|The following article is part of conference coverage from the 2018 American Psychiatric Association (APA) Annual Meeting in New York, New York. Psychiatry Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in psychiatry. Check back for the latest news from APA 2018.|
NEW YORK — Adjunctive treatment with brexpiprazole was safe and effective for long-term treatment of patients with major depressive disorder (MDD), according to research presented at the 2018 American Psychiatric Association (APA) Annual Meeting, held May 5-9, 2018 in New York City, New York.
“Brexpiprazole was developed for patients who have tried antidepressants … but are not able to respond to them sufficiently,” Nanco Hefting, MSc, lead scientific specialist at H. Lundbeck A/S in Copenhagen, Denmark, and clinical lead for brexpiprazole clinical development, told Psychiatry Advisor. “Those patients who have problems responding to antidepressants can then get brexpiprazole in addition to the antidepressant they are taking, and this adjunctive therapy has proven to be efficacious to get patients to respond.”
Patients were given brexpiprazole for 52 weeks as adjunctive antidepressant therapy. A total of 1865 of 2944 participants finished the study (NCT01360866) and were given brexpiprazole 0.5 to 3 mg/d; the mean dose was 1.51 mg/d. The incidence of discontinuation due to TEAEs was 8.6%. TEAEs with an incidence of ≥5% were weight gain (17.7%), somnolence (8.0%), headache (7.2%), akathisia (6.7%), insomnia (6.3%), and increased appetite (6.3%).
Safety was assessed by the frequency and severity of treatment-emergent adverse events (TEAEs). Efficacy was evaluated using the Clinical Global Impressions – Severity of Illness (CGI-S) and Improvement (CGI-I) scales, Sheehan Disability Scale (SDS), and Inventory of Depressive Symptomatology (Self Report) (IDS-SR).
“There is some weight gain with brexpiprazole, and a proportion of patients have weight increases during treatment of 7% or more,” Hefting noted. “It’s very individual issues for patients. We see that few patients actually withdraw from brexpiprazole treatment due to weight gain; and for those patients that do gain weight, it’s really an individual choice to either stop treatment or enjoy the efficacy of the compound.
“That said, if we look on average, the weight gain is between 2.5 and 3 kg over the period of 6 to 12 months of treatment. So initially there is weight gain, and it seems to plateau later during treatment.”
The researchers found that symptoms and functioning showed improvement during treatment. At Week 26, the mean change in CGI-S was -0.61 (standard deviation [SD] 0.99); CGI-I 2.54 (SD 1.26); SDS -0.70 (SD 2.20); and IDS-SR -5.23 (SD 9.97). At Week 52, mean change in CGI-S was -1.05 (SD 1.05); CGI-I 2.10 (SD 1.14); SDS -1.20 (SD 2.60); and IDS-SR -7.80 (SD 10.97).
Treatment with brexpiprazole 0.5 to 3 mg/d as adjunct antidepressant therapy was safe and effective in patients with MDD.
“This is a very large study — almost 3000 patients were included, and it confirms the safety profile that we’ve seen in short-term studies. The efficacy measures that were included in the study were not compared with any other treatment, but if we look over the study, we can see continuous improvement in the patients on average over the treatment period,” Hefting said.
“This treatment is, we think, a valuable addition to the treatment possibilities for those with depression and those who cannot respond enough to current antidepressants. This study shows that the safety profile of brexpiprazole in the long term is quite favorable, and patients can adhere to the treatment for longer periods of time, which is beneficial, in the end, for the patient.”
Disclosures: Hobart M, Zhang P, Skuban A, and Brewer C are employees of Ostuka Pharmaceutical Development & Commercialization Inc. Hefting N is an employee of H. Lundbeck A/S.
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Hefting N, Hobart M, Zhang P, Skuban A, Brewer C. Long-term safety and tolerability of brexpiprazole as adjunctive therapy in adults with major depressive disorder. Presented at: 2018 American Psychiatric Association (APA) Annual Meeting; New York, New York; May 5-9. Poster 69.