Short- and Long-Term Safety of PEG-J Used for Continuous Infusion of Levodopa-Carbidopa Intestinal Gel (P6.377)

OBJECTIVE: To assess the short- and long-term safety of the percutaneous endoscopic gastrojejunostomy (PEG-J) procedure and device used to deliver levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) in advanced Parkinson’s disease (PD) patients from our most recent clinical trial data cut.BACKGROUND: Continuous delivery of LCIG via PEG-J directly to the jejunum bypasses the stomach, reducing fluctuations in drug plasma levels and motor complications.METHODS: PEG-J procedure- and device-related treatment-emergent adverse events (AEs) reported during 4 phase 3 LCIG studies through March 31, 2014 (including an ongoing open-label extension study) were integrated. A single event could have been coded to u003e1 descriptive term.RESULTS: For the 395 patients who received PEG-J placement, the median (range) exposure to PEG-J was 986 (1-1972) days; the exposure length was ≥1095 days for 165 patients, ≥1260 days for 130 patients, and ≥1460 days for 70 patients. The incidence of serious AEs (SAEs) was highest in Week 1 (7[percnt]) and declined rapidly thereafter (1[percnt] Week 2, 1[percnt] Week 3, 0[percnt] Week 4). Long-term, procedure/device-associated AEs occurred in 300 (76[percnt]) patients, most commonly complication of device insertion (41[percnt]), abdominal pain (36[percnt]), procedural pain (27[percnt]), and postoperative wound infection (26[percnt]). SAEs occurred in 68 (17[percnt]), most commonly complication of device insertion (8[percnt]), abdominal pain (4[percnt]) and peritonitis (3[percnt]). Procedure/device-associated AEs led to discontinuation in 19 (4.8[percnt]) patients; those that led to discontinuation in u003e2 patients included complication of device insertion (n=10, 2.5[percnt]), and abdominal pain (n=4, 1.0[percnt]). CONCLUSIONS: The overall safety profile of LCIG via PEG-J is comparable to published data in immobile patients (Itkin, Gastroenterology, 2011). Incidence of SAEs declined after the first week post-procedure. The low discontinuation rate of LCIG treatment via PEG-J demonstrates this treatment can be maintained for long-term use in these mobile patients with advanced PD.Study Supported by: AbbVie Inc. Disclosure: Dr. Draganov has received personal compensation for activities with AbbVie as a consultant. Dr. Epstein has received personal compensation for activities with AbbVie, Zx Pharma, Aspire Bariatrics, Otsuka, Ferring, and Forest Laboratories for speaking, consulting, and/or participating in advisory boards. Dr. Hawes has received personal compensation for activities with AbbVie as a consultant. Dr. Johnson holds stock and/or stock options in CRH Medical Corporation. Dr. Vanagunas has received personal compensation for activities with AbbVie as a consultant and scientific advisory board member, and with CVS/Caremark Pharmacy and Therapeutics as a consultant, and with Forest Laboratories Inc. as a speaker. Dr. Robieson has received stock and/or stock options in AbbVie. Dr. Krai Chatamra holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Catamra was involved as an investigator. Dr. Benesh holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Benesh was involved as an investigator. Dr. Eaton has received personal compensation for activities with Biogen as an employee. Dr. Eaton holds stock and/or stock options in Biogen.