Dr. Kremer et al reply

Drs. Pincus, Bergman, and Yazici have raised some concerns about our published article comparing the Clinical Disease Activity Index (CDAI) with simultaneous measures of the Routine Assessment of Patient Index Data 3 (RAPID3).1 We believe our publication has clearly established that the validated CDAI scores provide a fundamentally different evaluation of disease status compared with the RAPID3.

AB0130 QUESTIONING THE USEFULNESS OF CDAI AS A MEASURE OF DISEASE ACTIVITY IN A TREAT TO TARGET PROGRAMME

Background:Rheumatoid arthritis (RA) is a chronic autoimmune condition which if not treated can lead to joint destruction and long term disability. In RA, the concept of T2T is recommended as the appropriate method to manage early arthritis 1. It has shown promising results to achieve clinical remission (CR) or low disease activity (LDA) 2.Objectives:The objective of this study was to investigate the potential to achieve remission or LDA according to the Clinical Disease Activity Index (CDAI) for RA, during treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs) and Biologics, and the factors that affect the remission/LDA outcome.Methods:We performed an observational prospective study on patients’ data available from our Early Arthritis Cohort. All patients with newly diagnosed RA who met the American College of Rheumatology (ACR) criteria were enrolled. Patients are managed by an Advanced Nurse Practitioner (ANP) with consultant supervision. To assess their response to treatment, we used the Clinical Disease Activity Index3. Analysis was performed using SPSS.Results:Out of a total of 459 patients, 353 completed the programme. 217 patients (61.5%) were female and (136) 38.5 % were male. Mean age was 53.98 (SD 14.66). 195 patients were on monotherapy, 40 on combination DMARDs and 115 were on Biologics/Janus Kinase Inhibitors (JAK-Inh). Remission-rates in the monotherapy and combination DMARDs groups were approximately 60%, whilst the remission rate in the Biologics/JAK-Inh group was 41.7%. Amongst female patients 15.9% had erosions on X-ray at the time of diagnosis whilst the equivalent figure for male patients was 29.6%.Conclusion:An association between male gender and the likelihood of erosions on X-Ray was observed. In addition an association between final medication and outcome was observed. An increased likelihood of non-remission was noted in patients that required escalation to Biologics/JAKs. A possible explanation for the lower levels of remission seen throughout the groups is the difficulty in achieving remission under the CDAI score as compared to DAS-28.References:[1]Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Annals of the Rheumatic Diseases. 2016;75(1):3.[2]Scott IC, Ibrahim F, Panayi G, Cope AP, Garrood T, Vincent A, Scott DL, Kirkham B; TITRATE Programme Investigators. The frequency of remission and low disease activity in patients with rheumatoid arthritis, and their ability to identify people with low disability and normal quality of life. Semin Arthritis Rheum. 2019 Aug;49(1):20-26. doi: 10.1016/j.semarthrit.2018.12.006. Epub 2018 Dec 28. PMID: 30685064.Disclosure of Interests:None declared

