Are Biologics Safe in the Immediate Postoperative Period? A Single-Center Evaluation of Consecutive Crohn's Surgical Patients.

BACKGROUND There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn's disease. OBJECTIVE The purpose of this study was to determine differences in the rates of 90-day superficial surgical site infections, intra-abdominal sepsis, and overall postoperative infectious complications among patients who were initiated on or restarted a biologic within 90 days postoperatively compared with those who were not. DESIGN This was a retrospective cohort study. SETTINGS The study was conducted at an IBD referral center. PATIENTS Adult patients with Crohn's disease who received a biologic therapy within 90 days of a major abdominal operation between May 20, 2014, and December 31, 2018, were included. MAIN OUTCOMES MEASURES Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. RESULTS A total of 680 patients with Crohn's disease were included: 351 were initiated on biologic therapy within 90 days after surgery and 329 were not. Patients exposed to biologic therapy postoperatively were younger (p < 0.001), had a lower BMI (p = 0.0014), were less often diabetic (p = 0.0011), and were more often exposed preoperatively to biologics (p < 0.0001) and immunomodulators (p < 0.0001) but not corticosteroids (p = 0.8399). Of those exposed postoperatively, nearly all (93.7%) had been on a biologics preoperatively, and most resumed the same biologic (68.0%). The median time to starting biologic therapy postoperatively was 31 days (range, 7-89 d). Postoperative biologic exposure was not associated with an increased risk of superficial surgical site infection (HR = 1.02 (95% CI, 0.95-1.09) per week; p = 0.59), intra-abdominal sepsis (HR = 1.07 (95% CI, 0.99-1.16); p = 0.73), or overall postoperative infectious complications (HR = 1.02 (95% CI, 0.98-1.07); p = 0.338); the overall rates of each at 90 days was 13%, 8%, and 28%. LIMITATIONS The study was limited by its retrospective design and single-center data. CONCLUSIONS Postoperative initiation or resumption of biologic therapy did not increase 90-day rates of superficial surgical site infection, intra-abdominal sepsis, or total infectious complications after major abdominal surgery for Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B207. ?SON SEGUROS LOS FARMACOS BIOLOGICOS EN EL POSTOPERATORIO INMEDIATO? UNA EVALUACION DE UN SOLO CENTRO DE PACIENTES QUIRURGICOS CONSECUTIVOS CON ENFERMEDAD DE CROHN: No hay ningun estudio hasta la fecha que examine la seguridad de iniciar o reiniciar la terapia biologica despues de una cirugia abdominal mayor en enfermedad de Crohn.Determinar las diferencias en las tasas a 90 dias de infecciones del sitio quirurgico superficial, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales entre los pacientes en que se inicio o reinicio un biologico dentro de los 90 dias despues de la operacion en comparacion con aquellos que no lo recibieron.Estudio de cohorte retrospectivo.Centro de referencia de enfermedad inflamatoria intestinal.Pacientes adultos con enfermedad de Crohn que recibieron una terapia biologica dentro de los 90 dias de una operacion abdominal mayor entre el 20 de mayo de 2014 y el 31 de diciembre de 2018.Infeccion superficial del sitio quirurgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 dias.Se incluyeron un total de 680 pacientes con enfermedad de Crohn: 351 se iniciaron en terapia biologica dentro de los 90 dias posteriores a la cirugia y 329 no. Los pacientes expuestos a terapia biologica despues de la operacion eran mas jovenes (p <0.001), tenian un indice de masa corporal mas bajo (p = 0.0014), eran con menos frecuencia diabeticos (p = 0.0011) y estaban expuestos con mayor frecuencia preoperatoriamente a farmacos biologicos (p <0.0001) e inmunomoduladores (p <0.0001) pero no a corticosteroides (p = 0.8399). De los expuestos postoperatoriamente, casi todos (93.7%) habian estado en terapia biologica en el preoperatorio, y la mayoria reanudo la misma terapia biologica (68%). La mediana de tiempo para comenzar la terapia biologica despues de la operacion fue de 31 dias (rango, 7-89 dias). La exposicion biologica postoperatoria no se asocio con un mayor riesgo de infeccion superficial del sitio quirurgico (HR 1.02 (0.95-1.09) por semana, p = 0.59), sepsis intraabdominal. (HR: 1.07 (0.99-1.16), p = 0.73), o complicaciones infecciosas postoperatorias generales (HR: 1.02, intervalo de confianza del 95% 0.98-1.07, p = 0.338); las tasas generales de cada uno a los 90 dias fue del 13%, 8% y 28%.Diseno retrospectivo, y datos de un centro unico.El inicio o la reanudacion en el postoperatorio de la terapia biologica no aumentaron las tasas a 90 dias de infeccion superficial de sitio quirurgico, sepsis intraabdominal o complicaciones infecciosas totales despues de una cirugia abdominal mayor por enfermedad de Crohn. Consulte el Video Resumen en http://links.lww.com/DCR/B207. (Traduccion-Dr Jorge Silva Velazco).