For Moderate to Severe Systemic Lupus Erythematosus, Epratuzumab Has the Potential to Offer Improvements over IV Belimumab in Health-Related Quality of Life and Time to Response

BURLINGTON, Mass., April 28, 2014 /PRNewswire/ -- Decision Resources Group finds that surveyed U.S. and EU5 rheumatologists agree that new therapies for the treatment of moderate to severe systemic lupus erythematosus (SLE) that offer improved effect on disease activity and renal organ domain scores over current therapies would be well received and poised for strong uptake. This finding reflects thought leader opinion that IV belimumab (GlaxoSmithKline's Benlysta) offers only modest efficacy on these attributes, while therapies typically used to treat moderate to severe renal manifestations are associated with a risk of serious side effects that limit their widespread use in patients with early stage renal involvement. Based on currently available clinical data and thought leader opinion, UCB's emerging therapy epratuzumab has the potential to offer improvements over belimumab in health-related quality of life and time to response, as well as an acceptable safety profile.

Other key findings from the DecisionBase 2014 report entitled Systemic Lupus Erythematosus: Significant Market Opportunity Awaits Therapies Offering Improvements in Efficacy over IV Belimumab for the Moderate to Severe Patient Segment:

• Lupuzor, epratuzumab, blisibimod: According to clinical data, emerging therapies rigerimod (ImmuPharma's Lupuzor, P140), epratuzumab and Anthera Pharmaceuticals' blisibimod may offer improved efficacy in disease activity over belimumab, with the latter agent specifically targeting the severe SLE patient segment; however, thought leaders are waiting for additional data to differentiate these agents from belimumab.
• Unmet need: In addition to improvements in efficacy, surveyed rheumatologists identify notable unmet need for therapies associated with a lower risk of serious infections. While thought leaders perceive that belimumab carries a relatively low risk, mycophenolate mofetil (Roche/Galenica's CellCept, generics) and rituximab (Biogen Idec/Roche/Genentech/Chugai/Zenyaku Kogyo's Rituxan, Roche's MabThera) are associated with higher risk of serious infections. To date, epratuzumab carries a similar risk as belimumab based on pooled safety data from completed and ongoing trials.
• Formulary inclusion: Surveyed U.S. managed care organization (MCO) pharmacy directors are receptive to new therapies that offer improved patient response rate on a composite index, with 85 percent willing to reimburse therapies offering improvement over belimumab even if priced at a greater than 5 percent premium to belimumab.

Comments from Decision Resources Group Analyst Alexandra Makarova, M.D., Ph.D.:

• "In light of the modest efficacy offered by the approved agent IV belimumab, and the safety concerns surrounding 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, emerging agent epratuzumab has the potential to fulfill these unmet needs."
• "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."

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SOURCE Decision Resources Group