Disclosures: Cynthia Comella, MD: aeon Pharmaceutical (Products/Services: No) (Consultant/Advisory Board)ipsen (Products/Services: No) (Consultant/Advisory Board)jazz (Products/Services: No) (Consultant/Advisory Board)Merz (Products/Services: Yes) (Consultant/Advisory Board)revance (Products/Services: Yes) (Consultant/Advisory Board)

Objective: To examine the pooled incidence of treatment-emergent adverse events (TEAEs) and immunogenicity by therapeutic indication in incobotulinumtoxinA (INCO) clinical trials.

Design: TEAEs were identified in the integrated clinical database of Merz-sponsored placebo (PBO)-controlled studies in adults with cervical dystonia (CD), blepharospasm, upper limb (UL) and lower limb (LL) spasticity, sialorrhea and essential tremor of the UL. Overall incidences of TEAEs, serious TEAEs (SAEs), TEAEs leading to discontinuation, fatal TEAEs, TEAEs of special interest (AESIs; indicating possible toxin spread) and treatment-related (TR) events were determined for INCO and PBO after a single injection cycle and for INCO after multiple cycles; the most frequent TEAEs, TR-TEAEs and TR-AESIs after a single cycle of INCO were summarized. Neutralizing antibody (NAb) testing was performed in most studies.

Setting: Integrated database of sponsored INCO clinical trials.

Participants: Adults with movement disorders participating in sponsored INCO clinical trials.

Interventions: PBO-controlled studies evaluating INCO in the treatment of adults with movement disorders.

Main Outcome Measures: The incidence of TEAEs and immunogenicity by therapeutic indication.

Results: After a single cycle, the incidences of overall TEAEs were similar between INCO and PBO in all indications. Most TEAEs were mild to moderate in intensity, and only one subject experienced a TR-SAE. Few TEAEs led to discontinuation; there were no fatal TEAEs in subjects receiving INCO. Repeated cycles did not increase the incidences of any TEAE category. The most frequent TEAEs and TR-TEAEs were indication-dependent, but often included nasopharyngitis, diarrhea and headache; TR-TEAEs generally included dysphagia for indications affecting the head or neck. TR-AESIs across all indications were most commonly muscular weakness and dry mouth. Few subjects developed NAb; the vast majority of those were positive at baseline and previously treated with other botulinum toxins.

Conclusions: Results of this pooled analysis support and extend the favorable safety and tolerability profile of INCO for the treatment of adult movement disorders and sialorrhea.

Level of Evidence: Level III

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/pooled-safety-snalysis-of-incobotulinumtoxina-in-the-treatment-of-adult-movement-disorders-and-sialorrhea/