Is adalimumab safe and effective in patients with intestinal Behcet’s disease in real-world practice?

Background/Aims@#The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. @*Methods@#This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. @*Results@#Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). @*Conclusions@#This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Is adalimumab safe and effective in patients with intestinal Behcet’s disease in real-world practice?

Background/Aims@#The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. @*Methods@#This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. @*Results@#Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). @*Conclusions@#This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Novel ic thermometer placed in the uterotubal junction to measure bovine uterine temperature technical note

No se ha reportado adecuadamente el ambiente fisiológico del útero bovino a las limitaciones en la metodología. El objetivo del estudio fue medir la temperatura uterina bovina (UT) con un nuevo termómetro intracorporal (IC). Los datos fueron comparados con la temperaturra rectal (RT) y vaginal (VT) convencional. El IC es un dispositivo alojado dentro de un botón de acero limpio, con 15 mm de longitud, 5 mm de ancho, y con un rango de +15 a +46°C en 0,125 incrementos de °C. Se calibró con un termómetro de mercurio normal y también se puso en correlación con un termómetro rectal instalado con una sonda sensora de temperatura (0,1°C de precisión). UT era medida a intervalos de 20 min durante 4 semanas, mientras RT y VT eran medidas cada 4 h. Once vacas Negras Japonessas, 8 en el verano y 3 en el invierno, se sometieron a secciones de cesárea (CS). Por laparotomía trans-lumbar el IC se instaló en el cuerno uterino izquierdo próximo a la unión del uterotubarica. durante una Cs. Después de grabar durante 4 semanas, el CI fue removido con una 2da CS y el dispositivo se montó en el lector del mismo, en la PC. Los datos acuamulados se analizaron por ANOVA para mediciones repetidas. La temperatura ambiental (AT) se grabó simultáneamente. En 5 vacas, se colectó sangre, diariamente, para determinaciones hormonales (estradiol) y se realizó ultrasonografía para supervisar la dinámica ovárica. La temperatura después de la cirugía fue temporalmente elevada durante 4 días (0,14°C) y se excluyó. Los promedioas en UT, RT y VT en verano (AT: 28,76°C) fueron 38,57 ± 0.23°C , 38,67 ± 0,23°C, 38,60 ± 0,35°C, y en invierno (AT: 14,46°C) fueron 38,63 ± 0,21°C, 38,68 ± 0,21°C, 38,67 ± 0,20°C, respectivamente. UT fue significativamente baja que RT o VT, y UT en el verano fue más baja que en el invierno (P<0,01). Se observó el ritmo diurno en todas las tres temperaturas más bajo a las 08:00 y más alto a las 20:00 hs. En la ovulación, UT en la fase luteal...