Session Information
Date: Thursday, June 23, 2016
Session Title: Dystonia
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To review clinical trials directly comparing botulinum neurotoxins (BoNT) for the treatment of movement disorders. To assess efficacy and safety from head-to-head clinical trials.
Background: BoNT are useful tools to treat patients with movement disorders, particularly focal dystonias (blepharospasm, cervical, laryngeal, limb), spasticity and hemifacial spasm. Five BoNT brands (four type A and one type B) are marketed in different countries; the approved indications also vary widely and usually encompass cervical dystonia, the most common focal dystonia type. Few head-to-head comparison have been performed so far. We reviewed all the available direct comparisons in order to ascertain safety and tolerability of different BoNT formulations.
Methods: Only double-blind randomized trials with active control and trials where the comparison of interest was made at least between two different active botulinum neurotoxins were included. The included trials were on patients with any type of dystonia, spasticity of hemifacial spasm. Considered interventions were intramuscular injections of any type of BoNTs in stabilized patients, regardless of the dose, number of treatments and time from onset. Approved rating scales for dystonia or spasticity were considered for comparison of efficacy.
Results: Direct comparisons included four BoNT/A brands (OnabotulinumtoxinA, AbobotulinumtoxinA, IncobotulinumtoxinA, Prosigne) and one BoNT/B brand (RimabotulinumtoxinB). Direct comparison did not reveal significant differences in efficacy across BoNT/A brands and differences in safety were found in one trial only. Comparison of BoNT/B with BoNT/A (that is OnabotulinumtoxinA) showed an increased in occurrence of adverse effects using RimabotulinumtoxinB, even if the difference did not reach significance in all case. The potency ratios were on average 1:1 (Ona vs Inco, Ona vs Prosigne), 1:3 (Ona vs Abo, Prosigne vs Abo), until 1:50 (Ona vs Rima).
Conclusions: There were no appreciable differences in efficacy among different BoNT/A products and also BoNT/B has equivalent effects compared with BoNT/A. Safety was also comparable among BoNT/A products; RimabotulinumtoxinB had more side effects, particularly autonomic, than OnabotulinumtoxinA. Different potency ratios were assessed with a preference in 1:1 ratio in Ona vs Inco and Ona vs Prosigne comparison.
To cite this abstract in AMA style:
R. Maggio, S. Lalli, A. Albanese. Direct comparisons for botulinum neurotoxins in movement disorders [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/direct-comparisons-for-botulinum-neurotoxins-in-movement-disorders/. Accessed November 24, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/direct-comparisons-for-botulinum-neurotoxins-in-movement-disorders/