INTRODUCTION:We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD).METHODS:This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation.RESULTS:A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-naive patients achieved significantly higher rates of clinical and endoscopic remissions at 63% and 55%, respectively. On multivariable analyses, prior antitumor necrosis factor (hazard ratio, 0.72; 95% confidence interval, 0.49–0.99) and vedolizumab exposure (hazard ratio, 0.65; 95% confidence interval, 0.48–0.88) were independently associated with lower likelihoods of achieving endoscopic remission. In patients who experienced loss of remission, 77 of 102 (75%) underwent dose optimization, and 44 of 77 (57%) achieved clinical response. An additional 152 of 681 patients (22.3%) were dose-optimized because of primary nonresponse incomplete response to UST, of whom 40.1% (61 of 152) responded. Serious infections occurred in 3.4% of patients while other noninfectious adverse events (lymphoma [n = 1], arthralgia [n = 6], rash [n = 6], headache [n = 3], hepatitis [n = 3], hair loss [n = 3], neuropathy [n = 1], and vasculitis [n = 1]) occurred in 2.4% of patients.DISCUSSION:UST represents a safe and effective treatment option for CD, with 40% of patients from a highly refractory cohort achieving clinical remission by 12 months. The greatest treatment effect of UST was seen in biologic-naive patients, and dose escalation may recapture clinical response.
INTRODUCTION: Lipase has historically been used to diagnose acute pancreatitis. Its role in prognostication and determining illness severity has been poorly elucidated. A recent literature review demonstrated an inconclusive role of serial lipase in managing acute pancreatitis. Our aim was to evaluate the frequency of repeat lipase and its effect on outcomes. METHODS: Retrospective chart review on patients admitted to 3 facilities with a new diagnosis of acute pancreatitis between 2016–2018. Patients (age > 18) who presented with epigastric pain and lipase levels > 1179 (3x ULN) were included. Those with an unclear admission diagnosis or prior pancreatitis were excluded. Data collected included baseline characteristics, admission and any repeat lipase values, admission SIRS and BUN, cause of pancreatitis, length of stay (LOS), and mortality. Statistical analysis was performed using SAS Institute Statistical Analysis Program Version 9.4. RESULTS: 203 patients met inclusion criteria. There were statistically significant differences in sex and pancreatitis etiology (Table 1). Baseline lipase was not significantly different between the repeat lipase group (RLG) and the non-repeat lipase group (NRLG) (13268.7 vs 7472.8, P = 0.059) (Table 1). LOS was significantly different (5.35 d in RLG vs 2.72 d in NRLG, P = 0.001) (Table 1). There was no difference in mortality (1.8% in RLG vs 0.0% in NRLG, P = 0.450). When done, lipase was repeated an average of 2.88 times and it dropped to <3x ULN in 81.2% of patients (Table 2). Lipase was repeated in 63.6% of patients after lipase to <3x ULN. There was no difference in LOS (5.57 d if lipase <3x ULN vs 4.22 d if lipase not <3x ULN on repeat, P = 0.095) and lipase trended down in 98.8% of patients (Table 2). CONCLUSION: Our study demonstrates a frequent remeasurement of lipase levels for first acute pancreatitis episodes. Patients who did not have their lipase repeated had a statistically significant shorter LOS. Age, SIRS, and BUN were used as surrogate markers of severity (BISAP unable to be calculated) and there were no statistically significant differences. Lipase trend unlikely affected discharge as there was no difference in LOS in patients whose lipase went to < 3x ULN. Lipase was repeated even after returning to <3x ULN, suggesting overuse of repeat lipase. There was no difference in mortality. Therefore, our study suggests that repeat lipase does not affect patient discharge and is being overutilized.
335 Background: There has been a paradigm shift in the treatment of stage 1 pancreatic adenocarcinoma (PAC) from surgery first followed by adjuvant therapy (AT) to Neoadjuvant therapy (NAT) first followed by surgery and this is reflected in the current NCCN guidelines as well. Data comparing these two modalities are limited. AIM: To compare long time survival between surgery vs Surgery + AT and NAT + Surgery in a large National Cancer Database. Methods: We identified patients with surgically resected AJCC clinical stage 1, 1A, and 1B PAC between 2004-2014. Patients were stratified into 3 groups to assess outcomes. Exclusion criteria: those with incomplete survival and sequence of therapy data. Hazard ratios (HR) were calculated for evaluation of survival, as well as for 30-Day and 90-Day Mortality between the 3 groups. Results were adjusted for age and Deyo-Charlson comorbidity index. Results: A total of 9684 pts with Clincal stage 1, 1A, 1B PAC between 2004-2014 were identified. Of these 2266 pts underwent surgery alone; 6222 had surgery followed by AT; and 1196 pts had neoadjuvant therapy followed by surgery. There was a HR of 0.995 (95% CI 0.935-1.058 p = 0.864) and 0.984 (95% CI 0.924-1.048, p = 0.617) for 30- and 90-Day mortality comparing upfront surgery to NAT, respectively. With AT as the reference group for survival, there was a HR of 1.362 (95% CI 1.286-1.443, p < 0.001) for surgery only and HR of 0.929 (95% CI 0.859-1.004, p = 0.064) for NAT. Conclusions: 1. Surgery alone had worse overall survival. 2. There was no significant difference in overall survival when comparing AT and NAT 3. A prospective randomized trial evaluating the differences in survival is needed.
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