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FRI0374 Outcomes in Systemic Lupus Erythematosus Patients with High Disease Activity Treated with Belimumab: 18 Month Results from the US Observe Study
  1. C.E. Collins1,
  2. M. Dall'Era2,
  3. C. Macahilig3,
  4. R. Pappu4,
  5. C. Molta4,
  6. H. Kan5,
  7. V. Koscielny6
  1. 1MedStar Washington Hospital Center, Washington
  2. 2University of California, San Francisco
  3. 3Medical Data Analytics, Parsippany
  4. 4GlaxoSmithKline, Philadelphia
  5. 5GlaxoSmithKline, RTP, United States
  6. 6GlaxoSmithKline, Middlesex, United Kingdom

Abstract

Background Certain baseline factors in the BLISS trials were associated with high disease activity and identified as predictors of improved belimumab response.

Objectives We examined clinical effectiveness of belimumab 10 mg/kg plus standard therapy in systemic lupus erythematosus (SLE) patients with high disease activity in US clinical practice.

Methods OBSErve US (BLM117295) is a multicentre, retrospective, medical chart review study. Rheumatologists (n=92) randomly identified SLE patients who had received ≥8 belimumab infusions as part of usual care. Clinical measures were assessed 6 months (m) before belimumab initiation (index date), and every 6 m after, up to 2 years. Primary outcome was physician impression of overall change in SLE disease manifestations every 6 m, relative to the previous timepoint. Post hoc analyses examined three patient subgroups with high disease activity at index date: high anti-dsDNA and low complement (C3/C4); steroid dose ≥7.5 mg/day; SELENA-SLEDAI (SS) >10. Safety was not assessed. We present 18-m results.

Results Of the 501 patient charts examined at 0–6 m, 121 were lost to follow-up/had outstanding data and 46 discontinued by 12 m (multiple reasons permitted: 16 patient request, 12 medication not effective, 9 lack of patient compliance, 8 disease progression, 3 insurance/reimbursement loss, 2 sepsis, 2 depression). 334 patients remained at 12–18 m; at index date 70.7% received steroid doses ≥7.5 mg/day; 53.0% had high anti-dsDNA and low C3/C4; 74.5% of 102 patients with available SS data scored >10. Characteristics across groups at index date appear similar (Table). SLE disease manifestations improved from 12–18 m (Table 1); only changes in the high anti-dsDNA and low C3/C4 subgroup were significantly different vs the remaining sample. Since index date all groups had mean SS score reductions of ≥8.5 at 18 m (in patients with available data) and mean steroid dose reductions of ≥14.9 mg/day (Table 1).

Table 1

Conclusions Based on physician impression, overall clinical response improved from 12–18 m with belimumab plus standard therapy; high anti-dsDNA and low C3/C4 patients had better responses vs the remaining sample.

Disclosure of Interest C. Collins Consultant for: GlaxoSmithKline, M. Dall'Era Consultant for: GlaxoSmithKline, C. Macahilig Grant/research support: GlaxoSmithKline, R. Pappu Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, C. Molta Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, H. Kan Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, V. Koscielny Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline

DOI 10.1136/annrheumdis-2014-eular.4968

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