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Primary Outcome Esophageal eosinophil count: P < .0001 for both dose groups Key Secondary Outcome Dysphagia clinical symptom frequency and severity (DSD): Not statistically significant for both dose groups Safety Assessment AEs All low frequency Headache Upper respiratory tract infection Arthralgia Nasopharyngitis Diarrhea Nausea SAEs All unrelated to treatment RPC4046 180 mg or 360 mg treatment for 16 weeks See editorial on page 545. BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is a chronic, esophageal, type 2 inflammatory response associated with increased serum levels of interleukin 13 (IL13), which might contribute to its pathogenesis. RPC4046, a recombinant humanized monoclonal antibody against IL13, prevents its binding to the receptor subunits IL13RA1 and IL13RA2. We performed a phase 2 trial to evaluate the efficacy and safety of RPC4046 in patients with EoE. METHODS: We performed a multicenter, double-blind trial of 99 adults with active EoE randomly assigned (1:1:1) to groups given RPC4046 (180 or 360 mg) or placebo once weekly for 16 weeks, from September 2014 through December 2015. Patients were seen at day 1 (baseline) and weeks 2, 4, 8, 12, and 16. They underwent esophagogastroduodenoscopy and biopsies were collected at baseline and week 16. Patients completed a daily dysphagia symptom diary through week 16 and patient-reported outcome data were collected. The primary outcome was change in mean esophageal eosinophil count in the 5 high-power fields (hpfs) with the highest level of inflammation. RESULTS: At week 16, mean changes in esophageal eosinophil count per hpf were a reduction of 94.8 ± 67.3 in patients who received 180 mg RPC4046 (P < .0001) and a reduction of 99.9 ± 79.5 in patients who received 360 mg RPC4046 (P < .0001) compared with a reduction of 4.4 ± 59.9 in patients who received placebo. The 360-mg RPC4046 group, compared with the placebo group, showed significant reductions in validated endoscopic severity score at all esophageal locations (P < .0001), validated histologic grade and stage scores (both P < .0001), and clinician's global assessment of disease severity (P ¼ .0352); they had a numerical reduction in scores from the dysphagia symptom diary (P ¼ .0733). Significant reductions in esophageal

Factor analytic studies of the State-Trait Anxiety Inventory (STAI) have provided support for the concepts of state and trait anxiety. This article reports the factor structure of the STAI (Form X) using 205 panic-disordered patients with and without agoraphobia. Results show that a two-factor oblique solution is the most appropriate, accounting for 41.1 per cent of the variance. Eighteen of the A-State items had salient loadings on factor 1 (state anxiety) and all 20 of the A-Trait items had salient loadings on factor 2 (trait anxiety). This study demonstrates the utility of the STAI in measuring anxiety in clinical populations and further supports the theoretical distinction between state and trait anxiety.

Non-compliance with drug treatment is widespread. When patients are given medication by their doctors, nearly half do not take the drug or do not take it as prescribed, and most will stop the treatment as soon as they are feeling better. A major problem in identifying the non-compliant patient is the unreliability of many of the measures used for assessing compliance. There are few social and demographic characteristics associated with non-compliance. The type of disease, also, generally has little influence on the level of compliance. Psychological factors such as the patients' levels of anxiety, motivation to recover, attitudes towards their illness, the drug and the doctor, as well as the attitudes and beliefs of significant others in their environment do influence the patients' levels of compliance. Many of the factors that are related to non-compliance with drug regimens are within the control of health care professionals. Contrary to the beliefs of many doctors, studies do not support the view that drug non-compliance is a deviant form of behaviour influenced by patient characteristics.