Observational Study to Compare Biological Drug Concentration Quantification Techniques and Immunogenicity in Patients with Immune-Mediated Diseases.

Measuring biological drugs' trough concentrations and the concentrations of anti-drug antibodies is a valuable practice for treatment optimization. ELISA techniques are the gold standard for biological drug concentration quantification, but new techniques such as chemiluminescence immunoassays present some advantages. The aim of this unicentric prospective observational study is to compare the infliximab, adalimumab, vedolizumab and ustekinumab trough levels and anti-adalimumab and anti-infliximab antibodies concentrations obtained when using a chemiluminescent instrument (i-TRACK®, Theradiag, Croissy-Beaubourg, France) and an ELISA instrument (TRITURUS®, Griffols, Barcelona, Spain). Linear regression, Pearson or Spearman tests, Bland-Altman plots and the Cohen kappa test were applied for every sample. The correlation was excellent for both assays in the measurement of all drug concentrations. In general, values were lower when measured using i-TRACK than when using TRITURUS, especially when the values were high. Both techniques proved valuable in clinical practice for monitoring adalimumab and infliximab drug concentration. However, the results were modest for ustekinumab and vedolizumab, so caution is recommended and further research is needed. The limited number of anti-drug antibody-positive samples precluded a comparison between the techniques.

Pharmacokinetic and clinical monitoring through posologic changes in adalimumab intensification regimen from 40 mg every week to 80 mg every other week

Background: adalimumab dose escalation is often recommended for inflammatory bowel disease (IBD) patients incases of loss of response (LOR). The usual adalimumabintensification regimen was 40 mg every week. Recently,the pharmaceutical companies commercialized the 80 mginjection pen. In the biosimilars era, this pen was sold atthe same price as the 40 mg pen. Due to this and for patientcomfort, we proposed that our stable intensified adalimumab patients on a 40 mg every-week (ew) regimen change toa dose of 80 mg every-other-week (eow).Aim and methods: an observational study was performedto monitor outcome through this posologic change. Clinical,analytic parameters and adalimumab trough levels wereprospectively obtained at baseline, four and 12 monthsafter posologic change. The evolution of this cohort andcalculates savings were described.Results: thirteen patients were included in the study and themedian time of adalimumab intensification prior to posologic change to 80 mg eow was 32 months (IQR 29-63). Atfour months, all patients maintained adalimumab 80 mgeow. After month 4, two patients returned to the previousregimen after mild worsening, without significant changes in C-reactive protein (CRP), calprotectin or adalimumab-trough-levels. At one year, adalimumab was stoppedin one patient in remission with undetectable levels andpositive adalimumab-antibodies. No significant differencesin adalimumab-trough-levels were noted before and afterthe posologic change. Costs fell from 16,276 €/patient/yearof treatment to 8,812.15 €/patient/year of treatment.Conclusion: in IBD patients with stable response to adalimumab intensification regimen of 40 mg ew, changingto 80 mg eow seems to maintain response and similaradalimumab-trough-levels. Furthermore, it is cost-saving,although some patients may perceive mild symptoms. (AU)

Pharmacokinetic and clinical monitoring through posologic changes in adalimumab intensification regimen from 40 mg every week to 80 mg every other week.

BACKGROUND: Adalimumab dose escalation is often recommended for inflammatory bowel disease patients in cases of loss of response. The usual adalimumab intensification regimen was 40 mg every week. Recently the pharmaceutical companies commercialized the 80mg injection pen. In the biosimilars era, this pen was sold at the same price as the 40mg pen. Due to this and for patient comfort, we proposed that our stable intensified adalimumab patients on a 40mg every-week regimen, change to a dose of 80mg every-other-week. AIM AND METHODS: an observational study was performed to monitor outcome through this posologic change. Clinical, analytic parameters and adalimumab trough levels were prospectively obtained at baseline, 4 and 12 months after posologic change. The evolution of this cohort and calculates savings were described. RESULTS: 13 patients were included in the study and the median time of adalimumab intensification prior to posologic change to 80mg eow was 32 months (IQR 29-63). At 4 months, all patients maintained adalimumab 80mg every-other-week. After month 4, two patients returned to the previous regimen after mild worsening, without significant changes in CRP, calprotectin or adalimumab-trough-levels. At 1 year, adalimumab was stopped in one patient in remission with undetectable levels and positive adalimumab-antibodies. No significant differences in adalimumab-trough-levels were noted before and after the posologic change. Costs fell from 16276 €/patient/year of treatment to 8812.15 €/patient/year of treatment. CONCLUSION: In IBD patients with stable response to adalimumab intensification regimen of 40 mg every-week, changing to 80mg every-other-week seems to maintain response and similar adalimumab-trough-levels. Furthermore, it is cost-saving, although some patients may perceive mild symptoms.

