Long-term botulinum toxin efficacy, safety, and immunogenicity

Mov Disord. 2005 May;20(5):592-7. doi: 10.1002/mds.20376.

Abstract

To determine the long-term efficacy of botulinum toxin (BTX) treatments, we analyzed longitudinal follow-up data on 45 patients (32 women; mean age, 68.8 years) currently followed in the Baylor College of Medicine Movement Disorders Clinic, who have received BTX treatments continuously for at least 12 years (mean 15.8 +/- 1.5 years). Their mean response rating after the last injection, based one a previously described scale 0-to-4 scale (0 = no effect; 4 = marked improvement) was 3.7 +/- 0.6 and the mean total duration of response was 15.4 +/- 3.4 weeks. Although the latency and total duration of the response to treatment have not changed over time, the peak duration of response (P < 0.005) and dose per visit (P < 0.0001) have increased since the initial visit. Furthermore, global rating (P < 0.02) and peak effect (P < 0.05) have improved. In total, 20 adverse events occurred in 16 of 45 (35.6%) patients after their initial visit and 11 adverse events in 10 of 45 (22.2%) patients at their most recent injection visit. Antibody (Ab) testing was carried out in 22 patients due to nonresponsiveness; blocking Abs were confirmed by the mouse protection assay in 4 of 22 (18%) patients. Of the Ab-negative patients, 16 resumed responsiveness after dose adjustments and 2 persisted as nonrespondents. Except for 1 patient, the 4 Ab-positive and the 2 clinical nonresponders are being treated with BTX-B. This longest reported follow-up of BTX injections confirms the long-term efficacy and safety of this treatment.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Antibodies / immunology*
  • Blepharoptosis / drug therapy
  • Blepharoptosis / immunology
  • Blepharoptosis / physiopathology
  • Botulinum Toxins, Type A / administration & dosage
  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / therapeutic use*
  • Deglutition Disorders / drug therapy
  • Deglutition Disorders / immunology
  • Deglutition Disorders / physiopathology
  • Drug Administration Schedule
  • Dystonia / drug therapy*
  • Dystonia / immunology*
  • Dystonia / physiopathology
  • Female
  • Hemifacial Spasm / drug therapy
  • Hemifacial Spasm / immunology
  • Hemifacial Spasm / physiopathology
  • Humans
  • Injections
  • Male
  • Middle Aged
  • Muscle Weakness / drug therapy
  • Muscle Weakness / immunology
  • Muscle Weakness / physiopathology
  • Neck Muscles / physiopathology
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Agents / therapeutic use*
  • Time Factors

Substances

  • Antibodies
  • Neuromuscular Agents
  • Botulinum Toxins, Type A