Radiographic progression can still occur in individual patients with low or moderate disease activity in the current treat-to-target paradigm: real-world data from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry

Abstract

BackgroundThe aim of this retrospective study was to examine the longitudinal association between disease activity and radiographic damage in a cohort of patients with early RA (symptom onset < 1 year) treated according to treat-to-target (T2T) therapy.MethodsBaseline to 3-year follow-up data were used from patients included in the DREAM remission induction cohort. Patients received protocolized T2T treatment, aimed at 28-joint disease activity score-erythrocyte sedimentation rate (DAS28-ESR) remission. Disease activity (DAS28-ESR and C-reactive protein, CRP) were assessed at least every 3 months; X-rays of the hand and feet at inclusion, 6 months, and 1, 2, and 3 years were scored using modified Sharp/van der Heijde scoring (SHS). Between and within-person associations between time-integrated disease activity and radiographic progression over time were examined.ResultsA subset of 229 out of 534 included patients were available for analysis. At the between-patient level, time-integrated DAS28-ESR scores were not significantly correlated with progression at the 6 month and 2-year follow-up and only weakly at the 1-year (Pearson’s correlation coefficient r = 0.17, P < 0.05) and 3-year follow-up (r = 0.21, P < 0.05). Individual slopes of the relationship between DAS28-ESR and progression scores in each time interval were significantly correlated over time and the slope of the first 6 months was moderately associated with this slope at later time points (r between 0.39 and 0.59; P values < 0.001). Between 15.9 to 22.7% and 16.7 to 38.5% of patients with low and moderate time-integrated disease activity, respectively, experienced relevant (ΔSHS ≥ 3) radiographic progression at the different time intervals. Analyses using CRP showed similar results.ConclusionsIn early RA patients treated according to T2T, radiographic progression appears to be an individually determined disease process, driven by factors other than consistent high disease activity. For individual patients, the intra-patient relation between disease activity and cumulative radiographic damage during the first 6 months is a good indicator for this relation in later years.Trial registrationNetherlands Trial Register NTR578, 12 January 2006.

Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients

“…Several studies have previously been conducted analyzing selections of ADRs for specific types of DMARDs in specific treatment cohorts in DREAM-RA [6,7,8,9]. However, the question remains whether the frequency of the real-world reported ADRs in RA patients in the DREAM-RA registry matches with data in the SmPC.…”

Fatigue is associated with disease activity in some, but not all, patients living with rheumatoid arthritis: disentangling “between-person” and “within-person” associations

“…However, it has been convincingly demonstrated that these assumptions are rarely met, and that "between-person" relations can be quite different from "within-person" relations both in magnitude and sometimes even in direction [16][17][18][19][20]: an observation referred to as Simpson's paradox [21]. For instance, our study examining the association between disease activity and radiographic progression in RA patients showed that different indices of disease activity were not or only weakly associated at the "between-patient" level, but more often and more strongly associated within individual patients over time [22].…”

Baricitinib further enhances disease-modifying effects by uncoupling the link between disease activity and joint structural progression in patients with rheumatoid arthritis

“…Interestingly, when following disease activity in individual patients over time, in patients in whom REM/LDA is achieved at endpoint, a drop in activity is already discernible within 4–12 weeks, in line with the treat-to-target recommendations2 and independent of whether patients have established or early RA. In contrast, those who remain in MDA/HDA never achieve any better status 30. The visualisation as ‘heatmaps’ allowed us to show these data for individual patients very clearly.…”

“…In contrast, those who remain in MDA/HDA never achieve any better status. 30 The visualisation as ‘heatmaps’ allowed us to show these data for individual patients very clearly. Another strength is the use of the CDAI for clinical disease activity assessment rather than a single measure.…”