Outcome of Biological Therapies and Small Molecules in Ulcerative Proctitis: A Belgian Multicenter Cohort Study.

BACKGROUND & AIMS: Several advanced therapies (biologic therapies and small molecules) have been approved for the treatment of moderate-to-severe ulcerative colitis. The registration trials for these agents typically excluded patients with isolated proctitis, leaving an evidence gap. We evaluated efficacy and safety of advanced therapies in patients with ulcerative proctitis (UP). METHODS: This multicenter retrospective cohort study included consecutive patients with active UP (Mayo endoscopy subscore of ≥2, rectal inflammation up to 15 cm) initiating advanced therapy, after failing conventional therapy. The primary end point was short-term steroid-free clinical remission (total Mayo score ≤2 with no individual subscore >1). In addition, drug persistence and relapse-free and colectomy-free survival were assessed. Both binary logistic and Cox regression analyses were performed. RESULTS: In total, 167 consecutive patients (52.0% female; median age 41.0 years; 82.0% bionaive) underwent 223 courses of therapy for UP (38 adalimumab, 14 golimumab, 54 infliximab, 9 ustekinumab, 99 vedolizumab, 9 tofacitinib). The primary end point was achieved with 36.3% of the treatment courses, and based on multivariate analysis, more commonly attained in bionaive patients (P = .001), patients treated with vedolizumab (P = .001), patients with moderate endoscopic disease activity (P = .002), and a body mass index <25 kg/m2 (P = .018). Drug persistence was significantly higher in patients treated with vedolizumab (P < .001) and patients with a shorter disease duration (P = .006). No new safety signals were observed. CONCLUSIONS: Advanced therapies are also efficacious and safe in patients with ulcerative colitis limited to the rectum. Therefore, the inclusion of patients with UP in future randomized-controlled trials should be considered.

Pulse wave analysis measurements: important, underestimated and undervalued parameters in cardiovascular health problems.

Background: Central aortic stiffness is established as a reliable measure of cardiovascular disease. While pulse wave velocity (PWV) analysis measures arterial distensibility, risk profile of cardiovascular diseases can be expanded with following pulse wave analysis measurements: central aortic systolic blood pressure (CABPS), central aortic pulse pressure (CAPP), central aortic reflection magnitude (CARM), central aortic augmented pressure (CAAP) and central aortic augmentation index (CAAIx). The aim of this study is to evaluate the clinical usefulness and importance of pulse wave analysis measurements in specific cardiovascular conditions and diseases, both in term of diagnosis and therapeutic monitoring. Methods: One thousand sixty-six subjects were included. According to age bracket, four cohorts were investigated-healthy subjects (NL), hypertensive patients (HP), ischemic heart disease (IHD) and valvular heart disease (VHD) patients. Arterial stiffness was analyzed through Sphygmocor XCEL Central Blood Pressure Measurement System and Sphygmocor XCEL PWV Measurement System. Furthermore we observed the pulse wave analysis measurements of 14 patients with diagnose of ADHD who were referred by a child psychiatrist, in order to investigate the initiation of methylphenidate treatment. Results: Statistically significant differences were found between NL and HP cohorts, across almost all age brackets, regarding pulse wave analysis measurements. In the risk stratification of arterial stiffness hypertension and especially central aortic blood pressure systolic (CABPS) seems a determining factor. Pulse wave analysis measurements for IHD and VHD cohort comparisons with NL counterparts, revealed non- statistically significant variations. Elevated CAAP, CAAIx and CARM within the youngest age group (0-10 years) in attention-deficit-hyperactivity-disorder (ADHD) patients warrant attention. Conclusions: Following such investigations, CABPS appears as a robust predominant factor in problems of arterial stiffness. Pulse wave analysis and PWV are important parameters in the evaluation and monitoring of arterial hypertension and cardiovascular diseases. There is a hypothesis that CAAP could be an important and even decisive parameter in the diagnosis of ADHD. Further investigation needed.

Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial.

