A retrospective chart review paints a glowing portrait of the effects of belimumab in patients with systemic lupus erythematosus (SLE). The biologic medication was associated with significant reduction in disease severity and glucocorticoid dose, according to the researchers.
“Over 80% of patients receiving belimumab for 6 months as part of clinical practice experienced a ≥20% improvement in physician-assessed disease severity and almost 60% received a ≥50% improvement in physician-assessed disease severity,” Zahi Touma, MD, PhD, Rheumatologist, Toronto Western Hospital, Ontario, and colleagues found.
The OBSErve Canada Study
As part of this OBSErve Canada multicenter study, the investigators parsed the medical records of 52 patients with SLE treated for their condition. Specifically, the study authors focused on adults with SLE who had received, as part of their usual care, ≥8 belimumab infusions.
Among the 52 patients included in the analysis, 94.2% were women; 40 patients had moderate disease, 9 had severe disease, and 3 had mild disease. Most of the patients had been diagnosed with SLE at least a decade earlier, and were also taking glucocorticoids concomitantly, with a mean prednisone equivalent dose of 13.6 mg/day. Reasons for starting belimumab treatment included lack of response to—or not tolerating—the previous treatment, decreased use of glucocorticoids, and worsening health. The investigators also determined SLE severity at the time of belimumab initiation.
Observed Improvements in Disease Severity
The percentage of improvement was determined based on physician global assessment. After 6 months of treatment, 81% of patients had ≥20% clinical improvement, whereas 58% and 17% had ≥50% or an 80% improvement, respectively. The trend was similar in patients with mild, moderate, or severe SLE. At 6 months, there was also a trend toward a lower number of patients taking glucocorticoids, and taking lower doses of them. Thirty-nine (75%) of the 51 patients were continued on glucocorticoids, and the mean dose had dropped 44% from 13.5 mg to 7.8 mg per day. The investigators highlighted the fact that the mean dose reduction among patients, who at baseline were taking ≥7.5 mg/day of glucocorticoids, fell from 17.8 mg/day to 9.6 mg/day.
“We are currently working on the data and I hope in 2 months we will have the manuscript ready,” lead investigator Dr Touma wrote in an e-mail to Value-Based Care in Rheumatology when asked when more detailed information on the statistical analyses would be available.
24-Month Data Available
Data recently published evaluated 24-month results from the OBSErve study (Lupus Sci Med. 2016;3:e000118. The study included 501 patients with a mean age of 43.3 years; 98% of patients had moderate-to-severe disease activity at baseline. Physician-assessed change in SLE was the primary outcome of the study. Change in steroid use, laboratory tests, and healthcare resource utilization were also evaluated. At the end of the study period, data were available for 277 patients. Overall, the authors found that patients with SLE who received belimumab plus standard of care for up to 24 months had improvements in disease severity and laboratory values, as well as a reduction in steroid use and healthcare resource utilization as early as 6 months.
- Touma Z, et al. Disease severity and glucocorticoids reduction in systemic lupus erythematosus patients receiving belimumab in clinical practice settings: results from OBSErve study in Canada. Presented at: The 2016 Canadian Rheumatology Association Annual Scientific Meeting; February 17-20, 2016 Lake Louise, Alberta. Abstract 112.