AB0119 DISCORDANCE OF RAPID3 AND CDAI IN RHEUMATOID ARTHRITIS

Background:The Clinical Disease Activity Index (CDAI) and the Routine Assessment of Patient Index Data 3 (RAPID3) ascertain rheumatoid arthritis (RA) disease activity and inform treatment decisions. The CDAI has provider and patient components, whilst the RAPID3 only has patient driven measures. During the COVID-19 pandemic, telemedicine visits relied on RAPID3 as a clinical outcome measure and subsequently was incorporated into all clinical visits in addition to the CDAI. On an ad-hoc basis, discrepancies were noted for the disease activity level generated by these two measures. The purpose of this retrospective study was to formally analyze the relationship between these measures.Objectives:To determine the concordance of the outcome measures RAPID3 with CDAI in patients with established RA as a quality improvement project.Methods:This is a retrospective study of 49 patients that fulfilled the American College of Rheumatology 2010 criteria for Rheumatoid Arthritis. IRB approval was obtained. The medical records of patients seen between June to October 2020 at the rheumatology department at UF health were reviewed. Data collected included age, gender, race, number of years with RA, Rheumatoid factor (RF) and anti-citrullinated protein antibody (CCP Ab) positivity, disease modifying treatments, ESR and CRP as well as CDAI and RAPID3 scores as calculated by clinic staff. The charts were reviewed by the authors and RAPID3 scores were verified.Results:The population ranged from 35- 90 years and duration of RA from 1- 30 years. CCP Ab was present in 75% of patients and RF in 71%. Patients were on DMARDs either monontherapy (29%), dual therapy (60%) or triple therapy (10%). Antirheumatic medications used were plaquenil, methotrexate, leflunomide, etanercept, adalimumab, infliximab, tofacitinib, upadacitinib and rituximab. ESR range was 2-110 and CRP 0.2- 83.1. The CDAI and RAPID3 concordance was found to be 37% with RAPID3 being higher in 45% of patients. RAPID3 was lower only in 14% of patients. There was incorrect calculation of the RAPID3 26% of the time by clinic staff. Table 1 summarizes this data. Figure 1 shows RAPID3 and CDAI compared in scatterplots.Table 1.Patient PopulationAge35-90 yearsRaceAfrican American-13Caucasian-10Hispanic-3Not Hispanic=13RF Positive35/49 (71)%CCP Ab37/49 (75%)Both RF and CCP Ab Positive32/49 (65%)Patients on monotherapy14/48 (29%)Patients on dual therapy29/48 (60%)Patients on triple therapy5/48 (10)Antirheumatic Drugs usedPlaquenil, methotrexate, leflunomide, etanercept, adalimumab, infliximab, tofacitinib, upadacitinib, rituximabCDAI and RAPID3 Concordance18/49 (37%)RAPID 3 Higher than CDAI22/49 (45%)RAPID 3 lower than CDAI7/49 (14%)Incorrect Calculation of RAPID3 by clinic staff11/42 (26%)Figure 1.Scatterplots of three RAPID3 strata. Red dots represent discordant subjects when compared to CDAI. Note: Panel C demonstrates the subjects that were in low disease activity in red that had a high severity RAPID3 scoreConclusion:This study shows that RAPID3 may overestimate disease activity level for patients above low disease activity. Treatment escalation based on RAPID3 in discordant patients may be inappropriate. When making treatment decisions, a measure that includes objective physical examination and provider judgment is desirable.References:[1]Kumar, B. S., Suneetha, P., Mohan, A., Kumar, D. P. & Sarma, K. V. S. Comparison of Disease Activity Score in 28 joints with ESR (DAS28), Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire Disability Index (HAQ-DI) & Routine Assessment of Patient Index Data with 3 measures (RAPID3) for assessing disease activity in patients with rheumatoid arthritis at initial presentation. Indian J Med Res146, S57–S62 (2017).[2]Pincus, T., Swearingen, C. J., Bergman, M. & Yazici, Y. RAPID3 (Routine Assessment of Patient Index Data 3), a Rheumatoid Arthritis Index Without Formal Joint Counts for Routine Care: Proposed Severity Categories Compared to Disease Activity Score and Clinical Disease Activity Index Categories. The Journal of Rheumatology35, 2136–2147 (2008).Disclosure of Interests:None declared

Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis

Objectives Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months. Methods We developed an app to deliver daily assessments to participants (RA App v.1.0). The app was tested as part of a randomized controlled trial examining potential clinical benefits. The current analyses focus on the adherence to the ePRO app for patients randomized to receive the app. We recruited RA patients from an academic rheumatology practice in the USA. Patients randomized to receive the app received daily notifications regarding ePROs. We examined adherence to the PRO questionnaires over the 6-month study and examined factors related to adherence. Results Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2 years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity). Median adherence to the daily questions was 79% (interquartile range 48–90%). Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). Conclusion We developed and tested an ePRO app for RA over a 6-month study. Adherence to the app was strong. There was correlation between older age and better disease control and increased adherence. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02822521.

