Elidel
Pimecrolimus: a review of its use in atopic dermatitis.

Wellington K, Noble S.

Adis International Inc., Yardley, Pennsylvania 19067, USA. demail adis.com

Pimecrolimus (Elidel) is a topically active, nonsteroid, calcineurin inhibitor that has shown efficacy in controlling symptoms of atopic dermatitis in adult and pediatric patients. Topical pimecrolimus 1% cream is approved in the US for the short-term and intermittent long-term treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients aged >/=2 years who do not respond well to, or may have adverse effects with, conventional treatments. Pimecrolimus 1% cream is an effective and well tolerated treatment for atopic dermatitis in infants, children, adolescents, and adults. Pimecrolimus is effective at reducing the incidence of disease flares and, thus, the need for rescue treatment with topical corticosteroids. The drug also improves the health-related quality of life (HR-QOL) of children and adolescents, and improves the QOL of parents of children with atopic dermatitis. Furthermore, pimecrolimus does not cause skin atrophy, a problem commonly associated with topical corticosteroids, and is not associated with clinically relevant systemic adverse events. Thus, topical pimecrolimus 1% cream is an effective treatment option for the management of mild-to-moderate atopic dermatitis.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15663345&dopt=Abstract pimecrolimus Elidel



Elidel
Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome.

Eichenfield LF, Lucky AW, Langley RG, Lynde C, Kaufmann R, Todd G, Lindsley L, Barbier N, Felser JM.

Children's Hospital, San Diego, CA, USA. leichenfield UCSD.edu

BACKGROUND: Pimecrolimus cream 1%, a cell-selective inhibitor of inflammatory cytokines, has been shown to be effective in treating atopic dermatitis (AD). This report examines the effect of ethnic origin and baseline disease severity on treatment outcomes in pediatric patients with AD treated with pimecrolimus cream 1%. METHODS: The analysis included 589 patients aged 3 months to 17 years from three 6-week, randomized, multicenter studies of similar design. Patients were treated with pimecrolimus cream 1% or vehicle twice daily. Efficacy, safety and tolerability in Caucasian and non-Caucasian groups were compared. In addition, the effect of baseline disease severity on treatment outcome was investigated. RESULTS: A total of 321 Caucasian and 268 non-Caucasian patients [Blacks, Asians and others (including Hispanics)] with mild, moderate or severe disease at baseline were included. Baseline characteristics were comparable between the pimecrolimus and vehicle control groups and between Caucasian and non-Caucasian groups. Significantly higher efficacy [measured by Investigators' Global Assessment and Eczema Area and Severity Index (EASI) scores] was achieved in the pimecrolimus-treated group, compared with the vehicle group, irrespective of ethnic origin. Baseline disease severity had no effect on treatment outcome: patients with both mild and moderate AD responded well to pimecrolimus (absolute change from baseline in EASI score -2.60 and -5.48, respectively; both P < 0.001). Pimecrolimus cream 1% was safe and well tolerated in all ethnic groups and at all levels of disease severity. CONCLUSIONS: Ethnic origin and baseline disease severity had no effect on treatment outcome with pimecrolimus cream 1% in patients with AD.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15663667&dopt=Abstract pimecrolimus Elidel



Elidel
Formulary review of therapeutic alternatives for atopic dermatitis: focus on pimecrolimus.

Weinberg JM.

Department of Dermatology, St. Luke's-Roosevelt Hospital Center, 1090 Amsterdam Ave., Suite 11D, New York, NY 10025, USA. jmw27 columbia.edu

OBJECTIVE: Atopic dermatitis (AD), often called eczema, is characterized by intense pruritus, erythema, dry skin, and inflammation. The condition is chronic and relapsing, and often occurs in patients with a family history of the atopic triad (asthma, allergic rhinitis, and AD). Use of topical steroids has been the mainstay of medical treatment for AD. Steroid-free treatments for AD, with a more favorable safety profile, have become available within the past 2 years. Tacrolimus ointment, a topical immunomodulator, became available in early 2001 and is indicated for moderate-to-severe AD. A similar but highly skinselective cytokine inhibitor, pimecrolimus cream 1%, became available in March 2002. Pimecrolimus is indicated for mild-to-moderate AD. The objective of this article is to review the key characteristics that differentiate pimecrolimus from steroids and tacrolimus in the treatment of AD. METHODS: Using secondary resources, the clinical aspects and conventional treatment strategies for AD are reviewed as are the pivotal clinical studies with pimecrolimus and literature on quality of life and economic burden of disease for AD patients and families. SUMMARY: Pimecrolimus is an effective, steroid-sparing therapy for mild-tomoderate AD. Early treatment prevents flares, the agent works quickly to reduce signs and symptoms of more advanced AD, and it is safe and appropriate for intermittent long-term therapy. Pimecrolimus has fewer side effects than topical steroids and a better side-effect profile than tacrolimus. It can also be used as a first-line therapy. In studies with patients aged 2 to 17 years, it has been shown to be particularly effective in improving eczema of the face and neck, and its use may improve quality of life for many patients, especially children. A single-strength dose (1%) is safe and medically beneficial for pediatric, adolescent, and adult patients. The direct drug cost of pimecrolimus compares favorably with tacrolimus, but it is significantly more expensive than generic topical steroid creams.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15667233&dopt=Abstract pimecrolimus Elidel



Elidel
Health plan budget impact analysis for pimecrolimus.

Chang J, Sung J.

Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080, USA. jane.chang pharma.novartis.com

OBJECTIVE: Budget impact models are useful tools for managed care organizations to make drug formulary decisions. The objective of this study was to estimate the incremental budgetary change in per-member-per-month (PMPM) medical and pharmacy costs for atopic dermatitis (AD) or eczema after the introduction of pimecrolimus cream 1%, a topical calcineurin inhibitor. METHODS: Estimates of the percentage of patients seeking care, treatment patterns, and quantities of medications dispensed for AD were measured using 2001 and 2002 medical and pharmacy records in a proprietary database for health plans distributed throughout the United States. Approximately 2.5 million health plan members had continuous health insurance coverage during the study period. Costs for medications were assigned using the 2003 wholesale acquisition cost, and costs for physician visits were based on average 2003 Medicare reimbursement rates. Efficacy data from clinical trials were used to model the impact of pimecrolimus on subsequent physician visits. Sensitivity analyses were performed to evaluate the impact of varying the percentage of patients seeking care, practice patterns, medication quantities, percentage of pimecrolimus users, and levels of patient cost sharing. RESULTS: The estimated percentage of health plan members seeking care for AD in 2001 was 3.2%. The estimated total cost PMPM for AD treatment prior to introduction of pimecrolimus was 0.362 dollars for all covered lives, assuming no patient cost sharing. In the year after its introduction, 5.2% of the AD population filled a prescription for pimecrolimus. The incremental increase in pharmacy benefit cost was 0.008 dollars PMPM in 2003 dollars, but the total incremental medical and pharmacy cost was 0.002 dollars PMPM after accounting for the projected reduction in physician visit costs, representing a 0.7% increase in all AD-related costs. Based on sensitivity analyses, the incremental total cost PMPM after the introduction of pimecrolimus ranged from -0.004 dollars to 0.026 dollars. CONCLUSION: Using claims data for the medical treatment of AD in 2001-2002 and the utilization of pimecrolimus, the addition of pimecrolimus as a treatment option for AD had a minimal impact on PMPM costs for AD-related care in 2003 dollars. As with all pharmacoeconomic models, health plans should perform their own budget forecasting using assumptions derived from their own pharmacy and medical claims data.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15667234&dopt=Abstract pimecrolimus Elidel