Abstract
The overall efficacy of NT 201 (Xeomin®, Merz Pharmaceuticals, Germany) in comparison to BTXCo (Botox®) has been assessed in the two largest controlled trials in cervical dystonia and blepharospasm. NT 201 has not been associated with immunogenicity in animal models in contrast to other preparations of botulinum neurotoxin. Methods: Analyses were performed on the pooled data from all subjects in 2 clinical trials (blepharospasm and cervical dystonia). 343 patients receiving NT 201 and 340 patients receiving BTXCo were included. Results: In the randomized, controlled, double-blind studies, NT 201 and BTXCo have been used with a conversion factor of 1:1. It has been demonstrated that NT 201 was equally efficacious as BTXCo. NT 201 and BTXCo were comparable regarding the duration of treatment effect analysed by the Kaplan–Meier survical method as well as the global impression scores by the physician, e.g. in 71.8% of the NT 201 patients the treatment effect was rated as very good or good at the end of the trial vs. 70.6% for BTXCo patients. The number of responders using the TWSTRS-severity score was 77.0% for NT 201 and 77.3% for BTXCo. Conclusions: In this pooled analysis NT 201 was equally efficacious as BTXCo when used with a conversion factor of 1:1, which has been previously determined in different trials. These data together with the known safety profile suggest that subjects can be easily switched from BTXCo to NT 201.
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