Belgian rheumatologists' preferences regarding measures of disease activity in patients with rheumatoid arthritis: results from a mixed-methods study.

The reliability and clinical usefulness of the different composite disease activity scores and their individual components in Rheumatoid Arthritis (RA) are still debated. This study investigated which measures of disease activity were preferred by rheumatologists. A mixed-method study was performed. First, ten Belgian rheumatologists were invited for individual interviews on their current practice and preferences for measurement of RA disease activity. Results of this qualitative study and evidence from literature served as input for developing a survey. This survey asked rheumatologists to rate preferred standard disease activity score(s), their individual components, ultrasound and related patient-reported outcomes (PROs), by maximum difference scaling. The relative importance score (RIS) for each indicator was calculated using hierarchical Bayes modeling. The qualitative study included 6/10 invited rheumatologists. Composite scores and components were perceived as useful, while PROs were found subjective. Interestingly, ultrasound was used to mediate discrepancies between physician and patient. The survey based on this was sent to 244 Belgian rheumatologists, 83/244 (34%) responded, including 66/83 (80%) complete and 17/83 (20%) incomplete surveys (two missing essential information). Most rheumatologists (75/81, 93%) used a disease activity score and 68/81 (84%) preferred the DAS28-CRP. Swollen joint count obtained the highest mean ± SD RIS (22.54 ± 2.64), followed by DAS28 ESR/CRP (20.61 ± 4.06), ultrasound (16.47 ± 7.97), CRP (13.34 ± 6.11) and physician's global assessment (12.59 ± 7.83). PROs including fatigue, pain, and patient's global assessment, and Health Assessment Questionnaire, obtained the lowest mean RIS (0.34-2.54). Rheumatologists place more faith in self-assessed disease activity components or in laboratory tests. Trust in PROs to evaluate disease activity is low in clinical practice.

Tapering of Etanercept is feasible in patients with Rheumatoid Arthritis in sustained remission: a pragmatic randomized controlled trial.

OBJECTIVE: In patients with rheumatoid arthritis (RA) in sustained remission, tapering of biological disease-modifying anti-rheumatic drugs can be considered. Tapering has already been investigated, but its feasibility remains to be determined. Therefore, we explored the feasibility of tapering etanercept in RA in a setting close to practice. METHOD: Patients with RA in 28-joint Disease Activity Score (DAS28) remission (≥ 6 months) and treated with etanercept 50 mg weekly (≥ 1 year) were included in the pragmatic 1 year open-label multicentre randomized controlled TapERA (Tapering Etanercept in Rheumatoid Arthritis) trial. Patients were assigned to continue etanercept weekly or to taper to every other week (EOW). Patients who lost remission [DAS28-C-reactive protein (CRP) ≥ 2.6] were re-escalated to etanercept weekly. The primary outcome was the proportion of patients maintaining DAS28-CRP remission for 6 months. RESULTS: Sixty-six patients were randomized to etanercept weekly (n = 34) or EOW (n = 32). After 6 months, 26/34 patients (76%) in the weekly and 19/32 (59%) in the EOW group maintained disease control (p = 0.136). In the EOW group, 20/32 patients (63%) remained on their tapered treatment during the trial. Two patients reintroduced weekly etanercept themselves. Ten patients were re-escalated to etanercept weekly by the rheumatologist, after a median (interquartile range) interval of 3.0 (2.0-6.0) months. Among these patients, 7/10 regained remission after re-escalation, four of them at the next study visit. CONCLUSIONS: Although non-inferiority could not be demonstrated, tapering of etanercept to EOW appeared feasible in patients in sustained remission.

A systematic review on the effect of DMARDs on fertility in rheumatoid arthritis.

