RESUMEN
Purpose: Bipolar I disorder (BP-I) is associated with significant disease burden, but evidence on treatment goals in people diagnosed with BP-I is scarce. This study sought to quantify treatment goals related to the pharmacological management of BP-I in adults in the US and to identify if subgroups of people with similar treatment goals exist. Patients and Methods: A best-worst scaling (BWS) of treatment goals was developed based on available literature and input from experts and patients and was distributed as part of a survey between August and September 2021. Survey participants were adults with a self-reported diagnosis of BP-I who were recruited via an online panel in the US. Participants were asked to prioritize the importance of 16 treatment goals using BWS. BWS scores were computed using multinomial logistic regression, with the scores across all goals summing to 100 for each participant. Subgroups of people with similar preferences were identified using latent class analysis. Results: The most important treatment goals for people diagnosed with BP-I (N=255) were "being less impulsive, angry, or irritable" (score: 9.73), or being "able to feel pleasure or happiness" (score: 9.54). Goals related to reducing the incidence of various potential adverse events of medication (scores: ≤4.51) or "reducing dependence on others" (score: 3.04) were less important. Two subgroups were identified. One subgroup (n=111) prioritized symptom-focused goals, considering "reducing frequency of mania, depression, and mixed episodes" and "being less impulsive, angry or irritable" the most important (scores: 12.46 and 11.85, respectively). The other subgroup (n=144) placed significantly more importance on social functioning-focused goals, including beginning or maintaining a relationship with a partner/significant other, and with family and/or friends (scores: 8.45 and 7.70, respectively). Conclusion: People diagnosed with BP-I prioritized emotional improvements. Subgroups of people with BP-I prioritized either symptom-focused or social functioning-focused treatment goals.
RESUMEN
Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) is a novel long-acting injectable (LAI) formulation of aripiprazole monohydrate for administration once every 2 months, developed for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults (indication will vary by country). Aripiprazole lauroxil 1064 mg (AL 1064) is an LAI formulation of aripiprazole lauroxil, an aripiprazole prodrug, for administration once every 2 months, indicated for the treatment of schizophrenia in adults. This analysis provides an indirect comparison of aripiprazole plasma concentrations following multiple doses of either formulation. Clinical trial data were used to determine average steady-state aripiprazole plasma concentration (Cavg,ss), maximum aripiprazole plasma concentration (Cmax), and other pharmacokinetic parameters of either formulation following four administrations (96 patients received Ari 2MRTU 960; 28 patients received AL 1064). All pharmacokinetic parameters were considered in the context of a minimum aripiprazole therapeutic concentration (Cmin) of ≥95 ng/mL. An exposure-response analysis using data from two Phase III trials of aripiprazole once-monthly (an aripiprazole monohydrate LAI, administered monthly), showed that patients with a Cmin ≥95 ng/mL are 4.41 times less likely to relapse than patients with a Cmin <95 ng/mL. A similar analysis has not been performed for AL 1064. However, consensus guidelines for therapeutic drug monitoring recommend a range of 100-350 ng/mL for aripiprazole. Following four administrations, mean (standard deviation [SD]) Cavg,ss over the 2-month dosing interval was 263 (133) ng/mL for Ari 2MRTU 960 and 140.7 (57.3) ng/mL for AL 1064. Mean (SD) Cmax during the fourth dosing interval was 342 (157) ng/mL for Ari 2MRTU 960 and 188.8 (79.8) ng/mL for AL 1064. This indirect comparison showed that, following four administrations, Ari 2MRTU 960 and AL 1064 delivered mean aripiprazole plasma concentrations that remained above the minimum therapeutic concentration of aripiprazole over the 2-month dosing interval.
