Effects of Concomitant Medication Use on Tardive Dyskinesia Outcomes in Long-Term Valbenazine Trials (P4.8-035)

Objective: To evaluate the effects of concomitant medications on treatment outcomes in long-term valbenazine trials. Background: The efficacy and safety of valbenazine, a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating tardive dyskinesia (TD) in adults, have been demonstrated in shorter- and long-term trials. Concomitant medications (e.g., antipsychotics, antidepressants, anticholinergics) needed to manage psychiatric conditions were allowed in the valbenazine clinical trials. Design/Methods: Data were pooled from two phase 3 trials, KINECT 3 (NCT02274558) and KINECT 4 (NCT02405091), in which participants received up to 48 weeks of once-daily valbenazine (40 or 80 mg). Outcomes included Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1–7) mean change from baseline (CFB) to Week 48 and AIMS response (≥50% total score improvement). Concomitant medication subgroups were defined as: antipsychotic (yes, no); antipsychotic type (atypical only, typical or both [typical+atypical]); antidepressant (yes, no); anxiolytic (benzodiazepines+others: yes, no); anticholinergic (yes, no). Subgroup categories were not mutually exclusive. Results: Of 304 participants, 85.5% were taking antipsychotics, 64.5% antidepressants, 30.3% anxiolytics, and 32.2% anticholinergics. AIMS total score CFB was significantly improved in all subgroups (P Conclusions: Results from long-term valbenazine trials indicate sustained TD improvements in patients taking different concomitant medications. Disclosure: Dr. Comella has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz Pharmaceutical, Revance Therapeutic, Retrophin Therapeutic. Dr. Comella receives compensation for services as a consultant or an advisory committee member: Acorda Therapeutics, Allergan, Inc; Lundbeck Ltd.; Medtronic Inc.; Merz Pharmaceuticals; Acadia Pharmaceuticals; Jazz Pharmaceuticals, Neurocrine Biosciences Inc., Revance Therapeutic. Dr. Comella receives royalties from Cambridge, Wolters Kluwer. Dr. Comella has received research support from Acorda, Revance, Merz, Eisai, Jazz Pharmacuetical, Parkinson’s Foundation. Dr. Singer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Adamas, Mitsubishi, AbbVie, and Revance. Dr. Singer has received research support from Sunovion Pharmaceuticals, Adamas Pharmaceuticals, Pharma2B, and Biogen. Dr. Kane has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alkermes, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest (Allergan), Genentech, H. Lundbeck. Intracellular Therapies, Janssen Pharmaceutica, Johnson and Johnson, Merck, Neurocrine, Otsuka, Pierre Fabre, Reviva, Roche, Sunovion, Takeda and Teva, Vanguard Research Group and LB Pharmaceuticals. Dr. Kane has received research support from Otsuka, Lundbeck and Janssen. Dr. Farahmand has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc. the supporter of this study. Dr. Burke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc.. Dr. Siegert has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc.