Janssen-Cilag International NV has announced results of the HOSPItal Use of Paliperidone Palmitate: A Prospective Non-Interventional Study (HOSPIPalm study) at the 12th World Congress of Biological Psychiatry in Athens, Greece, 14-18 June 2015. Data showed that symptomatic patients hospitalised for an exacerbation of schizophrenia and initiated with XEPLION® (paliperidone palmitate, a once-monthly long-acting therapy) for maintenance treatment, demonstrated statistically significant and clinically relevant reductions in symptom severity and improvements in personal and social functioning.

In addition patient satisfaction with XEPLION treatment at the end of the study was higher compared with their satisfaction with oral antipsychotic medication at baseline.1 This may also increase adherence thus potentially preventing relapse, hospitalisations and improving patient outcomes, allowing them to return to everyday activities such as work, education and independent living, which can support their recovery.

The new study is an international 6-week prospective, non-interventional, multi-centre, observational study designed to explore safety, tolerability, appropriate use and treatment outcomes of symptomatic adult patients hospitalised for an exacerbation of schizophrenia and treated with XEPLION in routine clinical practice (n=367).1 XEPLION was initiated for the maintenance treatment of schizophrenia according to the local label.

Key study findings:1

  • Primary outcome: Change at endpoint - mean Brief Psychiatric Rating Scale (BPRS) total score decreased from baseline (50.2) to endpoint (30.8), reflecting a statistically significant and clinically relevant improvement (p<0.0001)
  • Symptom severity: Statistically significant and clinically relevant improvements in BPRS total score observed as early as Day 8, with a mean ± standard deviation (SD) change from baseline (50.2) to Day 8 (43.7) of -6.5 ± 8.6, p<0.0001
  • Illness severity: At endpoint, 93.5% (318/340) of patients were rated minimally, much or very much improved Clinical Global Impression - Change (CGI-C)
  • Patient functioning: Significant improvement in patient functioning, as measured by the Personal and Social Performance Scale (PSP) total score, from baseline (49.4) to endpoint (63.7), p<0.0001
  • In addition, at baseline 23.7% (79/334) of patients were somewhat, very or extremely satisfied with their prior oral antipsychotic, vs 80.9% (271/335) of patients on XEPLION at study endpoint
  • Tolerability and safety: Mean (SD) Extrapyramidal Symptom Rating Scale (ESRS) total score reduced from 3.7 (5.9) at baseline to 2.0 (4.7) at study endpoint (mean [SD] change -1.7 [4.8], p<0.0001). At endpoint, the mean change in body weight from baseline ± SD was 0.95 ± 3.1 kg and mean change in BMI from baseline ± SD was 0.32 ± 1.0 kg/m2
  • No new safety issues were identified compared to previous studies and XEPLION was well tolerated by this naturalistic population

About XEPLION (paliperidone palmitate)

XEPLION is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. For complete EU prescribing information, please visit: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002105/WC500103317.pdf