Background Systemic Lupus Erythematosus (SLE) is an autoimmune disease, characterized by periods of remission and flares. Recently, a monoclonal anti-BLyS (B Lymphocyte Stimulator) antibody, Belimumab, has been approved for the treatment of SLE patients with active disease, refractory to conventional therapy. The evaluation of Quality of Life (QoL) is a critical issue in the global assessment of SLE patients, considering the possible influence in the work ability. Recently, LupusQoL questionnaire, specifically designed for SLE patients, has been validated.
Objectives The aim of the present study was to evaluate the effect of Belimumab treatment on QoL of SLE patients.
Methods SLE patients (1997 ACR criteria) candidate to start Belimumab treatment were enrolled. Patients received Belimumab 10 mg/kg at baseline, week 2, 4 and then every 4 weeks. According to study protocol, patients underwent physical examination, laboratory assessment and disease activity evaluation using SLEDAI-2K. All patients fulfilled LupusQoL-Italy  at the baseline (T0), and then at week 4 (T1), 12 (T2), and 24 (T3). The LupusQoL is a self-administered questionnaire, consisting of 34 questions, classified in 8 domains: Physical Health (PH), Pain (P), Planning (PL), Intimate Relationships (IR), Burden to Others (BO), Emotional Health (EH), Body Image (BI) and Fatigue (F). Answers are recorded according to Likert scale, from 0 (always) to 4 (never).
Results Eleven female patients were enrolled (mean age ± SD 41.3±10.1 years; mean disease duration ± SD 21.5±14 years). Table 1 shows mean values for each domain of LupusQoL, at each time-point. A statistically significant improvement in all the items was found at T2 except for IR, BI and F. The items P and EH progressively improved at all the time-points evaluated. Items PH, PL and BO showed an improvement from T0 to T2, not maintained at T3. The items PH, P and BO promptly improved after 4 weeks of treatment.
Conclusions The present study evaluated the effect of Belimumab treatment on QoL of SLE patients using LupusQoL-Italy. After 6 months, most of the items evaluated improved. It is not surprising that the items related with intimate relationship and body image did not improve. Fatigue in SLE is often associated with manifestations including depression and fibromyalgia, which may require a different therapeutic approach.
Conti F, Perricone C, Reboldi G, Gawlicki M, Bartosiewicz I, Pacucci V, Massaro L, Miranda F, Truglia S, Alessandri C, Spinelli F, Teh LS, Ceccarelli F, Valesini G. Validation of a disease-specific health-related quality of life measure in adult Italian patients with systemic lupus erythematosus: LupusQoL-IT. Lupus 2014;23: 743-751.
Disclosure of Interest None declared
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