ERCP and situs inversus.

An 85-year-old female with situs inversus totalis was admitted due to obstructive jaundice, secondary to multiple choledocholithiasis and distal biliary stenosis due to adenocarcinoma of the head of the pancreas, with duodenal infiltration and metastatic liver disease. An endoscopic retrograde cholangiopancreatography (ERCP) was attempted in the supine position but bile duct cannulation was not possible due to duodenal infiltration. Finally, a palliative biliary stent was placed percutaneously, with resolution of the jaundice.

Colonic diverticular bleeding: urgent colonoscopy without purging and endoscopic treatment with epinephrine and hemoclips.

Diverticular disease is the most frequent cause of lower gastrointestinal bleeding. Most of the times, bleeding stops without any intervention but in 10-20% of the cases it is necessary to treat the hemorrhage. Several modalities of endoscopic treatment have been described after purging the colon. We present five cases of severe diverticular bleeding treated with injection of epinephrine and hemoclips. All the colonoscopies were performed without purging of the colon in an emergency setting, with correct visualization of the point of bleeding. Patients recovered well avoiding other aggressive procedures such as angiography or surgery.

Hemorragia diverticular de colon: colonoscopia urgente sin preparación y tratamiento endoscópico con hemoclips y adrenalina / Colonic diverticular bleeding: urgent colonoscopy without purging and endoscopic treatment with epinephrine and hemoclips

La enfermedad diverticular en la causa más frecuente de hemorragia digestiva baja. En la mayoría de las ocasiones el sangrado cesa sin ninguna intervención, pero en un 10-20 % de los casos es necesario tratar la hemorragia. Se han descrito varias modalidades de tratamiento endoscópico tras preparar el colon. Presentamos cinco casos de hemorragia diverticular severa tratados con inyección de adrenalina y hemoclips. Todas las colonoscopias se realizaron de urgencia y sin preparación del colon, con correcta visualización del punto de sangrado. Los pacientes evolucionaron favorablemente evitando otros procedimientos agresivos como una arteriografía o cirugía (AU)

Diverticular disease is the most frequent cause of lower gastrointestinal bleeding. Most of the times, bleeding stops without any intervention but in 10-20 % of the cases it is necessary to treat the hemorrhage. Several modalities of endoscopic treatment have been described after purging the colon. We present five cases of severe diverticular bleeding treated with injection of epinephrine and hemoclips. All the colonoscopies were performed without purging of the colon in an emergency setting, with correct visualization of the point of bleeding. Patients recovered well avoiding other aggressive procedures such as angiography or surgery (AU)

Self-expandable stents in malignant colonic obstruction: insertion assisted with a sphincterotome in technically difficult cases.

BACKGROUND: Stent placement is effective in relieving malignant colonic obstruction. Nevertheless, the technique may offer difficulties in sharply angulated lesions. METHODS: Guidewire insertion assisted with a sphincterotome was performed in 4 patients with intestinal obstruction caused by malignant colonic strictures. The manipulation of the sphincterotome by turning and bending its tip allows the cannulation of the lesion with the guidewire and, as a consequence, the stent insertion. OBSERVATIONS: The procedure was successfully performed in 4 technically difficult cases in which it had been impossible to pass the guidewire with the standard catheter. CONCLUSIONS: In technically difficult cases, with the use of a sphincterotome, insertion of the guidewire appears to be easier. This new method may improve technical success rates in stent placement.