Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up

Daniel J Wallace; Caroline Gordon; Vibeke Strand; Kathryn Hobbs; Michelle Petri; Kenneth Kalunian; Frederic Houssiau; Paul P Tak; David A Isenberg; Lexy Kelley; Brian Kilgallen; Anna N Barry; William A Wegener; David M Goldenberg

doi:10.1093/rheumatology/ket129

Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up

Daniel J Wallace, Caroline Gordon, Vibeke Strand, Kathryn Hobbs, Michelle Petri, Kenneth Kalunian, Frederic Houssiau, Paul P Tak, David A Isenberg, Lexy Kelley, Brian Kilgallen, Anna N Barry, William A Wegener, David M Goldenberg

Immunology and Immunotherapy

Research output: Contribution to journal › Article › peer-review

88 Citations (Scopus)

Abstract

Objective. To evaluate epratuzumab treatment in patients with moderately-to-severely active SLE in two international, randomized, controlled trials (ALLEVIATE-1 and -2) and an open-label extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, median BILAG score 12.0) received standard of care plus 10 total doses of placebo (n = 37) or 360 mg/m(2) (n = 42) or 720 mg/m(2) (n = 11) epratuzumab, administered across 12-week cycles for up to 48 weeks, with BILAG assessments every 4 weeks. Patients were followed for ≥6 months and their data combined for analysis. The primary endpoint was BILAG response at week 12 (all BILAG A scores reduced to B/C/D and B scores to C/D, no new A and

Original language	English
Pages (from-to)	1313-22
Number of pages	10
Journal	Rheumatology (Oxford)
Volume	52
Issue number	7
DOIs	https://doi.org/10.1093/rheumatology/ket129
Publication status	Published - Jul 2013

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Wallace, D. J., Gordon, C., Strand, V., Hobbs, K., Petri, M., Kalunian, K., Houssiau, F., Tak, P. P., Isenberg, D. A., Kelley, L., Kilgallen, B., Barry, A. N., Wegener, W. A., & Goldenberg, D. M. (2013). Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Rheumatology (Oxford), 52(7), 1313-22. https://doi.org/10.1093/rheumatology/ket129

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title = "Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up",

abstract = "Objective. To evaluate epratuzumab treatment in patients with moderately-to-severely active SLE in two international, randomized, controlled trials (ALLEVIATE-1 and -2) and an open-label extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, median BILAG score 12.0) received standard of care plus 10 total doses of placebo (n = 37) or 360 mg/m(2) (n = 42) or 720 mg/m(2) (n = 11) epratuzumab, administered across 12-week cycles for up to 48 weeks, with BILAG assessments every 4 weeks. Patients were followed for ≥6 months and their data combined for analysis. The primary endpoint was BILAG response at week 12 (all BILAG A scores reduced to B/C/D and B scores to C/D, no new A and ",

author = "Wallace, {Daniel J} and Caroline Gordon and Vibeke Strand and Kathryn Hobbs and Michelle Petri and Kenneth Kalunian and Frederic Houssiau and Tak, {Paul P} and Isenberg, {David A} and Lexy Kelley and Brian Kilgallen and Barry, {Anna N} and Wegener, {William A} and Goldenberg, {David M}",

year = "2013",

month = jul,

doi = "10.1093/rheumatology/ket129",

language = "English",

volume = "52",

pages = "1313--22",

journal = "Rheumatology (Oxford)",

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Wallace, DJ, Gordon, C, Strand, V, Hobbs, K, Petri, M, Kalunian, K, Houssiau, F, Tak, PP, Isenberg, DA, Kelley, L, Kilgallen, B, Barry, AN, Wegener, WA & Goldenberg, DM 2013, 'Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up', Rheumatology (Oxford), vol. 52, no. 7, pp. 1313-22. https://doi.org/10.1093/rheumatology/ket129

Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. / Wallace, Daniel J; Gordon, Caroline; Strand, Vibeke et al.
In: Rheumatology (Oxford), Vol. 52, No. 7, 07.2013, p. 1313-22.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus

T2 - results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up

AU - Wallace, Daniel J

AU - Gordon, Caroline

AU - Strand, Vibeke

AU - Hobbs, Kathryn

AU - Petri, Michelle

AU - Kalunian, Kenneth

AU - Houssiau, Frederic

AU - Tak, Paul P

AU - Isenberg, David A

AU - Kelley, Lexy

AU - Kilgallen, Brian

AU - Barry, Anna N

AU - Wegener, William A

AU - Goldenberg, David M

PY - 2013/7

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N2 - Objective. To evaluate epratuzumab treatment in patients with moderately-to-severely active SLE in two international, randomized, controlled trials (ALLEVIATE-1 and -2) and an open-label extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, median BILAG score 12.0) received standard of care plus 10 total doses of placebo (n = 37) or 360 mg/m(2) (n = 42) or 720 mg/m(2) (n = 11) epratuzumab, administered across 12-week cycles for up to 48 weeks, with BILAG assessments every 4 weeks. Patients were followed for ≥6 months and their data combined for analysis. The primary endpoint was BILAG response at week 12 (all BILAG A scores reduced to B/C/D and B scores to C/D, no new A and

AB - Objective. To evaluate epratuzumab treatment in patients with moderately-to-severely active SLE in two international, randomized, controlled trials (ALLEVIATE-1 and -2) and an open-label extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, median BILAG score 12.0) received standard of care plus 10 total doses of placebo (n = 37) or 360 mg/m(2) (n = 42) or 720 mg/m(2) (n = 11) epratuzumab, administered across 12-week cycles for up to 48 weeks, with BILAG assessments every 4 weeks. Patients were followed for ≥6 months and their data combined for analysis. The primary endpoint was BILAG response at week 12 (all BILAG A scores reduced to B/C/D and B scores to C/D, no new A and

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DO - 10.1093/rheumatology/ket129

M3 - Article

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SN - 1462-0324

VL - 52

SP - 1313

EP - 1322

JO - Rheumatology (Oxford)

JF - Rheumatology (Oxford)

IS - 7

ER -