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Open AccessArticle

Safety and Stability of Pulmonary Function in Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA

1
Rancho Los Amigos National Rehabilitation Center, Downey, CA 90242, USA
2
Clinical Professor of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA 90095, USA
3
Department of Physical Medicine and Rehabilitation, Western University of Health Sciences, Pomona, CA 91766, USA
4
Department of Neurology, University of California, Sacramento, CA 95817, USA
5
Department of Neurology, Jagiellonian University, 31-007 Krakow, Poland
6
Sound Physicians, San Francisco, CA 95116, USA
7
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA 90502, USA
8
Allergan plc, an AbbVie Company, Irvine, CA 92612, USA
9
Department of Neurology, University of California, Irvine, CA 92697, USA
*
Author to whom correspondence should be addressed.
Toxins 2020, 12(10), 661; https://doi.org/10.3390/toxins12100661
Received: 21 August 2020 / Revised: 25 September 2020 / Accepted: 7 October 2020 / Published: 19 October 2020
(This article belongs to the Section Bacterial Toxins)
Two randomized, placebo-controlled studies evaluated the pulmonary function safety of onabotulinumtoxinA (onabotA) for treatment of upper and/or lower limb spasticity. Patients with stable baseline respiratory status received one or two treatments with placebo, 240 U, or 360 U of onabotA. Pulmonary function tests, adverse events, and efficacy were measured at least every 6 weeks for 18 weeks (Study 1) or 30 weeks (Study 2). Study 1 enrolled 109 patients (n = 36–37/group) and Study 2 enrolled 155 patients (n = 48–54/group). Mean baseline forced vital capacity (FVC) was 76–78% of predicted per group in Study 1 and 71% of predicted per group in Study 2. In Study 1, change from baseline FVC values were significantly (p < 0.05) decreased vs. placebo at weeks 3 (240 U −57 mL vs. placebo +110 mL) and 12 (360 U −6 mL vs. +167 mL placebo). In Study 2, change from baseline FVC values were significantly decreased in the 360 U group vs. placebo at weeks 6 (−78 mL vs. +49 mL placebo), 13 (−60 mL vs. +119 mL placebo), 18 (−128 mL vs. +80 mL placebo), and 24 (−82 mL vs. +149 mL placebo). Individual pulmonary function-related adverse events were not correlated with PFT decreases. The most frequent pulmonary-related adverse events were nasopharyngitis (Study 1) and upper respiratory tract infection (Study 2). Ashworth scores were significantly improved at multiple time points in both studies. Injection of onabotA for spasticity in patients with decreased pulmonary function, at single and repeated doses of up to 360 U, was associated with small but statistically significant decreases in FVC or forced expiratory volume 1 s (FEV1) (>12% and 200 mL) that were subclinical and not correlated with any adverse clinical pulmonary events. View Full-Text
Keywords: onabotulinumtoxinA; botulinum toxin type A; pulmonary function testing; spasticity; respiratory function; forced vital capacity; forced expiratory volume onabotulinumtoxinA; botulinum toxin type A; pulmonary function testing; spasticity; respiratory function; forced vital capacity; forced expiratory volume
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MDPI and ACS Style

Ayyoub, Z.; Brashear, A.; Banach, M.; Schoene, R.; Stringer, W.; Boodhoo, T.; Yushmanova, I.; Dimitrova, R.; Brin, M.F. Safety and Stability of Pulmonary Function in Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA. Toxins 2020, 12, 661.

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