OP0252 Organ damage progression and long-term safety of belimumab (BEL) in patients with systemic lupus erythematosus (SLE): an extension of pivotal phase 3 bliss studies
Authors: R.F. Van Vollenhoven, S.V. Navarra, R.A. Levy, M. Thomas, A. Heath, T. Lustine, A. Adamkovic, J. Fettiplace, M.L. Wang, B. Ji, D. Roth
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Non-United States completers of the Phase 3 BLISS-52 (BEL110752) and BLISS-76 (BEL110751) studies could continue treatment with BEL. <h3>Objectives</h3> To evaluate long-term safety, tolerability and organ damage progression in patients with SLE treated with BEL. <h3>Methods</h3> In this multicentre, open-label long-term study (BEL112234/NCT00712933), patients received intravenous BEL every 4 weeks, plus standard SLE therapy. Safety was assessed at each visit. Organ damage (Systemic Lupus International Collaborative Clinics/American College of Rheumatology Damage Index [SDI]) was assessed as a safety endpoint every 48 weeks. The study continued until BEL was commercially available in each patient's country and included an 8 week follow–up period. <h3>Results</h3> In total, 738 patients entered the long-term study and were treated for up to 9 years (3352 patient-years). Of these, 735 (99.6%) received ≥1 dose of BEL; the mean (SD) number of infusions was 56.4 (27.02). The incidence of adverse events (AEs) remained stable or declined over time (table 1). The most common AEs were headache (n=205, 27.9%), nasopharyngitis (n=155, 21.1%), diarrhoea (n=143, 19.5%), arthralgia (n=136, 18.5%) and influenza (n=134, 18.2%). Sixty-nine patients (9.4%) experienced an AE resulting in discontinuation of BEL or study withdrawal. Eleven deaths occurred, one of which (cardiogenic shock) was possibly related to BEL. Three serious AEs of suicide attempt/ideation (0.4%) occurred. The mean (SD) SDI score was 0.6 (1.02) at baseline (prior to the first dose of BEL). At Year 8 87.7% of patients had no change in SDI score from baseline, indicating low organ damage accrual (figure 1). <sup>a</sup>Number of patients; <sup>b</sup>included opportunistic infections, tuberculosis, herpes zoster (recurrent and disseminated) and sepsis; <sup>c</sup>two deaths during post-treatment follow-up. <h3>Conclusions</h3> BEL displayed a stable safety profile with no new safety signals. There was minimal organ damage progression. <h3>Acknowledgements</h3> Study funded by GSK. Emma Hargreaves, MA, Fishawack Indicia Ltd, UK, provided editorial assistance funded by GSK. <h3>Disclosure of Interest</h3> R. Van Vollenhoven Grant/research support from: GSK, Consultant for: GSK, S. Navarra Speakers bureau: GSK, R. Levy Employee of: BLISS-52 investigator and GSK employee since ,<sup><sup>Jan 2018</sup></sup> M. Thomas Grant/research support from: GSK, Consultant for: GSK, A. Heath Shareholder of: GSK, Employee of: GSK, T. Lustine Shareholder of: GSK, Employee of: GSK, A. Adamkovic Shareholder of: GSK, Employee of: GSK, J. Fettiplace Shareholder of: GSK, Employee of: GSK (at the time of study), M. L. Wang Shareholder of: GSK, Employee of: GSK, B. Ji Shareholder of: GSK, Employee of: GSK, D. Roth Shareholder of: GSK, Employee of: GSK