A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept for the treatment of patients with paediatric psoriasis in a naturalistic setting.

BACKGROUND: Psoriasis is a chronic inflammatory skin disorder that affects 125 million people worldwide, with one-third having childhood onset. OBJECTIVES: The PURPOSE study evaluated long-term safety and effectiveness of etanercept in paediatric psoriasis. MATERIALS & METHODS: This observational study enrolled patients with paediatric psoriasis who were prescribed etanercept per routine care in eight EU countries. Patients were followed retrospectively (first dose prior to 30 days before enrolment) or prospectively (first dose within 30 days prior to or any time after enrolment) for five years. Safety endpoints included serious infections, opportunistic infections, malignancies, other serious adverse events (SAEs) and adverse events. Effectiveness endpoints (prospective patients) included treatment patterns, dose change/discontinuation, and physicians' global subjective assessment of change in disease severity from baseline to follow-up. RESULTS: In total, 72 patients were enrolled (32 prospectively, 40 retrospectively), with mean age of 14.5 years and mean disease duration of 7.1 years. No serious or opportunistic infections/malignancies were reported. Psoriasis (n=8) and subcutaneous tissue disorders (system organ class) (erythema nodosum, erythrodermic psoriasis; n=1 for each) were the most frequently reported SAEs, which occurred in six (8.3%) patients with current/recent treatment and four (7.4%) with previous treatment. Of 25 treatment-emergent SAEs, seven (28.0%) were possibly related to etanercept. Assessments of prospective patients revealed that 28 (87.5%) completed 24 weeks, five (15.6%) required at least one subsequent course, and 93.8% experienced decreased disease severity. It is possible that some rare adverse events were not noted in this relatively small sample. CONCLUSION: These real-world data are consistent with the known safety and efficacy profile of etanercept in paediatric patients with moderate to severe plaque psoriasis.

The incident command system in disasters: evaluation methods for a hospital-based exercise.

OBJECTIVES: No universally accepted methods for objective evaluation of the function of the Incident Command System (ICS) in disaster exercises currently exist. An ICS evaluation method for disaster simulations was derived and piloted. METHODS: A comprehensive variable list for ICS function was created and four distinct ICS evaluation methods (quantitative and qualitative) were derived and piloted prospectively during an exercise. Delay times for key provider-victim interactions were recorded through a system of data collection using participant- and observer-based instruments. Two different post-exercise surveys (commanders, other participants) were used to assess knowledge and perceptions of assigned roles, organization, and communications. Direct observation by trained observers and a structured debriefing session also were employed. RESULTS: A total of 45 volunteers participated in the exercise that included 20 mock victims. First, mean, and last victim delay times (from exercise initiation) were 2.1, 4.0, and 9.3 minutes (min) until triage, and 5.2, 11.9, and 22.0 min for scene evacuation, respectively. First, mean, and last victim delay times to definitive treatment were 6.0, 14.5, and 25.0 min. Mean time to triage (and range) for scene Zones I (nearest entrance), II (intermediate) and III (ground zero) were 2.9 (2.0-4.0), 4.1 (3.0-5.0) and 5.2 (3.0-9.0) min, respectively. The lowest acuity level (Green) victims had the shortest mean times for triage (3.5 min), evacuation (4.0 min), and treatment (10.0 min) while the highest acuity level (Red) victims had the longest mean times for all measures; patterns consistent with independent rather than ICS-directed rescuer activities. Specific ICS problem areas were identified. CONCLUSIONS: A structured, objective, quantitative evaluation of ICS function can identify deficiencies that can become the focus for subsequent improvement efforts.