MED-MI-TD-US-0101 v3...739 patients were clinically evaluated – 535 (72.4%) in cohort 1: patients without visible signs of uncontrollable or involuntary body movements or with movements

MED-MI-TD-US-0101_v3

Full Dataset Analysis

Awareness and Impact by Underlying Psychiatric Diagnosis Analysis

Correlation between Patient, Caregiver and Clinician Reported Assessments Analysis

Caregiver Burden Analysis

2

3

Prospective screening study that included 37 outpatient psychiatry practices across the US

Key eligibility criteria:

– ≥18 y.o. with ≥3 months of cumulative lifetime exposure to ≥1 antipsychotic medication(s)

– Clinician confirmed psychiatric disorder meeting DSM-5 criteria

2-tiered prevalence estimate of possible tardive dyskinesia (TD)

– Step 1: visual observation by staff member for involuntary movements (i.e. possible TD) in any of 4 main body regions (head/face, neck/trunk, upper limbs, lower limbs)

– Step 2: clinician assessment & confirmation whether movements can be considered possible TD; clinician assigns patients into two different cohorts

Cohort 1: outpatients without visible signs of involuntary movement or with movements not deemed consistent with TD

Cohort 2: outpatients with visible signs of involuntary movement (i.e. clinician-confirmed possible TD)

– Followed for 12 months

Simplified clinician assessment was developed to identify the presence, location, and severity of involuntary movements and confirm possible TD for cohort assignment

Included EQ-5D-5L questionnaire and Sheehan Disability Scale (SDS) completed by patients –health-related quality of life (HRQoL) measurements

4

Tanner CM et al. AAN 2018; Los Angeles, CA

5Tanner CM et al. AAN 2018; Los Angeles, CA

739 patients were clinically evaluated

– 535 (72.4%) in cohort 1: patients without visible signs of uncontrollable or involuntary body movements or with movements not deemed consistent with TD

(“Per your observation, does the subject currently experience uncontrollable or involuntary movements anywhere on their head/body?”) or movements not consistent with TD (“Do you [the clinician] feel the movements are consistent with TD?”)

– 204 (27.6%) in cohort 2: patients with visible signs of uncontrollable or involuntary body movements; confirmed as possible TD during clinician assessment



Cohort 1

(n=535)

Cohort 2

(n=204)Female, n (%) 309 (57.8) 104 (51.0)

Age, mean (SD), years 47.6 (14.6) 54.6 (13.6)

Race, n (%)a

White 385 (72.1) 149 (73.0)

Black 89 (16.7) 36 (17.6)

Otherb 63 (11.8) 19 (9.3)

Marital Status, n (%)

Single 253 (47.4) 98 (48.0)

Married 152 (28.5) 43 (21.1)

Divorced 86 (16.1) 46 (22.5)

Otherc 43 (8.0) 18 (18.8)

Current Living/Domestic Situation, n (%)

Living alone 120 (22.4) 57 (27.9)

Living with a partner or spouse, family, friends 351 (65.6) 105 (51.5)

Otherd 63 (11.8) 41 (20.1)

Employment Status, n (%)a

Employed, full-time 85 (15.9) 14 (6.9)

Employed, part-time 61 (11.4) 25 (12.3)

Homemaker 16 (3.0) 3 (1.5)

Student 22 (4.1) 1 (0.5)

Unemployed 85 (15.9) 19 (9.3)

Retired 48 (9.0) 32 (15.7)

Disabled 225 (42.1) 111 (54.4)

Other 8 (1.5) 3 (1.5)

Some missing data were observed (7 patients for race; 2 patients for living situation and employment status; 1 patient for gender and marital status).aNot mutually exclusive. bIncludes Asian, Indian/Alaska Native, or other. cincludes widowed, separated, or other (not specified). dIncludes living with children,

parents, assisted living, group home, with caregiver or other non-family member


Cohort 1

(n=535)

Cohort 2

(n=204)

Disorder, n (%)1

Schizophrenia 102 (19.1) 71 (34.8)

Anxiety disorder 133 (24.9) 55 (27.0)

Bipolar disorder 176 (32.9) 53 (26.0)

Schizoaffective disorder 72 (13.5) 43 (21.1)

Major depressive disorder 188 (35.1) 40 (19.6)

Other disordersb 101 (18.9) 17 (8.3)

