Jorveza (budesonide orodispersible tablets) / Dr Falk - LARVOL DELTA

Loss of response to off-label swallowed topical corticosteroids in eosinophilic esophagitis can be overcome by a switch to an esophageal-targeted budesonide formulation. (PubMed, Am J Gastroenterol) - "Most patients non-responding to olSTC are not true corticosteroid-refractory but respond to an esophageal-targeted budesonide formulation. Age below 30 years, longer treatment duration and low adherence are associated with olSTC-failure."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

The Effectiveness of Budesonide Once Daily as Maintenance Treatment of Eosinophilic Esophagitis. (PubMed, J Clin Gastroenterol) - "In this retrospective study, we demonstrated favorable results in the majority of patients treated with budesonide 1 mg OD as maintenance treatment for eosinophilic esophagitis."

Journal • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: an Open-Label Extension Study. (PubMed, Clin Gastroenterol Hepatol) - P3 | "Clinical and histological remission of EoE could be maintained with BOT in a large majority of patients for up to 96 weeks, and for up to 144 weeks in patients with uninterrupted BOT therapy across all trials. No additional safety concerns were identified with long-term BOT treatment. (ClinicalTrials.gov, Number: NCT02493335)."

Journal • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Pharmacologic Treatment of Eosinophilic Esophagitis: Efficacious, Likely Efficacious, and Failed Drugs. (PubMed, Inflamm Intest Dis) - "Before the approval of Jorveza® and Eohilia®, several investigator-initiated randomized controlled clinical studies evaluated esophagus-targeted formulations of either budesonide or fluticasone to treat pediatric and adult EoE patients...Dupilumab (Dupixent®), a monoclonal antibody targeted against IL-4 and IL-13, was approved by regulatory authorities in the USA, Europe, Canada, but not yet Australia...Due to lack of efficacy or unfavorable safety profile, the following drugs are not recommended for EoE treatment: systemic steroids, sodium cromoglycate, montelukast, azathioprine, TNF-antagonists (e.g., infliximab), vedolizumab (mAb against α4β7), benralizumab (mAb against IL-5 receptor), mepolizumab (mAb against IL-5), reslizumab (mAb against IL-5), omalizumab (mAb against IgE), and lirentelimab (mAb against Siglec-8). Long-term effectiveness and safety data on different drugs are currently sparse. Concerted efforts of different stakeholders will be..."

Journal • Review • Eosinophilic Esophagitis • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • Pediatrics • IL13 • IL4 • IL5 • SIGLEC8

Switch from Off-Label Swallowed Topical Corticosteroids to Budesonide Orodispersible Tablets in Eosinophilic Esophagitis patients. (PubMed, Clin Gastroenterol Hepatol) - No abstract available

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Comparing budesonide treatment in eosinophilic esophagitis: a specialized center cohort versus a population-based cohort. (PubMed, Scand J Gastroenterol) - "The budesonide orodispersible tablet (BOT) is recommended as second-line treatment according to the Danish guideline. However, the authors acknowledge that further evidence is necessary before considering changes in clinical practice. Conflicting treatment responses, and discontinuation of treatment due to side effects remains a notable concern."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A retrospective real-world study on the safety and efficacy of budesonide orodispersible tablets for the induction therapy of eosinophilic oesophagitis. (PubMed, Therap Adv Gastroenterol) - "No significant adverse events were identified. Budesonide orodispersible tablet is an effective induction therapy for eosinophilic oesophagitis, as evidenced by its high histologic remission rate and favourable safety profile."

Journal • Real-world • Real-world evidence • Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

SERUM EOTAXIN-3 AND IL-10 ARE USEFUL NON-INVASIVE BIOMARKERS FOR THE DIAGNOSIS AND MONITORING OF EOSINOPHILIC ESOPHAGITIS: A PROSPECTIVE, LONGITUDINAL STUDY (UEGW 2024) - "Following treatment (T1), remission of EoE was achieved by 18/25 (72%) of EoE patients taking budesonide orodispersible tablets or PPIs... Serum Eotaxin-3 and IL-10 are promising non-invasive biomarkers for the diagnosis of EoE with high specificity. In addition, Eotaxin-3 and IL-10 can monitor therapeutic response in patients with EoE."

