{
  "abstract": "Background Long-term real-world safety and utilization data are limited for onabotA treatment of concomitant multiple indications.Methods SYNCHRONIZE, a retrospective chart review study conducted at 10 US clinics, evaluated onabotA safety for ≥2 different therapeutic indications within 3-month treatment periods(TPs) in adults. This analysis evaluated safety of onabotA for up to seven repeat TPs within 24months.Results 279 patients were treated for ≥2 therapeutic indications across all treatment indication combination groups analyzed (Period1; mean age, 49.2y; 79% female;56% White) with a gradual decrease to 80 patients during the last TP (Period7). Mean onabotA treatments over the study period was9.3 (range 2–48); the most common indications combination was cervical dystonia and chronic migraine (range 34–44%). Compared to baseline, no significant change in comorbidities and concomitant medications were observed over repeat TPs. In total, 28.7%(80/279) patients reported ≥1 treatment-emergent adverse event (TEAE) after Period1; proportion remained consistent; 29.7%, 29.6%, and 31.3% after Periods 3, 5 and 7, respectively.Common TEAEs across all TPs were UTI (range 0.7–5.7%), neck pain (3.7–9.1%), headache (2.9–6.5%), and migraine (2.5–6.4%). Most patients had a dosage interval of ≤24h (62–98%). Most patients received ≥200-<400U of cumulative 3-months onabotA dose (43–50%) with mean total 3-month dose ranging from 232–287U. There was no apparent trend between TEAE incidence and dosage intervals or cumulative 3-month dose. No patients were determined to have lack of effect.Conclusion OnabotA demonstrated consistent safety with no new signals observed in patients treated concomitantly for ≥2 therapeutic indications over repeat treatments up to 24months.",
  "authors": [
    {
      "affiliations": [
        "NeuroPain Care Center, NYU Langone, New Hyde Park, NY, USA"
      ],
      "name": "Grace Forde"
    },
    {
      "affiliations": [
        "Kansas City Bone and Joint Clinic, Overland Park, KS, USA"
      ],
      "name": "Atul Patel"
    },
    {
      "affiliations": [
        "Neurology and Pain Specialty Center, Aliso Viejo, CA, USA"
      ],
      "name": "Kenneth Martinez"
    },
    {
      "affiliations": [
        "Swedish Neuroscience Institute, Seattle, WA, USA"
      ],
      "name": "Angeli Mayadev"
    },
    {
      "affiliations": [
        "NYU Langone Health, New York, NY, USA"
      ],
      "name": "Benjamin Brucker"
    },
    {
      "affiliations": [
        "EvergreenHealth Kirkland, Kirkland, WA, USA"
      ],
      "name": "Theodore Brown"
    },
    {
      "affiliations": [
        "Ranchos Los Amigos National Rehabilitation Center, Downey, CA, USA"
      ],
      "name": "Ziyad Ayyoub"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Ritu Singh"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Mariana Nelson"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Ahunna Ukah"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Irina Yushmanova"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Simona Battucci"
    },
    {
      "affiliations": [
        "Abbvie, Irvine, California, USA"
      ],
      "name": "Kim Becker Ifantides"
    },
    {
      "affiliations": [
        "Norton Neuroscience Institute, Louisville, Kentucky, USA"
      ],
      "name": "Christopher Rhyne"
    },
    {
      "affiliations": [
        "Abbvie, Mascot, NSW, Australia"
      ],
      "name": "Juanita Kidd"
    }
  ],
  "title": "3468 Real-world retrospective safety analysis in patients treated with onabotulinumtoxinA for multiple therapeutic indications over repeat treatment periods",
  "uid": "7f022795-ccff-56b6-8e13-e64109f5c69f"
}