Lifetime exposure to antipsychotic medication, mean (SD),

yearsc 7.8 (8.6) 15.0 (13.9)

Average overall health status, mean (SD)d 4.4 (3.0) 4.7 (2.8)

aPatients may appear in more than one category. bOther disorders includes patients with attention-deficit/hyperactivity disorder, adjustment disorder, personality

disorder, eating disorder, post-traumatic stress disorder, substance use disorder, or unspecified mood. cCohort 1, n=531; cohort 2, n=203. dAverage overall health

status was self-reported; 0=no health problems to 10=health as bad as you can imagine.; cohort 1, n=505; cohort 2, n=190. SD, standard deviation

The most common antipsychotic-treated disorders were bipolar and major depressive disorders in cohort 1 and schizophrenia, anxiety and bipolar disorders in cohort 2

Anxiety disorder was a frequent comorbidity in both cohorts


In cohort 2 (n=204), all body regions except for trunk were affected (“some” or “a lot”) by uncontrollable/involuntary movements based on simplified clinician assessment

– 47.1% of patients in cohort 2 were impacted in 1 body region and 52.9% were impacted in 2 or more regions

– The maximum severity across the 4 body regions was 1 (“some”) in 66.7% of patients and 2 (“a lot”) in 33.3%

Some missing data were observed (1 patient for head, upper, and lower extremities; 3 patients for trunk)

Head/face: facial muscles, lips, tongue, or jaw

• None: 33.8%

• Some: 45.6%

• A lot: 20.1%

Neck/truck: neck, shoulders, chest, or hips

• None: 77.9%

• Some: 16.2%

• A lot: 4.4%

Upper extremities: arms, hands, or fingers

• None: 40.7%

• Some: 48.5%

• A lot: 10.3%

Lower extremities: legs, feet, or toes

• None: 57.4%

• Some: 34.3%

• A lot: 7.8%

10Caroff S et al. AMCP Annual Meeting 2018; Boston, MA

In cohort 2, >30% of patients reported that uncontrollable movements had “some” or “a lot” of impact on their usual activities (32.3%), talking (30.4%), productivity (36.2%), or socializing (36.3%)

Some missing data were observed (7 patients for talking; 6 patients for all other listed activities)

23.0 21.619.1

7.4

28.4

20.626.0

9.3 8.8 8.3

1.5

7.8 5.910.3

64.7 66.269.6

88.2

60.8

70.6

60.8

0

20

40

60

80

UsualActivities

Talking Eating Breathing Productivity Self-Care Socializing

Some A Lot None

Co

ho

rt 2

Resp

on

den

ts, %

Level of Impact

Usual Activities Talking Eating Breathing Productivity Self-Care Socializing


EQ-5D-5L is an HRQoL questionnaire that consist of five dimensions (completed by the patients)

– 1 = no problem; 5 = extreme/unable to function

No statistical hypothesis testing was performed. The sample size for this study is not powered for statistical comparisons, as the objectives are primarily descriptive in nature. All analyses are descriptive and based on observed outcomes.

Table includes patients with self-reported rating of 2 to 5 (2=slight problems, 3=moderate problems, 4=severe problems, 5=unable to perform)

A higher percentage of cohort 2 patients (vs. cohort 1) (score ≥2 [“slight problems”] to 5 [“unable to perform”]) reported problems in all EQ-5D-5L domains

Domain, n/N (%)a Cohort 1 Cohort 2

Mobility: walking about 174/530 (32.8) 84/201 (41.8)

Self-care: washing or dressing self 111/531 (20.9) 66/203 (32.5)

Usual activities: work, study,

housework, family or leisure

activities

249/532 (46.8) 103/203 (51.0)

Pain/discomfort 299/529 (56.5) 129/202 (63.9)

Anxiety/depression 385/531 (72.5) 155/202 (76.7)

n, number of patients who met criteria; N, number of patients with available data

SDS is a brief, patient rated, measure of disability and impairment in three inter-related domains; work/school, social and family life

The patient rates the extent to which work/school, social life, and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale

No statistical hypothesis testing was performed. The sample size for this study is not powered for statistical comparisons, as the objectives are primarily descriptive in nature. All analyses are descriptive and based on observed outcomes.

12Rush JA, et al. Handbook of Psychiatric Measures, 2000 American Psychiatric Association;113-115.

