Epratuzumab for patients with moderate to severe flaring SLE: Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006

Vibeke Strand, Michelle Petri, Kenneth Kalunian, Caroline Gordon, Daniel J. Wallace, Kathryn Hobbs, Lexy Kelley, Brian Kilgallen, William A. Wegener, David M. Goldenberg

Research output: Contribution to journalArticle

Abstract

Objective. To evaluate health-related quality of life (HRQOL) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international, multicentre, randomized controlled trials of epratuzumab (ALLEVIATE-1 and -2) and a long-term extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, mean BILAG score 13.2) were randomized to receive 360 mg/m2 (n = 42) or 720 mg/m2 (n = 11) epratuzumab or placebo (n = 37), plus standard of care, in 12-week cycles. Corticosteroid use, patient and physician global assessments of disease activity (PtGA and PGA) and 36-item Medical Outcomes Survey Short Form (SF-36) results were recorded at baseline and every 4 weeks. Both trials were prematurely discontinued due to a drug supply interruption; patients followed for ≥6 months were analysed. Twenty-nine patients continued in SL0006, with interim analysis at a median exposure of 120 (range 13-184) weeks. Results. At week 12, proportions of patients with a PGA ≥20% above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm. PGA and PtGA improvements were sustained but did not reach statistical significance. At week 24, mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m2 were 1051 and 1973mg less than placebo (P = 0.034 and 0.081, respectively). At week 48, SF-36 scores approached or exceeded US age- and gender-matched norms in five domains with the 360 mg/m2 treatment. Improvements were maintained in SL0006 over ~2 years. Conclusion. Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA, PtGA and HRQOL and reductions in corticosteroid doses.

Original languageEnglish (US)
Article numberket378
Pages (from-to)502-511
Number of pages10
JournalRheumatology
Volume53
Issue number3
DOIs
StatePublished - Mar 2014

Fingerprint

Prostaglandins A
Adrenal Cortex Hormones
Randomized Controlled Trials
Quality of Life
Placebos
Standard of Care
epratuzumab
Physicians
Therapeutics
Pharmaceutical Preparations

Keywords

  • ALLEVIATE
  • CD22
  • Clinical trial
  • Corticosteroids
  • Epratuzumab
  • HRQOL
  • Lupus
  • Monoclonal antibody
  • SF-36
  • SLE

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Epratuzumab for patients with moderate to severe flaring SLE : Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006. / Strand, Vibeke; Petri, Michelle; Kalunian, Kenneth; Gordon, Caroline; Wallace, Daniel J.; Hobbs, Kathryn; Kelley, Lexy; Kilgallen, Brian; Wegener, William A.; Goldenberg, David M.

In: Rheumatology, Vol. 53, No. 3, ket378, 03.2014, p. 502-511.

Research output: Contribution to journalArticle

Strand, Vibeke ; Petri, Michelle ; Kalunian, Kenneth ; Gordon, Caroline ; Wallace, Daniel J. ; Hobbs, Kathryn ; Kelley, Lexy ; Kilgallen, Brian ; Wegener, William A. ; Goldenberg, David M. / Epratuzumab for patients with moderate to severe flaring SLE : Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006. In: Rheumatology. 2014 ; Vol. 53, No. 3. pp. 502-511.
@article{66aa2bd314f24c63be153199fd0b94f2,
title = "Epratuzumab for patients with moderate to severe flaring SLE: Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006",
abstract = "Objective. To evaluate health-related quality of life (HRQOL) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international, multicentre, randomized controlled trials of epratuzumab (ALLEVIATE-1 and -2) and a long-term extension study (SL0006). Methods. Ninety ALLEVIATE patients (43{\%} BILAG A, mean BILAG score 13.2) were randomized to receive 360 mg/m2 (n = 42) or 720 mg/m2 (n = 11) epratuzumab or placebo (n = 37), plus standard of care, in 12-week cycles. Corticosteroid use, patient and physician global assessments of disease activity (PtGA and PGA) and 36-item Medical Outcomes Survey Short Form (SF-36) results were recorded at baseline and every 4 weeks. Both trials were prematurely discontinued due to a drug supply interruption; patients followed for ≥6 months were analysed. Twenty-nine patients continued in SL0006, with interim analysis at a median exposure of 120 (range 13-184) weeks. Results. At week 12, proportions of patients with a PGA ≥20{\%} above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm. PGA and PtGA improvements were sustained but did not reach statistical significance. At week 24, mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m2 were 1051 and 1973mg less than placebo (P = 0.034 and 0.081, respectively). At week 48, SF-36 scores approached or exceeded US age- and gender-matched norms in five domains with the 360 mg/m2 treatment. Improvements were maintained in SL0006 over ~2 years. Conclusion. Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA, PtGA and HRQOL and reductions in corticosteroid doses.",
keywords = "ALLEVIATE, CD22, Clinical trial, Corticosteroids, Epratuzumab, HRQOL, Lupus, Monoclonal antibody, SF-36, SLE",
author = "Vibeke Strand and Michelle Petri and Kenneth Kalunian and Caroline Gordon and Wallace, {Daniel J.} and Kathryn Hobbs and Lexy Kelley and Brian Kilgallen and Wegener, {William A.} and Goldenberg, {David M.}",
year = "2014",
month = "3",
doi = "10.1093/rheumatology/ket378",
language = "English (US)",
volume = "53",
pages = "502--511",
journal = "Rheumatology",
issn = "1462-0324",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - Epratuzumab for patients with moderate to severe flaring SLE

