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AB0633 Epratuzumab-treated SLE patients report improvements in health-related quality of life: Interim results from a us open-label extension study
  1. V. Strand1,
  2. K. Kalunian2,
  3. D.J. Wallace3,
  4. K. Hobbs4,
  5. B. Kilgallen5,
  6. E. Nikaï6,
  7. W. Wegener7
  1. 1Stanford University, Palo Alto
  2. 2UCSD School of Medicine, La Jolla
  3. 3Cedars-Sinai Medical Center, Los Angeles
  4. 4Denver Arthritis Clinic, Denver
  5. 5UCB Pharma, Smyrna, United States
  6. 6UCB Pharma, Brussels, Belgium
  7. 7Immunomedics Inc, Morris Plains, United States

Abstract

Background Epratuzumab, an anti-CD22 monoclonal antibody, is in development for the treatment of systemic lupus erythematosis (SLE). SL0006 is an ongoing, open-label extension study following the randomized double blind ALLEVIATE trials, which were prematurely terminated due to interruption of drug supply.1Assessment of health-related quality of life (HRQoL) alongside measures of disease activity and damage provides a more comprehensive view of therapeutic responses,2 and is recommended in SLE clinical trials.3

Objectives To assess the effect of epratuzumab on HRQoL in SL0006 using SF-36.

Methods All patients enrolled in ALLEVIATE US sites who received randomized treatment (n=60) were eligible for enrolment in SL0006, subject to physician judgment. Twenty-nine patients (90% female, 79% Caucasian, mean age 40 years) entered SL0006, having received placebo (n=8), 360 (n=17) or 720 (n=4) mg/m2 epratuzumab during ALLEVIATE. In SL0006, all patients received 12-week cycles of 360 mg/m2 epratuzumab; two infusions on weeks 0 and 1 of each cycle. SF-36 was assessed at screening and every 4 weeks thereafter. This interim analysis extends through 31 Dec 2009, representing a median 120 weeks (range 13–184) of exposure. Data are summarized using descriptive statistics.

Results At ALLEVIATE baseline, SF-36 domain scores were 7.9–48.5 points lower than for age- and gender-matched norms, reflecting the broad impact of active SLE on HRQoL. In ALLEVIATE, patients reported improvements ≥ minimum clinically important differences (MCID) in physical summary (PCS) and four physical SF-36 domain scores. Further improvement in HRQoL was evident early in SL0006 (week 4), and sustained through weeks 44–48 of treatment (Table 1). Scores stabilized during the 2ndyear; further improvements were reported at weeks 96–100, after which numbers of patients were small (n<19). The greatest improvements were observed in the Role Physical, Bodily Pain, General Health and Vitality domains of SF-36. Mean changes from SL0006 entry in Physical Function, Role Physical, Bodily Pain, General Health, Vitality and Social Function domains≥ MCID were reported by week 48 (n=28). Mental Health scores approached norms by week 12 and were maintained thereafter.

Conclusions Patients treated with epratuzumab in SL0006 reported clinically meaningful improvements in HRQoL, sustained over 2 years of treatment.

  1. Strand. Arthritis Rheum 2008;57(Suppl):1086.

  2. Strand et al. Expert Rev Pharmacoecon Outcomes Res 2005;5:317-26.

  3. Strand et al. Expert Rev Pharmacoecon Outcomes Res 2011;11:455-68.

Disclosure of Interest V. Strand Consultant for: UCB Pharma, K. Kalunian Consultant for: UCB Pharma, D. Wallace Consultant for: UCB Pharma, K. Hobbs Consultant for: UCB Pharma, B. Kilgallen Employee of: UCB Pharma, E. Nikaï Employee of: UCB Pharma, W. Wegener Employee of: Immunomedics Inc

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