13Caroff S et al. APA 2018; New York, NY

Per SDS results, a higher proportion of cohort 2 vs. cohort 1 reported “moderate” or “marked/extreme” disruption in work/school (46.9% vs. 52.2%) and social life domains (46.7% vs. 52.8%)

Cohort 1 Cohort 2

Work/School, n (%) N=363 N=111

None 111 (20.7%) 25 (12.3%)

Mild 82 (15.3%) 28 (13.7%)

Moderate 79 (14.8%) 25 (12.3%)

Marked 55 (10.3%) 22 (10.8%)

Extreme 36 (6.7%) 11 (5.4%)

Social Life N=531 N=203

None 146 (27.3%) 57 (27.9%)

Mild 137 (25.6%) 39 (19.1%)

Moderate 113 (21.1%) 56 (27.5%)

Marked 96 (17.9%) 32 (15.7%)

Extreme 39 (7.3%) 19 (9.3%)

Family Life/Family Responsibilities N=530 N=203

None 154 (28.8%) 57 (27.9%)

Mild 119 (22.2%) 50 (24.5%)

Moderate 136 (25.4%) 49 (24.0%)

Marked 85 (15.9%) 35 (17.2%)

Extreme 36 (6.7%) 12 (5.9%)

14

15Caroff SN et al. AMCP Nexus 2018; Orlando, FL

Consent formNOT signed:no further

action

Site staff (pre-appointment)• Reviews charts to identify potentially eligible patients • Calls patient to confirm usual-care visit

Site staff (at intake)• Screens for eligibility (N=1148)• Provides information about study and reviews informed consent• Enrolls eligible and consenting patients into the study (N=739)

Clinician (during assessment)• Observes patient for uncontrollable or involuntary movements • Determines whether movements are consistent with possible TD

• EQ-5D-5L and SDS (completed by patient)• Patient questionnaire (administered by clinician)

• Clinician questionnaire (completed by clinician)• 12-month retrospective chart review

Baseline Assessments

Patients with schizophrenia/ schizoaffective disorder

(n=111)

Cohort 2 (N=204)• Patients with visible movements and possible TD per clinician

assessmentCohort 1 (N=535)• 508 patients without visible movements• 27 patients with visible movements that were NOT consistent with

possible TDPatients with mood/other

psychiatric disorders (n=93)


CharacteristicSchizophrenia/Schizoaffective

Disorder (n=111)Mood/Other Psychatric

Disorder (n=93) P-Valuea

Gender, n (%) <0.0001

Male 69 (62.2) 31 (33.3)

Female 42 (37.8) 62 (66.7)

Age, mean (SD), years 52.7 (12.4) 56.9 (14.7) 0.0263

Race, n (%)b

Caucasian 69 (62.2) 80 (86.0) 0.0001

African-American 29 (26.1) 7 (7.5) 0.0005

Asian 6 (5.4) 2 (2.2) 0.2329

Hawaiian/Pacific Islander 1 (0.9) 0 0.3588

Indian/Alaska Native 2 (1.8) 0 0.1933

Other 6 (5.4) 3 (3.2) 0.4502

Missing 1 (0.9) 1 (1.1) --

Marital status, n (%) 0.0271

Single 65 (58.6) 32 (34.4)

Married 19 (17.1) 24 (25.8)

Divorced 19 (17.1) 27 (29.0)

Widowed 3 (2.7) 3 (3.2)

Separated 5 (4.5) 7 (7.5)

Current living/domestic situation, n (%) 0.0521

Living alone 30 (27.0) 27 (29.0)

Living with partner, spouse, family, or friends 51 (45.9) 54 (58.1)

Otherb 29 (26.1) 12 (12.9)

Missing 1 (0.9) 0aP-values are for the category if responses were mutually exclusive. For questions or items that allowed >1 response, P-values are provided for each response. bIncludes living with caregiver or other non-family member, assisted living, or group home. cBased on available data: schizophrenia/schizoaffective disorder, n=105; mood/other psychiatric disorders, n=85. dPer clinician impression. ePer patient report: 0=no health problems to 10=health as bad as you can imagine.SD, standard deviation.


CharacteristicSchizophrenia/Schizoaffective Disorder

(n=111)Mood/Other Psychatric

Disorder (n=93) P-Valuea

Employment status, n (%)b

Employed, full-time 1 (0.9) 13 (14.0) 0.0002

Employed, part-time 12 (10.8) 13 (14.0) 0.4920

Homemaker 1 (0.9) 2 (2.2) 0.4602

Student 1 (0.9) 0 0.3588

Unemployed 16 (14.4) 3 (3.2) 0.0062

Retired 12 (10.8) 20 (21.5) 0.0364

Disabled 69 (62.2) 42 (45.2) 0.0152

Other 1 (0.9) 2 (2.2) 0.4602

Missing 1 (0.9) 0 --

Lifetime exposure to antipsychotic medication, mean (SD), yearsc 19.5 (14.7) 9.5 (10.6) <0.0001

Severity of psychiatric condition, n (%)d 0.0336

Normal 0 7 (7.5)

Minimal 19 (17.1) 8 (8.6)

Mild 36 (32.4) 32 (34.4)

Moderate 36 (32.4) 31 (33.3)

Marked 16 (14.4) 10 (10.8)

Severe 4 (3.6) 5 (5.4)

Among the most severe 0 0

Average overall health status, mean (SD)e 4.5 (2.9) 5.1 (2.7) 0.1194

Number of psychotropic medications (antipsychotics + others), n (%) 0.0093

None 3 (2.7) 2 (2.2)

One 20 (18.0) 4 (4.3)

Two or more 88 (79.3) 87 (93.5)

Antipsychotic type (last 12 months), n (%)

Atypical 92 (82.9) 77 (82.8) 0.9869

Typical 23 (20.7) 4 (4.3) 0.0006

Both 105 (94.6) 81 (87.1) 0.0600aP-values are for the category if responses were mutually exclusive. For questions or items that allowed >1 response, P-values are provided for each response. bIncludes living with caregiver or other non-family member, assisted living, or group home. cBased on available data: schizophrenia/schizoaffective disorder, n=105; mood/other psychiatric disorders, n=85. dPer clinician impression. ePer patient report: 0=no health problems to 10=health as bad as you can imagine.SD, standard deviation.


Schizophrenia/

Schizoaffective Disorder

Mood/Other Psychiatric

Disorder

Clinician

reported (%)

Patient

reported (%)

Clinician

reported (%)

Patient

reported (%)

Head/face: facial

muscles, lips,

tongue, or jaw

N 110 58 93 53

None 30.0 27.6 38.7 34.0

Some 49.1 51.7 41.9 34.0

A lot 20.9 20.7 19.4 32.1

Neck/trunk: neck,

shoulders, chest,

or hips

N 109 58 92 53

None 72.5 67.2 87.0 84.9

Some 22.0 24.1 9.8 9.4

A lot 5.5 8.6 3.3 5.7

Upper extremities:

arms, hands, or

fingers

N 111 58 92 53

None 41.4 36.2 40.2 35.8

Some 48.6 41.4 48.9 45.3

A lot 9.9 22.4 10.9 18.9

Lower extremities:

legs, feet, or toes

N 110 58 93 54

None 56.4 55.2 59.1 55.6

Some 35.5 32.8 33.3 29.6

A lot 8.2 12.1 7.5 14.8

Maximum severity

score across all

body regions

N 111 58 93 54

None 0 0 0 0

Some 67.6 56.9 65.6 48.1

A lot 32.4 43.1 34.4 51.9

Total number of

body regions

impacted

N 111 58 93 54

One 43.2 32.8 51.6 40.7

Two 28.8 34.5 28.0 37.0

Three 14.4 19.0 15.1 16.7

Four 13.5 13.8 5.4 5.6

N, number of available assessments;

TD, tardive dyskinesia.


Based on available assessments: schizophrenia/schizoaffective disorder, n=107; mood/other psychiatric disorders, n=91TD, tardive dyskinesia*Other (schizophrenia/schizoaffective disorder, n=42; mood/other psychiatric disorders, n=41 ) Free Text Responses: trouble walking up steps; driving; bathingQuestion: “Over the past 4 weeks, how much did your visible, uncontrollable movements impact your ability to..?”Domains: Continue your usual activities (like going to the grocery store or doctor’s appointment, doing household chores, etc.); Be productive (like going to work or school, or completing your work, etc.); Take care of yourself (like bathing, getting dressed, etc.); Socialize (like going out with friends or family for dinner, to the movies, going shopping, etc.)

