Introduction

Pruritus is common in primary biliary cholangitis (PBC) and can significantly impact patients' quality of life (QoL). Cholestyramine is recommended as the first-line treatment option for pruritus in PBC, but tolerability, inconvenient administration, and limited efficacy data restrict its use. Patient-focused drug development can help address this unmet need, but an understanding of patients' perspectives on pruritus and treatments is required. This study conducted semi-structured qualitative patient interviews to explore patients’ experiences, expectations, and concerns with regards to pruritus and treatments.

Aims & Methods

Semi-structured virtual interviews were designed following a literature review and conducted with patients from the USA, Germany, UK, and Italy. Eligible patients self-reported a PBC diagnosis and had a worst itch score of ≥4 on a 0–10 numerical rating scale (NRS) in the past 2 months. Interviews had four parts:
1) pruritus experience,
2) treatment desires and concerns,
3) treatment experience,
4) hypothetical choice questions that required patients to make trade-offs between two options.
Responses were used in an inductive thematic analysis and visually summarized.

Results

Ten patients per country were interviewed (N=40); most were female (78%) and mean (standard deviation) age was 52.5 (15.2) years. For 53% (n=21), pruritus had started within the last 3 years. On the NRS, patients rated their pruritus over the last 2 months on average as mean 5.4 (range 2–10), and worst itch as mean 7.1 (range 4–10). Key themes that emerged from patient discussions were visualized with a concept map. Pruritus was widespread over patients’ bodies, persistent despite scratching, and described as ‘crawling’, ‘burning’ and ‘nettles’. Pruritus impacted social interactions, sleep quality, appearance, emotional stability, and work productivity. Many patients wished for complete resolution, but primarily wanted treatment to reduce pruritus severity (60%; n=23). Of those who had ever received cholestyramine (n=12), 62% reported a repulsive taste and texture; 50% mentioned concerns about interactions between cholestyramine and PBC medication. From five potential pruritus medication side effects, diarrhea and nausea were of greatest concern.

Conclusion

Pruritus impacts QoL in PBC in several ways and the limitations of existing treatments mean patients would welcome alternative options. Future research will establish the relative importance to patients of treatment aspects such as administration, benefits, and tolerability.
Funding: GSK (218705).
Encore statement: This abstract was originally presented as poster 4550-C at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting on November 13, 2023, this encore is presented on behalf of the original authors with their permission.

Disclosure

HTS, AW and PJFT are employees of, and hold stocks/shares in, GSK. AH is an employee of, and holds stocks/shares in, GSK and is a former employee of, and holds stocks/shares in, Novartis. DS and KM are employees of Evidera who were funded by GSK to carry out this study. JS and SH are employees of Evidera who were funded by GSK to carry out this study and are minority stockholders in Thermofisher Scientific as part of their employment with Evidera.

Introduction

The Maastricht V/ Florence Consensus has updated guidelines for the management of Helicobacter Pylori (HP) infection with special emphasis in high clarithromycin resistance settings as it is the case in our country. In line with the recommendations of the European Guidelines on surgery of severe obesity [1] and the recommendations of the American Society of Gastrointestinal Endoscopy on endoscopy of the bariatric patient [2) a policy of systematic HP screening and overtime updated eradication was implemented in obese patients undergoing Roux-en Y gastric bypass (RYGB) surgery.

Aims & Methods

Five year period (2020-2024) single center study. The aim was, in obese patients undergoing RYGB surgery, to assess the cumulative HP eradication rate by adopting, at first line, a 10 days bismuth quadruple therapy (BQT) - proton pump inhibitor (PPI) bid and three-in-one single capsule containing bismuth, metronidazole, and tetracycline qid - and, at second line, a 14 days levofloxacin based therapy ( LBT) – PPI bid, amoxicillin 1000 mg bid and levofloxacin 500mg bid. HP infection status was assessed, at baseline, by histology or urea breath test and post treatment, by urea breath test 4-6 weeks after the end of the therapy.

