PARIS – Belimumab produced significant clinical improvement in 74% of patients with systemic lupus erythematosus who took it over a 6-month period, reducing disease symptoms and steroid use and significantly improving quality of life.
Results from the multicenter German OBSErve study paralleled – and even exceeded – those of the BLISS randomized trials, Dr. Andreas Schwarting said at the annual European Congress of Rheumatology.
Michele G. Sullivan/Frontline Medical News
Dr. Andreas Schwarting
"OBSErve data suggest even greater improvements and lower discontinuation rates in real-world practice," said Dr. Schwarting of the Johannes Gutenberg University of Mainz (Germany). "We also saw a lower discontinuation rate than in the BLISS trials, and our study shows that you can identify responders well within 6 months."
Dr. Schwarting was the lead author of the retrospective, observational study , which included 102 patients with active lupus who were treated with open-label belimumab (Benlysta) over a 6-month period. Most (85%) had moderate or severe disease, and 80% had been on four to five different lupus medications before starting belimumab. The most common reasons for starting belimumab were ineffective prior treatment (88%), worsening disease (61%), and the need to decrease steroid use (40%).
At baseline, the mean steroid dose was 13.7 mg/day; 62% were taking a high dose, with a mean of 17.5 mg/day.
The primary endpoint was overall clinical response after 6 months of treatment. Most (75) had a disease activity improvement of at least 20%, including 35 who had an improvement of up to 49%, 31 with at least a 50% improvement, and 9 with at least an 80% improvement.
Five patients showed no improvement. Two became worse on the medication, and 14 had less than a 20% improvement. Six patients discontinued the drug: three because of disease progression, one because of an allergic reaction, one as a result of a lack of compliance, and one because of heart failure after hospitalization. The patient with heart failure died, but Dr. Schwarting said there was no apparent causal relationship with belimumab.
The improvement occurred in all lupus manifestations, including arthritis (71% response rate), a high level of anti–double-stranded DNA antibodies (50%), low complement levels (34%), fatigue (65%), and rash (62%).
The Systemic Lupus Erythematosus Disease Activity Index scores decreased from a mean of 10.6 to 5.6.
Belimumab exerted a steroid-sparing effect, Dr. Schwarting noted. The mean daily steroid dose decreased from 13.7 mg to 7.6 mg. Among those using more than 17.5 mg/day, the dosage decreased to 8.6 mg/day.
GlaxoSmithKline sponsored the study. Dr. Schwarting said he has received honoraria, consulting, and speakers fees from the company.
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