INTRODUCTION: Drug therapy could alter fertility in patients with rheumatoid arthritis (RA). We aimed to perform a systematic review to evaluate if Disease-modifying antirheumatic drug (DMARD) therapy influences fertility as this is an important point to consider in shared decision making on RA therapy. METHODS: A search was conducted at 18/10/2019 in EMBASE, PubMed (including MEDLINE) and the Web of Science Core Collection. Our inclusion criteria were studies involving women or men diagnosed with RA, older than 18 years and on DMARD therapy, with as outcome a fertility parameter. Systematic reviews, meta-analyses, case reports, case series and animal studies were excluded. Studies not in English or Dutch or published before 2004 were excluded. Quality appraisal was performed by the CASP systematic review checklist. RESULTS: After duplicate removal, 9030 references were identified. After title/abstract screening, 82 articles remained. After full text screening, 4 articles could be retained. No studies were found through backward snowballing. Only studies involving women could be retained. The included studies investigated the effect of methotrexate, certolizumab pegol, etanercept and sulfasalazine on fertility. No detrimental effects of these DMARDs on time-to-pregnancy, anti-Müllerian hormone serum level or presence of a history of infertility, were reported. CONCLUSION: This systematic review underlines the gap in knowledge regarding the effect of DMARDs on fertility in women and especially men with RA. DMARD treatment, contrary to general belief, seemed to have no harmful effect on fertility, possibly because it resulted in better controlled disease activity. More research is needed to improve guidance for patients with RA with a child wish.

Graded response model fit, measurement invariance and (comparative) precision of the Dutch-Flemish PROMIS® Upper Extremity V2.0 item bank in patients with upper extremity disorders.

BACKGROUND: The Dutch-Flemish PROMIS® Upper Extremity (DF-PROMIS-UE) V2.0 item bank was recently developed using Item Response Theory (IRT). Unknown for this bank are: (1) if it is legitimate to calculate IRT-based scores for short forms and Computerized Adaptive Tests (CATs), which requires that the items meet the assumptions of and fit the IRT-model (Graded Response Model [GRM]);(2) if it is legitimate to compare (sub) groups of patients using this measure, which requires measurement invariance; and (3) the precision of the estimated patients' scores for patients with different levels of functioning and compared to legacy measures. Aims were to evaluate (1) the assumptions of and fit to the GRM, (2) measurement invariance and (3) (comparative) precision of the DF-PROMIS-UE v2.0. METHODS: Cross-sectional data were collected in Dutch patients with upper extremity disorders. Assessed were IRT-assumptions (unidimensionality [bi-factor analysis], local independence [residual correlations], monotonicity [coefficient H]), GRM item fit, measurement invariance (absence of Differential Item Functioning [DIF] due to age, gender, center, duration, and location of complaints) and precision (standard error of IRT-based scores across levels of functioning). To study measurement invariance for language [Dutch vs. English], additional US data were used. Legacy instruments were the Disability of the Arm, Shoulder and Hand (DASH), the QuickDASH and the Michigan Hand Questionnaire (MHQ). RESULTS: In total 521 Dutch (mean age ± SD = 51 ± 17 years, 49% female) and 246 US patients (mean age ± SD = 48 ± 14 years, 69% female) participated. The DF-PROMIS-UE v2.0 item bank was sufficiently unidimensional (Omega-H = 0.80, Explained Common Variance = 0.68), had negligible local dependence (four out of 1035 correlations > 0.20), good monotonicity (H = 0.63), good GRM fit (no misfitting items) and demonstrated sufficient measurement invariance. Precise estimates (Standard Error < 3.2) were obtained for most patients (7-item short form, 88.5%; standard CAT, 91.3%; and, fixed 7-item CAT, 87.6%). The DASH displayed better reliability than the DF-PROMIS-UE short form and standard CAT, the QuickDASH displayed comparable reliability. The MHQ-ADL displayed better reliability than the DF-PROMIS-UE short form and standard CAT for T-scores between 28 and 50. For patients with low function, the DF-PROMIS-UE measures performed better. CONCLUSIONS: The DF-PROMIS-UE v2.0 item bank showed sufficient psychometric properties in Dutch patients with UE disorders.