Pentasa (mesalamine) / Ferring, Takeda - LARVOL DELTA

MesaCAPP: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Ann-Sofie Backman | N=260 ➔ 150 | Trial completion date: Oct 2038 ➔ Sep 2045 | Trial primary completion date: Oct 2028 ➔ Sep 2032

Enrollment change • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Genetic Disorders • Oncology • Solid Tumor • EPCAM • MLH1 • MSH2 • MSH6

Enhancing UC Treatment: Combine PENTASA® Oral + Rectal Suppository for Comprehensive Relief (IMKASID 2024) - "European guid elines usually recommend the 5 -ASA combination as the first -line therapy for inducing remission in left -sided and extensive colitis. In this lecture, I will highlight the enhancement of UC treatment using a combination treatment of 5 -ASA oral and rectal su ppositories."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Xijing Hospital of Digestive Diseases | N=40 ➔ 0 | Unknown status ➔ Withdrawn

Enrollment change • Trial withdrawal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

The effect of esomeprazole on the upper GI tract release and systemic absorption of mesalazine from colon targeted formulations. (PubMed, Int J Pharm) - "To this end, gastric, jejunal and systemic concentrations of mesalazine and its metabolite N-acetyl mesalazine were monitored in 5 healthy volunteers following oral intake of Pentasa or Claversal with or without PPI pre-treatment (cross-over study). The faster release of mesalazine in the GI tract and/or the increased systemic absorption following PPI pre-treatment may reduce the ability of mesalazine to reach the colon. Future research assessing mesalazine disposition in the lower GI tract is warranted."

Journal • Gastrointestinal Disorder

MesaCAPP: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: Ann-Sofie Backman | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2021 ➔ Mar 2022

Enrollment open • Trial initiation date • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Oncology • Solid Tumor • EPCAM • MLH1 • MSH2 • MSH6

Efficacy and safety of oral Pentasa® (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis. (PubMed, Curr Med Res Opin) - "Upon inclusion of real-world study data, Pentasa was significantly better at maintaining remission compared both to Eudragit-S mesalazine and sulfasalazine (ARD 0.04, 95% CI 0.02‒0.06; p < 0.001). This study confirms oral Pentasa is efficacious and well-tolerated in treating active UC and maintaining remission. The availability of multiple forms of Pentasa supports physicians' ability to individualize treatment and optimize dosing to improve outcomes."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

MesaCAPP: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome (clinicaltrials.gov) - P2; N=260; Not yet recruiting; Sponsor: Ann-Sofie Backman

New P2 trial • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Oncology • Solid Tumor • EPCAM • MLH1 • MSH2 • MSH6

An investigation of the mechanism of rapid relief of ulcerative colitis induced by Five-Flavor Sophora flavescens Enteric-Coated Capsules based on network pharmacology. (PubMed, Comb Chem High Throughput Screen) - "The molecular mechanism of UC remission induced by FSEC was predicted by network pharmacology. These findings provide an important theoretical basis for further study of the effective substances and mechanism of FSEC in the treatment of UC."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL17A • NFKB1

"عذرا دكتور والبنتازا Pentasa من فضلك هل هو آمن ايضاً اثناء الحمل والرضاعه؟؟" (@Bushra_t01)

"Yo también tomo Inmurel y Pentasa. Pienso, q lo mejor es consultar con nuestro especialista de digestivo." (@Nuria67A)

"استخدمت الـ🧪infliximab خلال الحمل حتى الأسبوع 20 أوقفت الطبيبة العلاج بسبب زيادة الأعراض وتكوين أجسام مضادة لـ🧪ووصفت لي Pentasa لاستخدامه حتى موعد الولادة ثم تغيير الـ🧪 إلى Vedoziulmab بعد الولادة. لم يشجع طبيبي استخدام🧪أثناء🤱🏻ونصح بالإرضاع الصناعي🍼" (@Afnan0o)

Application of inulin/Eudragit RS in 5-ASA pellet coating with tuned, sustained-release feature in an animal model of ulcerative colitis. (PubMed, Int J Pharm) - "The coated pellets offered a superior therapeutic outcome compared to uncoated pellets and Pentasa in terms of colitis activity index (CAI), and the colon's tissue enzymes of GSH and MDA. The optimum coating composed of inulin and RS could offer a tuned sustained release of 5-ASA throughout the small and large intestine with the sensitivity of drug release to microbial degradation."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea (clinicaltrials.gov) - P=N/A; N=15000; Not yet recruiting; Sponsor: Ferring Pharmaceuticals; Trial completion date: Jan 2021 ➔ May 2021; Initiation date: Nov 2020 ➔ Mar 2021; Trial primary completion date: Jan 2021 ➔ May 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] Patient' survey of PENTASA® Sachet 2g in Korea: In patient's perspective of adherence and compliance (AOCC 2020) - "Ferring Pharmaceuticals sponsored symposium"

Clinical

[VIRTUAL] Evaluation of gastroenterology prescribing patterns in a full risk health plan and implementation of an outpatient prescription verification queue to impact specialty prescription use (ASHP 2020) - "Chart review were conducted for top cost biologics (adalimumab, infliximab, ustekinumab, vedolizumab) and oral drugs (mesalamine CR/Pentasa® capsules, rifaximin) to determine adherence to FDA-approved dosing and health plan guidelines. Retrospective drug utilization reviews provide useful data when developing cost-saving interventions. In this review of gastroenterology prescribing, high-cost drugs were prescribed appropriately. However, significant barriers exist from the point of prescribing to receipt of the first dose."

