Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia.

BACKGROUND: tofacitinib is a Janus kinase inhibitor approved for the treatment of moderate-severe ulcerative colitis (UC). This study aimed to evaluate its efficacy in a real-life setting. METHODS: a retrospective and multicenter observational study was performed with UC patients treated with tofacitinib. Short and long-term treatment effectiveness, treatment survival, need for dose escalation and safety were analyzed. Clinical response and remission were defined in accordance with the partial Mayo score. RESULTS: seventy-four patients were included, 98.3 % had received prior biological treatment, 55.4 % with three or more biologicals and up to 64.9% with two or three different mechanisms of action. Clinical remission and response rates were 37.8 % and 77 % at eight weeks, and 41.8 % and 70.1 % at 16 weeks. With regard to non-responders at eight weeks, 37.5 % achieved a delayed clinical response at 16 weeks. Mean treatment duration was 19 months (95 % CI: 16-22), with a treatment survival of 56 % at 28 months, and remission and response rates at 24 months of 53.8 % and 61.5 %. Twenty-three treatments were withdrawn, most of them (18) during the induction period. There were adverse events in a quarter of the patients; only four were severe and led to treatment discontinuation. CONCLUSION: tofacitinib has a demonstrated efficacy in clinical practice to induce and maintain clinical response in treatment-refractory UC patients, with an acceptable safety profile.

Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study.

Adalimumab biosimilar experience is still recent. Interchangeability differences could reduce persistence times. Our goal was to compare biosimilar persistence differences with a reference. A retrospective observational study was performed in three groups divided according to the adalimumab received. The primary outcome measure was persistence, represented with Kaplan-Meier analysis, and we secondarily evaluated security, efficacy, and biomarkers. We obtained approval from the regional ethical committee, and the study was conducted following the Helsinki Declaration as revised in 2013. Data from 104 patients were collected: 50 received the biosimilar, 29 received the reference, and 25 switched from the original to the biosimilar. After a follow-up of 12 months, the biosimilar's persistence was higher, without differences in mild adverse events per group. In contrast, there were differences in severe events, with the switched group's frequency being higher. Biomarkers were reduced at similar proportions in all groups, and 43% had a clinical response at week 20 without differences. Adalimumab biosimilars are a valuable option for IBD based on clinical equivalence that are less expensive than the original drug. Their use does not have a detrimental influence on disease, although there are a few nuances in terms of interchangeability. These results support increasing confidence in using biosimilars, thus promoting the better sustainability of health systems.

Usefulness of Dynamic Assessment of Clinical and Laboratory Factors in Severe Acute Pancreatitis.

Background/Objectives: Early identification of patients at risk of developing severe acute pancreatitis (SAP) is still an issue. Dynamic assessment of clinical and laboratory parameters within the first 48 h of admission may offer valuable insights into the prediction of unfavorable outcomes such as SAP and death. Methods: A prospective observational study was conducted on a cohort of patients admitted for AP at a tertiary referral hospital. Clinical and laboratory data were collected on admission and at 48 h. Patients were classified based on the Revised Atlanta classification. Logistic regression analysis was performed to identify independent risk factors for SAP. Likelihood ratios and post-test probabilities were calculated to assess the clinical usefulness of predictive markers. Results: 227 patients were included, with biliary etiology being the most common and a prevalence of SAP and death of 10.7% and 5.7%, respectively. BISAP ≥ 2 on admission, presence of SIRS after 48 h, rise in heart rate over 20 bpm, and any increase in BUN after 48 h were independent risk factors for SAP. The combination of these factors increased the post-test probability of SAP and death, with BISAP ≥ 2 combined with the presence of SIRS after 48 h showing the highest probability (82% and 73%, respectively). Conclusions: Dynamic assessment of BUN, heart rate, and SIRS within the first 48 h of admission can aid in predicting the development of SAP and death in patients with AP. These findings underscore the importance of continuous monitoring, although multicenter studies are warranted to refine predictive models for SAP.

Endoscopic ultrasound as a diagnostic and predictive tool in idiopathic acute pancreatitis.

BACKGROUND: Endoscopic ultrasound (EUS) is useful in the diagnostic workup of idiopathic acute pancreatitis but its role as a predictor of recurrence has not been thoroughly assessed. Our aim was to study the performance of EUS in idiopathic acute pancreatitis, its impact on the natural history of the disease, and the factors related to recurrence. METHODS: Patients with idiopathic acute pancreatitis referred to our endoscopy unit were enrolled and followed, with assessment of the performance of endoscopic retrograde cholangiopancreatography (ERCP), cholecystectomy, and the incidence of recurrence. EUS findings and recurrence rates were compared between patients with a first episode or recurrent attacks and in patients with previous cholecystectomy versus those with gallbladder in situ. RESULTS: One hundred six patients were included (mean follow up: 53.59±27.79 months). Biliary disease related to stones was the most common finding on EUS (49.1%), and patients referred for recurrent attacks showed the highest recurrence rate during follow up (57.1%). ERCP or cholecystectomy reduced recurrences to 14.3% in patients with biliary disease. Age under 65 (odds ratio [OR] 3.56, 95% confidence interval [CI] 1.21-10.44; P=0.02), previous cholecystectomy (OR 3.19, 95%CI 1.11-9.17; P=0.03), and no lithiasis on EUS (OR 2.87, 95%CI 1.04-7.87; P=0.04) were independent risks factors for recurrence. CONCLUSIONS: EUS-directed ERCP/cholecystectomy was associated with lower relapse rates in idiopathic acute pancreatitis. Along with age and gallbladder status, it provides predictive information about recurrence likelihood.