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Practice Management, Leadership, and Quality Improvement

Treatment of Upper Limb Spasticity With OnabotulinumtoxinA in US Clinical Practices: Evaluation of Individualized, Real-World Practice Patterns and Efficacy From the ASPIRE Study

(Research Hub Theater) Treatment of Upper Limb Spasticity with OnabotulinumtoxinA in US Clinical Practices: Evaluation of Individualized, Real-world Practice Patterns and Efficacy from the ASPIRE Study

Friday, November 17, 2023
8:00 AM – 9:15 AM CT

    Co-Author(s)

  • Gerard E. Francisco, MD

    Professor and Chairman
    University of Texas Health Science Center At Houston PM&R Program
    UTHealth at Houston McGovern Medical Schoo
    Houston, Texas

  • Wuwei Feng, MD

    Professor of Neurology
    Duke University Medical Center
    Durham, North Carolina

    • Primary Author(s)

  • Michael C. Munin, MD

    Professor, Vice Chair Strategic Planning and Program Development
    University Pittsburgh School of Med
    Pittsburgh, Pennsylvania

    • Co-Author(s)

  • KN

    Kenneth Ngo, MD

    Medical Director
    Brooks Rehabilitation Hospital
    Jacksonville, Florida

  • MS

    Marc Schwartz, Other

    Founder/CEO
    MS Biostatistics, LLC
    Clermont, Florida

  • Aleksej Zuzek, PhD

    Senior Scientific Director of Therapeutic Neurotoxins
    AbbVie
    Irvine, California

  • Aleks Zuzek, PhD

    Sr. Scientific Director
    AbbVie
    Irvine, California

  • Alberto Esquenazi, MD

    Chairman and Professor, Department of PM&R and Director of Gait and Motion Analysis Laboratory
    MossRehab & Albert Einstein Medical Center, Elkins Park, PA, USA.
    Elkins Park, Pennsylvania

Background and/or Objectives: The US label for onabotA was recently expanded to include treatment of 8 additional muscles associated with adult UL spasticity including those of the elbow and forearm (brachialis, brachioradialis, pronator teres, pronator quadratus), intrinsic hand (lumbricals, interossei), and thumb (flexor pollicis brevis, opponens pollicis). More information is required to maximize effectiveness in patients with UL spasticity. We examined onabotulinumtoxinA (onabotA) treatment utilization patterns in the United States (US) for pronated forearm and intrinsic plus hand postures in patients with upper limb (UL) spasticity over a 2-year period.

Design: This post hoc analysis utilized data from the multicenter, prospective, observational Adult Spasticity International Registry (ASPIRE) study (NCT01930786; 2013–2017).

Setting: United States

Participants: Adult patients with UL spasticity

Interventions: OnabotA (total dose ≤400 U per treatment session)

Main Outcome Measures: Centering on the 2021 onabotA expanded label, we evaluated treatment utilization for pronated forearm and intrinsic plus hand postures in patients with UL spasticity to determine if there is an educational opportunity for optimized treatment in the real-world setting. Treatment efficacy was evaluated by various patient and physician assessments.

Results: Of 316 US patients in ASPIRE treated for UL spasticity, 135/316 (43%) had pronated forearm and 89/316 (28%) had intrinsic plus hand postures. OnabotA (≤400 U) treatment was delivered to select UL muscles of 45 patients (mean [SD] age 51.3 [16.0] years, 23/45 [51%] onabotA-naive, 26/45 [58%] male) consistent with the expanded US label. New postures treated included intrinsic plus hand (9/45; 20.0%) and pronated forearm (14/45; 31.1%). One of 36 adverse events (AEs) was treatment-related (muscular weakness); no treatment-related serious AEs were reported. Efficacy outcomes will be presented.

Conclusions: This analysis of ASPIRE data provides real-world evidence that may inform clinicians on the potential to individualize and optimize treatment of pronated forearm and intrinsic plus hand postures in accordance with the expanded label for onabotA.