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Daily practices regarding safety monitoring of low-dose methotrexate and comparison to guidelines: A population-based
Canelle Mazaud1, Laurence Fardet2
1Service de dermatologie, hôpital Henri-Mondor, 51, avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France.
Purpose:
To describe daily practices regarding safety monitoring of methotrexate prescribed at low-(i.e.≤30mg/week). To identify determinants of these practices. To assess association between monitoring and early methotrexate discontinuation.
Methods:
Population-based cohort study using the French claims database échantillongénéralistedebénéficiaires (EGB) over the period 2009-2015. Incident methotrexate users were included. The pre-treatment and post-treatment monitoring prescribed to these patients was analyzed. Determinants of monitoring were identified using a logistic regression model. Association between monitoring and early methotrexate discontinuation was assessed using Cox proportional-hazards model.
Results:
During the study period, 615924 individuals had data in the EGB and 2472 (0.40%) were incident methotrexate users (63.3% women; mean age: 54.7±17.8 years; mean weekly dosage: 13.0±5.3mg). Among these incident users, only 50-70% had an albumin testing (67.0%); HIV (49.7%), hepatitis B (54.8%) or C (55.0%) serology; or chest X-ray (57.4%) within the year before initiating methotrexate. Only 65.7% had a least one CBC, transaminase and urea-creatinine testing combined within the three months before initiation. During the first three months of exposure, the median number of CBC, transaminase and urea-creatinine testing was 2 [1-4], 2 [1-4], and 2 [1-3], respectively. The monitoring modalities depend more on prescriber characteristics than on patient or treatment characteristics. There was a significant positive association between frequency of monitoring during exposure and early methotrexate discontinuation.
Conclusion:
Monitoring of patients prescribed low-dose methotrexate is much less frequent than recommended. Frequent monitoring is associated with early methotrexate discontinuation.
Insights
Safety monitoring for low-dose methotrexate is infrequent, with only 50-70% of patients receiving recommended tests. Increased monitoring frequency correlates with earlier discontinuation of methotrexate treatment.
Area of Science:
- Pharmacovigilance
- Real-world evidence in drug safety
- Methotrexate therapy monitoring
Background:
- Low-dose methotrexate is widely prescribed.
- Optimal safety monitoring practices are crucial for patient well-being.
- Current monitoring adherence requires investigation.
Purpose of the Study:
- To characterize safety monitoring practices for low-dose methotrexate (≤30mg/week).
- To identify factors influencing these monitoring practices.
- To evaluate the relationship between monitoring frequency and early methotrexate discontinuation.
Main Methods:
- Population-based cohort study using French claims data (2009-2015).
- Analysis of pre-treatment and post-treatment monitoring for incident methotrexate users.
- Logistic regression and Cox proportional-hazards models were employed.
Main Results:
- Only 2472 incident methotrexate users (0.40%) were identified.
- Pre-treatment testing rates for albumin, serologies, and chest X-ray ranged from 49.7% to 67.0%.
- Frequent monitoring during treatment was associated with early methotrexate discontinuation.
Conclusions:
- Safety monitoring for low-dose methotrexate is less frequent than recommended.
- Higher monitoring frequency is linked to earlier treatment cessation.
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