What about regular hematological monitoring during clozapine treatment? A compliance analysis using the French health insurance database

ABSTRACT

Background

The inherent risk of agranulocytosis associated with clozapine requires the realization of weekly white blood cell monitoring (WBCM) during the 18 first weeks of treatment. The aim of this study was to assess the compliance with WBCM during clozapine initiation for schizophrenia and Parkinson’s disease (PD) subjects.

Research design and method

The analysis was conducted using SNDS data on a cohort of new users of clozapine in 2018. We analyzed all reimbursements for WBCM from 2 weeks before the index date to 18 weeks after (optimal monitoring during hospitalization was assumed). The primary outcome was the proportion of good realization of WBCM according to different thresholds of completion (70%; 80%; 90%). Descriptive and comparative analyses with chi-squared test or Student’s t-test were performed.

Results

Two hundred and ninety-six subjects were included. Rates of patients with WBCM realization over 70%, 80%, and 90% of WBCM expected were, respectively, 78.1%, 70.0%, and 56.9% for subjects with schizophrenia and 71.3%, 63.2%, and 47.8% for PD subjects. Only hospitalization during the follow-up period for schizophrenia subjects was significantly associated with good WBCM realization.

Conclusions

We observed rather good results for compliance with clozapine initial monitoring. Other studies are needed to confirm our results.

KEYWORDS:

• Clozapine
• health insurance database
• schizophrenia
• schizoaffective disorder
• Parkinson’s disease

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics approval

Data were extracted and analyzed according to the French national agency regulating data protection laws (CNIL). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki

Consent to participate

NA

Consent to publication

NA

Data availability statement

All datasets generated for this study are included in the manuscript.

Code availability

Statistical analyses were performed by the Healthcare Insurance Medical Department using SAS Enterprise software.

Author contributions

• Edouard-Jules LAFORGUE: Conceptualization, Writing – Original Draft, Writing – Review & Editing

• Marie GRALL-BRONNEC: Conceptualization, Writing – Review & Editing

• Marion ISTVAN: Writing – Review & Editing

• Marylène GUERLAIS: Writing – Review & Editing

• Anicet CHASLERIE: Methodology, Formal analysis, Writing – Review & Editing

• Pascal ARTARIT: Methodology, Formal analysis, Writing – Review & Editing

• Genevieve VALLOT: Methodology, Formal analysis, Writing – Review & Editing

• Pascale JOLLIET: Writing – Review & Editing, Supervision

• Caroline VICTORRI-VIGNEAU: Conceptualization, Methodology, Writing – Review & Editing

Additional information

Funding

This paper was not funded.