Background Large-scale clinical trials have demonstrated clinical efficacy of belimumab in SLE patients.
Objectives This study examined the clinical outcomes associated with belimumab in clinical practice settings in Germany.
Methods OBSErve (GSK 117214) is a multi-center retrospective medical chart review study. Twenty-one rheumatologists from Germany treating >10 SLE-patients annually and with at least >5 yrs of practice experience were selected for data reporting. Adult SLE patients meeting the ACR classification criteria who received belimumab (10mg/kg) as part of usual care were identified for chart abstraction. Index date was the date of belimumab initiation. The primary outcome measures were the physician assessment of change in SLE disease manifestations from baseline to six months after belimumab initiation, as well as overall clinical response. Reasons for premature treatment discontinuation were collected, and corticosteroid use and dosage within the first six months of belimumab therapy reported.
Results 102 eligible patient charts were abstracted. The mean patient age was 42.5 years, 91% were female; 23.5% were diagnosed with SLE ≤5 years ago; 70% of the patients had low C3 or C4 and 72% high anti-ds-DNA at baseline; 8%, 60% and 25% had mild, moderate and severe SLE at baseline. The top-3 reasons for initiating belimumab (10mg/kg) were an ineffective previous treatment regimen (88%), worsening patient condition (61%), and the intent to decrease corticosteroid use (40%). Among those with at least six months of belimumab treatment (n=96) 78%, 42% and 9% of patients had an overall clinical improvement of ≥20%, ≥50% and ≥80%, respectively. For the most frequent SLE manifestations arthritis, high anti-ds-DNA, fatigue, low complement and rash, physicians observed a ≥50% improvement in 56%, 21%, 25%, 23% and 51% of the patients, respectively. Six months post-index period, 6 patients (6%) had discontinued belimumab due to disease progression/insufficient treatment response (3 patients, week 5, 6, 12), patient request (1 patient) or severe/adverse event (2 patients; suspected allergic reaction; death from heart failure, not related to belimumab). 94% of SLE patients received oral corticosteroids concomitantly. These patients had a mean reduction in corticosteroid dose of 5,8mg/day from 13.6 to 7.8mg/day. Of 62 patients who received a high corticosteroid dose (>7,5mg/d) at initiation, 48% were below this threshold or had discontinued corticosteroids after six months of belimumab treatment.
Conclusions Among SLE patients with at least six months of belimumab in clinical practice in Germany, clinical improvements, including corticosteroid sparing effects, were observed. Belimumab was well-tolerated; only 6 of 102 patients discontinued the treatment within the first six months.
Acknowledgements Research funded by GlaxoSmithKline, UK.
Disclosure of Interest A. Schwarting Consultant for: GlaxoSmithKline, V. Koscielny Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, H. Carnarius Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, C. Cholmakow-Bodechtel: None declared, T. Alexander: None declared, C. Fiehn: None declared, C. Specker Consultant for: GlaxoSmithKline, M. Schmalzing Consultant for: GlaxoSmithKline