32.7 33.6

23.4

8.4

33.6

24.3

33.6

4.8

34.1

28.9

34.1

9.9

41.8

30.8

41.8

2.4

0

10

20

30

40

50

UsualActivities

Talking Eating Breathing Productivity Self-Care Socializing Other

Schizophrenia/Schizoaffective Disorder

Mood/Other Psychiatric Disorder

Co

ho

rt 2

Pa

tie

nts

, %

Continue

Usual

Activities

Talk Eat Breathe Be

Productive

Take Care

of Self

Socialize Others*

No significant differences between mood/other psychiatric disorder and schizophrenia-schizoaffective disorder subgroups were found for SDS mean scores at baseline

– Self-reported impact of possible TD was generally worse (as indicated by higher scores) in patients with mood/other psychiatric disorders vs schizophrenia/schizoaffective disorder:

Total score (12.8 vs 10.8 [range, 0–30])

Work/school (4.1 vs 4.2 [range, 0–10])

Social life (4.3 vs 3.7 [range, 0–10])

Family life/home responsibilities (4.1 vs 3.5 [range, 0–10])


No significant differences between mood/other psychiatric disorder and schizophrenia-schizoaffective disorder subgroups were found for the following:

– The EQ-5D-5L utility score* (0.68 vs 0.74 [range 0–1.00, higher scores indicate better health]) or

– The EQ-5D-5L health state visual analog scale (64.8 vs 68.5 [range 0, worst health you can imagine – 100, best health you can imagine, higher scores indicate better health])


*A weighting algorithm is used to derive health-state utility scores (also referred to as EQ-5D-5L index value), which ranges from 0–1, from the five response categories. The health states map to the utility scale of 1 = best possible health and 0 = dead.

22

23Caroff SN et al. Psych Congress 2018; Orlando, FL

Baseline Assessments• EQ-5D-5L and SDS (completed by patient)

• Patient questionnaire (administered by clinician)

• Clinician questionnaire (completed by clinician)

• 12-month retrospective chart review

Consent form

NOT signed:

no further action

Site staff (pre-appointment)• Reviews charts to identify potentially eligible

patients

• Calls patient to confirm usual-care visit

Clinician (during assessment)• Observes patient for uncontrollable or involuntary

movements

• Determines whether movements are consistent

with possible TD

Cohort 1 (N=535)• 508 patients without visible movements

• 27 patients with visible movements that were

NOT consistent with possible TD

Cohort 2 Caregivers (N=41)• Qualified and consenting caregivers are enrolled

• Caregivers who noticed their patient’s visible,

uncontrollable movements (N=36)

Cohort 2 (N=204)• Patients with visible movements and

possible TD per clinician assessment

Site staff (at intake)• Screens for eligibility (N=1148)

• Provides information about study and reviews

informed consent

• Enrolls eligible and consenting patients into

the study (N=739)

Spearman’s correlations (ρ) were conducted for the following outcomes:

– Patient’s overall health status (patient/caregiver)

– Time spent by patient managing health conditions (patient/caregiver)

– Location and severity of possible TD movements (patient/clinician, caregiver/clinician)

– Total number of patient’s body regions impacted by possible TD (patient/clinician, caregiver/clinician)

– Maximum rating of possible TD severity in any body region (patient/clinician, caregiver/clinician)



Cohort 2 Patients

(N=204)

Cohort 2 Caregiversa

(N=41)

Female, n (%) 104 (51.0) N/A

Age, mean (SD), years 54.6 (13.6) N/A

Race, n (%)b

Caucasian 149 (73.0) 27 (65.9)

African American 36 (17.6) 7 (17.1)

Otherc 20 (9.8) 7 (17.1)

Missing 2 (1.0) 0

Marital status, n (%)b

Single 98 (48.0) 5 (12.2)

Married 43 (21.1) 28 (68.3)

Divorced 46 (22.5) 6 (14.6)

Otherd 18 (8.8) 2 (4.9)

Current living/domestic situation, n (%)

Living alone 57 (27.9) 3 (7.3)

Living with a partner, spouse, family, or friends 105 (51.5) 35 (85.4)

Other 41 (20.1)e 3 (7.3)

Missing 1 (0.5) 0

Employment status, n (%)b

Employed, full-time 14 (6.9) 16 (39.0)

Employed, part-time 25 (12.3) 4 (9.8)

Unemployed 19 (9.3) 4 (9.8)

Retired 32 (15.7) 11 (26.8)

Disabled 111 (54.4) 5 (12.2)

Otherf 7 (3.4) 1 (2.4)

