ABILIFY (Page 7 of 24)

Weight Gain

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Adults

In an analysis of 13 placebo-controlled monotherapy trials, primarily from pooled schizophrenia and bipolar disorder, with a median exposure of 21 to 25 days, the mean change in body weight in ABILIFY-treated patients was +0.3 kg (N=1673) compared to –0.1 kg (N=1100) in placebo-controlled patients. At 24 weeks, the mean change from baseline in body weight in ABILIFY-treated patients was –1.5 kg (n=73) compared to
–0.2 kg (n=46) in placebo-treated patients.

In the trials adding ABILIFY to antidepressants, patients first received 8 weeks of antidepressant treatment followed by 6 weeks of adjunctive ABILIFY or placebo in addition to their ongoing antidepressant treatment. The mean change in body weight in patients receiving adjunctive ABILIFY was +1.7 kg (N=347) compared to +0.4 kg (N=330) in patients receiving adjunctive placebo.

Table 14 shows the percentage of adult patients with weight gain ≥7% of body weight by indication.

Table 14:Percentage of Patients From Placebo-Controlled Trials in Adult Patients with Weight Gain ≥7% of Body Weight

Weight gain ≥7% of body weight	Indication	Treatment Arm	N	Patients n (%)
	Schizophreniaa	ABILIFY	852	69 (8.1)
		Placebo	379	12 (3.2)
	Bipolar Maniab	ABILIFY	719	16 (2.2)
		Placebo	598	16 (2.7)
	Major Depressive Disorder (Adjunctive Therapy)c	ABILIFY	347	18 (5.2)
		Placebo	330	2 (0.6)
a 4-6 weeks duration. b 3 weeks duration. c 6 weeks duration.

Pediatric Patients and Adolescents

In an analysis of two placebo-controlled trials in adolescents with schizophrenia (13 to 17 years) and pediatric patients with bipolar disorder (10 to 17 years) with median exposure of 42 to 43 days, the mean change in body weight in ABILIFY-treated patients was +1.6 kg (N=381) compared to +0.3 kg (N=187) in placebo-treated patients. At 24 weeks, the mean change from baseline in body weight in ABILIFY-treated patients was +5.8 kg (n=62) compared to +1.4 kg (n=13) in placebo-treated patients.

In two short-term, placebo-controlled trials in patients (6 to 17 years) with irritability associated with autistic disorder with median exposure of 56 days, the mean change in body weight in ABILIFY-treated patients was +1.6 kg (n=209) compared to +0.4 kg (n=98) in placebo-treated patients.

In two short-term, placebo-controlled trials in patients (6 to 18 years) with Tourette’s Disorder with median exposure of 57 days, the mean change in body weight in ABILIFY-treated patients was +1.5 kg (n=105) compared to +0.4 kg (n=66) in placebo-treated patients.

Table 15 shows the percentage of pediatric and adolescent patients with weight gain ≥7% of body weight by indication.

Table 15:Percentage of Patients From Placebo-Controlled Monotherapy Trials in Pediatric and Adolescent Patients with Weight Gain ≥7% of Body Weight

Weight gain ≥7% of body weight	Indication	Treatment Arm	N	Patients n (%)
	Pooled Schizophrenia and Bipolar Maniaa	ABILIFY	381	20 (5.2)
		Placebo	187	3 (1.6)
	Irritability Associated with Autistic Disorderb	ABILIFY	209	55 (26.3)
		Placebo	98	7 (7.1)
	Tourette’s Disorder c	ABILIFY	105	21 (20.0)
		Placebo	66	5 (7.6)
a 4-6 weeks duration. b 8 weeks duration. c 8-10 weeks duration.

In an open-label trial that enrolled patients from the two placebo-controlled trials of adolescents with schizophrenia (13 to 17 years) and pediatric patients with bipolar disorder (10 to 17 years), 73.2% of patients (238/325) completed 26 weeks of therapy with ABILIFY. After 26 weeks, 32.8% of patients gained ≥7% of their body weight, not adjusted for normal growth. To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for the natural growth of pediatric patients and adolescents by comparisons to age- and gender-matched population standards. A z-score change <0.5 SD is considered not clinically significant. After 26 weeks, the mean change in z-score was 0.09 SD.

In an open-label trial that enrolled patients from two short-term, placebo-controlled trials, patients (6 to 17 years) with irritability associated with autistic disorder, as well as de novo patients, 60.3% (199/330) completed one year of therapy with ABILIFY. The mean change in weight z-score was 0.26 SDs for patients receiving >9 months of treatment.

When treating pediatric patients for any indication, weight gain should be monitored and assessed against that expected for normal growth.