$156 Abstracts J ALLERGY CLIN IMMUNOL FEBRUARY 2003 47 Physical and Psychosocial Functioning of Children with Atopic Dermatitis A. S. Kaugars, M. D. Klinnert, M. Price, M. L. Polintan, IF. M. Atkins, D. L. Bratton; National Jewish Medical and Research Center, Denver, CO. RATIONALE: There is a dearth of information available about the impact of pediatric atopic dermatitis (AD) on child and family functioning. METHODS: Parents of 39 children receiving treatment for AD in a mul- tidisciplinary day treatment program participated. Upon program entry, parents answered the standardized, well-validated Child Health Question- naire (CHQ-PF50) and questions specific to AD (eg, time spent caring for AD, extent of child's itching). RESULTS: The majority of parents reported spending a great deal of time caring for their child's AD (42% spent 11-20 hrs/wk; 46% spent 21+ hrs/wk). Parents of young children ( 1-5 years; n= 13) rated their children's skin as significantly more itchy than parents of older children (6-17 years; n=26; p<.05). Means of CHQ-PF50 scale scores were compared with norms of children with diagnosed asthma using Wilcoxon Signed-Rank tests. Parents of children with AD rated child and family functioning as significantly more impaired on 9 of 12 scales assessing limitations in social activities, general health perceptions, bodily pain, parental impact of time, parental emotional distress, self-esteem, and mental health. Par- ents who rated their children's skin as more itchy reported more distress (r=-.51, p<.01) and rated their children as having more bodily pain and discomfort (r=--.57, p<.01) on the CHQ. CONCLUSIONS: Given the significant distress and limitations in phys- ical and psychosocial functioning experienced by children with AD and their parents, multidisciplinary interventions are indicated to address the many facets of functioning affected by AD. Measures in the present study will be used to assess treatment outcomes. Funding: Scholl Foundation 348 Patients with Severe Atopic Dermatitis Benefit from Tacrolimus Ointment Monotherapy L. Schneider ], W. Berger2, M. Rico3; ]Allergy and Immunology Pro- gram, Children's Hospital, Harvard Medical School, Boston, MA, 2South- ern California Research Center, Mission Viejo, CA, 3Fujisawa Healthcare, Inc, Deerfield, IL. RATIONALE: To evaluate the efficacy and safety of tacrolimus oint- ment monotherapy in adult and pediatric patients with severe atopic der- matitis (AD). METHODS: Data from two large, open-label, non-comparative, multicen- ter studies were retrospectively analyzed to assess the efficacy and safety of tacrolimus ointment when applied twice daily in the severe AD population. RESULTS: A total of 4,396 patients are included in the data analyses: 56% were 2-15 years of age. The mean percentage body surface area (%BSA) affected at baseline was 50%. The mean treatment duration was 264 days (range 1 to 1183 days). A total of 2,792 cases (64%) were fol- lowed until study completion. There was a 51% reduction from baseline in the %BSA affected at Month I and a 71% decrease at Month 12. Study drug related adverse events included transient, mild skin burning and pru- ritus, which were of short duration and decreased in prevalence with con- tinued use. Patients rarely discontinued due to an adverse event (6%) or lack of efficacy (5%). Improvement of AD was rapid, continuous and maintained. The incidence rates of flu-like symptoms and headache were consistent with expected rates in the general population: skin infections, including herpes simplex and warts, was comparable to or lower than that previously reported in patients with AD. CONCLUSIONS: Even in AD patients with severe disease, tacrolimus ointment monotherapy has a rapid onset of action, leads to continuous improvement and sustained disease control, and presents an excellent safety profile with a low incidence of adverse events. Funding: lndusto, 349 Tacrolimus Ointment Monotherapy ,sa Safe and Efective Treatmentfor Mild Atopic Dermatitis J. M. Spergei l, B. M. Prenner 2, J. Rico3; ]Children's Hospital of Philadelphia, Philadelphia, PA, 2Allergy Associates Medical Group, lnc, San Diego, CA, 3Fujisawa Healthcare, Inc, Deerfield, IL. RATIONALE: To evaluate the safety and efficacy of tacrolimus oint- ment monotherapy in adult and pediatric patients with mild atopic der- matitis (AD). METHODS: Data from two large, open-label, non-comparative, multicen- ter studies were retrospectively analyzed to assess the safety and efficacy of tacrolimus ointment when applied twice daily in the mild AD population. RESULTS: A total of 404 patients are included in the data analyses; 43% were children 2-15 years of age. The mean percentage body surface area (%BSA) affected at baseline was 6%. The mean treatment duration was 272 days (range 1 to I 169 days). A total of 240 cases (59%) were followed until study completion. Patients rarely discontinued due to an adverse event (5%) or lack of efficacy (5%). There was a 46% decrease from base- line in the mean %BSA affected at Month 1 and a 67% decrease at Month 12. Improvement of AD was rapid, continuous and maintained. Study drug related adverse events included transient, mild skin burning (15%) and pruritus (17%) whose prevalence decreased with continued use. There were no reports of skin atrophy or striae at the application site. Incidence rates of flu-like symptoms and headache were consistent with expected rates in the general population over this length of time. CONCLUSIONS: Tacrolimus ointment monotherapy of mild AD in pediatric and adult patients has a rapid onset of action and leads to con- tinuous improvement and sustained disease control. The tacrolimus oint- ment safety profile is benign in patients with mild disease, and is without evidence of skin atrophy. Funding: FujisawaHealthcare, Inc 50 The Effect of Pimecrolimuson Prick Skin Testing E. E. Chang l, J. M. El-Dahr2; IClinical Immunology, Allergy and Rheumatology, Tulane University Health Science Center, New Orleans, LA, 2Section of Clinical Immunology, Allergy and Rheumatology, Tulane University Health Science Center, New Orleans, LA. BACKGROUND: Skin testing is an indispensable tool for the evaluation of patients with atopic dermatitis, because allergens are known to cause eczema exacerbations. Topical steroids are often used in the treatment of atopic dermatitis, but they are known to suppress response to skin testing. Pimecrolimus, an ascomycin derivative used to treat inflammatory skin diseases, suppresses the production of inflammatory cytokines by selec- tively inhibiting T-cell activation in the skin. It has been approved tbr the treatment of atopic dermatitis. Pimecrolimus has less side effects than cor- ticosteroid creams but its effect on skin testing has not been determined. OBJECTIVE: To determine the effect of pimecrolimus on skin testing. METHODOLOGY: After Investigational Review Board approval, sev- enteen healthy adults with rhinitis but no other medical problems were prick skin tested, duplicated on both arms, to common aeroallergens, his- tamine and saline. Fifteen subjects had positive skin tests to one or more aeroallergens. These atopic subjects applied pimecrolimus twice a day to their right forearm for two weeks. After two weeks, the skin testing to aeroallergens was repeated on both arms. RESULTS: The skin test results were unchanged by the use of pime- crolimus. There was no difference in the reactivity level of skin testing noted on either ann before or after application of pimecrolimus for two weeks. CONCLUSIONS: Unlike topical steroids, pimecrolimus does not alter the response to allergy skin testing. Pimecrolimus offers effective therapy for atopic dermatitis without limiting the appropriate evaluation of this disease. Funding: Self-funded 351 Atopic Eczema/Dermatitis Syndrome in South Europe--How Important is FoodAllergy? S. Prates, E. Pargana, M. Borrego, S. Oliveira, C. Santa-Marta, J. Rosa- do-Pinto; Immunoallergy Department, D. Esteffinia Hospital, Lisbon, PORTUGAL. INTRODUCTION: Atopic dermatitis (AD) is a chronic cutaneous