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Survey: Epratuzumab Tops Belimumab in Treatment of SLE Patients

Unmet needs include improved effect on disease activity

In a new survey conducted by Decision Resources Group, a health care research firm located in Burlington, Mass., surveyed U.S. and E.U. rheumatologists agreed that new therapies for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) that offer an improved effect on disease activity and renal organ-domain scores over current therapies would be well received.

This finding reflects the opinion of thought leaders that intravenous (IV) belimumab (Benlysta, GlaxoSmithKline) offers only modest efficacy on these attributes, while therapies typically used to treat moderate-to-severe renal manifestations of SLE are associated with a risk of serious adverse effects that limit their widespread use in patients with early-stage renal involvement.

Based on currently available clinical data and thought leaders’ opinions, the emerging therapy epratuzumab (UCB) — a humanized monoclonal antibody targeting CD22 receptors on B lymphocytes — has the potential to offer improvements over IV belimumab in health-related quality of life and the time to response, as well as an acceptable safety profile, according to the report.

“In light of the modest efficacy offered by the approved agent IV belimumab, and the safety concerns surrounding the use of rituximab and mycophenolate mofetil, interviewed thought leaders indicate a need for drugs with greater efficacy that are also accompanied by a suitable safety profile. To date, the emerging agent epratuzumab has the potential to fulfill these unmet needs,” said analyst Alexandra Makarova, MD, PhD.

In addition to epratuzumab, clinical data indicate that the emerging therapies rigerimod (Lupuzor, ImmuPharma) and blisibimod (Anthera Pharmaceuticals) may offer improved efficacy in disease activity compared with belimumab, with blisibimod specifically targeting patients with severe SLE. However, thought leaders are waiting for additional data to differentiate these agents from belimumab.

Surveyed rheumatologists identified an unmet need for therapies associated with a lower risk of serious infections. While thought leaders perceived that belimumab carries a relatively low risk, mycophenolate mofetil (CellCept, Roche/Galenica, and generics) and rituximab (Rituxan, Biogen Idec/Roche/Genentech, and MabThera, Roche) are associated with a higher risk of serious infections. To date, epratuzumab carries an infection risk similar to that of belimumab, based on pooled safety data from completed and ongoing trials.

Surveyed pharmacy directors at U.S. managed care organizations (MCOs) were receptive to new therapies that offer an improved patient response rate on a composite index, with 85% willing to reimburse therapies that offer improvement over belimumab, even if they are priced more than 5% higher than belimumab.

“The responses from our survey of MCO pharmacy directors indicate that improved patient response rates on composite indices such as the SLE Responder Index [SRI] represent a valuable attribute for an emerging therapy. Payer opinion likely reflects the fact that SRI response represents several disease activity indices combined into a single end point,” Makarova said.

Source: Decision Resources; April 28, 2014.

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