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.
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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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