Clinical • HEOR • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Intestinal concentrations and efficacy of different mesalazine tablets in patients with ulcerative colitis. Valutazioni delle concentrazioni intestinali e dell'efficacia di diverse compresse di mesalazina in paziente con colite ulcerosa. (clinicaltrialsregister.eu) - P4; N=36; Completed; Sponsor: CONSORZIO UNIVERSITARIO UNIFARM

Clinical • New P4 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation. (PubMed, Sci Rep) - "We investigated the rate of continuous treatment of mesalazine granules and examined the changes in Crohn's Disease Activity Index (CDAI) and serum C-reactive protein (CRP), albumin, and hemoglobin (Hb) levels 2 years after the switch. No change in the compliance rate was found. Our results suggest that mesalazine granule formulation may have a remission maintenance effect that is superior to that of mesalazine tablets."

Clinical data • Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP

Medicinal products with controlled drug release for local therapy of inflammatory bowel diseases from perspective of pharmaceutical technology. (PubMed, Ceska Slov Farm) - "Specifically, it focuses on pharmaceutical drugs containing 5-aminosalicylic acid (Asacol®, Pentasa®, Salofalk®) and budesonide (Budenofalk®, Cortiment®, Entocort®). As a part of this paper, basic recommendations and practical information that can be used in clinical practice are also given."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. (PubMed, Cochrane Database Syst Rev) - "There is high-certainty evidence that 5-ASA is superior to placebo for maintenance therapy in UC. There is high-certainty evidence that 5-ASA is inferior compared to SASP. There is probably little or no difference between 5-ASA and placebo, and 5-ASA and SASP in commonly reported AEs such as flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia. Oral 5-ASA administered once daily has a similar benefit and harm profile as conventional dosing for maintenance of remission in quiescent UC."

Clinical • Journal • Review • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. (PubMed, Cochrane Database Syst Rev) - "There is high-certainty evidence that 5-ASA is superior to placebo, and moderate-certainty evidence that 5-ASA is not more effective than SASP. Considering relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. High-certainty evidence suggests 5-ASA dosed once daily appears to be as efficacious as conventionally-dosed 5-ASA. There may be little or no difference in efficacy or safety among the various 5-ASA formulations."

Clinical • Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

[VIRTUAL] OVERLAPPING CROHN'S DISEASE AND SEXUALLY TRANSMITTED DISEASES (UEGW 2020) - "4 grams a day of mesalazine granules was prescribed for the patient...Treatment with penicillin was ineffective, while doxycycline reduced proctalgia and bleeding...Based on these changes and patient's complaints, treatment with subcutaneous injection of Adalimumab 40mg twice a month and Azathioprine 100mg a day for suspected Crohn's disease was initiated... Sexually transmitted diseases should be considered in patients with intestinal symptoms and a history of unprotected intercourses. A comprehensive investigation is important before starting any immunosuppressive treatment."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

[VIRTUAL] OVERLAPPING CROHN'S DISEASE AND SEXUALLY TRANSMITTED DISEASES (UEGW 2020) - "4 grams a day of mesalazine granules was prescribed for the patient...Treatment with penicillin was ineffective, while doxycycline reduced proctalgia and bleeding...Based on these changes and patient's complaints, treatment with subcutaneous injection of Adalimumab 40mg twice a month and Azathioprine 100mg a day for suspected Crohn's disease was initiated... Sexually transmitted diseases should be considered in patients with intestinal symptoms and a history of unprotected intercourses. A comprehensive investigation is important before starting any immunosuppressive treatment."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

[VIRTUAL] OVERLAPPING CROHN'S DISEASE AND SEXUALLY TRANSMITTED DISEASES (UEGW 2020) - "4 grams a day of mesalazine granules was prescribed for the patient...Treatment with penicillin was ineffective, while doxycycline reduced proctalgia and bleeding...Based on these changes and patient's complaints, treatment with subcutaneous injection of Adalimumab 40mg twice a month and Azathioprine 100mg a day for suspected Crohn's disease was initiated... Sexually transmitted diseases should be considered in patients with intestinal symptoms and a history of unprotected intercourses. A comprehensive investigation is important before starting any immunosuppressive treatment."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

[VIRTUAL] MESALAZINE INDUCES EARLY HISTO-ENDOSCOPIC MUCOSAL HEALING IN ACTIVE MILD-MODERATE ULCERATIVE COLITIS: POST-HOC ANALYSIS OF POOLED DATA FROM 4 DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTER, RANDOMIZED TRIALS (UEGW 2020) - "Patients were treated with 1.5g/d, 3g/d or 4.5g/d mesalazine granules for 8 weeks... Short-term treatment with granulated mesalazine induced rapid histo-endoscopic mucosal healing in a significant proportion of mildly or moderately active UC patients. Higher doses of mesalazine were superior to the low dose of 1.5g/d. A mesalazine dose of 3g/d was found as the optimal dose, confirming previous results on other endpoints (1)."

Clinical • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] MESALAZINE INDUCES EARLY HISTO-ENDOSCOPIC MUCOSAL HEALING IN ACTIVE MILD-MODERATE ULCERATIVE COLITIS: POST-HOC ANALYSIS OF POOLED DATA FROM 4 DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTER, RANDOMIZED TRIALS (UEGW 2020) - "Patients were treated with 1.5g/d, 3g/d or 4.5g/d mesalazine granules for 8 weeks... Short-term treatment with granulated mesalazine induced rapid histo-endoscopic mucosal healing in a significant proportion of mildly or moderately active UC patients. Higher doses of mesalazine were superior to the low dose of 1.5g/d. A mesalazine dose of 3g/d was found as the optimal dose, confirming previous results on other endpoints (1)."

Clinical • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis