Page 138 - THE EVOLUTION OF EARLY ARTHRITIS AND CARDIOVASCULAR RISK Samina A. Turk

CHAPTER 7
cohort includes patients aged 18 years and older with no prior treatment with disease- modifying antirheumatic drugs (DMARDs). Patients who fulfilled the ACR/ EULAR 2010 criteria for RA(24), and consented to start treatment with methotrexate (escalated to 25 mg/ week) with 5 mg folic acid and glucocorticoids (30 mg/ day tapered to 7,5 mg in nine weeks)(25), between June 2014 and December 2016, were selected for inclusion. Approval was obtained from the local ethics committee (P0120, Ethics Committee of the Slotervaart Hospital and Reade, Amsterdam, The Netherlands) and all patients gave written informed consent according to the Declaration of Helsinki.
Measurements
Patients were interviewed by research nurses, at baseline and after 12 weeks to record clinical characteristics as well as the DAS44. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF) and anti-citrullinated protein (ACPA) were determined. The Health Assessment Questionnaire (HAQ) and Rheumatoid Arthritis Impact of Disease (RAID) questionnaires were filled out(4;26;27). The RAID evaluates the impact of RA on daily activities and comprises 7 domains that are evaluated as continuous variables from zero (best) to ten (worst).
Patient- and physician perceived remission were determined after 12 weeks of treatment. To assess patient-perceived remission the following question was phrased: “Would you say that, at this moment, your disease activity is as good as gone? Yes or no?”(13). Patients answering ‘yes’ were in ‘self-perceived remission’. Physician- perceived remission was assessed at the moment the physician assessed the patient in the outpatient clinic, using the ‘VAS physician’, phrased as: “How active do you think the rheumatoid arthritis of your patient is today?” and scored on a visual analogue (VAS) scale of 0-100 mm. Where a VAS ≤10 mm was defined as physician-perceived remission, according to the ACR/EULAR Boolean-based definition of remission(22).
Response after 12 weeks of treatment was determined, using the following clinical response and remission definitions: DAS44 remission (DAS44 <1.6 points at week 12), EULAR good response (defined as DAS44 improvement of 1.2 points and a DAS44 score at week 12 ≤ 2.4)(23), ACR70 response(21), and ACR/EULAR Boolean-based remission(22).
Statistical analyses
For descriptive purposes, mean (standard deviation (SD)), median (interquartile range (IQR)) or frequencies (percentages) were used. Differences between baseline and week 12 data were determined by the paired t-test when outcome variables were normally distributed. Otherwise, the Wilcoxon signed- rank test was applied.
First, the frequencies of patients who achieved DAS44 remission, EULAR good response, ACR70 response and Boolean-based remission were calculated, as well as the number of patients who were in physician- and patient-perceived remission. Second, the agreement of physician-perceived remission and patient-perceived remission with and between all
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