Comparative effectiveness of less commonly used systemic monotherapies and common combination therapies for moderate to severe psoriasis in the clinical setting.

BACKGROUND: The effectiveness of psoriasis therapies in real-world settings remains relatively unknown. OBJECTIVE: We sought to compare the effectiveness of less commonly used systemic therapies and commonly used combination therapies for psoriasis. METHODS: This was a multicenter cross-sectional study of 203 patients with plaque psoriasis receiving less common systemic monotherapy (acitretin, cyclosporine, or infliximab) or common combination therapies (adalimumab, etanercept, or infliximab and methotrexate) compared with 168 patients receiving methotrexate evaluated at 1 of 10 US outpatient dermatology sites participating in the Dermatology Clinical Effectiveness Research Network. RESULTS: In adjusted analyses, patients on acitretin (relative response rate 2.01; 95% confidence interval [CI] 1.18-3.41), infliximab (relative response rate 1.93; 95% CI 1.26-2.98), adalimumab and methotrexate (relative response rate 3.04; 95% CI 2.12-4.36), etanercept and methotrexate (relative response rate 2.22; 95% CI 1.25-3.94), and infliximab and methotrexate (relative response rate 1.72; 95% CI 1.10-2.70) were more likely to have clear or almost clear skin compared with patients on methotrexate. There were no differences among treatments when response rate was defined by health-related quality of life. LIMITATIONS: Single time point assessment may result in overestimation of effectiveness. CONCLUSIONS: The efficacy of therapies in clinical trials may overestimate their effectiveness as used in clinical practice. Although physician-reported relative response rates were different among therapies, absolute differences were small and did not correspond to differences in patient-reported outcomes.

Food patch testing for irritable bowel syndrome.

BACKGROUND: The traditional classification of irritable bowel syndrome (IBS) as a functional disorder has been challenged in recent years by evidence of ongoing low-grade gastrointestinal tract inflammation. Inflammation may alter gastrointestinal motility and thus be central to the pathogenesis of IBS. Many foods and food additives are known to cause allergic contact dermatitis. We hypothesize that allergenic foods and food additives may elicit a similar allergic reaction in the gastrointestinal tract, giving rise to symptoms suggestive of IBS. OBJECTIVE: We sought to determine whether skin patch testing to a panel of foods and food additives may identify food allergens that may be responsible for symptoms of IBS. METHODS: We performed skin patch testing to common allergenic foods and food additives on individuals with a history of or symptoms suggestive of IBS. We used patch test-guided avoidance diets to determine whether avoidance alleviates IBS symptoms. RESULTS: Thirty of the 51 study participants showed at least 1 doubtful or positive patch test result. Fourteen of the participants reported symptomatic improvement, ranging from slight to great, upon avoidance of the foods/food additives to which they reacted. LIMITATIONS: Double-blind study design, inclusion of only patients with active IBS, larger sample size, more balanced gender distribution, testing of more foods/food additives, and longer duration of and more precise quantification of response to dietary avoidance are suggested for future studies. CONCLUSION: Allergic contact enteritis to ingested foods, food additives, or both may contribute to IBS symptoms. Patch testing may be useful in identifying the causative foods.

Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome.

This study investigated the utility of skin patch testing to identify delayed-type food hypersensitivities that trigger irritable bowel syndrome (IBS) symptoms. Using an extensive panel of type IV food allergens, patch testing was performed on individuals with IBS symptoms, after which patch test-directed avoidance diets were implemented in those patients with patch test reactions. All patients placed on avoidance diets were invited to participate in a questionnaire-based study assessing IBS symptom response to the diet. Primary end points included average abdominal pain during the more than 3-month food avoidance period and degree of improvement in overall IBS symptoms 3 or more months after initiation of the avoidance period. The results from this study add to the expanding body of evidence of a role for delayed-type food hypersensitivities in the pathogenesis of some cases of IBS. Skin patch testing to type IV food allergens offers a new approach to evaluating and managing these patients.

The utility of the TRUE test in a private practice setting.

BACKGROUND: Studies suggest that the Thin-Layer Rapid-Use Epicutaneous Test (TRUE Test) may be inadequate to completely diagnose a significant number of patients with allergic contact dermatitis (ACD). OBJECTIVE: To study the usefulness of the TRUE Test as a triage tool in a private practice setting. METHODS: A retrospective chart review of patients who were patch-tested with the TRUE Test between July 1, 2000, and June 30, 2004, in four private dermatology practices was conducted. RESULTS: Of the 183 patients evaluated, 50.8% had at least one positive reaction, 31.7% had a diagnosis of ACD, and 24.0% were suspected to have ACD from other allergens. Of the patients with positive reactions, 62.4% were determined to have reactions that were of present relevance. CONCLUSIONS: The TRUE Test allows patients with dermatitis to be triaged systematically in a private practice setting. It is important to supplement patch testing with the patients' personal products, especially in cases of facial or periorbital dermatitis, and to be aware of potential false negatives, particularly with fragrance and rubber additives.

Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting.

OBJECTIVE: To compare the effectiveness of biologic systemic therapy, nonbiologic systemic therapy, and phototherapy for treatment of psoriasis. DESIGN: A cross-sectional design was used. SETTING: Ten outpatient dermatology sites across the United States participating in the Dermatology Clinical Effectiveness Research Network contributed to the study. PARTICIPANTS: A total of 713 patients with plaque psoriasis receiving systemic monotherapy (ie, methotrexate sodium, adalimumab, etanercept, or ustekinumab) or narrowband UV-B phototherapy. MAIN OUTCOME MEASURES: The primary outcome of the study was clear or almost clear skin on the Physician Global Assessment scale. Secondary outcomes were score on the Psoriasis Area and Severity Index, affected body surface area, and score on the Dermatology Life Quality Index. RESULTS: The proportion of patients with clear or almost clear ratings on the Physician Global Assessment scale differed among treatments: methotrexate (23.8%), adalimumab (47.7%), etanercept (34.2%), ustekinumab (36.1%), and narrowband UV-B (27.6%) (P < .001). In adjusted analyses, patients receiving adalimumab (relative response rate, 2.15; 95% CI, 1.60-2.90), etanercept (1.45; 1.06-1.97), and ustekinumab (1.57; 1.06-2.32) were more likely to have clear or almost clear skin vs patients receiving methotrexate. Patients receiving phototherapy showed no significant difference (1.35; 95% CI, 0.93-1.96) compared with those receiving methotrexate. No response difference was observed with respect to quality of life. Treatment doses were double the recommended doses in 36.1% of patients taking etanercept and 11.8% of those taking adalimumab;10.6% of patients undergoing phototherapy received the recommended treatment frequency. CONCLUSIONS: The effectiveness of psoriasis therapies in clinical practice may be lower than that reported in previous trials. Although relative differences in objective response rates among therapies may exist, absolute differences are small and may not be clinically significant. Dosing of common therapies varied from trial recommendations. These results provide novel benchmarks emphasizing the critical importance of studying effectiveness in real-world practice.