{
  "abstract": "Objectives To characterize infusion site events (ISEs) in patients with advanced Parkinson’s disease (aPD) treated with foslevodopa/foscarbidopa (LDp/CDp).Methods This post hoc analysis was conducted in patients receiving LDp/CDp in a 12-week, phase 3, randomized study ( NCT04380142). ISEs were recorded by investigators, including median time to onset/resolution and severity. Clinical management of presumed infusion site infections were summarised for the 3 most commonly reported preferred terms (infusion site infection, infusion site cellulitis, and infusion site abscess). Infections were presumed in most cases due to infrequently performed site cultures.Results Of 74 patients receiving LDp/CDp, infusion site reactions were reported in 46 (62.2%) and presumed infusion site infections in 21 (28.4%). Of these, most experienced infusion site reactions/infections that were mild or moderate in severity (45/46 [97.8%] and 20/21 [95.2%], respectively); 2 patients experienced serious infusion site infections. The median time to onset of infusion site reactions/infections was 5 and 32 days, respectively; median time to resolution was 7 and 18 days, respectively. Most patients who experienced ISEs continued LDp/CDp. Roughly half of presumed infections were empirically treated with oral antibiotics and resolved with or without treatment.Conclusions Presumed infusion site infections represented a small subset of ISEs; most were non-serious, mild to moderate in severity, did not result in discontinuation, and resolved with or without antibiotics. Better outcomes may result when patients/care partners use aseptic techniques, rotate infusion sites more often than every third day, use a new infusion set upon changes in the skin, and monitor for early infection signs.",
  "authors": [
    {
      "affiliations": [
        "AbbVie, Mascot, NSW, Australia"
      ],
      "name": "Elena Petrova"
    },
    {
      "affiliations": [
        "Abbvie INC, North Chicago, USA"
      ],
      "name": "Lars bergmann"
    },
    {
      "affiliations": [
        "Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA"
      ],
      "name": "Stuart H Isaacson"
    },
    {
      "affiliations": [
        "Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA"
      ],
      "name": "Robert S Kirsner"
    },
    {
      "affiliations": [
        "Steward Medical Group, St. Elizabeth’s Medical Center, Brighton, Massachusetts, USA"
      ],
      "name": "Okeanis Vaou"
    },
    {
      "affiliations": [
        "Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA"
      ],
      "name": "Rajesh Pahwa"
    },
    {
      "affiliations": [
        "University of South Florida Parkinson’s Disease and Movement Disorders Center of Excellence, Tampa, Florida, USA"
      ],
      "name": "Robert A Hauser"
    },
    {
      "affiliations": [
        "Abbvie INC, North Chicago, USA"
      ],
      "name": "Resmi Gupta"
    },
    {
      "affiliations": [
        "Abbvie INC, North Chicago, USA"
      ],
      "name": "Megha B Shah"
    },
    {
      "affiliations": [
        "Abbvie INC, North Chicago, USA"
      ],
      "name": "Shane Varughese"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Adelaide, Adelaide, SA, Australia"
      ],
      "name": "Thomas E Kimber"
    }
  ],
  "title": "3483 Evaluation of infusion site adverse events with foslevodopa/foscarbidopa in a 12 week, randomized study",
  "uid": "ac231ef6-0a50-56b7-ba9c-d3cddda92775"
}