Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. PG - 128-40 LID - 10.1093/rheumatology/kep346 [doi] AB - OBJECTIVE: To compare the efficacy and safety of mycophenolate mofetil (MMF) and intravenous cyclophosphamide (IVC) as induction treatment for lupus nephritis (LN), by race, ethnicity and geographical region. METHODS: A total of 370 patients with active Class III-V LN received MMF (target dose 3.0 g/day) or IVC (0.5-1.0 g/m(2)/month), plus tapered prednisone, for 24 weeks. Renal function, global disease activity, immunological complement (C3 and C4) and anti-dsDNA levels are the outcomes that were assessed in this study. RESULTS: MMF was not superior to IVC as induction treatment (primary objective). There were important pre-specified interactions between treatment and race (P = 0.047) and treatment and region (P = 0.069) (primary endpoint). MMF and IVC response rates were similar for Asians (53.2 vs 63.9%; P = 0.24) and Whites (56.0 vs 54.2%; P = 0.83), but differed in the combined Other and Black group (60.4 vs 38.5%; P = 0.03). Fewer patients in the Black (40 vs 53.9%; P = 0.39) and Hispanic (38.8 vs 60.9%; P = 0.011) groups responded to IVC. Latin American patients had lower response to IVC (32 vs 60.7%; P = 0.003). Baseline disease characteristics were not predictive of response. The incidence of adverse events (AEs) was similar across groups. Serious AEs were slightly more prevalent among Asians. CONCLUSIONS: MMF and IVC have similar efficacy overall to short-term induction therapy for LN. However, race, ethnicity and geographical region may affect treatment response; more Black and Hispanic patients responded to MMF than IVC. As these factors are inter-related, it is difficult to draw firm conclusions about their importance. FAU - Isenberg, David AU - Isenberg D AD - Centre for Rheumatology, University College London, London, UK. FAU - Appel, Gerald B AU - Appel GB FAU - Contreras, Gabriel AU - Contreras G FAU - Dooley, Mary A AU - Dooley MA FAU - Ginzler, Ellen M AU - Ginzler EM FAU - Jayne, David AU - Jayne D FAU - Sanchez-Guerrero, Jorge AU - Sanchez-Guerrero J FAU - Wofsy, David AU - Wofsy D FAU - Yu, Xueqing AU - Yu X FAU - Solomons, Neil AU - Solomons N LA - eng SI - ClinicalTrials.gov/NCT00377637 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20091120 PL - England TA - Rheumatology (Oxford) JT - Rheumatology (Oxford, England) JID - 100883501 RN - 0 (Immunosuppressive Agents) RN - 8N3DW7272P (Cyclophosphamide) RN - HU9DX48N0T (Mycophenolic Acid) RN - VB0R961HZT (Prednisone) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Child MH - Cyclophosphamide/adverse effects/therapeutic use MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Humans MH - Immunosuppressive Agents/adverse effects/*therapeutic use MH - Lupus Nephritis/complications/*drug therapy/*ethnology MH - Middle Aged MH - Mycophenolic Acid/adverse effects/analogs & derivatives/therapeutic use MH - Opportunistic Infections/complications/ethnology MH - Prednisone/adverse effects/therapeutic use MH - Prospective Studies MH - Treatment Outcome MH - Young Adult PMC - PMC2789586 EDAT- 2009/11/26 06:00 MHDA- 2010/11/06 06:00 PMCR- 2009/11/20 CRDT- 2009/11/26 06:00 PHST- 2009/11/26 06:00 [entrez] PHST- 2009/11/26 06:00 [pubmed] PHST- 2010/11/06 06:00 [medline] PHST- 2009/11/20 00:00 [pmc-release] AID - kep346 [pii] AID - 10.1093/rheumatology/kep346 [doi] PST - ppublish SO - Rheumatology (Oxford). 2010 Jan;49(1):128-40. doi: 10.1093/rheumatology/kep346. Epub 2009 Nov 20.