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AB0511 The effect of milnacipran on fatigue in a clinically stable lupus cohort

Background Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the physical wellbeing and health related quality of life (HRQOL) of patients1. Fatigue occurs in up to 90% of SLE patients and affects their HRQOL2. The purpose of this pilot study is to determine the effect of milnacipran, a norepinephrine and serotonin reuptake inhibitor used to treat fibromyalgia, on fatigue in clinically stable SLE patients with widespread pain (WSP). To date, no clinical trials have demonstrated efficacy for the primary treatment of fatigue and WSP in adult SLE patients. Objectives The objective is to determine the effect of milnacipran on fatigue in a clinically stable lupus cohort. Methods SLE patients, 18 years and older, with fatigue, WSP and on more than 4 weeks of stable therapy were recruited for a 15 week prospective, double-blind, placebo-controlled study. Patients were randomised at a 1:1 ratio to receive 14 weeks of milnacipran 50–100 mg twice a day or placebo. Disease activity was measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Measurements of fatigue, pain and a patient’s general impression of change from baseline were assessed at baseline and week 14 using the Fatigue Severity Scale(FSS), the Short-Form McGill Pain Questionnaire (SF-MPQ)3, and the Patient’s Global Impression of Change (PGIC) respectively. Results A total of 14 patients were included in the final analysis with seven patients in each group. Upon entry and throughout this study, both groups had low disease activity (mean SLEDAI <3.5 at week 0 and week 14). Fatigue as measured by FSS in the intervention group improved from 5.70 at week 0 to 5.14 at week 14 and improved in the placebo group from 5.90 to 5.59 respectively (Delta=0.56, 0.31 for the intervention and placebo group, respectively, p=0.70). Pain as measured by the SF-MPQ changed in the treatment group from 20.80 at week 0 to 18.80 at week 14, and in the placebo group from 15.40 to 13.2 respectively (Delta=2.00, 2.20 for the intervention and placebo group, respectively, p=0.97). The patient’s Global impression of change was greater in the intervention group than the placebo group (0.67, 0.49, p=0.21). Conclusions Although results were not significantly different in this pilot study, improvement in fatigue and the patient’s impression of global change appeared to be greater in the intervention group than the placebo group even though lupus activity remained low in both groups and the difference in pain between the two groups were nearly identical. Therefore, milnacipran may improve fatigue independently of disease activity and pain in lupus patients. Future randomised controlled trials of the drugs effect with larger cohorts are needed to confirm these findings. References [1] Kuriya B, et al. Arthritis and Rheum. 2008;59(2):181–5. [2] Abina-Zubieta JA, etal. Arthritis and Rheum. 2007;56(8): 1348–1357. [3] Burckhardt CS, Jones KD. Arthritis and Rheum. 2003; 49(5S): S96-S104. Acknowledgements Kendall Boyd, PhD, Loma Linda University Allergan/Forest Laboratories Disclosure of Interest E. Katsaros Grant/research support from: Allergan/Forest Laboratories, F. Dong: None declared, I. Moldovan: None declared