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Dupilumab, a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling, which have key roles in eosinophilic esophagitis. We conducted a three-part, phase 3 trial in which patients 12 years of age or older underwent randomization in a 1:1 ratio to receive subcutaneous dupilumab at a weekly dose of 300 mg or placebo (Part A) or in a 1:1:1 ratio to receive 300 mg of dupilumab either weekly or every 2 weeks or weekly placebo (Part B) up to week 24. Eligible patients who completed Part A or Part B continued the trial in Part C, in which those who completed Part A received dupilumab at a weekly dose of 300 mg up to week 52 (the Part A-C group); Part C that included the eligible patients from Part B is ongoing. The two primary end points at week 24 were histologic remission (≤6 eosinophils per high-power field) and the change from baseline in the Dysphagia Symptom Questionnaire (DSQ) score (range, 0 to 84, with higher values indicating more frequent or more severe dysphagia). In Part A, histologic remission occurred in 25 of 42 patients (60%) who received weekly dupilumab and in 2 of 39 patients (5%) who received placebo (difference, 55 percentage points; 95% confidence interval [CI], 40 to 71; P<0.001). In Part B, histologic remission occurred in 47 of 80 patients (59%) with weekly dupilumab, in 49 of 81 patients (60%) with dupilumab every 2 weeks, and in 5 of 79 patients (6%) with placebo (difference between weekly dupilumab and placebo, 54 percentage points; 95% CI, 41 to 66 [P<0.001]; difference between dupilumab every 2 weeks and placebo, 56 percentage points; 95% CI, 43 to 69 [not significant per hierarchical testing]). The mean (±SD) DSQ scores at baseline were 33.6±12.41 in Part A and 36.7±11.22 in Part B; the scores improved with weekly dupilumab as compared with placebo, with differences of -12.32 (95% CI, -19.11 to -5.54) in Part A and -9.92 (95% CI, -14.81 to -5.02) in Part B (both P<0.001) but not with dupilumab every 2 weeks (difference in Part B, -0.51; 95% CI, -5.42 to 4.41). Serious adverse events occurred in 9 patients during the Part A or B treatment period (in 7 who received weekly dupilumab, 1 who received dupilumab every 2 weeks, and 1 who received placebo) and in 1 patient in the Part A-C group during the Part C treatment period who received placebo in Part A and weekly dupilumab in Part C. Among patients with eosinophilic esophagitis, subcutaneous dupilumab administered weekly improved histologic outcomes and alleviated symptoms of the disease. (Funded by Sanofi and Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03633617.).

Purpose This study examined the effects of individualized dietary modifications based on the volume-viscosity swallow test (V-VST) on functional oral intake, incidence of pneumonia, and swallowing-related quality of life in individuals with intracerebral hemorrhage. Methods One hundred and seven participants with signs of dysphagia in the acute and early subacute phases of stroke following intracerebral hemorrhage were randomly assigned into an experimental group for individualized dietary modifications based on V-VST plus routine standard care ( n  = 53), and a control group for routine care alone ( n  = 54). Incidence of pneumonia, functional oral intake scale (FOIS) ratings and Eating Assessment Tool (EAT-10) scores before and after intervention were evaluated. Results A significantly lower incidence of pneumonia was found in the experimental group than in the control group ( p  < 0.05). Significant group differences were found in functional oral intake and in quality of life, with significantly higher FOIS ratings and significantly lower EAT-10 scores in the experimental group post-intervention ( p  < 0.001). Conclusion These findings suggested that despite being a noninstrumental screening tool, V-VST could facilitate individualized dietary modifications and could be an effective clinical option for reducing the risk of pneumonia, improving functional oral intake and enhancing quality of life in individuals with dysphagia following intracerebral hemorrhage. Future studies should explore how dietary modifications could be more precisely implemented based on the International Dysphagia Diet Standardization Initiative framework.

Objective This study evaluated the effectiveness of an enhanced dysphagia assessment method combined with dietary interventions for patients experiencing dysphagia post-stroke. Methods A prospective randomized controlled trial was conducted with 98 hospitalized post-stroke patients suffering from dysphagia. Participants were randomly assigned into two groups: the study group (receiving enhanced dysphagia assessment and dietary interventions) and the control group (receiving standard nursing care), using a computer-generated randomization list. Swallowing function was assessed using the Mann Assessment of Swallowing Ability (mMASA), Dysphagia Severity Scale (DSS), and Wada’s water swallowing test. Additionally, quality of life and nutritional status were evaluated for both groups, before and after the intervention. Results Post-intervention, the study group exhibited significantly better scores on mMASA and Wada’s water swallowing test, and lower DSS scores compared to the control group (all P  < 0.05). Initially, no significant differences were observed between the groups concerning aspiration symptoms, nutritional and respiratory dysfunction, psychological disorders, and total scores (all P  > 0.05). However, post-intervention, the study group showed significant improvements in these parameters and lower scores compared to the control group (all P  < 0.05). Additionally, the study group demonstrated higher BMI, albumin (ALB), and hemoglobin (Hb) levels post-intervention (all P  < 0.05), and a markedly lower incidence of aspiration and aspiration pneumonia (all P  < 0.05). Conclusion Enhanced dysphagia assessment combined with dietary interventions significantly improves swallowing function, quality of life, and nutritional status in post-stroke dysphagia patients. This approach also reduces the incidence of related complications, suggesting substantial clinical benefits.

We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence-based management of fever, hyperglycaemia, and swallowing dysfunction in acute stroke units (ASUs). In the Quality in Acute Stroke Care (QASC) study, a single-blind cluster randomised controlled trial, we randomised ASUs (clusters) in New South Wales, Australia, with immediate access to CT and on-site high dependency units, to intervention or control group. Patients were eligible if they spoke English, were aged 18 years or older, had had an ischaemic stroke or intracerebral haemorrhage, and presented within 48 h of onset of symptoms. Intervention ASUs received treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers. Control ASUs received only an abridged version of existing guidelines. We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency (modified Rankin scale [mRS] ≥2), functional dependency (Barthel index), and SF-36 physical and mental component summary scores. Research assistants, the statistician, and patients were masked to trial groups. All analyses were done by intention to treat. This trial is registered at the Australia New Zealand Clinical Trial Registry (ANZCTR), number ACTRN12608000563369. 19 ASUs were randomly assigned to intervention (n=10) or control (n=9). Of 6564 assessed for eligibility, 1696 patients' data were obtained (687 pre-intervention; 1009 post-intervention). Results showed that, irrespective of stroke severity, intervention ASU patients were significantly less likely to be dead or dependent (mRS ≥2) at 90 days than control ASU patients (236 [42%] of 558 patients in the intervention group vs 259 [58%] of 449 in the control group, p=0·002; number needed to treat 6·4; adjusted absolute difference 15·7% [95% CI 5·8–25·4]). They also had a better SF-36 mean physical component summary score (45·6 [SD 10·2] in the intervention group vs 42·5 [10·5] in the control group, p=0·002; adjusted absolute difference 3·4 [95% CI 1·2–5·5]) but no improvement was recorded in mortality (21 [4%] of 558 in intervention group and 24 [5%] of 451 in the control group, p=0·36), SF-36 mean mental component summary score (49·5 [10·9] in the intervention group vs 49·4 [10·6] in the control group, p=0·69) or functional dependency (Barthel Index ≥60: 487 [92%] of 532 patients vs 380 [90%] of 423 patients; p=0·44). Implementation of multidisciplinary supported evidence-based protocols initiated by nurses for the management of fever, hyperglycaemia, and swallowing dysfunction delivers better patient outcomes after discharge from stroke units. Our findings show the possibility to augment stroke unit care. National Health & Medical Research Council ID 353803, St Vincent's Clinic Foundation, the Curran Foundation, Australian Diabetes Society-Servier, the College of Nursing, and Australian Catholic University.

We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE). We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6). Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions. Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement. NCT03656380.

Transcranial direct current stimulation (tDCS) has been extensively utilized in the treatment of post-stroke dysphagia; however, the effect of different tDCS protocols remains uncertain. This study aims to investigate the effect of tDCS on dysphagia after hemispheric stroke and compare the effect of tDCS among three protocols. A total of 90 hemispheric stroke patients were randomized into three groups: bilateral, contralesional, and ipsilesional tDCS. Each group received anodal tDCS over the orofacial sensorimotor cortex (S1M1) of the bilateral, contralesional, and ipsilesional hemispheres, respectively, administered for 20 sessions overall, combined with exercise-based swallowing therapy. After tDCS, both the dysphagia assessment scale and the swallow severity scale showed significant improvement in all three groups (all p  < 0.01). In the comparisons among the three groups, the bilateral tDCS demonstrated significantly greater improvement than the contralesional and ipsilesional tDCS group in terms of the dysphagia assessment scale (all p  < 0.001), and superior to contralesional tDCS group in terms of the swallow severity scale ( p  = 0.019). The analysis of ApEn showed increased cortical activity in both stimulated and non-stimulated areas of bilateral hemispheres after bilateral and unilateral tDCS. Moreover, larger cortical areas of bilateral hemispheres were activated after bilateral tDCS, compared to those after unilateral tDCS. Trial registration Chinese Clinical Trial Registry Identifier: ChiCTR-TRC-14004955, 16/07/2014.

Dysphagia may present in all critically ill patients and large-scale clinical data show that e.g. post-extubation dysphagia (PED) is commonly observed in intensive care unit (ICU) patients. Recent data demonstrate that dysphagia is mostly persisting and that its presence is independently associated with adverse patient-centered clinical outcomes. Although several risk factors possibly contributing to dysphagia development were proposed, the underlying exact mechanisms in ICU patients remain incompletely understood and no current consensus exists on how to best approach ICU patients at risk. From a clinical perspective, dysphagia is well-known to be associated with an increased risk of aspiration and aspiration-induced pneumonia, delayed resumption of oral intake/malnutrition, decreased quality of life, prolonged ICU and hospital length of stay, and increased morbidity and mortality. Moreover, the economic burden on public health care systems is high. In light of high mortality rates associated with the presence of dysphagia and the observation that dysphagia is not systematically screened for on most ICUs, this review describes epidemiology, terminology, and potential mechanisms of dysphagia on the ICU. Furthermore, the impact of dysphagia on affected individuals, health care systems, and society is discussed in addition to current and future potential therapeutic approaches.

Oropharyngeal dysphagia in chronic post-stroke (PS-OD) patients is associated with impaired oropharyngeal sensory/motor function. We aimed to evaluate the effect of transcutaneous electrical stimulation (TES) on the biomechanics and kinetics of swallowing in PS-OD patients in a randomized controlled clinical trial with 1-year follow-up. 71 PS-OD patients with impaired safety of swallow (ISS) were randomized into 2 groups, (1) 26 with compensatory treatment (CT): thickeners and texture-modified diets, and (2) 45 with active treatment (TES + CT) with 2 cycles of TES (VitalStim; Enovis, USA), at baseline and 6 months. Each TES cycle consisted of 15 1-hour sessions over 2 weeks. Its effect was assessed by videofluoroscopy (baseline, post-treatment 1, 6 months, post-treatment 2, 12 months). Both groups were homogeneous, patients had 74.41 ± 11.28 years (31.00% women), functional decline (Barthel 72 ± 31), comorbidities (Charlson 3.00 ± 1.57), nutritional risk (MNA-sf 10.29 ± 2.59) and moderate stroke (NIHSS 3.35 ± 4.01). All had ISS (penetration-aspiration scale [PAS] 4.61 ± 1.67, only 9.86% could swallow thin liquid safely) and biomechanical delay (time to laryngeal vestibular closure [LVC] 402.82 ± 111.98ms). Swallowing parameters improved significantly between baseline and 12 months in the TES group (ISS, p  < 0.001; PAS, safe thin liquid hydration, LVC, p  < 0.0001; bolus kinematics, p  < 0.05). No changes were observed in hyoid bone movement or timing. The CT group did not show any significant biomechanical changes. No relevant adverse events were associated with TES. TES is a safe and effective therapy for PS-OD. After 1 year of follow up, it improved ISS, time to LVC, bolus kinetics, and reduced the need for thickening agents.

The aims of this exploratory study and clinical phase II trial were to assess the specific nature and extent of dysphagia in laryngectomized patients with self-reported dysphagia, and its rehabilitation potential using the novel Swallowing Exercise Aid (SEA 2.0). Twenty laryngectomized patients participated in a six-week exercise program with the SEA 2.0. Exercises consisted of Chin Tuck Against Resistance (CTAR), Jaw Opening Against Resistance (JOAR), and Effortful Swallow Against Resistance, conducted three times per day. Swallowing was assessed at baseline (T0), six (T1) and 14 (T2) weeks, consisting of patient-reported outcomes, BMI, videofluoroscopy, swallowing capacity, and muscle strength measurements. Dysphagia significantly impacts quality of life, with impaired swallowing speed and bolus propulsion as main reported issues. Subjective dysphagia parameters, swallowing capacity, and pharyngeal residue clearance were reduced, but BMI was normal. Muscle and tongue strength were within normal ranges. All participants managed to use the SEA 2.0. Adherence was 95%. At T1, subjective swallowing parameters (MDADI and EAT-10) showed clinically relevant improvements. Objectively, CTAR and JOAR strength increased with 27.4 and 20.1 Newton, respectively. Also, swallowing capacity (from 2.4 g/s to 3.8 g/s) and pharyngeal residue clearance improved. At T2, results were slightly lower than at T1, but still better than at baseline. Dysphagia in laryngectomized patients affects quality of life, but swallowing can be improved with a six-week rehabilitation program using the novel SEA 2.0. Adherence was excellent and several subjective and objective swallowing parameters improved.