TY - JOUR
T1 - Primary results from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE)
AU - Jankovic, Joseph
AU - Adler, Charles H.
AU - Charles, David
AU - Comella, Cynthia
AU - Stacy, Mark
AU - Schwartz, Marc
AU - Manack Adams, Aubrey
AU - Brin, Mitchell F.
N1 - Funding Information:
Editorial assistance for manuscript development was provided by Jennifer Giel, PhD, of Evidence Scientific Solutions, and was funded by Allergan, Inc . The authors would like to thank all of the investigators in the CD PROBE Study Group for their dedication to this study. The following gave their permission to be acknowledged at the time of manuscript submission: Lefkos Aftonomos, Richard L. Barbano, Peter J. Barbour, Jay R. Bhatt, David N. Bowers, Allison Brashear, Mary Caire, Mahan Chehrenama, Shilpa Chitnis, Francis Conidi, Diane R. Counce, Paul Cullis, Khashayar Dashtipour, Lisa R. Davidson, Antonelle de Marcaida, Richard M. Dubinsky, Jeffery J. Esper, Stanley Fisher, Grace Forde, Karen Frei, Ramon Gil, John L. Goudreau, Vanessa K. Hinson, Patrick Hogan, Tomas Holmlund, Stuart H. Isaacson, Bahman Jabbari, Katie Kompoliti, Rajeev Kumar, Eugene C. Lai, Julie Leegwater-Kim, Peter A. LeWitt, Tsao-Wei Lang, Steven E. Lo, Zoltan Mari, Anthony May, Eric S. Molho, Sri Nalamachu, Odinachi Oguh, Padraig O'Suilleabhain, Atul T. Patel, Diana Pollock, J. Ben Renfroe, Perry K. Richardson, Ramon L. Rodriguez, Jason Charles Rosenberg, Kyle W. Ruffing, Aliya I. Sarwar, Scott Sherman, Holly A. Shill, Carlos Singer, Thyagarajan Subramanian, Natividad P. Stover, William R. Sunter, David Swope, Martin Taylor, Margaret C. Tilton, Richard M. Trosch, Winona Tse, Miodrag Velickovic, Maureen W. Watts, Cindy Zadikoff, Lin Zhang, and Chonghao Zhao.
Funding Information:
This study and its analysis were sponsored by Allergan, Inc., Irvine, CA. Dr Jankovic received research and Center of Excellence grants from Allergan, Inc., Ceregene, Inc, CHDI Foundation, GE Healthcare, Huntington's Disease Society of America, Huntington Study Group, Ipsen Limited, Lundbeck Inc, Michael J. Fox Foundation for Parkinson Research, Medtronic, Merz Pharmaceuticals, National Institutes of Health, National Parkinson Foundation, St. Jude Medical, Teva Pharmaceutical Industries Ltd, UCB Inc, University of Rochester, and Parkinson Study Group; has served as a consultant or an advisory committee member for Allergan, Inc., Auspex Pharmaceuticals, Inc, Ipsen Biopharmaceuticals, Inc., Lundbeck Inc, and Teva Pharmaceutical Industries Ltd; has received royalties from Cambridge, Elsevier, Future Science Group, Hodder Arnold, Lippincott Williams & Wilkins, and Wiley-Blackwell; has served on editorial boards without financial compensation for Medlink : Neurology , Expert Review of Neurotherapeutics , Neurology in Clinical Practice , The Botulinum Journal , PeerJ , Therapeutic Advances in Neurological Disorders , Neurotherapeutics , Tremor and Other Hyperkinetic Movements , Journal of Parkinson ' s Disease , and UpToDate ; has served on foundation advisory boards without financial compensation for American Academy of Neurology, Benign Essential Blepharospasm Research Foundation, Dystonia Medical Research Foundation, International Essential Tremor Foundation, International Neurotoxin Association, and Michael J. Fox Foundation for Parkinson Research. Dr Adler received compensation from Allergan, Merz, and Xenoport for consulting services, and received research support from Avid Radiopharmaceuticals. Vanderbilt University receives income from grants and contracts with Allergan, Ipsen, Merz, and Medtronic for research led by Dr Charles. Dr Charles receives income for Allergan, Ipsen, Merz, and Medtronic for education and consulting services. Dr Comella received compensation from Allergan, Inc., Ipsen, Merz, NeuPathe, and Medtronic for consulting services; she received research support from Allergan, Inc., Ipsen, Merz, NIH, and Dystonia Study Group. Dr Stacy has received grant/research support from Ceregene, Michael J. Fox Foundation, NIH, and Parkinson Study Group; served as a consultant for Acorda, Allergan, Chelsea, General Electric, Genzyme, Johnson & Johnson, Lilly, Merz, Neuronova, Novartis, Osmotica, Pfizer, ProStraken, SK Life Sciences, UCB, and Vanda; has served on a protocol steering committee for Allergan; and has received royalties from Informa Press for Handbook of Dystonia. Mr Schwartz is an employee of MedNet Solutions, Inc., which was contracted by Allergan, Inc. to provide statistical support. Drs Manack Adams and Brin are employees of Allergan, Inc. and receive salary, stock, and stock options from Allergan, Inc.
Publisher Copyright:
© 2014 Elsevier B.V.
PY - 2015/2/15
Y1 - 2015/2/15
N2 - Background The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Methods Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≤16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. Results 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189.8 ± 87.1 U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n = 479) decreased from 39.2 at baseline to 27.1 at final visit (P <.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n = 479, 91.2% vs 95.0%; P <.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n = 470, 83.0% vs 91.7%; P <.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n = 407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Conclusions Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.
AB - Background The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Methods Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≤16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. Results 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189.8 ± 87.1 U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n = 479) decreased from 39.2 at baseline to 27.1 at final visit (P <.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n = 479, 91.2% vs 95.0%; P <.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n = 470, 83.0% vs 91.7%; P <.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n = 407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Conclusions Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.
KW - Botulinum toxin
KW - Cervical dystonia
KW - OnabotulinumtoxinA
KW - Pain
KW - Torticollis
UR - http://www.scopus.com/inward/record.url?scp=84924007555&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84924007555&partnerID=8YFLogxK
U2 - 10.1016/j.jns.2014.12.030
DO - 10.1016/j.jns.2014.12.030
M3 - Article
C2 - 25595221
AN - SCOPUS:84924007555
VL - 349
SP - 84
EP - 93
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
SN - 0022-510X
IS - 1-2
ER -