REAL-WORLD SAFETY AND EFFECTIVENESS OF LURASIDONE IN CHINESE CHILDREN AND ADOLESCENTS WITH SCHIZOPHRENIA: A POST-HOC ANALYSIS OF A POST-MARKETING SURVEILLANCE STUDY

Background

Compared to adults, dosing in children and adolescents with schizophrenia should be more individualized due to potential age-related differences in drug metabolism. This analysis aimed to investigate the real-world use of lurasidone in Chinese pediatric patients with schizophrenia, using data from a post-marketing surveillance (PMS).

Methods

Patients receiving lurasidone monotherapy were included in this post-hoc analysis, using data from a 12-week, prospective, observational, single arm, open-label, multi-center PMS conducted in patients with schizophrenia receiving lurasidone in China. Patients were stratified into pediatric ( < 18 years) and adult (≥18 years) groups. Pediatric patients were also stratified based on whether their final titration dose exceeded 40 mg/d to assess differences in safety. Adverse events (AEs) were collected to evaluate the safety profile. Brief Psychiatric Rating Scale (BPRS) and International Classification of Diseases 11th Revision (ICD-11) Symptom Rating Scale were used to evaluate effectiveness.

Results

One hundred and forty pediatric patients (51 male/89 female) were included, accounting for 9.5% of the total 1481 patients receiving lurasidone monotherapy. 96.4% patients (135/140) completed the surveillance. The average age was 15.4 (range: 10-17) years old. The initial dose of lurasidone was slightly lower for pediatric patients than for adults (mean±SD: 35.7±10.94 mg/day vs. 39.4±10.70 mg/day, p < 0.001). The proportion of pediatric patients starting lurasidone at 20, 40, 60, and 80 mg was 25.7%, 72.1%, 0.0%, and 2.1%, respectively, while the corresponding figures for adults were 11.7%, 83.9%, 0.2%, and 4.2%. Pediatric patients underwent rapid titration, with the first dose adjustment occurring approximately 1 week (7.1±8.87 d) after initiating lurasidone, increasing to 58.4±19.65 mg/d. In contrast, adults had their first dose escalation after 10.3±13.07 days, adjusting to 60.1±20.95 mg/d. The mean daily doses for pediatric patients and adults were 65.1±17.95 and 61.7±21.53 mg/d, respectively (p = 0.044). Six AEs (4 cases of weight gain and 2 cases of drowsiness) occurred in 6 pediatric patients (4.3%, 6/140) during the surveillance. All AEs were mild. In comparison, 61 AEs occurred in 54 adult patients (4.1%, 54/1332), with weight gain (1.8%), prolactin elevation (0.8%), akathisia (0.4%), and nausea (0.3%) being the most frequent. The mean weight gain at week 12 from baseline was 0.1±2.21 kg in pediatric patients and 0.2±2.07 kg in adults. Lurasidone also led to a greater reduction in the BPRS anxiety/depression subscore in pediatric patients compared to adults (4.6±3.47 vs 3.5±3.33, p < 0.001), from 10.8±4.15 at baseline to 6.4±2.85 at week 12. Similar trends were seen in ICD-11 ratings, with greater reductions in depressive mood (p = 0.052), cognitive (p = 0.013), and positive symptoms (p = 0.001) in pediatric patients compared with adults.

Conclusion

Lurasidone use in Chinese pediatric patients featured a lower initial dose but faster titration to a slightly higher mean daily dose compared to adults. Lurasidone 40-80 mg/d was well-tolerated, with low AE rates, and demonstrated significant efficacy, particularly for anxiety/depression symptoms. It has excellent metabolic advantages, which are of vital importance for children and adolescents in the growth and development stage. Lurasidone appears to be a promising treatment option for Chinese children and adolescents with schizophrenia.