Background/AimsChicago classification version 4.0 (CCv4.0) of esophageal motility disorders developed a more stringent diagnostic criteria for ineffective esophageal motility (IEM) than version 3.0. We studied the implications of the new diagnostic criteria on the prevalence of IEM, and clinically characterized and compared the population of patients who no longer meet diagnostic criteria for IEM to those who retain the diagnosis.
MethodsWe included all consecutively performed high-resolution esophageal impedance manometries from 2014 to 2021. Three cohorts of patients with IEM were created: Patients with IEM by Chicago classification version 3.0 (CCv3.0; CC3 group), by CCv4.0 only (CC4 group), and by CCv3.0 who are now considered normal (Normal group). Demographics, manometric and reflux parameters, and clinical outcomes were compared.
ResultsA total of 594 manometries were analyzed. Of those, 66 (11.1%) met criteria for IEM by CCv3.0 (CC3), 41 (62.0%) retained an IEM diagnosis using CCv4.0 criteria (CC4), while 25 (38.0%) patients no longer met criteria for IEM (Normal). The CC4 group had higher esophageal acid exposure, especially supine (% time -18.9% vs 2.2%; P = 0.005), less adequate peristaltic reserve (22.0% vs 88.0%; P = 0.003), and higher Demeester score (49.0 vs 21.2; P = 0.017) compared to the Normal group. There was no difference in bolus clearance between the groups.
ConclusionsIEM under CCv4.0 has a stronger association with pathologic reflux, especially supine reflux, and inadequate peristaltic reserve, but impairment in bolus clearance is unchanged when compared with IEM diagnosed based on CCv3.0. Further studies are required to determine the implications of these findings on management strategies.
The purpose is to report a case series of increasing prevalence of ocular Dirofilariasis in tropical areas of South India and the importance of the disease with travel to tropical areas Human Dirofilariasis, caused by Dirofilaria repens, have been reported to occur widely throughout Asia, Europe, and Africa. The Dirofilaria are natural parasites of mammals and are transmitted to man by zooanthrophilic mosquitoes. It is emphasized that both clinicians and microbiologists should have an increased awareness of this entity and include dirofilariasis in the differential diagnosis of patients presenting with subcutaneous nodules. Excision of the lesion is both diagnostic and therapeutic.
Introduction: Ozanimod (OZA) is approved in the USA and EU for treatment (tx) of moderate/severe UC. OZA binding internalizes S1P 1 receptors, reducing egress of lymphocyte subsets into circulation. OZA was approved in this patient (pt) population based on results of the phase 3 True North (TN) study (NCT02435992). Methods: We evaluated association between absolute lymphocyte count (ALC) and OZA efficacy/safety during TN's induction period (IP) and maintenance period (MP). Pts were randomized to double-blind (DB) OZA 0.92 mg or placebo (PBO) or open-label (OL) OZA during 10-week (W) IP. Pts with clinical response to OZA at W10 were rerandomized to DB OZA or PBO for MP through W52. Rectal bleeding (RB), stool frequency (SF), composite Mayo, Physician's Global Assessment (PGA), and endoscopy scores were assessed at baseline and as clinical outcomes at W10 and W52. Efficacy endpoints (EPs; clinical remission, clinical response, endoscopic improvement, mucosal healing, and histologic remission) were assessed at W10 and W52. Tx-emergent adverse events (TEAEs) and ALC were evaluated at baseline and W5, W10, W18, W28, W40, and W52. Results: During IP, 645 pts received DB OZA (n5429) or PBO (n5216) and 367 received OL OZA; for MP, 230 and 227 OZA-treated pts were rerandomized to OZA and PBO, respectively. Baseline ALC was not significantly correlated with clinical outcome at W10 or W52 as measured by changes from baseline RB, SF, Mayo, PGA, and endoscopy scores in pts on OZA or PBO. Baseline ALC was not predictive or prognostic for W10 and W52 responses based on the efficacy EPs. Reductions from baseline in mean ALC occurred by W5 with OZA and were significantly greater with OZA (53-54%) vs PBO (2.3%; P, .001). ALC plateaued by W10 and was maintained through W52 in pts on continuous OZA. ALC returned to PBO levels by W52 in pts who switched to PBO during MP. Change in ALC at W10 was generally not significantly correlated with changes in clinical outcomes at W10 or W52. Change in ALC at W5 was not predictive of W10 response; change in ALC at W10 was not predictive of W52 response. Reductions from baseline in ALC at all weeks were similar in OZA-treated pts with/without $1 TEAE and with/without infection TEAEs. Conclusion: ALC reductions occurring with OZA were reversed upon tx discontinuation and were not associated with TEAEs. Baseline ALC and ALC reductions were not predictive or prognostic for response. These findings support ALC as a pharmacodynamic biomarker but not as a prognostic or predictive biomarker.
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