Abstract
ObjectiveDespite the development of new biologic therapies, methotrexate (MTX) remains the preferred initial disease-modifying anti-rheumatic drug to treat rheumatoid arthritis (RA). Adherence to disease-modifying anti-rheumatic drugs is suspected to be highly variable potentially leading to reduced treatment effectiveness. This work aimed to develop and validate the Methotrexate Experience Questionnaire (MEQ), a tool to identify and characterize non-adherence to oral MTX.MethodsMEQ development included a literature review and qualitative interviews with RA patients and physicians in the United States. A retrospective, cross-sectional study using data from Optimum Patient Care Research Database, a large primary care database of electronic medical records in the United Kingdom, was conducted to finalize the MEQ and evaluate its psychometric properties.ResultsThree hundred seven e-consented subjects (66% women, mean age of 65 years) completed the MEQ remotely, and were included in this analysis. Item-convergent and divergent validity were generally supportive of the construct validity of the MEQ and Cronbach’s alpha of 0.87 supported its reliability. The MEQ Total score presented statistically significant correlations of small to medium size with all selected concurrent scales, as expected; the highest correlation was obtained between the general acceptance score of ACCEPT and the MEQ Total score (0.55, p < 0.001). Known-groups validity was demonstrated as a logical pattern of higher MEQ scores was obtained for patients considered adherent with both the 6- and 12-month Proportion of Days Covered (mean MEQ total score 82.7 for 12-month PDC ≥ 80% against 76.3 for 12-month PDC < 80%, p< 0.0001). Additionally, a pattern of lower MEQ scores was obtained for patients with more severe disease assessed with Routine Assessment of Patient Index Data 3.ConclusionThe 24-item MEQ is a reliable and valid instrument to assess the adherence of RA patients taking MTX, potentially improving over historical refill rate metrics by providing insights into the individual reasons for lack of adherence. This information should facilitate clinician-patient discussions and help inform treatment decisions.
Highlights
Over the last decade, major progress has been made in the treatment of rheumatoid arthritis (RA) with the development of new biologic and targeted therapies recommended for use at later stages of the sequential RA treatment algorithm [1]
It is to note that while patients reported some of these barriers when discussing about one mode of administration in particular, it is most likely that some of these barriers could be attributed to a poor adherence in general, regardless of the mode of administration, Questions generic to both oral and injected MTX were generated using each patient’s own wording
The Methotrexate Experience Questionnaire (MEQ) provides a comprehensive multi-dimensional assessment of patient adherence to MTX. It captures reasons for non-adherence allowing an adequate discussion between the physician and the patient around barriers encountered by the patient and what could be done to improve the patient adherence to the prescribed treatment regimen
Summary
Major progress has been made in the treatment of rheumatoid arthritis (RA) with the development of new biologic and targeted therapies recommended for use at later stages of the sequential RA treatment algorithm [1]. For the initial therapy of patients with RA conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) are still the standard of care and methotrexate (MTX) remains the initial preferred csDMARD [2]. As with other csDMARDs, MTX may lead to undesired side effects contributing to suboptimal adherence with patients discontinuing therapy to avoid these side effects. Up to half of RA patients discontinue MTX [3] and MTX adherence and persistence measured with a wide variety of different tools appears highly variable in patients with RA [4, 5]. Identifying the drivers of nonadherence to csDMARDs is essential to improve disease management. Inadequate or poor adherence reduces the effectiveness of treatment, which may lead to complications and deterioration in patients’ health and well-being
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