Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: A pooled analysis of two phase 2 clinical trials.

BACKGROUND AND PURPOSE: There is a need for new treatment options for moderate-to-severe atopic dermatitis (AD) in adults. Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, has recently been approved for this indication. METHODS: A pooled analysis of a phase 2a (NCT01548404) and a phase 2b (NCT01859988) study and a subanalysis of the 2b study evaluated the efficacy and safety of subcutaneous dupilumab 300 mg once weekly (qw) and every 2 weeks (q2w) in adults with moderate-to-severe AD. RESULTS: Dupilumab significantly improved clinical outcomes in both analyses at week 12. Itch was significantly improved in the pooled analysis as measured by peak pruritus Numerical Rating Scale, 5-dimension pruritus scale, and SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) pruritus scores (all p < .0001 vs. placebo at week 12). Sleep loss was significantly improved (SCORAD VAS sleep loss score; p < .0001 vs. placebo at week 12); similar results were shown for the q2w dose. Dupilumab had an acceptable safety profile. CONCLUSIONS: Consistent with previous studies, dupilumab qw and q2w significantly improved signs and symptoms of AD at week 12, including improvements in itch and sleep loss. IMPLICATIONS FOR PRACTICE: Subcutaneous dupilumab is an effective new treatment option for adults with moderate-to-severe AD.

Patient and physician perspectives vary on atopic dermatitis.

We compared the written responses of physicians (n=303) and patients (n=961) from a nationwide US survey concerning atopic dermatitis (AD). Physicians, primarily dermatologists, responded to 32 questions, and patients responded to 44 questions about AD and its management. Most physicians and patients were in agreement regarding disease severity, the relative lack of effectiveness of over-the-counter products, concerns about drug adverse effects, and the need for more patient support groups. However, physicians were more concerned about long-term adverse effects than were patients. Additionally, 91% of physicians versus 46% of patients rated prescription medications as "moderately" or "very" effective. Patients were generally pleased with their overall AD-related medical care: 42% were "a lot" or "very" satisfied, while only 8% were dissatisfied. Although physician and patient perceptions sometimes differed, both groups preferred treatments offering greater effectiveness, fewer adverse effects, and greater applicability to the pediatric population.

Prehydration is effective for rapid control of recalcitrant atopic dermatitis.

BACKGROUND: Skin care remains a key component in atopic dermatitis (AD) management; there are no data available guiding optimal bathing recommendations. OBJECTIVE: This study aims to determine whether 15-minute to 20-minute baths followed by topical corticosteroid application (prehydration therapy) are effective for clearing moderate to severe AD. METHODS: In the Oregon Health & Science University outpatient dermatology clinic, a retrospective review was done of the health records of patients with AD seen first between January 1, 2007, and December 31, 2011, who were then reevaluated within 1 to 3 weeks of starting the therapy. Qualifying patients underwent the prehydration regimen and were reevaluated. The primary outcome was therapeutic response using the Investigators' Global Assessment Scale. Secondary outcomes were measured using the dynamic Treatment Response Scale. Of 110 distinct electronic records, 35 patients were excluded. At the initial visit, 75 patients were evaluated with the Investigators' Global Assessment Scale. Forty-eight patients (64%) were severe, and 27 patients (36%) were moderate. All subjects began prehydration therapy followed by topical corticosteroid. At follow-up visit in 1 to 3 weeks when using the patient's or provider's assessment of treatment response, 59 patients (79%) had marked improvement, and 3 patients (4%) were clear. CONCLUSIONS: Prehydration followed by topical corticosteroid therapy seems to be a highly effective regimen that achieves rapid control of moderate to severe disease.

Does food allergy cause atopic dermatitis? Food challenge testing to dissociate eczematous from immediate reactions.

The objective is to evaluate and diagnose, in a controlled setting, suspected food allergy causation in patients hospitalized for management of severe, unremitting atopic dermatitis (AD). Nineteen children were hospitalized at Oregon Health and Science University with atopic dermatitis from 1986 to 2003 for food restriction, then challenge, following standard recommendations. Challenges were prioritized by categories of (a) critical foods (e.g., milk, wheat, egg, soy); (b) important foods; and (c) other suspected foods. Patients were closely observed for evidence of pruritus, eczematous responses, or IgE-mediated reactions. If results were inconsistent, double-blind, placebo-controlled food challenge was performed. A total of 17 children with atopic dermatitis were assessed. Two could not be fully evaluated, thus were excluded from data tabulations. Only one positive eczematous food response was observed of 58 challenges. Three children had well-documented histories of food-induced IgE-mediated anaphylactoid or urticaria reactions to seafood and/or nuts and were not challenged with those foods. Atopic dermatitis, even in the highest-risk patients, is rarely induced by foods. Undocumented assumptions of food causation detract from proper anti-inflammatory management and should be discouraged. Immediate IgE-mediated food reactions are common in atopic dermatitis patients; such reactions are rapid onset, typically detected outside the clinic, and must be distinguished from eczematous reactions. Diagnosis of food-induced eczema cannot be made without food challenge testing. Such tests can be practical and useful for dispelling unrealistic assumptions about food allergy causation of atopic dermatitis.

Patterns of care and referral in children with atopic dermatitis and concern for food allergy.

Although many providers believe that up to 30% of atopic dermatitis (AD) is food induced, food challenge studies show that food-induced eczematous reactions are rare. When food allergy is suggested to cause AD, it often leads to allergy testing with a high false-positivity rate, in turn further focusing parents on food allergy. Study subjects were children less than 11 years old with AD and food allergy suspicion. Prior diagnoses, provider, and testing patterns were assessed by questionnaire given to the parents. Thirty-eight patients with AD were enrolled. Most subject's parents suspected food allergy induced AD. Initial skin diagnoses were made by pediatricians (79%) and family practitioners (18%) as eczema. Allergy was suggested by providers as cause for AD in 63% of the present study's patients. Seventy-nine percent had allergy testing. Greater than 90% of parents claimed their children had food allergy and food-induced AD. Sixty-six percent had positive food allergy tests and 37% had definite history of immediate IgE reactions to food. The majority of this population had allergy suggested as causative for eczema by their primary care provider and were subsequently evaluated by allergist and allergy testing. Consensus about the role of food allergy between the different providers of AD in children would result in more effective, efficient, and less costly health care.