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6 Presence and Impact of Possible Tardive Dyskinesia in Patients Prescribed Antipsychotics: Results from the RE-KINECT Study

Published online by Cambridge University Press:  12 March 2019


Andrew J. Cutler
Affiliation:
Chief Medical Officer, Meridien Research, Tampa, FL
Stanley N. Caroff
Affiliation:
Emeritus Professor CE of Psychiatry, Corporal Michael J. Crescenz Veterans Affairs Medical Center and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Caroline M. Tanner
Affiliation:
Professor, UCSF School of Medicine and San Francisco VA Health Care System, San Francisco, CA
Huda Shalhoub
Affiliation:
Research Scientist, Evidera, Waltham, MA
William R. Lenderking
Affiliation:
Vice President and Executive Director, Patient-Centered Research, Evidera, Waltham, MA
Jun Chen
Affiliation:
Lead Data Analyst, Evidera, Waltham, MA
Karen Yeomans
Affiliation:
Research Scientist and Director, Real-World Evidence, Evidera, Montreal, QC, Canada
Ericha Anthony
Affiliation:
Manager, Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA
Chuck Yonan
Affiliation:
Senior Director, HEOR, Neurocrine Biosciences, Inc., San Diego, CA

Abstract

Objective

Tardive dyskinesia (TD) is a hyperkinetic movement disorder associated with antipsychotic treatment. RE KINECT (NCT03062033), a real-world study of outpatients prescribed antipsychotics, was designed to identify the presence of possible TD and characterize the impact of involuntary movements on functioning and quality of life. Data from RE-KINECT were used to compare the impact of possible TD in patients with schizophrenia/schizoaffective disorder [SZD] versus mood/other psychiatric disorders [Mood].

Methods

Adults with ≥3months of lifetime exposure to antipsychotics and ≥1 psychiatric disorder were recruited. The presence of possible TD was based on clinicians’ observation of involuntary movements in 4 body regions (head, trunk, upper extremities, and lower extremities). Baseline outcomes included demographics, medication history, location/severity of abnormal movements, impact of abnormal movements on daily activities, the Sheehan Disability Scale (SDS), and the EuroQoL 5-Dimensional questionnaire (EQ-5D-5L).

Results

Of 204 patients with clinician-confirmed possible TD, 111 (54.4%) had a SZD diagnosis and 93 (45.6%) had a mood/other psychiatric diagnosis. Significant differences found between groups (Mood vs SZD) included: mean age (56.9 vs 52.7 years; P=0.0263); male sex (33.3% vs 62.2%; P<0.0001); African-American race (7.5% vs 26.1%; P=0.0005); mean lifetime exposure to antipsychotics (9.5 vs 19.5 years; P<0.0001); and percentage of patients currently taking ≥2 psychiatric medications (93.5% vs 79.3%; P=0.0093). Based on clinician observation, there were no significant differences between diagnosis groups in the number of body regions impacted by abnormal movements, maximum severity score across all 4 regions, or patient awareness of possible TD. Over 30% of patients in both groups reported that involuntary movements had “some” or “a lot” of impact on their ability to continue usual activities, be productive, and socialize. No significant differences between the diagnosis groups (Mood vs SZD) were found for mean SDS total score (12.8 vs 10.8), SDS domain scores (work/school [4.1 vs 4.2], social life [4.3 vs 3.7], family life [4.1 vs 3.5]), EQ-5D-5L utility score (0.68 vs 0.74), or EQ-5D-5L health state VAS (64.8 vs 68.5).

Conclusions

In this cohort of outpatients with possible TD, those with Mood disorders were more likely to be older, female, and white than patients with SZD. The ability to function and quality of life were equally impaired in both groups. Further studies on the impact of TD are needed.

Funding Acknowledgements: Neurocrine Biosciences, Inc.


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© Cambridge University Press 2019 

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