Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics

Abstract

PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (−7.5 to −10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.

Once-monthly paliperidone palmitate in early stage schizophrenia &ndash; a retrospective, non-interventional 1-year study of patients with newly diagnosed schizophrenia

“…The safety results in the present study suggest that the treatment for those patients receiving PP1M for 12 months or longer was well tolerated and ADRs were consistent with the known safety profile of PP1M. 13 , 18 , 24 , 25 This is noteworthy given that patients with newly diagnosed schizophrenia may be particularly susceptible to antipsychotic side effects, such as weight gain, metabolic abnormalities, and extrapyramidal symptom (EPS) side effects. 26 , 27 The mean changes in body weight and body mass index observed in the current study did not differ from those changes observed in other studies with PP1M in patients with more chronic schizophrenia.…”

Discontinuation rates during long‐term, second‐generation antipsychotic long‐acting injection treatment: A systematic review

“…PALMFlexS was a study analyzing the effectiveness of PP1M in patients diagnosed with clinically stable forms of SCZ spectrum disorders after unsuccessful treatment with RIS‐LAI or FGA‐LAI . The discontinuation rate in patients switched from RIS‐LAI or FGA‐LAI to PP1M ranged between 14.3% and 32.6% (main reasons for discontinuation being withdrawal of consent, onset of adverse events, or lack of efficacy).…”

“…47,[49][50][51]53,55 The only study reporting the advantage of PP1M on oral antipsychotics showed several limitations, the main being a suboptimal statistical power due to the small sample size and the inclusion in the study cohort of both new and old PP1M users. 54 The main causes of drug discontinuation before the planned study end were adverse events 45,46,61,62,65 and ineffectiveness. 47,51,59,62,65,66 The two available long-term studies on PPM3 showed a rate of premature discontinuation similar to that shown by the active comparator (PP1M).…”

“…54 The main causes of drug discontinuation before the planned study end were adverse events 45,46,61,62,65 and ineffectiveness. 47,51,59,62,65,66 The two available long-term studies on PPM3 showed a rate of premature discontinuation similar to that shown by the active comparator (PP1M). 68,69 However, only one 68 reported the reasons of premature withdrawal (the most frequent being the occurrence of adverse events).…”

“…PALMFlexS was a study analyzing the effectiveness of PP1M in patients diagnosed with clinically stable forms of SCZ spectrum disorders after unsuccessful treatment with RIS-LAI or FGA-LAI. 62 The discontinuation rate in patients switched from RIS-LAI or FGA-LAI to PP1M ranged between 14.3% and 32.6% (main reasons for discontinuation being withdrawal of consent, onset of adverse events, or lack of efficacy). PALMFlexS was also performed in patients diagnosed with SCZ spectrum disorders and showing florid psychotic symptoms who switched to PP1M because of previous unsuccessful treatment with antipsychotics in oral formulations.…”