Brown TM, Olanrewaju B, Deal L, Katz EC, Chiou C, Martin S, Fehnel S. Assessing pruritus among patients with atopic dermatitis: targeted literature and instrument review. Poster presented at the ISPOR 17th Annual International Meeting; June 6, 2012. [abstract] Value Health. 2012 Jun; 15(4):A253.

OBJECTIVES: Pruritus is a key criterion in the diagnosis of atopic dermatitis (AD) and has been associated with lower levels of health-related quality of life in both pediatric and adult patients. The objective of this study was to identify information and instruments relevant to the measurement of pruritus in adolescent and adult AD patients.

METHODS: A PubMed search was conducted to identify relevant literature and existing PRO measures (items, subscales, and instruments) designed to assess the severity, frequency, and/or impact of AD-related pruritus. Articles were limited to studies conducted in humans, published since 2000, and in English. Search terms included atopic dermatitis, itch, and pruritus. In addition to using sources identified during the literature review, a search of published PRO instrument sources (e.g., Patient-Reported Outcome & Quality of Life Instruments Database [PROQOLID]) and the RTI-HS internal PRO instrument repository was conducted. Identified PRO instruments were evaluated based on the criteria described in the Food and Drug Administration’s 2009 guidance on PROs for product label claims.

RESULTS: Literature review results confirmed pruritus is a central feature of AD and affects both daytime functioning and nighttime sleep in many AD patients. In addition, the effective treatment of pruritus represents an unmet need among patients with AD. Nine PRO instruments measuring AD-related pruritus were identified and evaluated. Only one of these measures had been developed exclusively in patients with AD, and none of these measures were developed or evaluated with the scientific rigor outlined in the FDA’s PRO guidance.

CONCLUSIONS: The results of this targeted review indicate the need for new treatments that improve pruritus among patients with AD. In addition, to communicate this treatment benefit, the development of a new AD-related pruritus instrument is warranted in order to more accurately describe the effect of therapy on this important disease symptom.

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