Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.

Dellon, Evan S; Collins, Margaret H; Rothenberg, Marc E; Assouline-Dayan, Yehudith; Evans, Larry; Gupta, Sandeep; Schoepfer, Alain; Straumann, Alex; Safroneeva, Ekaterina; Rodriguez, Cristian; Minton, Neil; Hua, Steven Y; Hirano, Ikuo (2020). Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. (In Press). Clinical gastroenterology and hepatology Elsevier 10.1016/j.cgh.2020.03.036

[img] Text
Dellon ClinGastroenterolHepatol 2020_AAM .pdf - Accepted Version
Restricted to registered users only until 21 March 2021.
Available under License Publisher holds Copyright.

Download (21MB) | Request a copy

BACKGROUND & AIMS The short-term efficacy of RPC4046, a monoclonal antibody against interleukin-13, has been demonstrated in patients with eosinophilic esophagitis (EoE). We investigated the long-term efficacy and safety of RPC4046 in an open-label, long-term extension (LTE) study in adults with EoE. METHODS We analyzed data from 66 patients who completed the 16-week double-blind induction portion of a phase 2 study of RPC4046 (180 mg or 360 mg/weekly) vs placebo and then completed a 52-week LTE, receiving open-label RPC4046 360 mg/weekly. The study was conducted at 28 centers in 3 countries; patients were enrolled between September 2014 and January 2017. Outcomes were stratified by double-blind dose group and included esophageal eosinophil counts, EoE endoscopic reference score, EoE histologic scoring system score, symptom-based EoE activity index score, and safety. RESULTS By Week 12 of the LTE, esophageal eosinophil mean and peak counts, total EoE endoscopic reference scores, and EoE histologic scoring system grade and stage scores did not differ considerably between patients who originally received placebo vs RPC4046. Most patients maintained responses through week 52. Symptom remission (symptom-based EoE activity index score of 20 or less) increased from 14% at LTE entry to 67% at LTE week 52 in placebo‒RPC4046 patients and from 30% to 54% in RPC4046 (either dose)‒RPC4046 patients. Of the 28 patients who did not have a histologic response to RPC4046 during the double-blind induction phase, 10 patients (36%) achieved response during the LTE. The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%). CONCLUSION One year treatment with RPC4046 is generally well tolerated and results in continued improvement and/or maintenance of endoscopic, histologic, and clinical measures of EoE disease activity relative to baseline.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

UniBE Contributor:

Safroneeva, Ekaterina

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1542-3565

Publisher:

Elsevier

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

07 Apr 2020 17:10

Last Modified:

16 Apr 2020 15:50

Publisher DOI:

10.1016/j.cgh.2020.03.036

PubMed ID:

32205221

Uncontrolled Keywords:

EEsAI EREFS EoEHSS inflammation

BORIS DOI:

10.7892/boris.142736

URI:

https://boris.unibe.ch/id/eprint/142736

Actions (login required)

Edit item Edit item
Provide Feedback