ABSTRACT
BACKGROUND: Carriers of the human leucocyte antigen variant HLADQA1*05 (rs2097432) are at risk of developing antibodies against infliximab and adalimumab with reduced tumor necrosis factor (TNF) antagonist persistence. The impact of proactive therapeutic drug monitoring (PTDM) on this association has been barely assessed. METHODS: We conducted a retrospective single-center cohort study including patients with inflammatory bowel disease starting anti-TNF therapy between January 2017 and March 2021. Proactive therapeutic drug monitoring was defined as periodic drug level measurement (≥2 determinations during the first year of treatment and ≥1/annual determination during the following years), regardless of clinical condition, followed by dose optimization. Variables associated with treatment persistence were assessed with multivariable Cox regression analysis. RESULTS: A total of 112 patients were included, 52 (46.4%) HLA-DQA1*05 carriers, with a median follow-up of 73.9 (interquartile range, 35.4-133.1) weeks. Combination therapy with thiopurines was more frequent among HLA-DQA1*05 noncarriers (28 [46.7%] vs 12 [23.1%]; P = .01). Clinical remission rates at week 14 (77.9% vs 73.9%; P = .69) and 56 (73.2% vs 68.4%; P = .64) were similar between HLA-DQA1*05 noncarriers and carriers. Drug persistence was higher among HLA-DQA1*05 carriers (hazard ratio [HR], 0.32; 95% confidence interval, 0.14-0.71; P = .01). Multivariable Cox regression analysis identified systemic steroids at anti-TNF initiation (HR, 4; 95% confidence interval, 1.7-9.7) as a risk factor and HLA-DQA1*05 carriers (HR, 0.31; 95% confidence interval, 0.12-0.81) as a protective factor of treatment cessation. CONCLUSION: In adult patients with PTDM, a positive HLA-DQA1*05 genotype does not associate a higher risk of treatment cessation nor worse clinical outcomes.
This is a retrospective cohort study including 112 inflammatory bowel disease patients starting anti-TNF therapy under proactive therapeutic drug monitoring (PTDM). The HLA-DQA1*05 carriers did not present lower drug persistence or remission rates, suggesting PTDM overcomes the reduced treatment survival expected in HLA-DQA1*05 carriers.
Subject(s)
Inflammatory Bowel Diseases , Tumor Necrosis Factor Inhibitors , Humans , Adult , Tumor Necrosis Factor Inhibitors/therapeutic use , Retrospective Studies , Cohort Studies , Drug Monitoring , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/genetics , Infliximab , Adalimumab/therapeutic use , Genotype , Tumor Necrosis Factor-alphaABSTRACT
ANTECEDENTES: las guías de práctica clínica vigentes recomiendan el empleo de escalas objetivas como criterio de alta postendoscopia con sedación. OBJETIVO: valorar el tiempo de recuperación, las complicaciones y el grado de satisfacción del paciente empleando la escala mPADSS. MATERIAL Y MÉTODOS: se recogieron datos demográficos y antecedentes médicos. Se midieron constantes vitales, ansiedad y dolor abdominal preendoscopia. Se aleatorizó a los pacientes, que fueron divididos en grupo control, el cual recibió el alta según la práctica habitual, y grupo intervención, al cual se le pasó la escala mPADSS cada diez minutos, hasta alcanzar una puntuación objetivo. RESULTADOS: fueron aleatorizados 118 pacientes (78 colonoscopias, 32 gastroscopias, tres gastro + colonoscopia y 15 colangiopancreatografía retrógrada endoscópica/ultrasonografía endoscópica [CPRE/USE]). Como antecedentes médicos, 36 pacientes presentaron hipertensión arterial (HTA) y 19, diabetes mellitus (DM); 15 tenían medicación anticoagulante/antiagregante y 21, hipnótica/ansiolítica. Se requirió una media de 160 mg de propofol por paciente y se emplearon también flumazenilo y midazolam en 49 pacientes. Se registraron dos episodios de vómitos y tres de desaturación leves, todos ellos en grupo control. Incluimos 60 pacientes en grupo control y 58 en grupo mPADSS, los cuales recibieron el alta en 15 y 10 minutos de media respectivamente (p < 0,005). Se dispone de datos de seguimiento telefónico las 24-48 h de 105 sujetos. Se registraron cuatro reingresos (tres control y uno mPADSS). No hubo diferencias en cuanto a dolor y síntomas postsedación. El grado de satisfacción en cuanto a la atención y al tiempo de estancia fue similar en ambos grupos. CONCLUSIONES: este trabajo muestra la eficiencia, seguridad y satisfacción del paciente ante el empleo de la escala mPADSS, por lo que puede recomendarse su empleo
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Subject(s)
Humans , Male , Middle Aged , Aged , Patient Discharge , Ambulatory Surgical Procedures/statistics & numerical data , Health Status Indicators , Endoscopy, Digestive System/methods , Patient Satisfaction , Anesthesia Recovery Period , Deep Sedation , Colonoscopy/statistics & numerical data , Cholangiopancreatography, Endoscopic Retrograde/statistics & numerical data , Endoscopy/statistics & numerical data , Recovery Room/statistics & numerical data , Recovery Room/standardsABSTRACT
BACKGROUND: current clinical practice guidelines recommend the use of objective scales as a criterion for post-endoscopy sedation discharge. OBJECTIVE: to assess the recovery time, complications and patient satisfaction level using the mPADSS scale. MATERIAL AND METHODS: demographic data and medical history were collected. Vital signs, anxiety and abdominal pain were measured pre-endoscopy. Patients were randomized into a control group, discharged according to the usual practice, and the intervention group, who underwent the mPADSS scale every ten minutes, until an objective score was reached. RESULTS: one hundred and eighteen patients were randomized (78 colonoscopies, 32 gastroscopies, three gastro + colonoscopies and 15 endoscopic retrograde cholangiopancreatographies/endoscopic ultrasound [ERCP/USE]). With regard to medical history, there were 36 cases of elevated blood pressure and 19 diabetes cases, 15 with anticoagulant/antiplatelet and 21 with hypnotic/anxiolytic medication. An average of 160 mg of propofol was required per patient, with additional flumazenil and midazolam in 49. There were two episodes of vomiting and three of mild desaturation, all of them in the control group. Sixty patients were included in the control group and 58 in the mPADSS group, who were discharged in 15 and 10 minutes on average respectively (p < 0.005); 24-48h telephone call follow-up data were available for 105 subjects. There were four readmissions (three control and one mPADSS). There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups. CONCLUSIONS: this study shows the efficiency, safety and patient satisfaction using the mPADSS scale. Thus, its use is recommend.
