Defining the physician global assessment threshold equivalent to remission in patients with systemic lupus erythematosus.

OBJECTIVES: The optimal threshold of the physician global assessment (PGA) for remission in SLE has never been evaluated systematically. The aim of this study was to assess the ideal PGA threshold associated with physician remission and to investigate its impact on remission rates in our Lupus cohort. METHODS: In this monocentric cross-sectional study, patients with SLE were evaluated for physician remission by asking the treating physicians if they considered their patient in remission regardless of objective remission criteria. Further, two objective remission definitions were applied: 1) DORIS remission using a PGA of < 2 (0-10) (corresponding to < 0.5 on a VAS 0-3 used in DORIS); 2) DORIS remission with omission of PGA (modDORIS). A receiver operating characteristic analysis and regression analyses were performed to assess the ideal PGA threshold and factors influencing PGA. RESULTS: Of the 233 patients included, 126 patients (54.0%) were in physician remission, 42.5% in DORIS remission and 67.0% in modDORIS remission. A PGA of < 2 NRS 0-10) had the highest sensitivity (79%) and specificity (81%) for physician remission and modDORIS (AUC 0.85 and 0.69). PGA of patients fulfilling any of the remission definitions was associated with pain and hypocomplementemia. Damage was numerically higher in patients in modDORIS only; no association between PGA and damage was found in regression analysis. CONCLUSION: Using a PGA threshold of < 2 (0-10), corresponding to < 0.6 (0-3) resulted in best prediction of physician remission. PGA levels seem to be influenced by pain and complement levels but not disease damage.

Time interval between the onset of connective tissue disease symptoms and first contact with a rheumatologist: results from the German National Database of collaborative arthritis centers.

The long-term outcome of connective tissue diseases is associated with the time from symptom onset to diagnosis. To understand gaps in care, we determine whether the length of time between symptom onset and first presentation to a rheumatologist has changed in Germany in recent decades. We analyzed data on patients diagnosed with connective tissue diseases (n = 19,662) collected from the German National Database of the Regional Cooperative Rheumatology Centers. We reviewed the onset of relevant symptoms listed at first presentations from 1993 to 2018 and performed a quantitative analysis of the intervals until first presentation to a rheumatologist. We compared time intervals and performed a linear mixed regression model with random effects to identify associated factors. Although the interval between the onset of symptoms and first presentation to a rheumatologist has diminished since 1980 for all connective tissue diseases, there has been no relevant improvement during the past 2 decades. The interval between symptoms and presentation increases with patients age for all connective tissue diseases (e.g., Systemic sclerosis; for each 10-year-increment of patients age: ß 0.41, CI 0.38; 0.44). Among those diagnosed with systemic sclerosis, the mean interval was 1.5 years (95% CI 1.1; 1.8) for male patients and 2.6 years (95% CI 2.4; 2.8) for females. Patients presenting with different degrees of disease severity on their first visits and with different educational levels had similar mean intervals between symptoms and first presentation regardless of their final diagnoses. Over the past 2 decades, the time to first consultation with a rheumatologist has not continued to improve in Germany, but has stagnated at the same level. Selected patient subgroups, such as older patients with suspected connective tissue diseases and female patients with suspected systemic sclerosis, are at risk to present late and may in particular benefit from an earlier referral to a rheumatologist.

Beneficial effects associated to a healthy lifestyle in systemic lupus erythematosus: A cross-sectional study.

OBJECTIVE: To assess whether a healthy lifestyle is associated to beneficial effects on various systemic lupus erythematosus (SLE) health domains. METHODS: In a cross-sectional study, Mediterranean Diet Adherence Score (MEDAS), physical activity energy expenditure (PAEE), and smoking status were assessed by questionnaires, along with clinical parameters and various health domains including Systemic Lupus Disease Activity Score (SLEDAI), Depression Scale (CES-D), Fatigue Severity (FSS), functional status (FFbH), physical and mental quality of life (PCS, MCS). Lifestyle choices were assessed with respect to health domains by linear regression modeling. Additionally, SLE patients with a healthy lifestyle (MEDAS ≥ 4, ≥ 1 h sport per week, no smoking) were compared to those without by Wilcoxon's signed-rank test. RESULTS: 49 of 145 SLE patients (44.3 ± 31.7 years, 87.6% female) followed a healthy lifestyle and showed a higher physical quality of life (ß = 4.5 (95%-CI 1.5-7.9) p = 0.01), lower depression (ß = -5.0 (-8.2 to -0.2) p = 0.02) and lower fatigue (ß = -0.8 (-1.5 to -0.2) p = 0.01) independently of SLE disease activity. Furthermore, dsDNA-antibodies were lower (146 ± 540 vs 266 ± 146 U/mL, p = 0.049). In a more detailed analysis, physical activity had the highest impact on the various health domains when compared to smoking or diet adherence, which was consistent even after adjusting for multiple potential confounders. Each 1,000 kcal of weekly PAEE was associated to a 1.8 (0.9-2.6) point increase in the PCS (p = 0.0001), a 0.2 (0.03-0.4) point decrease in the CES-D (p = 0.01) and a 2.8 (1.2-4.4) point increase in the FFbH (p = 0.0006). CONCLUSION: A healthy lifestyle, especially physical activity is associated with beneficial effects including quality of life, depression and fatigue in SLE.

Determinants of patient and physician global assessments of disease activity in anti-neutrophil cytoplasmic antibody-associated vasculitis.

Objective: To compare physician and patient assessments of global disease activity in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and to identify associated factors. Methods: Global disease activity scores (0-10 points) were retrospectively analyzed from physicians and patients with AAV at each outpatient visit from 2010 to 2020. We compared the scores and performed a linear regression with a random effects to identify associated factors. Results: Patients (n = 143, 1,291 pairs, 52% female) had a mean 64 (±15) years of age and a mean disease duration of 9 (±7) years. Patients and physicians global disease activity assessments showed a moderate correlation (Pearson R 0.31, CI [0.23-0.52], p < 0.001). Linear regression showed a strong association between the physician-documented disease activity scores and serum CRP levels (ß = 0.22, CI [0.18, 0.28]), disease duration (ß = -0.022, CI [-0.04,-0.01]) and patients' assessment of disease activity (ß = 0.08, CI [0.04, 0.12]). By contrast, patient assessments were strongly associated with the degree of pain (ß = 0.30, CI [0.25, 0.35]), functional limitations in daily living (HAQ, ß = 0.49, CI [0.21, 0.78]) and the global physical well-being (NRS, ß = 0.39, CI [0.32, 0.46]). Conclusion: Patients' and physicians' assessments of disease activity correlated. High CRP levels and disease duration were associated with physician-assessed disease activity scores, while subjective limitations were associated with higher patient-assessed disease activity scores. These findings highlight and support the need to develop and evaluate patient-reported outcomes to assess disease activity in patients diagnosed with AAV.

Digitalization and disruptive change in rheumatology.

INTRODUCTION: Recently, many sectors have seen disruptive changes due to the rapid progress in information and communication technology (ICT). The aim of this systematic literature review was to develop a first understanding of what is known about new ICTs in rheumatology and their disruptive potential. METHODS: PubMed, LIVIVO, and EBSCO Discovery Service (EDS) databases were searched for relevant literature. Use of new ICTs was identified, categorized, and disruptive potential was discussed. Articles from 2008 to 2021 in German and English were considered. RESULTS: A total of 3539 articles were identified. After application of inclusion/exclusion criteria, 55 articles were included in the analyses. The majority of articles (48) used a non-experimental design or detailed expert opinion. The new ICTs mentioned in these articles could be allocated to four main categories: technologies that prepare for the development of new knowledge by data collection (n = 32); technologies that develop new knowledge by evaluation of data (e.g., by inventing better treatment; n = 11); technologies that improve communication of existing knowledge (n = 32); and technologies that improve the care process (n = 29). Further assessment classified the ICTs into different functional subcategories. Based on these categories it is possible to estimate the disruptive potential of new ICTs. CONCLUSION: ICTs are becoming increasingly important in rheumatology and may impact patients' lives and professional conduct. The properties and disruptive potential of technologies identified in the articles differ widely. When looking into ICTs, doctors have focused on new diagnostic and therapeutic procedures but rarely on their disruptive potential. We recommend putting more effort into investigation of whether ICTs change the way rheumatology is performed and who is in control of it. Especially technologies that potentially replace physicians with machines, take control over the definition of quality in medicine, and/or create proprietary knowledge that is not accessible for doctors need more research.

Evaluation of the use of video consultation in German rheumatology care before and during the COVID-19 pandemic.

Background: The COVID-19 pandemic led to transformations in healthcare infrastructures and increased use of (innovative) telemedicine (TM) tools. Comparison of the use of video consultation (VC) in rheumatology in the pre-pandemic period and during the pandemic might allow for evaluating this new form of consultancy in healthcare due to changing conditions and possibilities. Materials and methods: Cross-sectional nationwide online survey among German rheumatologists and rheumatologists in training between March and May 2021 promoted by newsletters and Twitter posts. Results: Results refer to 205 participants. The majority was male (59%), older than 40 years (90%). Thirty-eight percent stated to have employed TM before ("digital users"), 27% were using VC as part of their TM expertise ("VC-users"), 10% stated to have experience with TM but not VC ("TM-users"). Those negating the use of any TM (62%) were designated as "digital non-users." TM-Knowledge was self-rated as 4 [median on a Likert Scale 1 (very high) to 6 (very low)] with a significant difference between digital users (VC-user 2.7 ± 1.2, TM-user 3.2 ± 1.1) and digital non-users (4.4 ± 1.3). The reported significant increase of VC use during the lockdown periods and between the lockdowns compared to the pre-pandemic phase was regarded as a proxy for VC acceptance in the pandemic. Reasons for VC non-use were administrative/technical efforts (21%), lack of technical equipment (15%), time constraints (12%), time required for individual VC sessions (12%), inadequate reimbursement (11%), lack of demand from patients (11%), data security concerns (9%), poor internet connection (8%), and lack of scientific evaluation/evidence (5%). Physicians considered the following clinical situations to be particularly suitable for VC: follow-up visits (VC-user 79%, TM-user 62%, digital non-user 47%), emergency consultations (VC-user 20%, TM-user 33%, digital non-user 20%), and patients presenting for the first time (VC-user 11%, TM-user 19%, digital non-user 8%). Conclusion: Even though the pandemic situation, with social distancing and several lockdowns, provides an ideal environment for the implementation of new remote care forms as VC, its use and acceptance remained comparatively low due to multiple reasons. This analysis may help identify hurdles in employing innovative digital care models for rheumatologic healthcare.

One year of digital health applications (DiGA) in Germany - Rheumatologists' perspectives.

Background: Based on given legislation the German approach to digital health applications (DiGA) allows reimbursed prescription of approved therapeutic software products since October 2020. For the first time, we evaluated DiGA-related acceptance, usage, and level of knowledge among members of the German Society for Rheumatology (DGRh) 1 year after its legal implementation. Materials and methods: An anonymous cross-sectional online survey, initially designed by the health innovation hub (think tank and sparring partner of the German Federal Ministry of Health) and the German Pain Society was adapted to the field of rheumatology. The survey was promoted by DGRh newsletters and Twitter-posts. Ethical approval was obtained. Results: In total, 75 valid response-sets. 80% reported to care ≥ 70% of their working time for patients with rheumatic diseases. Most were working in outpatient clinics/offices (54%) and older than 40 years (84%). Gender distribution was balanced (50%). 70% knew the possibility to prescribe DiGA. Most were informed of this for the first time via trade press (63%), and only 8% via the scientific/professional society. 46% expect information on DiGA from the scientific societies/medical chambers (35%) but rarely from the manufacturer (10%) and the responsible ministry (4%). Respondents would like to be informed about DiGA via continuing education events (face-to-face 76%, online 84%), trade press (86%), and manufacturers' test-accounts (64%). Only 7% have already prescribed a DiGA, 46% planned to do so, and 47% did not intend DiGA prescriptions. Relevant aspects for prescription are provided. 86% believe that using DiGA/medical apps would at least partially be feasible and understandable to their patients. 83% thought that data collected by the patients using DiGA or other digital solutions could at least partially influence health care positively. 51% appreciated to get DiGA data directly into their patient documentation system/electronic health record (EHR) and 29% into patient-owned EHR. Conclusion: Digital health applications awareness was high whereas prescription rate was low. Mostly, physician-desired aspects for DiGA prescriptions were proven efficacy and efficiency for physicians and patients, risk of adverse effects and health care costs were less important. Evaluation of patients' barriers and needs is warranted. Our results might contribute to the implementation and dissemination of DiGA.

Off-label use of mycophenolate mofetil in the treatment of rare and complex rheumatic connective tissue diseases.

OBJECTIVES: We aimed to investigate the clinical off-label use of mycophenolate mofetil (MMF), including its safety and efficacy in patients with rare and complex rheumatic connective tissue diseases (rCTDs). METHODS: A survey was distributed across experts from ERN-ReCONNET reference centres in order to assess the experience with MMF off-label use. Patient-level data of patients with rCTDs under treatment with MMF was also collected for analysis of safety and efficacy. RESULTS: Twelve experts from eleven centres distributed throughout Europe (7 countries) answered the survey. The experience was concordant in that, despite of its off-label use, experts reported opting frequently for this therapeutic alternative with robust confidence on its efficacy and safety. The analysis of 108 patients with rCTDs under MMF revealed a good safety profile, as well as good clinical outcomes, especially for systemic lupus erythematosus and idiopathic inflammatory myopathies. The presence of interstitial lung disease was, as expected, associated with a worse clinical outcome despite use of MMF. CONCLUSIONS: MMF is widely used in reference centres for rCTDs. Its safety profile and efficacy seem to be recognised by experts and demonstrated with patient-level analysis. While selected rCTDs will likely remain an off-label indication for MMF, robust data seem to support this therapy as an appropriate alternative for safely and effectively treating many manifestations of rCTDs.

COVID-19 pandemic impairs medical care of vasculitis patients in Germany: Results of a national patient survey.

Objective: To analyze the impact of the COVID-19 pandemic on medical care and vaccination acceptance of vasculitis patients in Germany. Methods: A web-based national survey was developed by rheumatology centers and vasculitis patient advocacy groups. The survey was distributed nationwide by mail and flyers and could be accessed via a QR-code or weblink from December 2021 to April 2022. Descriptive statistics [mean, median, standard derivation (SD), 25%, 75% quantile] were calculated. 95% confidence intervals were presented for responses that were directly related to the impact of COVID-19 on parameters associated with vasculitis patient care. Results: The online survey was completed by 117 patients with small and large vessel vasculitis [granulomatosis with polyangiitis (n = 69), eosinophilic granulomatosis with polyangiitis (n = 16), microscopic polyangiitis (n = 12), giant cell arteritis (n = 17) and Takayasu's arteritis (n = 3)]. Prescheduled rheumatological appointments had been canceled due to the COVID-19 pandemic in 12.6% of the respondents [95% confidence interval (CI), 7.3-20.0%); in 9% (95% CI, 4.5-15.6%)] appointments had been replaced by digital services. Therapeutic regimens were changed (shifted, reduced, or discontinued) due to the pandemic in 15.5% (95% CI 9.5-22.2%). Vaccination coverages were generally high compared to patients with other rheumatic diseases and the general population. Highest vaccination coverage was observed against COVID-19 (98.1% 95% CI 93.9-99.6%). Conclusion: Vasculitis patients experienced changes in medical care during COVID-19 pandemic such as cancelation of prescheduled rheumatology appointments and modifications in therapeutic regimens. The overall acceptance rate for vaccination was comparatively high, particularly for vaccination against COVID-19.

Factors detrimental to work productivity and daily activities in systemic lupus erythematosus patients - Analysis of the German LuLa study.