T2 - Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006

AU - Strand, Vibeke

AU - Petri, Michelle

AU - Kalunian, Kenneth

AU - Gordon, Caroline

AU - Wallace, Daniel J.

AU - Hobbs, Kathryn

AU - Kelley, Lexy

AU - Kilgallen, Brian

AU - Wegener, William A.

AU - Goldenberg, David M.

PY - 2014/3

Y1 - 2014/3

N2 - Objective. To evaluate health-related quality of life (HRQOL) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international, multicentre, randomized controlled trials of epratuzumab (ALLEVIATE-1 and -2) and a long-term extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, mean BILAG score 13.2) were randomized to receive 360 mg/m2 (n = 42) or 720 mg/m2 (n = 11) epratuzumab or placebo (n = 37), plus standard of care, in 12-week cycles. Corticosteroid use, patient and physician global assessments of disease activity (PtGA and PGA) and 36-item Medical Outcomes Survey Short Form (SF-36) results were recorded at baseline and every 4 weeks. Both trials were prematurely discontinued due to a drug supply interruption; patients followed for ≥6 months were analysed. Twenty-nine patients continued in SL0006, with interim analysis at a median exposure of 120 (range 13-184) weeks. Results. At week 12, proportions of patients with a PGA ≥20% above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm. PGA and PtGA improvements were sustained but did not reach statistical significance. At week 24, mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m2 were 1051 and 1973mg less than placebo (P = 0.034 and 0.081, respectively). At week 48, SF-36 scores approached or exceeded US age- and gender-matched norms in five domains with the 360 mg/m2 treatment. Improvements were maintained in SL0006 over ~2 years. Conclusion. Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA, PtGA and HRQOL and reductions in corticosteroid doses.

AB - Objective. To evaluate health-related quality of life (HRQOL) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international, multicentre, randomized controlled trials of epratuzumab (ALLEVIATE-1 and -2) and a long-term extension study (SL0006). Methods. Ninety ALLEVIATE patients (43% BILAG A, mean BILAG score 13.2) were randomized to receive 360 mg/m2 (n = 42) or 720 mg/m2 (n = 11) epratuzumab or placebo (n = 37), plus standard of care, in 12-week cycles. Corticosteroid use, patient and physician global assessments of disease activity (PtGA and PGA) and 36-item Medical Outcomes Survey Short Form (SF-36) results were recorded at baseline and every 4 weeks. Both trials were prematurely discontinued due to a drug supply interruption; patients followed for ≥6 months were analysed. Twenty-nine patients continued in SL0006, with interim analysis at a median exposure of 120 (range 13-184) weeks. Results. At week 12, proportions of patients with a PGA ≥20% above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm. PGA and PtGA improvements were sustained but did not reach statistical significance. At week 24, mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m2 were 1051 and 1973mg less than placebo (P = 0.034 and 0.081, respectively). At week 48, SF-36 scores approached or exceeded US age- and gender-matched norms in five domains with the 360 mg/m2 treatment. Improvements were maintained in SL0006 over ~2 years. Conclusion. Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA, PtGA and HRQOL and reductions in corticosteroid doses.

KW - ALLEVIATE

KW - CD22

KW - Clinical trial

KW - Corticosteroids

KW - Epratuzumab

KW - HRQOL

KW - Lupus

KW - Monoclonal antibody

KW - SF-36

KW - SLE

UR - http://www.scopus.com/inward/record.url?scp=84894291466&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84894291466&partnerID=8YFLogxK

U2 - 10.1093/rheumatology/ket378

DO - 10.1093/rheumatology/ket378

M3 - Article

C2 - 24273022

AN - SCOPUS:84894291466

VL - 53

SP - 502

EP - 511

JO - Rheumatology

JF - Rheumatology

SN - 1462-0324

IS - 3

M1 - ket378

ER -