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Benlysta may reduce risk for organ damage in patients with SLE

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Patients with moderate-to-severe systemic lupus erythematosus who were treated with Benlysta in addition to standard care had a low incidence of organ damage after 5 years, according to recently presented research.

Researchers studied data from 998 patients with systemic lupus erythematosus (SLE) in a modified, intent-to-treat cohort. Mean age was 38.7 years, and mean disease duration was 6.69 years. Mean Systemic Lupus Erythematosus Disease Activity Index (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) was 8.2, and the Systemic Lupus International Collaborating Clinics (SLICC) Damage Index (SDI) was 0.7. Patients received Benlysta (belimumab, GSK) plus standard care every 4 weeks.

After 5 years to 6 years, 403 patients remained in the trial. Among these patients, 343 (85.1%) had no change from baseline in SDI, with 0.19 as the mean increase in SDI. Of the 162 patients with organ damage at baseline, 132 had no change in SDI, and the mean change was 0.23. Of 241 patients without organ damage at baseline, 211 (87.6%) had no change in SDI and the mean change was 0.15, according to the researchers.

Adverse events, including infections, gastrointestinal disorders and opportunistic infections, occurred in 433 patients (43.4%). Four patients had a serious opportunistic infection, and 87 (8.7%) had herpes zoster. Eighty-eight patients discontinued treatment with belimumab due to adverse events. Additionally, 11 deaths occurred during the study, and two deaths occurred following study exit. – by Shirley Pulawski

Reference:

Bruce IN, et al. Paper #OP0186. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosure s : Bruce reports grant/research support from UCB, GSK, Roche, Sanofi. Bruce is also a consultant for UCB, Eli Lilly, GSK, Medimmune and Pfizer; an employee of the University of Manchester; and on the speakers’ bureau for UCB, GSK and Medimmune. Please see the full study for a list of all other authors’ relevant financial disclosures.