Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety.

INTRODUCTION: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice. METHODS: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score. RESULTS: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation. DISCUSSION: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported.

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.

[Lymphoplasmacytic inflammatory pseudotumor of the liver]. / Pseudotumor inflamatorio hepático linfoplasmocítico.

We present the case of a middle-aged woman with antecedents of cholecystectomy and several episodes of resi-dual coledocolitiasis resolved endoscopically. She attended Emergency Services due to a new clinical picture of abdo-minal pain and alteration of hepatic enzymes. Image tests showed lesions that suggested hepatic abscesses without ruling out a malign origin. Given this doubt it was decided to carry out a thick needle biopsy obtaining a diagnosis of an inflammatory pseudotumour of the liver related to IgG4-related disease. This is an infrequent entity but must be taken into consideration because - unlike malign pathology, which is the main differential diagnosis - its behaviour is benign, with a good evolution with medical treatment. That is why a suitable diagnosis is vital to avoid aggressive, diagnostic-therapeutic procedures.

Pseudotumor inflamatorio hepático linfoplasmocítico / Lymphoplasmacytic inflammatory pseudotumor of the liver

Presentamos el caso de una mujer de mediana edad con antecedentes de colecistectomía y varios episodios de coledocolitiasis residual resueltos endoscópicamente. Acude al servicio de Urgencias por un nuevo cuadro de dolor abdominal y alteración de enzimas hepáticas, apreciándose en las pruebas de imagen lesiones sugestivas de abscesos hepáticos sin poder descartarse un origen maligno. Dada esta duda se decide realizar una biopsia con aguja gruesa llegando al diagnóstico de pseudotumor inflamatorio hepático relacionada con la enfermedad por IgG4. Ésta es una entidad infrecuente pero que debe ser tenida en cuenta debido a que, a diferencia de la patología maligna, que es el principal diagnóstico diferencial, su comportamiento es benigno, con buena evolución con tratamiento médico. Por ello es vital un adecuado diagnóstico para evitar procedimientos diagnóstico-terapéuticos agresivos (AU)

We present the case of a middle-aged woman with antecedents of cholecystectomy and several episodes of residual coledocolitiasis resolved endoscopically. She attended Emergency Services due to a new clinical picture of abdominal pain and alteration of hepatic enzymes. Image tests showed lesions that suggested hepatic abscesses without ruling out a malign origin. Given this doubt it was decided to carry out a thick needle biopsy obtaining a diagnosis of an inflammatory pseudotumour of the liver related to IgG4-related disease. This is an infrequent entity but must be taken into consideration because - unlike malign pathology, which is the main differential diagnosis - its behaviour is benign, with a good evolution with medical treatment. That is why a suitable diagnosis is vital to avoid aggressive, diagnostic-therapeutic procedures (AU)

[Predictive factors of unplanned hospital readmission in patients discharged at a short stay medical unit]. / Factores predictores de reingreso hospitalario no planificado en pacientes dados de alta de una Unidad de Corta Estancia Médica.

AIMS: To determine the independent factors that predict unplanned hospital readmission in patients who are admitted to a Short-Stay Medical Unit (SSMU). DESIGN AND FIELD OF THE STUDY: Prospective cohort. Sanitary area: 500,000 inhabitants. SUBJECTS: Patients who survived to an hospital admission in the SSMU of our hospital (n = 196, a = 0.05, d = 7). METHODS: We studied demographic variables, social situation, history of previous admissions to hospital, from each patient. From the index admission we included diagnosis, severity of the disease, complications, type of admission and co-morbility. Validated tests were done to measure functional capability, grade of dependence and psychologic situation. After a three month interval readmission was determined if there had been an urgent admission to any hospital in a 10-day, 28-day or 3-month interval after discharge caused by the same principal diagnosis. A descriptive analysis of the variables was made, and a univariate analysis to stablish their association to readmission. The predicting factors for readmission were calculated by means of logistic regression. RESULTS: The 60.2% were males, the median of the age was 72 years. 75% started or carried out only primary school; 40% were single, separated or widowed; 12% lived alone and 1.5% in an institution. Principal diagnosis at the time of index admission were: chronic obstructive pulmonary disease, congestive cardiac failure, ischemic heart disease, asthma, pneumonia, cardiac arrhythmia and acute cerebrovascular disease. Readmission rate at 10, 28 days and 3 months was 3.6%, 9.7% and 13.3%, respectively. The independent predicting factor for readmission in the 10 days interval from discharge was the number of days of hospitalization in the last year (OR: 1.02, 95% CI: 1.0-1.05). For readmission in a 28-day and 3-month interval from discharge, the only independent predicting factor was the number of admissions to any hospital in the last 3 years (OR: 1.71, 95% CI: 1.32-2.22 and OR: 1.62, 95% CI: 1.28-2.05 respectively). CONCLUSIONS: From the studied factors, those that predict unplanned hospital readmission of patients discharged from a Short-Stay Medical Unit cannot be modified.

Early-stage gastric MALT lymphomas: eradication of H. pylori and outcome.

BACKGROUNDS AND OBJECTIVE: Lymphomas of mucosa-associated lymphoid tissue are special because of their indolent course. Low-grade early-stage tumors resolve after Helicobacter pylori (HP) eradication in a high percentage of cases. The aim of this study was to evaluate this regression in our patients with EI1 stage-low-grade B gastric lymphomas after eradication therapy since the introduction of echoendoscopic examinations in the Gastroenterology Department of 'Juan Canalejo' Hospital. MATERIAL AND METHODS: A retrospective study of all cases of low-grade MALT gastric lymphomas in EI1 stage, diagnosed by histological and echoendoscopic examination, from June 1997 to December 2001. After eradication of HP with triple therapy, patients have been followed-up with endoscopic examinations at 2, 3 and 6 months, and yearly afterwards. RESULTS: There were 14 patients in this period with low-grade EI1 stage gastric MALT B cell lymphoma. The median age was 65 years, and 57% were females. HP was eradicated in all cases with first- or second-line (2 patients) antibiotic treatment. Complete remission was observed in 10 patients (71.4%) in a median time of 4.5 months. The other 4 patients needed chemotherapy because of non-remission or early relapse, and also as initial treatment. Complete remission was also obtained in these patients. Only 9 patients have been followed up in our unit for a median time of 20 months, period after which all remain free of disease. CONCLUSIONS: Low-grade early-stage MALT gastric B-cell lymphomas have a high rate of response to HP eradication therapy. Echoendoscopic staging helps in distinguishing the group of patients who will benefit from conservative treatment. These patients must be followed up as it remains unclear whether remission is maintained in the long term, and to know what factors could be associated with lymphoma relapse.