Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries.

OBJECTIVES: To explore patient-defined flares in psoriatic arthritis (PsA), compared to an increase in disease activity in psoriatic arthritis (DAPSA) and to analyze the validity of a patient-reported flare question. METHODS: ReFlap (NCT03119805) was a longitudinal study in 14 countries of consecutive patients with definite PsA. Patients were seen twice in the context of usual care, 4.5±2.2 months apart. Flares were reported by patients and physicians at the second visit using a single question. DAPSA worsening was defined as a change to a higher DAPSA category. Agreement between the definitions of worsening was calculated by prevalence adjusted bias adjusted kappa (PABAK). Validity of patient-reported flare was assessed by comparing patients with versus without flare and transition to flares. RESULTS: In 222 patients, mean disease duration 10.8±8.3 years, 127 (58.8%) males: disease activity was low (mean DAPSA 11.5±14.0); 63.3% received a bDMARD. Patient-reported flares between the 2 visits were seen in 27% patients (for these patients, mean 2.2±3.7 flares per patient, mean duration 12.6±21.0 days per flare). Physician- reported flares were seen in 17.6% and worsening in DAPSA in 40.1% of patients. Agreement between definitions was moderate (PABAK=0.32-0.59). Patients in flare had significantly more active disease than patients not in flare for all outcomes (all P<0.001). At the patient-level, transition to flare state was associated to a worsening in disease activity and impact outcomes. CONCLUSIONS: Patient flares were frequent and were associated with active and symptomatic disease. These findings provide preliminary validation for patient-reported flares in PsA.

Screening of dental and sinus infections in rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is associated with increased risk of infections. Screening for oral (dental and/or sinus) infection could be proposed before biologic disease-modifying antirheumatic drugs (bDMARDs) initiation but is not systematically recommended. The aim of our study was to assess the prevalence of oral infection in RA patients requiring bDMARDs. MATERIALS AND METHODS: This was a monocentric retrospective study. We included patients with RA and active disease requiring bDMARDs. Dental infection and sinusitis were assessed by a stomatologist and otorhinolaryngologist after clinical, panoramic dental X-ray and sinus CT evaluation. Factors associated with oral infections were analysed in uni- and multivariate models, estimating odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We included 223 RA patients (79.4% women, mean disease duration 8.9 ± 8.6 years). The mean age was 54.4 ± 10.9 years and mean Disease Activity Score in 28 joints 5.5 ± 2.6. Systematic dental screening revealed infection requiring treatment before bDMARDs initiation in 46 (20.9%) patients. Sinusitis was diagnosed by the otorhinolaryngologist in 33 (14.8%) patients. Among the 223 patients, 69 (30.9%) had dental and/or sinus infection. On univariate analysis, active smoking was associated with increased probability of oral infection (OR = 2.16 [95% CI 1.02-4.57], P = .038) and methotrexate with reduced probability (OR = 0.43 [95% CI 0.23-0.81], P = .006). On multivariate analysis, no RA variables were associated with oral infection. CONCLUSION: In our study, asymptomatic oral infection was confirmed in one third of RA patients.

Determinants of Patient-Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association With Sex in 458 Patients From Fourteen Countries.

OBJECTIVE: Sex differences may modify symptoms, disease expression, and treatment effects. The objective of this study was to evaluate the link between life impact and sex in psoriatic arthritis (PsA). METHODS: Remission and Flare in Psoriatic Arthritis (ReFlaP; ClinicalTrials.gov identifier: NCT03119805) was a study in 14 countries of consecutive adult patients with definite PsA. Participants underwent comprehensive PsA assessment using the following measures: Disease Activity in Psoriatic Arthritis (DAPSA), Minimal Disease Activity (MDA), and Psoriatic Arthritis Impact of Disease (PsAID). Disease activity was compared by sex using t-tests or Wilcoxon tests. The association of PsAID with sex was analyzed using hierarchical generalized linear models. RESULTS: Of 458 participants, 50.2% were male and the mean ± SD age was 53.1 ± 12.6 years. The mean ± SD PsA duration was 11 ± 8.2 years, and 51.5% of participants were being treated with biologic disease-modifying antirheumatic drugs. Women, compared to men, had worse mean ± SD Leeds Enthesitis Index scores (0.8 ± 1.7 versus 0.3 ± 0.9), pain on a numerical rating scale (NRS; range 0-10) (4.7 ± 2.7 versus 3.5 ± 2.7), HAQ DI scores (0.9 ± 0.7 versus 0.5 ± 0.6), fatigue on an NRS (5.2 ± 3 versus 3.3 ± 2.8), and PsAID scores (4.1 ± 2.4 versus 2.8 ± 2.3) (P < 0.001 for all). Women were also less frequently at treatment target compared to men according to DAPSA (cutoffs of ≤4 for remission and >4 and ≤14 for low disease activity; mean ± SD score 16.9 ± 14.9 in women versus 12.6 ± 16.6 in men) and MDA (25.7% versus 50.0%; P < 0.001 for all) scores. High life impact (PsAID score ≥4) was associated with female sex (odds ratio [OR] 2.3), enthesitis (OR 1.34), tender joints (OR 1.10)(P < 0.001 for all), and comorbidities (OR 1.22, P = 0.002). CONCLUSION: High life impact was independently associated with female sex, enthesitis, comorbidities, and tender joints. At treatment target, women had higher life impact compared to men. It is necessary for life impact to become a part of PsA treat-to-target strategies.

Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries.

BACKGROUND: The objective was to compare different definitions of remission and low disease activity (LDA) in patients with psoriatic arthritis (PsA), based on both patients' and physicians' perspectives. METHODS: In ReFlap (Remission/Flare in PsA; NCT03119805), adults with physician-confirmed PsA and >2 years of disease duration in 14 countries were included. Remission was defined as very low disease activity (VLDA), Disease Activity index for PSoriatic Arthritis (DAPSA) ≤4, and physician-perceived and patient-perceived remission (specific question yes/no), and LDA as minimal disease activity (MDA), DAPSA <14, and physician-perceived and patient-perceived LDA. Frequencies of these definitions, their agreement (prevalence-adjusted kappa), and sensitivity and specificity versus patient-defined status were assessed cross-sectionally. RESULTS: Of 410 patients, the mean age (SD) was 53.9 (12.5) years, 50.7% were male, disease duration was 11.2 (8.2) years, 56.8% were on biologics, and remission/LDA was frequently attained: respectively, for remission from 12.4% (VLDA) to 36.1% (physician-perceived remission), and for LDA from 25.4% (MDA) to 43.9% (patient-perceived LDA). Thus, patient-perceived remission/LDA was frequent (65.4%). Agreement between patient-perceived remission/LDA and composite scores was moderate to good (kappa range, 0.12-0.65). When patient-perceived remission or LDA status is used as reference, DAPSA-defined remission/LDA and VLDA/MDA had a sensitivity of 73.1% and 51.5%, respectively, and a specificity of 76.8% and 88.0%, respectively. Physician-perceived remission/LDA using a single question was frequent (67.6%) but performed poorly against other definitions. CONCLUSION: In this unselected population, remission/LDA was frequently attained. VLDA/MDA was a more stringent definition than DAPSA-based remission/LDA. DAPSA-based remission/LDA performed better than VLDA/MDA to detect patient-defined remission or remission/LDA. Further studies of long-term outcomes are needed.