BACKGROUND: Elective switching between anti-tumour necrosis factor (TNF) agents not necessarily dictated by efficacy or tolerability occurs in clinical practice. A study was undertaken to evaluate prospectively the impact of elective switching of patients with Crohn's disease well controlled with intravenous infliximab to subcutaneous adalimumab in a controlled trial. METHODS: An open-label randomised single-centre trial recruited 73 patients with ongoing response to at least 6 months of scheduled maintenance infliximab. Patients were randomised to continue intravenous 5 mg/kg infliximab or to switch to subcutaneous adalimumab 80 mg at baseline followed by 40 mg every other week for 1 year. Dose optimisation was allowed for intermittent flares, and patients with loss of response or intolerance could cross over to the alternative treatment group. Tolerability, patient preference and efficacy of both treatment options were the primary outcomes. RESULTS: Dose optimisation or interruption of treatment occurred in 17/36 patients (47%) in the adalimumab group and in 6/37 patients (16%) in the infliximab group (p=0.006). One patient interrupted infliximab treatment and 10 patients interrupted adalimumab treatment (p=0.003), mostly for loss of tolerance. Overall, patients preferred adalimumab treatment. All five serious adverse events were related to complicated Crohn's disease and occurred in patients randomised to adalimumab. Injection site reactions were more frequent than infusion reactions (8 vs 1, p=0.01), but only the latter caused cessation of further dosing. Anti-TNF serum levels were stable throughout the 1-year period in both groups. CONCLUSION: Elective switching from infliximab to adalimumab is associated with loss of tolerance and loss of efficacy within 1 year. Adherence to the first anti-TNF agent is recommended.

Importance of strain imaging in cardiac rehabilitation.

Cardiac rehabilitation improves the subjective condition of the patient; but are there associated structural and functional cardiac adaptations? The study group consisted of 39 patients with an inferior infarction and 21 patients with an anterior infarction, treated by surgical revascularization followed by 4 months of cardiac rehabilitation. Maximal exercise testing and Doppler echocardiography were performed before and after the rehabilitation program. Performance capacity was significantly improved after cardiac rehabilitation, but left ventricular function remained unchanged on Doppler imaging. Only by analyzing the subgroups using strain imaging significant differences were noted after cardiac rehabilitation: patients with an inferior infarction exhibited improved strain values in the anterior wall; those with an anterior infarction had improved strain values in the inferior wall. Strain values in the infarcted regions were worse after cardiac rehabilitation. Strain imaging indicated that cardiac rehabilitation could bring about improvements in cardiac function exclusively in the healthy non-infarcted myocardium, while there were signs of further deterioration of myocardial function in the highly ischemic zones.

[Ischemic colitis]. / Ischemische colitis.

Ischaemic colitis is the most frequent form of mesenteric ischaemia and is most frequently the result of a non-occlusive disease process. Elderly patients, especially those with underlying co-morbid conditions are at greatest risk. The symptoms are often non-specific and diagnosis is usually established upon the clinical setting and colonoscopy with biopsy. In the majority of cases, ischaemic colitis can be treated non-surgically with a successful outcome.

The 'CARFEM' vascular index as a predictor of coronary atherosclerosis.

BACKGROUND: The purpose of the study was detection of coronary atherosclerosis and identification of persons at risk by means of non-invasive examination of the carotid and peripheral arteries. MATERIAL/METHODS: Investigation of 366 patients: 229 males and 137 females divided into groups according to age and the severity of the coronary atherosclerotic lesions. Only patients with a coronary stenosis of more than 90%, who needed angioplasty or coronary bypass surgery, were included. Group I consisted of patients with normal coronary arteries; Group II, critical one-vessel disease; Group III, two-vessel disease; Group IV, critical three-vessel disease. By means of a vascular duplex scan we measured bilaterally the intima-media thickness of the posterior wall of the common carotid artery. In order to provide a more accurate estimation of the total atherosclerotic burden we have created the 'CARFEM' index (combination index of intima media thickness of carotid artery and total wall thickness of the superficial femoral artery). RESULTS: The anthropometric data were identical among the different groups. There are statistically highly significantly differences in the intima-media thickness of the common carotid artery when patients with normal coronary arteries are compared with patients with three-vessel coronary disease. By calculating the 'CARFEM' index not only we can differentiate between patients with normal coronary arteries and patients with critical three-vessel disease, but there are also ways to differentiate between different subgroups and to assess possible one-vessel, two-vessel or three-vessel coronary artery disease. CONCLUSIONS: The determination of the intima-media thickness of the common carotid artery clearly enables us to detect possible coronary atherosclerosis and to predict its severity in a non-invasive way. The combined assessment of the carotid and the femoral arterial walls permits us to make a distinction between the different subgroups, divided according to the severity of the underlying coronary atherosclerosis.