An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients / 결핵및호흡기질환

Background@#Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. @*Methods@#This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 μg/25 μg) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician’s evaluation (effective, ineffectiveo change, worsening, indeterminable) and lung function improvement. @*Results@#Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. @*Conclusion@#This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

Sensitization to animal allergens and allergic symptoms during exposure to them in Korean veterinary researchers

PURPOSE: Veterinary researchers are exposed to variable animal allergens. However, sensitization to them and allergic symptoms during exposure to them in this group are not sufficiently evaluated worldwide, especially in Korea. The objective of this study is to evaluate sensitization to animal allergens and allergic symptoms during exposure to them in Korean veterinary researchers. METHODS: Thirty-two veterinary researchers who participated in the 2016 annual symposium of the Korean Society of Veterinary Science were asked to answer questionnaires regarding allergic symptoms during animal exposure and underwent skin prick tests for animal allergens. Animal allergens consisted of chicken feather and 10 mammals, epithelia as well as cow's milk, hen's egg, and 7 animal types of meat. RESULTS: There were 13 subjects who complained of allergic symptoms during exposure to certain animal epithelia and 19 who did not. Between the 2 groups, there were no differences in age, sex, underlying allergic disease, family history of allergy, current occupation and its duration, numbers and specie of contact animals, or daily contact time. Meanwhile, the sensitization rates to mouse, horse, rabbit, and guinea pig were significantly higher in the symptomatic group. Rhinoconjunctivitis symptoms were the most common allergic symptoms related to animal exposure were most common followed by dermatologic symptom, and symptom of lower respiratory tract. CONCLUSION: We found that sensitizations to some animal epithelia were more frequent in Korean veterinary researchers with allergic symptoms during exposure to animal compared to those without it, and their most common symptoms were rhinoconjunctivitis symptoms.

A Successful Planned Pregnancy and Delivery with Eculizumab Maintenance in a Woman with Paroxysmal Nocturnal Hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH) is a hematologic disorder characterized by complement-mediated hemolysis leading to severe complications, such as life threatening thrombosis. Eculizumab, a humanized anti-C5 monoclonal antibody, has dramatically improved outcomes of patients with PNH. Despite this new revolutionary treatment, clinical information regarding eculizumab use in pregnant women with PNH is limited. A 30-year-old female with PNH underwent acute aggravation of PNH presented with acute kidney injury (AKI) triggered by an infectious event. After the stabilization of AKI with supportive care and later continuous eculizumab use, a planned pregnancy was attempted and achieved because she and her spouse wanted to have a baby. We monitored the patient carefully throughout her pregnancy with 100 mg/day of aspirin and the maintenance of 900 mg of intravenous eculizumab every 2 weeks. She remained stable during pregnancy and a successful delivery was achieved without maternofetal complication.