Missing 1 (0.5) 0

Patient’s overall health status, mean (SD)g 4.7 (2.8) 5.3 (2.4)aCaregivers of patients with clinician-confirmed possible TD; bNot mutually exclusive; cIncludes Asian, Indian/Alaska Native, Hawaiian/Pacific Islander, or other (unspecified); dIncludes widowed, separated, or

other (not specified); eIncludes living with caregiver or other non-family member, assisted living, or group home; fIncludes homemaker, student, and other (unspecified); gScores range from 0=no health

problems to 10=health as bad as you can imagine (available responses: patients, n=203; caregivers, n=41)

N/A, not available; SD, standard deviation


The most common psychiatric diagnosis in Cohort 2 was schizophrenia (36.8%), followed by anxiety disorders (27.0%), bipolar disorder (26.5%), and schizoaffective disorder (21.1%)

Based on patient report and caregiver perception, >50% of Cohort 2 patients spent the most time managing mental health conditions

– Significant patient/caregiver correlations were found for serious, long-term diseases or disorders (P<0.001) and movement disorders, including uncontrollable body movements (P<0.01)

Category, n (%)respondents could select all that apply

Patient Reported Caregiver PerceptionSpearman’s

Correlation, ρ

Mental health 112 (54.9) 32 (78.0) 0.07

Movement disorder, including uncontrollable body

movements36 (17.6) 16 (39.0) 0.43**

Pain management 36 (17.6) 14 (34.1) 0.22

Physical activity and nutrition 39 (19.1) 11 (26.8) 0.26

Serious, long-term disease or disorder 30 (14.7) 6 (14.6) 0.67***

Mild or short-term health conditions 14 (6.9) 3 (7.3) 0.22

Other 10 (4.9) 8 (19.5) -0.08

None 24 (11.8) 0 ---

**P<0.01 and ***P<0.001


Head/face: facial muscles, lips,

tongue, or jaw (N=31)

• None: 29.0%

• Some: 41.9%

• A lot: 29.0%

Neck/trunk: neck, shoulders,

chest, or hips (N=30)

• None: 70.0%

• Some: 16.7%

• A lot: 13.3%

Upper extremities: arms,

hands, or fingers (N=34)

• None: 32.4%

• Some: 47.1%

• A lot: 20.6%

Lower extremities: legs,

feet, or toes (N=34)

• None: 32.4%

• Some: 50.0%

• A lot: 17.6%

Caregiver Reported

Maximum rating in any

body region (N=36)

• None: 0%

• Some: 50.0%

• A lot: 50.0%

Total number of body

regions (N=36)

• One: 27.8%

• Two: 44.4%

• Three: 13.9%

• Four: 13.9%



• None: 34.0%

• Some: 45.8%

• A lot: 20.2%



• None: 79.1%

• Some: 16.4%

• A lot: 4.5%



• None: 40.9%

• Some: 48.8%

• A lot: 10.3%



• None: 57.6%

• Some: 34.5%

• A lot: 7.9%

Clinician Reported


body region (N=204)

• None: 0%

• Some: 66.7%

• A lot: 33.3%


regions (N=204)

• One: 47.1%

• Two: 28.4%

• Three: 14.7%

• Four: 9.8%



• None: 30.6%

• Some: 43.2%

• A lot: 26.1%



• None: 75.7%

• Some: 17.1%

• A lot: 7.2%



• None: 36.0%

• Some: 43.2%

• A lot: 20.7%



• None: 55.4%

• Some: 31.3%

• A lot: 13.4%

Patient Reported


body region (N=112)

• None: 0%

• Some: 52.7%

• A lot: 47.3%


regions (N=112)

• One: 36.6%

• Two: 35.7%

• Three: 17.9%

• Four: 9.8%

N, number of available assessments.


Patient/clinician correlations were significant for severity of involuntary movements by body region and for maximum severity score across all 4 regions.