Biomarker • Clinical • Longitudinal study • Observational data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL10 • IL4 • IL5

BLOOD EOSINOPHILS ACCURATELY PREDICT A DIAGNOSIS OF EOSINOPHILIC ESOPHAGITIS AMONG PATIENTS REPORTING DYSPHAGIA AND TREATMENT RESPONSE IN EOSINOPHILIC ESOPHAGITIS: A PROSPECTIVE MULTI-CENTER STUDY (UEGW 2024) - " Of the 92 included patients, 33 had active EoE, 18 had EoE in histological remission while on budesonide orodispersible tablets (BOT) or proton pump inhibitors (PPI), and 41 had NED... AEC and EosPercent are within the normal range in most EoE patients regardless of histological disease activity. Nevertheless, AEC and EosPercent values accurately predict a diagnosis of EoE among patients reporting dysphagia, as well as histological remission among BOT- or PPI-treated EoE patients. If these findings are replicated on a larger scale, AEC and EosPercent could be used as biomarkers in clinical practice."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

REAL-WORLD EVIDENCE OF THE EFFECTIVENESS AND SAFETY OF ORODISPERSIBLE BUDESONIDE FOR THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS: A MULTICENTRE PROSPECTIVE STUDY EVALUATING THE INDUCTION PERIOD (UEGW 2024) - "Recently, a new budesonide orodispersible tablet (BOT) has become available, showing in the registration trials great efficacy compared to placebo in inducing clinical, endoscopic and histological disease remission... This study confirms the effectiveness of the treatment with BOT in the induction of EoE remission in a real-life setting, either considering clinical, endoscopic and histologic outcomes. Our data also showed a good safety profile, with a few patients requiring drug interruption. Further investigations are necessary to evaluate BOT effectiveness in the long-term period."

Clinical • HEOR • Real-world • Real-world evidence • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

BUDESONIDE ORODISPERSIBLE TABLETS EFFECTIVELY INDUCE CLINICO-HISTOLOGICAL REMISSION IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS PREVIOUSLY TREATED WITH SWALLOWED TOPICAL CORTICOSTEROIDS (UEGW 2024) - "This post-hoc analysis of the BUL-1 and BUL-2 study program demonstrates that pre-treatment with STC other than BOT does not reduce the likelihood of achieving clinico-histological remission by treatment with BOT.One explanation for successful induction of remission despite prior STC treatment is that initial relapse on STC may be due to insufficient delivery of STC to the esophageal mucosa, and/or insufficient equivalent dose of alternative topical steroid compound, rather than patients becoming truly corticosteroid-refractory. In addition, the specialized formulation of BOT that delivers budesonide precisely to the esophageal mucosa may also improve adherence, owing to a more standardized and convenient method of administration."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

RISK FACTORS FOR ORAL AND ESOPHAGEAL CANDIDIASIS DURING BUDESONIDE TREATMENT IN EOSINOPHILIC ESOPHAGITIS PATIENTS (UEGW 2024) - "Oral and esophageal candidiasis is a well-known side effect of budesonide orodispersible tablets in eosinophilic esophagitis. Our results suggest that consistent eosinophilic count (> 35/HPF) and concomitant PPI therapy could represent risk factors in developing mycosis in EoE patients. According to literature, major esophageal inflammation, PPI-induced elimination of the gastric acid barrier and corticosteroid immunosuppression are the main mechanisms leading to oral and esophageal candida colonization."

Clinical • Candidiasis • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

PATIENT PREFERENCES REGARDING MEDICAL TREATMENT OPTIONS IN EOSINOPHILIC ESOPHAGITIS (UEGW 2024) - "Since the approval of a budesonide orodispersible tablet (BOT), the first biological agent (Dupilumab) has been approved by the EMA and FDA, and another budesonide oral suspension has been received approval by the FDA recently. Patients with EoE prefer topical agents over other available routes of administration. Patient education should be carried out to address reservations about long-term treatment."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

An Australian paediatric experience using orodispersible budesonide in eosinophilic oesophagitis (AGW-GESA 2024) - "Jorveza® is an effective treatment for inducing histologic remission in children with EoE but is affected by compliance. Gender and medication adherence are significantly associated with histologic remission."

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pediatrics

The effectiveness of budesonide orodispersible tablets in the real-world is lower than in clinical trials: a multicentre cohort study (AGW-GESA 2024) - "This real-world multi-centre retrospective study demonstrated a 58% histological remission rate at a median of 80 days of treatment. This lower rate in comparison with clinical trials may at least be partly attributable to incorrect technique and limited timely access to endoscopy. Changed PBS prescribing criteria may improve this response rate, but further larger studies are required to fully determine the true real-world response to BOT therapy."

Clinical • Real-world • Real-world evidence • Allergic Rhinitis • Asthma • Atopic Dermatitis • Candidiasis • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Respiratory Diseases

The first randomised controlled trial of Jorveza (budesonide) compared to PPI (pantoprazole) for eosinophilic oesophagitis: Progress report of a multi-site Australian study (AGW-GESA 2024) - "The first randomised controlled trial of Jorveza vs PPI is underway, feasible and recruitment to schedule. More data to follow, additional sites to activate will speed recruitment and results. Aims: To compare the efficacy of Jorveza (budesonide 1mg Po BD) compared to PPI (pantoprazole 40mg Po BD) in adult patients with EoE defined by histological remission (<5 eosinophils/HPF – primary endpoint, secondary endpoint endoscopic appearance, dysphagia symptom scores and QOL)."

