Background An unmet therapeutic need remains in patients with ulcerative colitis (UC). U-ACHIEVE is one of two phase 3 induction trials evaluating the safety and efficacy of the selective Janus kinase–1 inhibitor upadacitinib (UPA) 45 mg once daily (QD) in adults with UC. Methods U-ACHIEVE is a multicentre, double-blind, placebo (PBO)–controlled trial (NCT02819635) that randomized patients with moderately to severely active UC 2:1 to UPA 45 mg QD or PBO for 8 weeks. Patients were stratified by response to biologic therapy (inadequate vs non–inadequate responder), baseline corticosteroid use (yes or no), and baseline adapted Mayo score (≤7 or >7). The primary endpoint was proportion of patients achieving clinical remission (per adapted Mayo Score) at week 8.Ranked secondary endpoints included endoscopic improvement, endoscopic remission, and clinical response per adapted Mayo Score at week 8; clinical response per partial adapted Mayo Score at week 2; and histologic-endoscopic mucosal improvement at week 8. Non-responder imputation incorporating multiple imputations for missing data due to COVID-19 are reported. Safety was assessed through week 8. Results 474 patients were randomized (UPA, n=319; PBO, n=155). Baseline characteristics were well balanced between groups (Table 1). A significantly higher proportion of patients receiving UPA (26.1%) vs PBO (4.8%) achieved clinical remission at week 8 (adjusted treatment difference [95% CI], 21.6% [15.8, 27.4]; P<0.001; Figure 1). For all ranked secondary endpoints, UPA was superior to PBO (P<0.001; Figure 1). A significant difference in clinical response favouring UPA vs PBO was seen as early as week 2 (60.1% vs 27.3%) and was sustained over 8 weeks (79.0% vs 41.6%; Figure 2). There were more serious adverse events (AEs), severe AEs, and AEs leading to study drug discontinuation with PBO (Table 2). The most common AEs were acne, creatine phosphokinase elevation, and nasopharyngitis with UPA and worsening of UC and anaemia with PBO. Incidence of serious infection was similar between UPA and PBO. Neutropenia and lymphopenia were reported more frequently with UPA vs PBO (Table 2).No adjudicated gastrointestinal perforation, major cardiovascular AEs, or thrombotic events and no active tuberculosis, malignancy, or deaths were reported. Conclusion In patients with moderately to severely active UC, UPA 45 mg QD induction therapy was superior to PBO in inducing clinical remission/response, and endoscopic remission/response over 8 weeks; responses were significant and rapid. UPA 45 mg QD was well tolerated; safety was comparable with the known safety profile of UPA, and no new safety signals were identified.
Background: Percutaneous endoscopic gastrostomy (PEG) is generally used for long-term enteral nutrition. Patients who require PEG placement are often very sick, and postoperative complications, especially aspiration pneumonia, can be fatal. Objective: In this study we investigated the risk factors for aspiration pneumonia after PEG using a simple two-step swallowing provocation test (S-SPT), as reported in 1999 by Teramoto et al. Methods: The study included 29 patients (10 men, 19 women; mean age 84.6 years) who underwent S-SPT before PEG. We evaluated the presence of reflux esophagitis (RE) and esophageal hiatal hernia (EHH) with PEG. According to the S-SPT results, a normal response to the 1st step S-SPT was given a score of 0, a normal response to the 2nd step S-SPT was given a score of 1, and an abnormal response to the 2nd step S-SPT was given a score of 3. In addition to S-SPT, the presence of RE was given a score of 3, the absence of RE was given a score of 0, the presence of EHH was given a score of 2, and the absence of EHH was given a score of 0. We evaluated the association between the presence of aspiration pneumonia, as an early and critical complication, up to 1 month after PEG and determined the total risk score (score of S-SPT+ score of RE+ score of EHH). Results: The group with an abnormal response to the 2nd step S-SPT and the group with RE both exhibited aspiration pneumonia. The patients with aspiration pneumonia all achieved total scores ≧3, and 8 of 13 patients without aspiration pneumonia achieved scores ≤2. Conclusions: S-SPT is particularly useful in PEG patients. The scores provided by S-SPT and endoscopic examination can be very useful for aspiration pneumonia after PEG. The patients with scores ≤2 appear to be at very low risk for aspiration pneumonia, and patients with the scores ≧3 should be carefully followed up.
Nutritional status might be a predictive factor for early mortality after PEG. In patients with poor nutritional status, nutritional supporting period before PEG might improve the outcomes and reduce unnecessary PEG.
A 61-year-old woman with a 2-year medication-free history of idiopathic thrombocytopenic purpura was referred to our hospital complaining of right lower abdominal pain. The platelet count was about 3-4x10(4)/mm3. This patient was diagnosed with mucocele of the appendix on computed tomography and colonoscopy. We performed only right hemicolectomy without splenectomy. The pathological diagnosis was mucinous cystadenoma of the appendix. The platelet count increased to 18.1x10(4)/mm3 on postoperative-day 7, and remained stable, at 20-24x10(4)/mm3, for 14 months after the operation. Platelet-associated immunoglobulin G decreased remarkably after the operation, to 30.2 ng/10(7) cells, from 240 ng/10(7) cells preoperatively. We describe the first case of recovery from idiopathic thrombocytopenic purpura following right hemicolectomy performed for mucocele of the appendix. Considering our patients clinical course, it is possible that mucinous cystadenoma of the appendix may have influenced the thrombocytopenia. Findings in this patient suggest that mucocele of the appendix may be associated with a new diagnosis and idiopathic thrombocytopenic purpura treatment.
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