Patients’ vs Clinicians’ Evaluation

Caregivers’ vs Clinicians’ Evaluation

Head/face 0.76*** 0.65***

Neck/trunk 0.61*** 0.43*

Upper extremities 0.75*** 0.57***

Lower extremities 0.75*** 0.49**

Total number of impacted body regions 0.24*** 0.46**

Maximum rating in any body region 0.50*** 0.24

*P<0.05, **P<0.01, ***P<0.001

TD, tardive dyskinesia

29

30Cutler A et al. APA 2018; New York, NY

aCaregivers of patients with clinician-confirmed possible TDbIncludes widowed or other (not specified)

Of 204 cohort 2 patients, 41 had a caregiver who consented to enrollmentCohort 2 Caregiversa

(N=41)

Race, n (%)

White 27 (65.9)

Black 7 (17.1)

Asian 7 (17.1)

Marital status, n (%)

Single 5 (12.2)

Married 28 (68.3)

Divorced 6 (14.6)

Otherb 2 (4.9)

Current living/domestic situation, n (%)

Living alone 3 (7.3)

Living with a partner, spouse, family, or friends 35 (85.4)

Other 3 (7.3)

Employment status, n (%)

Employed, full-time 16 (39.0)

Employed, part-time 4 (9.8)

Unemployed 4 (9.8)

Retired 11 (26.8)

Disabled 5 (12.2)

Other 1 (2.4)

Relationship to patient, n (%)

Family member 29 (70.7)

Friend 4 (9.8)

Someone the patient lives with 1 (2.4)

Other 7 (17.1)

14.6

78.0

26.834.1

39.0

7.3

19.5

0

19.5

68.3

39.0

24.429.3

9.8 9.8

00

20

40

60

80

100

Serious,Long-TermDisease orDisorder

Mental Health PhysicalActivity and

Nutrition

PainManagement

MovementDisorder

Mild or Short-Term HealthConditions

Other None


Based on caregivers’ assessment, a majority of cohort 2 caregivers and patients spent the most time managing the patient’s mental health or a movement disorder

Based on caregiver ratings (range, 0=no problem/impact to 10=as bad as you can imagine), mean (SD) scores were 5.3 (2.4; n=41) for the patient’s overall health status and 5.2 (3.3; n=41) for the impact of patient’s health on caregiver’s life

aConditions are not mutually exclusivebPer caregiver responses, health condition(s) the Cohort 2 patient spent the most time managingcPer caregiver responses, health condition(s) the Cohort 2 caregiver spent the most time assisting

Participant Spent the Most Time Managing (Caregivers’ Assessment)b

Caregiver Spent the Most Time Assistingc

Ca

reg

ive

r R

es

po

nd

en

ts, %


Of the 41 enrolled caregivers, 36 (87.8%) noticed uncontrollable movements in their patient

– Affected regions included head/face, neck/trunk, upper extremities, and lower extremities

– 26 (72.2%) of the 36 caregivers reported that their patient experienced involuntary movements in ≥2 body regions

aAny visible uncontrollable movements as reported by the caregiver (n=36)

Some missing caregiver data were observed (5 for head; 2 for upper and lower extremities; 6 for trunk)

Head/face: facial muscles, lips, tongue, or jaw

• None: 25.0%

• Some: 36.1%

• A lot: 25.0%

Neck/truck: neck, shoulders, chest, or hips

• None: 58.3%

• Some: 13.9%

• A lot: 11.1%

Upper extremities: arms, hands, or fingers

• None: 30.6%

• Some: 44.4%

• A lot: 19.4%

Lower extremities: legs, feet, or toes

• None: 30.6%

• Some: 47.2%

• A lot: 16.7%


36.1

41.738.9

44.4

25.0

33.3

44.4

38.9

13.916.7

11.1 11.1

5.6 5.6

22.2

16.7

44.4

36.1

47.2

41.7

69.4

61.1

33.3

44.4

0

20

40

60

80

100

Some A Lot None

Some missing caregiver data were observed (1 for self-care and socializing; 2 for usual activities and productivity)aBased on caregivers’ ratings (“none”, “some”, “a lot”) of how patient’s uncontrollable movements affected their own daily act ivities,

emotional distress, and overall impact on life

Pe

rce

nta

ge

of

Care

giv

ers

Level of Impacta

Impacts

Usual

Activities

Impacts

Productivity

Impacts

Self-Care

Impacts

Socializing

Level of

Embarrassment

Level of

Frustration

or Anger

Time Spent

Managing

Patient’s

Movements

Overall

Impact on

Caregiver’s

Life

Based on caregivers’ assessments, cohort 2 patients’ uncontrollable movements had social, emotional and functional impacts on their caregivers’ lives

Documents

MED-MI-TD-US-0101 v3...739 patients were clinically evaluated – 535 (72.4%) in cohort 1: patients without visible signs of uncontrollable or involuntary body movements or with movements