Results

One thousand four hundred and forty-nine consecutive HP‑positive patients completed BQT treatment: 1160 (80.1%) female, age 43.5 (±10.5) years, median age of 44 years), age range of 18-69 years. HP was eradicated in 1220 patients – 84.2% (95%CI: 82.2%-86.0%). In the remaining 229 patients, 87 patients withdrew and HP was eradicated in 118 patients out of 145 with LBT. The intention to treat (ITT) and per protocol (PP) cumulative eradication rates were, respectively, 92.3% (95%CI: 90.9%-93.6%). and 98.0% (95%CI: 97.1%-98.6%). Eradication rates were not significantly different by gender and age.

Conclusion

By adopting the Maastricht V/ Florence Consensus BQT first line therapy and second line LBT therapy, high ITT and PP cumulative HP eradication rates are achieved leaving only a residual number of obese patients undergoing RYGB in need of the culture and susceptibility testing prior to third line treatment.

References

1. Fried M, Hainer V, Basdevant A, et al. European Guidelines on surgery of severe obesity. . International Journal Of Obesity 2007;31:569-577.
2. ASGE Guidelines. Role of endoscopy in the bariatric patient. Gastrointest Endosc 2008; 68:1-10.

Disclosure

NO CONFLICT OF INTEREST

Clinical Case Summary

Introduction: Locally advanced pancreatic tumors can lead to both biliary and duodenal obstruction by invasion or compression. Quality of life is severely affected if obstruction occurs: jaundice, emesis and pain can become invalidating and patients become too frail for palliative chemotherapy and are sometimes declared unfit even for derivative surgery. Recently, endoscopic techniques under EUS or ERCP guidance are being used to create biliodigestive and enteral anastomoses.
Clinical case: A 75-year-old female was diagnosed with locally advanced pancreatic head adenocarcinoma in January 2024. The tumor was declared unresectable and chemotherapy was initiated. A plastic stent was inserted into the main biliary duct (MBD) to ensure biliary drainage. In May 2024, she presented with cholangitis and emesis. EGD revealed duodenal stenosis and ERCP failed due to tumor infiltration. A combined endoscopic approach was performed: EUS-guided hepatico-gastrostomy (EHG) for biliary drainage and EUS-guided gastro-enterostomy using a lumen-apposing metal stent (LAMS). In July 2024, the plastic stent was removed, and in August 2024, two fully covered 60 x 10 mm SEMS were inserted antegrade through the EHG into the MBD to improve patency. At 11 months post-intervention, the patient returned for routine reassessment, declaring good clinical performance: she remained asymptomatic, with routine blood tests, including bilirubin levels within normal range and with all stents patent and correctly positioned (confirmed radiologically and endoscopically). The patient was able to maintain oral intake and continue chemotherapy. No late adverse events were noted.
Conclusion: This case demonstrates the long-term clinical and technical success of a staged endoscopic triple bypass for the management of complex biliary and duodenal obstruction due to unresectable pancreatic cancer. The approach was minimally invasive, well tolerated and remarkably improved the patient's quality of life.

References

1. Adler, Douglas G MD; Baron, Todd H MD, FACP. Endoscopic Palliation of Malignant Gastric Outlet Obstruction Using Self-Expanding Metal Stents: Experience in 36 Patients. American Journal of Gastroenterology 97(1):p 72-78, January 2002. | DOI: 10.1111/j.1572-0241.2002.05423.x
2. Giovannini, Marc. (2019). EUS-guided hepaticogastrostomy. Endoscopic Ultrasound. 8. 35. 10.4103/eus.eus_47_19.
3. Dumonceau, Jean-Marc & Tringali, Andrea & Blero, Daniel & Devière, J & Laugiers, R & Heresbach, D & Costamagna, Guido. (2012). Biliary stenting: Indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 44. 277-98. 10.1055/s-0031-1291633.
4. Van Der Merwe, S. W., Van Wanrooij, R. L., Bronswijk, M., Everett, S., Lakhtakia, S., Rimbas, M., ... & Van Hooft, J. E. (2022). Therapeutic endoscopic ultrasound: European society of gastrointestinal endoscopy (ESGE) guideline. Endoscopy, 54(02), 185-205. 10.1055/a-1717-1391

Introduction

Aims & Methods

Results

Conclusion

Disclosure