Clinical • Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology • Inflammation

EOS-4: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (clinicaltrials.gov) - P3 | N=308 | Recruiting | Sponsor: Dr. Falk Pharma GmbH

Head-to-Head • New P3 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Effectiveness of treatment with budesonide orodispersible tablets in 76 patients with eosinophilic oesophagitis - real-life experience from the population-based DanEoE cohort. (PubMed, Scand J Gastroenterol) - "Complications were rare. In non-responders and those with unacceptable side effects, alternative treatment options such as biologic agents might be needed."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Prophylactic endoscopic vacuum therapy for stricture prevention following wide-field endoscopic submucosal dissection of superficial esophageal cancer. (PubMed, Gastrointest Endosc) - "The prophylactic combination of EVT and BOT is a novel and promising strategy for reducing post-ESD strictures."

Journal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

Budesonide Orodispersible Tablet for the Treatment of Refractory Esophageal Lichen Planus. (PubMed, ACG Case Rep J) - "We describe a severe case of esophageal lichen planus and recurrent esophageal stricture that was refractory to acid suppression, local and systemic steroid formulations, and dilatation. We present the first reported use of budesonide orodispersible tablet for this condition, including the excellent clinical, endoscopic, and histopathological response."

Journal • Dermatology • Dermatopathology • Gastrointestinal Disorder • Lichen Planus

Cohort Profile Update: The Swiss Eosinophilic Esophagitis Cohort Study (SEECS). (PubMed, Inflamm Intest Dis) - "At inclusion, 686 (95.8%) of EoE patients were on ongoing treatment (orodispersible budesonide tablet [Jorveza®] in 281 patients [41%]; budesonide or fluticasone syrup or swallowed powder in 290 patients [42.3%]; proton-pump inhibitors in 162 patients [23.6%]; elimination diets in 103 patients [15%]; and esophageal dilation at last visit in 166 patients [24.2%]). SEECS continuously grows and is operational using fully electronic data capture. SEECS offers up-to-date epidemiologic and real-world clinical efficacy data on EoE and promotes clinical and translational research."

Journal • Allergy • Asthma • Atopic Dermatitis • Conjunctivitis • Dermatology • Eosinophilic Esophagitis • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Evaluation of Efficacy, Safety and Patient' Satisfaction of Therapeutic Switch From Off-Steroids to Budesonide (clinicaltrials.gov) - P=N/A | N=31 | Completed | Sponsor: Istituto Clinico Humanitas | Not yet recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Mucoadhesive Budesonide Solution for the Treatment of Pediatric Eosinophilic Esophagitis. (PubMed, Pharmaceuticals (Basel)) - "Jorveza® (budesonide) and Dupixent® (dupilumab) are treatments for Eosinophilic Esophagitis approved by the European Medicines Agency in adults but not in children. The formulation showed rheological and mucoadhesive properties suitable for an Eosinophilic Esophagitis local prolonged treatment. In this way, pharmacists can prepare stable budesonide-based mucoadhesive solutions, providing both patients and physicians with a new therapeutic option for Eosinophilic Esophagitis pediatric treatment."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Pain • Pediatrics

THE EFFECTIVENESS OF BUDESONIDE ONCE DAILY AS MAINTENANCE TREATMENT FOR EOSINOPHILIC ESOPHAGITIS: A RETROSPECTIVE ANALYSIS. (DDW 2024) - "5mg N= ) either budesonide orodispersible tablet (BOT Jorveza Dr... In this retrospective study we demonstrated favorable histological and clinical results in the majority of patients of once daily dosing of 1mg budesonide during maintenance treatment of eosinophilic esophagitis."

Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

EVALUATION OF EFFICACY, SAFETY AND PATIENT'S SATISFACTION OF THERAPEUTIC SWITCH FROM OFF-LABEL SWALLOWED TOPICAL CORTICOSTEROIDS TO BUDESONIDE ORODISPERSIBLE TABLETS IN PATIENTS WITH EOSINOPHILIC ESOPHAGISITIS (DDW 2024) - P | "% fluticasone 5. BOT treatment was effective to maintain previous remission and to achieve a deep histologic remission in those patients who showed previously an active disease. Moreover patients reported a significant major willing of assumption of budesonide orodispersible tablets"

Clinical • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease