Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm-a randomized trial.

Abstract

IncobotulinumtoxinA (NT 201, Xeomin) is a highly purified botulinum neurotoxin type A formulation, free from complexing proteins. A randomized, placebo-controlled, double-blind trial of efficacy and safety compared incobotulinumtoxinA (up to 50 U per eye) to placebo administered in a single treatment session to patients with blepharospasm. All patients had documented satisfactory response to 2 previous treatments with botulinum neurotoxin type A other than incobotulinumtoxinA and had Jankovic Rating Scale severity subscores ≥ 2. Patients (n = 109) were randomized in a 2:1 ratio to incobotulinumtoxinA or placebo and followed up to 20 weeks; 94% completed the study. A significant difference was observed in the primary efficacy variable (change in Jankovic Rating Scale severity subscore rated by an independent rater 6 weeks following treatment), favoring incobotulinumtoxinA by 1.0 point (95% CI [0.5-1.4]; P < .001). Functional impairment, as measured by the Blepharospasm Disability Index, improved by 0.5 points (95% CI [0.2-0.7]; P = .002) compared with placebo. There was a strong correlation between the 2 scale scores. In addition, all secondary outcome measures favored incobotulinumtoxinA. Patients rated the mean therapeutic effect of incobotulinumtoxinA significantly better than placebo (P < .001). Adverse events were reported in 70.3% of incobotulinumtoxinA patients and 58.8% of placebo patients. Eyelid ptosis (18.9% vs 5.9%), dry eye (18.9% vs 11.8%), and dry mouth (14.9% vs 2.9%) occurred most frequently. Tolerability was rated good/very good by 91.9% of incobotulinumtoxinA versus in 85.2% of placebo patients. In conclusion, incobotulinumtoxinA was well tolerated and was associated with statistically significant and clinically relevant reductions in blepharospasm severity and functional impairment.

• Authors: Joseph Jankovic, Cynthia Comella, Angelika Hanschmann, Susanne Grafe
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 26 Issue 8 Pg. 1521-8 (Jul 2011) ISSN: 1531-8257 [Electronic] United States
• PMID: 21520284 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Movement Disorder Society.

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• incobotulinumtoxinA

Topics

• Aged
• Blepharoptosis (chemically induced)
• Blepharospasm (drug therapy, immunology)
• Botulinum Toxins, Type A (therapeutic use)
• Canada
• Disability Evaluation
• Double-Blind Method
• Electrocardiography
• Enzyme-Linked Immunosorbent Assay
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Neuromuscular Agents (therapeutic use)
• Severity of Illness Index
• Time Factors
• Treatment Outcome
• United States
• Xerostomia (chemically induced)