Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia

Figures & data

Figure 1. Study design. * Patients who were already receiving oral aripiprazole treatment entered the open-label treatment phase (Phase B) without entering the oral conversion phase (Phase A). SOC, standard-of-care.

Table 1. Demographics and baseline characteristics for all patients that received treatment in Phase B (n = 181).

	Phase B (n = 181)
Age, mean (SD), years	42.2 (12.1)
Male/female, n	127/54
Body weight, mean (SD), kg	88.2 (19)
BMI, mean (SD), kg/m^2	29.8 (6.2)
Race, n (%)
White	92 (50.8)
Black or African American	80 (44.2)
Other	9 (5.0)
PANSS total score, mean (SD)	76.7 (18.3)
Conceptual disorganisation (P2), mean (SD)	2.9 (1.2)
Suspiciousness (P6), mean (SD)	3.3 (1.2)
Hallucinatory (P3), mean (SD)	3.1 (1.4)
Unusual thought content (G9), mean (SD)	2.7 (1.1)
CGI-S score, mean (SD)	3.9 (0.8)
Age at first diagnosis, mean (SD), years	26.5 (10.2)

BMI, body mass index; CGI-S, Clinical Global Impressions–Severity; PANSS, Positive and Negative Symptom Scale; SD, standard deviation.

Table 2. Patient disposition and reasons for discontinuation.

	Phase A tolerability assessment, n (%)	Phase B aripiprazole once-monthly, n (%)	Total enrolled, n (%)
Entered	148 (100.0)	183 (100.0)	227 (100.0)
Treated	148 (100.0)	181 (98.9)	226 (99.6)
Received ≥3 months treatment in Phase B	NA	121 (66.1)	NA
Completed*	NA	101 (55.2)	NA
Discontinued	44 (29.7)	82 (44.8)	135 (59.5)†
Lost to follow-up	6 (4.1)	13 (7.1)	19 (8.4)
Adverse events	12 (8.1)	26 (14.2)	38 (16.7)
Subject met withdrawal criteria	4 (2.7)	2 (1.1)	8 (3.5)
Subject withdrawn from participation by investigator	6 (4.1)	5 (2.7)	11 (4.8)
Subject withdrew consent‡	14 (9.5)	28 (15.3)	46 (20.3)
Protocol deviation	1 (0.7)	4 (2.2)	5 (2.2)
Lack of efficacy as determined by the investigator	1 (0.7)	4 (2.2)	5 (2.2)

*Patients completing Week 24 of Phase B.

†9 patients discontinued in Phase C.

‡Withdrawal of consent was not associated with adverse events.

NA, not applicable.

Figure 2. Total psychiatric hospitalisation rates following the switch to aripiprazole once-monthly (prospective) compared with the same patients treated with oral anti-psychotics (retrospective). p-value derived from Exact McNemar test.

Table 3. Analysis of total psychiatric hospitalisation rates following the switch to aripiprazole once-monthly (prospective) compared with the same patients treated with oral anti-psychotics (retrospective) between retrospective period Months −4 to −1 and prospective period Months 4–6 and between retrospective period Months −7 to −1 and prospective period Months 1–6.

Hospitalisation status		Total psychiatric hospitalisations by period, n (%)
Retrospective period	Prospective period	3-month period in patients receiving ≥3 months of aripiprazole once-monthly in Phase B (n = 121)	6-month period in all patients entering Phase B for treatment with aripiprazole once-monthly (n = 183)
Hospitalisation	Hospitalisation	5 (4.1)	17 (9.3)
No hospitalisation	Hospitalisation	3 (2.5)*	9 (4.9)*
Hospitalisation	No hospitalisation	29 (24.0)*	59 (32.2)*
No hospitalisation	No hospitalisation	84 (69.4%)	98 (53.6)
*McNemar p-value		p < 0.0001	p < 0.0001

*Note that discordant rates (defined as hospitalisation in one or the other period) are the rates upon which the McNemar p-value is calculated.

Table 4. Incidence of treatment-emergent adverse events occurring in ≥2% of all patients treated in Phase B (n = 181).

Adverse event, n (%)	All patients who received treatment in Phase B (n = 181)
Psychotic disorder	14 (7.7)
Akathisia	13 (7.2)
Insomnia	13 (7.2)
Schizophrenia, paranoid type	10 (5.5)
Back pain	9 (5.0)
Schizophrenia	9 (5.0)
Headache	6 (3.3)
Hallucination, auditory	6 (3.3)
Anxiety	5 (2.8)
Diarrhoea	5 (2.8)
Dizziness	5 (2.8)
Nausea	5 (2.8)
Tremor	5 (2.8)
Decreased appetite	4 (2.2)
Fatigue	4 (2.2)
Suicide ideation	4 (2.2)
Toothache	4 (2.2)
Upper respiratory tract infection	4 (2.2)
Weight decreased	4 (2.2)
Weight increased	4 (2.2)