Rheumatologists Report Patients’ Concern Over Infection Risk as Primary Barrier to Biologics Usage, According to Study by GfK Market Measures

Despite benefits of biologic therapies in treatment of rheumatoid arthritis, potential risk of infection remains roadblock for many patients; safety is key brand differentiator

EAST HANOVER, NJ, July 2, 2008 — Despite the fact that biologics represent a sea change in medication effectiveness for the treatment of rheumatoid arthritis and other autoimmune disorders, potential safety concerns stemming from increased risk of infection are having a negative influence on patients’ decision to trial the therapy, according to new research by GfK Market Measures. 

Since 1999, the U.S. Food and Drug Administration has issued warnings about the potential for infection and other health risks in patients treated with biologic therapies, including Enbrel, Humira, Orencia, Remicade and Rituxan.  More recently, in May the FDA reinforced this point by elevating the infection risk for Enbrel to black box warning status.  GfK’s recent research with rheumatologists, the primary prescribers of biologic therapies, shows the warnings are having an impact.

Rheumatologists report that each month approximately 10 percent of their patient base is recommended a biologic but chooses not to trial the product.  The top reason for patients declining a biologic, according to rheumatologists, is "concern about safety/risk of infection” (reported by 30 percent of patients), with "high out-of-pocket expense” as the second-most given reason (reported by 24 percent of patients).  Interestingly, up against the perceived risks, rheumatologists report discontinuance of a biologic because of infections constitutes only 16 percent of patients.  In contrast, nearly 50 percent of patients discontinue biologic therapy because of lack of initial efficacy or diminished efficacy.

"Biologics marketers need to be aware of patients’ continued concern of infection risk.  Clearly, long-term safety remains a critically important component of brand success,” said Geoff Penney, vice president and category business leader, autoimmune, GfK Market Measures.  "Better patient support materials and tools to help physicians convince patients of the improved efficacy and slowed disease progression that can be gained from the biologics may help convert these nonadopters.”

Reflecting their own concerns for patients’ safety, rheumatologists rate "safe for long-term therapy” among the top attributes in importance when selecting a biologic (reported by 63 percent), surpassed only by "controls signs and symptoms of RA” (reported by 67 percent) and "inhibits disease progression” (reported by 78 percent).  Interestingly though, "low risk of infection” as an attribute is rated much further down on the list by rheumatologists (reported by only 32 percent).

For patients at risk for infection, Enbrel and Orencia are the preferred therapies (reported by 38 percent and 33 percent of rheumatologists, respectively).

"For some time, Amgen/Wyeth has published clinical trial data reinforcing Enbrel’s long-term safety record.  These efforts have seen success as rheumatologists most associate Enbrel with ‘safe for long-term therapy,’” said Mr. Penney.  "Orencia is a relative newcomer to this market and although generally a third-line treatment option, it has made inroads as a second-line therapy and distinguishes itself most by a strong association with ‘low risk of infection.’”

259 Physicians Share Their Insights

Reflecting insights from 259 physicians including rheumatologists, internists and general/family practitioners, fielded via Internet questionnaire in April 2008, GfK Market Measures’ 2008 Treatment of Rheumatoid Arthritis Study provides a comprehensive analysis of the rheumatoid arthritis market from the perspective of treating physicians.