Disease Characteristics, Quality of Life, and Work Productivity by Enthesitis Site: Real- World Data From the US Corrona Psoriatic Arthritis/Spondyloarthritis Registry

Objective To assess the impact of clinical enthesitis by body site in patients with psoriatic arthritis (PsA). Methods Adults with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013–March 2018) were included. Enthesitis at enrollment was assessed via the Spondyloarthritis Research Consortium of Canada Enthesitis Index and classified by affected sites (upper, lower, or both). Disease activity (eg, Clinical Disease Activity Index, clinical Disease Activity Index for PsA), patient-reported outcomes (PROs; eg, patient-reported pain and fatigue), and work productivity were compared between those with and without enthesitis using t or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher exact tests for categorical variables. The association of enthesitis with disease activity and PRO measures vs no enthesitis was modeled using multivariable-adjusted linear or logistic regression. Results Of 2003 patients with PsA, 391 (19.5%) had enthesitis: 80 (20.5%) in upper sites only, 137 (35.0%) in lower sites only, and 174 (44.5%) in both. Regardless of location, disease activity and PROs were worse in patients with vs without enthesitis. In adjusted models, presence of enthesitis at any site was significantly associated with worse disease activity vs no enthesitis. Enthesitis in lower or both upper and lower sites was associated with higher pain and fatigue scores and greater work impairment vs no enthesitis. Conclusion Patients with clinical enthesitis had worse disease activity regardless of enthesitis location vs those without enthesitis, and patients with enthesitis in lower or both upper and lower sites had worse pain, fatigue, and work impairment.

The Belief about Medicines among a Sample of Iraqi Patients with Rheumatoid Arthritis

Rheumatoid arthritis is a chronic, progressive, inflammatory autoimmune disease of unidentified etiology, associated with articular, extra-articular and systemic manifestation that require long-standing treatment. Taking patient’s beliefs about the prescribed medication in consideration had been shown to be an essential factor that affects adherence of the patient in whom having positive beliefs is an essential for better adherence. The purpose of the current study was to measure beliefs about medicines among a sample of Iraqi patients with Rheumatoid arthritis and to determine possible association between this belief and some patient-certain factors. This study is a cross-sectional study carried out on 250 already diagnosed rheumatoid arthritis patients who attended to Baghdad Teaching Hospital/Medical City/Rheumatology department. The mean age of the patients was (50.8 ± 13.1 years). Belief about medicines was measured via the Arabic version of the Beliefs about Medicines Questionnaire. The majority of the patients (88%) had strong beliefs in the necessity of treatment (specific-necessity score greater than specific-concern). There was a significant direct correlation between age, male gender, number of other chronic disease, disease activity score 28 and clinical disease activity index with specific necessity, and direct correlation between clinical disease activity index with specific concern. Future studies should investigate how interventional approaches addressing these predictors may lead to improve beliefs about medicines among rheumatoid arthritis patients and their impression on disease control.

Association of Serum Tocilizumab Trough Concentrations with Clinical Disease Activity Index Scores in Adult Patients with Rheumatoid Arthritis

Objective.To determine whether serum trough concentrations of tocilizumab (TCZ) administered as a fixed-dose subcutaneous (SC) injection for the treatment of rheumatoid arthritis (RA) are associated with disease activity responses.Methods.We analyzed datasets from the Israeli branch of the multinational TOZURA study, which evaluated a weekly subcutaneous TCZ treatment regimen in a real-life clinical setting. Generalized estimating equations (GEE) were used to evaluate associations between the TCZ levels and the study outcomes. Linear models and GEE were used to evaluate associations between patient characteristics and TCZ levels.Results.A significant association between the TCZ concentrations and the change in the Clinical Disease Activity Index (CDAI) score was observed. In a multivariate binary GEE model, every increase of 10 µg/ml in the concentration of TCZ was associated with being in a state of CDAI remission or low disease activity (OR 1.41) versus a moderate/high disease activity state. An OR of 1.52 was associated with being in a state of Health Assessment Questionnaire–Disability Index remission. In univariate linear models, there was an inverse association between body mass index (BMI) and improvement in the CDAI score, and the BMI score was associated with lower TCZ concentrations. Patients who weighed > 100 kg had lower TCZ concentrations.Conclusion.In the first 24 weeks of treatment with SC TCZ injections, TCZ concentrations were associated with clinical improvement, while body weight and BMI were inversely associated with TCZ concentrations. Personalizing the dose of SC TCZ to body weight may improve outcomes of clinical disease activity in patients with RA.