Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study.

David Isenberg, Gerald B. Appel, Gabriel Contreras, Mary A. Dooley, Ellen M. Ginzler, David Jayne, Jorge Sánchez-Guerrero, David Wofsy, Xueqing Yu, Neil Solomons

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Abstract

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.

Original languageEnglish
Pages (from-to)128-140
Number of pages13
JournalRheumatology (Oxford, England)
Volume49
Issue number1
StatePublished - Jan 1 2010
Externally publishedYes

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Lupus Nephritis
Mycophenolic Acid
Cyclophosphamide
Therapeutics
Hispanic Americans
Complement C4
Complement C3
Immune System Diseases
Prednisone
Kidney
Safety
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Isenberg, D., Appel, G. B., Contreras, G., Dooley, M. A., Ginzler, E. M., Jayne, D., ... Solomons, N. (2010). Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford, England), 49(1), 128-140.

Influence of race/ethnicity on response to lupus nephritis treatment : the ALMS study. / Isenberg, David; Appel, Gerald B.; Contreras, Gabriel; Dooley, Mary A.; Ginzler, Ellen M.; Jayne, David; Sánchez-Guerrero, Jorge; Wofsy, David; Yu, Xueqing; Solomons, Neil.

In: Rheumatology (Oxford, England), Vol. 49, No. 1, 01.01.2010, p. 128-140.

Research output: Contribution to journalArticle

Isenberg, D, Appel, GB, Contreras, G, Dooley, MA, Ginzler, EM, Jayne, D, Sánchez-Guerrero, J, Wofsy, D, Yu, X & Solomons, N 2010, 'Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study.', Rheumatology (Oxford, England), vol. 49, no. 1, pp. 128-140.
Isenberg D, Appel GB, Contreras G, Dooley MA, Ginzler EM, Jayne D et al. Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford, England). 2010 Jan 1;49(1):128-140.
Isenberg, David ; Appel, Gerald B. ; Contreras, Gabriel ; Dooley, Mary A. ; Ginzler, Ellen M. ; Jayne, David ; Sánchez-Guerrero, Jorge ; Wofsy, David ; Yu, Xueqing ; Solomons, Neil. / Influence of race/ethnicity on response to lupus nephritis treatment : the ALMS study. In: Rheumatology (Oxford, England). 2010 ; Vol. 49, No. 1. pp. 128-140.
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abstract = "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.",
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AU - Jayne, David

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N2 - 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.

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.

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