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Response to Benlysta by patients with SLE varies by age, race subgroups
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Investigators of this study found patients with systemic lupus erythematosus responded variably to treatment with Benlysta and discovered differences in response to treatment by age and race. However, they noted favorable outcomes across racial groups.
Ten rheumatologists were recruited by invitation from nine locations in the United States and one location in Sweden. The physicians conducted evaluations of patients with systemic lupus erythematosus (SLE) treated with Benlysta (belimumab; GlaxoSmithKline). The evaluation included a single-page questionnaire for completion at 3-month intervals.
At baseline prior to the initiation of belimumab, 195 patients with SLE treated with belimumab were enrolled. Of these patients, 92% were women; 29% were black and 11% were Hispanic. Four patients were older than 65 years, and four patients were younger than 18 years at baseline. Investigators found 39 patients had childhood-onset SLE. Four patients were anti-nuclear antibody negative.
Overall, 74% of patients received corticosteroids; 73% received antimalarials; 21% received azathioprine and 34% received mycophenolate mofetil. No patients were treated with cyclophosphamide or Rituxan (rituximab; Genentech), and seven patients received no background medication. Proteinuria was detected in 11% of patients prior to treatment with belimumab.
At 3 months, 52% of patients responded to treatment with belimumab, including 78% of patients with renal involvement, 61% of patients who initiated belimumab for arthritis and 43% of patients with rash. Of 120 patients with available data at 6 months, a clinical response was demonstrated in 51% of patients, including 57% who initiated for renal involvement; 46% who initiated for arthritis and 52% of patients who initiated for rash.
An increase in complement-3 of at least 25% was observed in 68 of 103 patients and anti-dsDNA antibodies were reduced by 25% in 35 of 72 patients at 3 months. The results appeared to be sustained at 6 months.
A greater clinical response was observed among patients who were black, with 82% who demonstrated a response compared with 45% of other patients. Of 21 patients with data available at 6 months, 67% had a positive response to belimumab.
Lupus nephritis and 24-hour proteinuria above 1,000 mg were present in 12 patients at baseline. Of six patients with follow-up data, three patients had a 50% or greater improvement in proteinuria levels.
In patients with childhood-onset SLE, the initiation of belimumab resulted in a clinical response in 41% of patients at 3 months and at 6 months, investigators found 65% of patients with childhood-onset SLE had a clinical response. At 6 months, 45% of patients with adult-onset SLE showed a clinical response. One patient of the four older than 65 years had a response to treatment.
“The higher clinical response rate among black patients, with comparable safety, is reassuring and should help alleviate concerns regarding the use of belimumab in this racial group,” the researchers wrote. “Overall, belimumab appears to be well tolerated; however, caution is advised with its use in patients with SLE who have active neuropsychiatric SLE and/or renal disease until more data are available.” – by Shirley Pulawski
Disclosure s : The researchers report funding from the Systemic Lupus Erythematosus International Collaborating Clinics from GlaxoSmithKline. Please see the full study for a list of all other authors’ relevant financial disclosures.
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