Abstracts
3427239
(#60) Characterization of Injection Site Reactions and Local Tolerability With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults with Schizophrenia: Results From the Phase 3 SOLARIS Trial
Abstract: Background: Long-acting injectable antipsychotics (LAIs) have demonstrated benefits in schizophrenia; however, injection site reactions (ISRs) could contribute to treatment discontinuation. TV-44749 is an innovative, investigational, subcutaneous LAI olanzapine that showed significantly greater efficacy versus placebo for the treatment of schizophrenia in adults in the phase 3 SOLARIS trial (NCT05693935). This analysis characterizes ISRs associated with TV-44749 in SOLARIS.
Methods: Safety was evaluated across ≤56 weeks in patients who received ≥1 dose of once-monthly TV-44749 (318, 425, or 531 mg). ISRs and local tolerability were periodically and proactively assessed, including numeric pain ratings and size-based grading.
Results: ISRs were observed in 30% (180/604) of patients, most frequently injection site induration (12%), pain (12%), and erythema (10%). ISR frequency decreased with successive injections (1st, 24% [146/604]; 2nd, 14% [69/492]; 3rd, 6% [22/378]; stabilizing at ≈2% from ≥7th injection). ISRs led to discontinuation in 2% (10/604) of patients. ISRs were most commonly mild (21%) or moderate (8%) in severity; five severe ISRs were reported. A subset of ISRs, treatment initiation local reactions, were reported in 7% (42/604) of patients, mainly after the first injection (6% [39/604]; 1% incidence thereafter), and led to discontinuation in 1% (8/604). Local tolerability findings (erythema, induration/swelling, and pain) were absent for most patients, were generally minimal when present, and decreased with successive injections.
Conclusions: In SOLARIS, ISRs with TV-44749 were predominantly mild or moderate in severity, occurred most frequently early in treatment, and declined with successive injections. Findings support TV-44749 as a well-tolerated treatment in adults with schizophrenia.
Short Description: TV-44749 is an innovative, subcutaneous LAI olanzapine that showed significantly greater efficacy versus placebo for the treatment of schizophrenia in adults in the phase 3 SOLARIS trial. Injection site reactions (ISRs) associated with TV-44749 were evaluated in SOLARIS. Overall, ISRs with TV-44749 were predominantly mild or moderate in severity, occurred most frequently early in treatment, and declined with successive injections. Findings support TV-44749 as a well-tolerated treatment in adults with schizophrenia.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
Methods: Safety was evaluated across ≤56 weeks in patients who received ≥1 dose of once-monthly TV-44749 (318, 425, or 531 mg). ISRs and local tolerability were periodically and proactively assessed, including numeric pain ratings and size-based grading.
Results: ISRs were observed in 30% (180/604) of patients, most frequently injection site induration (12%), pain (12%), and erythema (10%). ISR frequency decreased with successive injections (1st, 24% [146/604]; 2nd, 14% [69/492]; 3rd, 6% [22/378]; stabilizing at ≈2% from ≥7th injection). ISRs led to discontinuation in 2% (10/604) of patients. ISRs were most commonly mild (21%) or moderate (8%) in severity; five severe ISRs were reported. A subset of ISRs, treatment initiation local reactions, were reported in 7% (42/604) of patients, mainly after the first injection (6% [39/604]; 1% incidence thereafter), and led to discontinuation in 1% (8/604). Local tolerability findings (erythema, induration/swelling, and pain) were absent for most patients, were generally minimal when present, and decreased with successive injections.
Conclusions: In SOLARIS, ISRs with TV-44749 were predominantly mild or moderate in severity, occurred most frequently early in treatment, and declined with successive injections. Findings support TV-44749 as a well-tolerated treatment in adults with schizophrenia.
Short Description: TV-44749 is an innovative, subcutaneous LAI olanzapine that showed significantly greater efficacy versus placebo for the treatment of schizophrenia in adults in the phase 3 SOLARIS trial. Injection site reactions (ISRs) associated with TV-44749 were evaluated in SOLARIS. Overall, ISRs with TV-44749 were predominantly mild or moderate in severity, occurred most frequently early in treatment, and declined with successive injections. Findings support TV-44749 as a well-tolerated treatment in adults with schizophrenia.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
