Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate

Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections

“…Results from this analysis align with a post hoc assessment of a phase 3 study determining the efficacy of PP3M for the treatment of schizophrenia. 14 The post hoc analysis showed that adequate stabilization with PP1M prior to transitioning to PP3M is crucial for optimizing treatment response. In the phase 3 study, only patients who met stabilization criteria at 17 weeks after beginning open-label treatment with PP1M and at 12 weeks after the first dose of PP3M (week 29) were randomized to double-blind treatment with PP3M or placebo.…”

“…A recent post hoc analysis of a Phase 3 placebo-controlled trial of PP3M (NCT01529515) demonstrated that adequate, label-consistent stabilization with PP1M prior to transitioning to PP3M is crucial for optimizing treatment response. 14 In the trial, only patients who continuously met Positive and Negative Syndrome Scale (PANSS)-based stabilization criteria before and 12 weeks after transition from PP1M to PP3M were randomly assigned to double-blind treatment, creating a proxy for the evaluation of “adequate treatment” (randomly assigned patients) versus “not adequate treatment” (nonrandomly assigned patients) with PP1M in the post hoc analysis. The results of the analysis demonstrated that adequately treated (AT) patients were more stable with respect to symptoms, psychosocial functioning, and overall clinical condition compared with not adequately treated (NAT) patients at all time points evaluated in a clinical trial setting where 1 of the objectives was to administer PP3M as indicated by the label.…”

“…12,13 Optimization of the PP1M dose prior to transitioning to PP3M is essential to prevent relapse or adverse events that may result from doses that are too low or too high, respectively. 14 Because of the long-acting nature of PP3M, it may be difficult to adjust the dose after initiating treatment because changes in plasma concentration will not be fully evident for several months (compared with days or weeks for OAPs). 15,16 Following the recommended prescribing information dosing plays a critical role in providing guidance to ensure the safe and appropriate administration of a therapeutic agent.…”

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“…La decisión de cuándo realizar la transición a la formulación cada tres meses se basa en la sintomatología del paciente mientras recibe la formulación mensual, siendo fundamental confirmar la estabilización adecuada con paliperidona mensual antes de la transición a la formulación trimestral para maximizar la respuesta al tratamiento. Los médicos deben considerar la transición de pacientes a la formulación trimestral de paliperidona solo si responden bien a la formulación mensual durante al menos cuatro meses y sus dos últimas dosis consecutivas son las mismas 19 .…”

Omówienie wybranych metod współczesnej terapii schizofrenii

“…Zgodnie z powyższym, niewątpliwą zaletą tego leku jest możliwość wykonywania iniekcji co 2-4 tygodnie lub nawet co 3 miesiące. Istnieje możliwość, aby u pacjentów uprzednio ustabilizowanych klinicznie za pomocą palmitynianu paliperydonu (w iniekcjach co 1 miesiąc) zmienić częstość dawkowania i stosować lek raz na 3 miesiące -obydwie metody wykazują podobną skuteczność w leczeniu schizofrenii [48,49]. Substancja ta została zarejestrowana w 2006 roku i posiada korzystniejszy profil bezpieczeństwa w porównaniu ze starszymi lekami.…”