V Osborne, J Slade, D Layton, SAW Shakir, Joe Reilly
OBSERVA is a SCEM study being conducted as part of the EU Risk Management Plan to monitor the short-term safety and utilisation of asenapine prescribed to new user patients (pts) by psychiatrists in the mental health care setting in England and Wales.
To describe utilisation characteristics of pts prescribed asenapine at interim and assess use in relation to the license.
Single exposure observational cohort of pts prescribed asenapine over 3yrs. Pts identified via network of psychiatrists in collaboration with Mental Health Research Network. Data are abstracted from medical records. After pt consent, questionnaires completed by study investigators collect: baseline data incl.exposure and 12wks post index date outcomes. At interim, pts were recruited from 14 NHS trusts Feb13-Feb14 (interim data lock). Descriptive statistics calculated (% specified, excl.missing).
Interim cohort=57 consented pts; of which 46 pts evaluable with baseline data. Most frequent indication was bipolar disorder (36,78.3%) though 10 non-licensed indications were reported (21.7%). Most frequent dose at index date was 5mg 2x daily in 16 pts (16/46,34.8%), whilst at maintenance it was 10mg 2x daily (9/42,21.4%). Doses other than 5 or 10mg 1x or 2x daily were reported for 3pts at index (6.5%) and 5pts at maintenance (11.9%). Past history (>28days prior) of psychiatric conditions (suicide/self-injury & depression) was common (19/46;41.3% & 25/46;54.4%, respectively). Past history of diabetes mellitus was also common (5/46;10.9%). Of risk factors for potential misuse at baseline, majority of pts had no prior or current history of alcohol misuse (25/45,55.6%) or substance abuse (29/43,67.4%).
The majority of new user pts at interim were treated with asenapine for licensed indications. Prior history of psychiatric conditions is as expected for populations treated for mental health conditions. Prevalence of off-label indications was common, as were risk factors for potential misuse. These interim data demonstrate the importance of SCEM to gather real-world data to support post-marketing risk:benefit management.