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Background: D2T-RA definition offers a glimpse of multi-drug resistant patients presenting with evidence of inadequate disease control1. Even though data regarding the prevalence and characterization of D2T RA patients in real-life settings emerged, data regarding the maintenance of the condition over time and the principal drivers of the D2T status are absent. Objectives: Our study aimed to identify and characterize patients based on a time-based criterion of D2T status. Moreover, we sought to assess the rate of the definition criteria fulfillment to unveil any driver of the persistent (p)D2T status. Methods: In our 610 adult RA patients' cohort, we identified 104 patients refractory to ≥2 b/tsDMARDs with different mechanisms of action. We collected demographic, clinical, and disease activity data for each patient at enrollment, as well as retrospectively from the medical records of the visits conducted bimonthly in the previous 12 months. Extrapolated the prevalence of D2T patients from each timepoint, we defined patients fulfilling the D2T definition for more than 6 months as pD2T patients and compared them to episodic D2T (eD2T, less than 6 months) patients with univariate and logistic regression analyses. Lastly, we assessed how the fulfillment rate of 3 definition criteria (the disease activity, CRP values, and inability to taper glucocorticoids criteria) would impact the persistence of the D2T status and evaluate whether one of such criteria would serve as the main driver of the pD2T definition through an ANOVA analysis and Tukey test. Results: At enrollment, 41.3% of the 104 refractory patients fulfilled the D2T definition criteria, while the prevalence of D2T patients in the previous 12 months ranged constantly between 29 to 31%. 29/104 patients (27.9%) fulfilled the pD2T definition, 32 (30.8%) were episodic D2T, while 43 (41.3%) never fulfilled the definition in the 12-month observation period. In univariate analysis, pD2T patients showed a higher frequency of male sex (p=0.01), higher HAQ (p=0.031) and SDAI scores (pp=0.004), a higher number of failed b/tsDMARDs (p=0.028), use of glucocorticoids (pp=0.039). Applying logistic regression analysis, higher SDAI scores (OR 1.23, p=0.001), CRP values (OR 2.22, p=0.035), and use of glucocorticoid (OR 24.29, p=0.004) were associated with pD2T, as well as more frequent use of analgesics (OR 4.5, p=0.046) (Table 1). The inability to taper glucocorticoid dosage appeared to be the most frequent criterion fulfilled across the entire population. The "at least moderate disease activity" criterion (ppp=0.053). Nevertheless, a trend for a more frequent inability to taper glucocorticoids emerged (p=0.083 vs moderate disease activity; p=0.093 vs CRP) (Figure 1). Conclusion: In our cohort, the employment of a time-based criterion revealed a subset of refractory patients (27.9%) that persistently fulfilled the D2T-RA definition instead of patients that did so only episodically during the observation period. The application of a temporal criterion may thus increase the homogeneity of the D2T population for research purposes. Moreover, the inability to taper glucocorticoids appeared to be the main driver of D2T and pD2T status, suggesting that possibly different management strategies in real life could reshape this population. REFERENCES: 1 Nagy G, Roodenrijs NM, Welsing PM, et alEULAR definition of difficult-to-treat rheumatoid arthritisAnnals of the Rheumatic Diseases 2021;80:31-35. Table 1. Characteristics of persistent and non-persistent D2T patients Acknowledgements: NIL. Disclosure of Interests: None declared.
Cincinelli et al. (Sat,) studied this question.