OBJECTIVE: The aim of this study was to identify factors associated with impaired work productivity and impaired daily activities in patients with systemic lupus erythematosus (SLE). METHODS: The LuLa study is a longitudinal patient-reported study. Beyond sociodemographic data, work productivity, daily activities and fatigue, several other clinical outcome parameters (e.g. mental health-related quality of life and physical functioning, disease activity, damage and pain) were surveyed with validated questionnaires. The effects of confounders on work productivity (WPAI 2) and daily activity domains (WPAI 4) were studied by multivariate regression analysis. RESULTS: A total of 585 patients completed the questionnaire of whom 259 were employed and analysed. The median impairment in work productivity (WPAI 2) was 20% (Q1-3 0-40), and the median impairment in daily activities (WPAI 4) was 30% (Q1-3 10-50%). Multivariate regression analysis revealed that fatigue, pain, disease activity and health-related quality of life affected WPAI 2 and 4. Furthermore, we observed distinct synergistic effects of fatigue, disease activity and pain on both work productivity and daily activities: a higher impact of fatigue was associated with the reported extent of pain or disease activity. CONCLUSION: In employed patients with SLE, impaired work productivity and impaired daily activities were frequently reported. Fatigue, pain, disease activity and health-related quality of life demonstrated a detrimental impact, with a synergistic effect of fatigue, disease activity and pain. Hence, both optimized pain management and targeted immunomodulatory therapy are important for preserving active participation in life among patients with fatigue.

Methyl donor micronutrients, CD40-ligand methylation and disease activity in systemic lupus erythematosus: A cross-sectional association study.

OBJECTIVE: Hypomethylation of CD40-ligand (CD40L) in T-cells is associated with increased disease activity in systemic lupus erythematosus (SLE). We therefore investigated possible associations of dietary methyl donors and products with CD40L methylation status in SLE. METHODS: Food frequency questionnaires were employed to calculate methyl donor micronutrients in 61 female SLE patients (age 45.7 ± 12.0 years, disease duration 16.2 ± 8.4 years) and compared to methylation levels of previously identified key DNA methylation sites (CpG17 and CpG22) within CD40L promotor of T-cells using quantitative DNA methylation analysis on the EpiTYPER mass spectrometry platform. Disease activity was assessed by SLE Disease Activity Index (SLEDAI). Linear regression modelling was used. P values were adjusted according to Benjamini & Hochberg. RESULTS: Amongst the micronutrients assessed (g per day), methionine and cysteine were associated with methylation of CpG17 (ß = 5.0 (95%CI: 0.6-9.4), p = 0.04; and ß = 2.4 (0.6-4.1), p = 0.02, respectively). Methionine, choline, and cysteine were additionally associated with the mean methylation of the entire CD40L (ß = 9.5 (1.0-18.0), p = 0.04; ß = 1.6 (0.4-3.0), p = 0.04; and ß = 4.3 (0.9-7.7), p = 0.02, respectively). Associations of the SLEDAI with hypomethylation were confirmed for CpG17 (ß=-32.6 (-60.6 to -4.6), p = 0.04) and CpG22 (ß=-38.3 (-61.2 to -15.4), p = 0.004), but not the mean methylation of CD40L. Dietary products with the highest impact on methylation included meat, ice cream, white bread, and cooked potatoes. CONCLUSIONS: Dietary methyl donors may influence DNA methylation levels and thereby disease activity in SLE.

The PICASO cloud platform for improved holistic care in rheumatoid arthritis treatment-experiences of patients and clinicians.

BACKGROUND: Multimorbidity raises the number of essential information needed for delivery of high-quality care in patients with chronic diseases like rheumatoid arthritis (RA). We evaluated an innovative ICT platform for integrated care which orchestrates data from various health care providers to optimize care management processes. METHODS: The Horizon2020-funded research project PICASO (picaso-project.eu) established an ICT platform that offers integration of care services across providers and supports patients' management along the continuum of care, leaving the data with the owner. Strict conformity with ethical and legal legislations was augmented with a usability-driven engineering process, user requirements gathering from relevant stakeholders, and expert walkthroughs guided developments. Developments based on the HL7/FHIR standard granting interoperability. Platform's applicability in clinical routine was an essential aim. Thus, we evaluated the platform according to an evaluation framework in an observational 6-month proof-of-concept study with RA patients affected by cardiovascular comorbidities using questionnaires, interviews, and platform data. RESULTS: Thirty RA patients (80% female) participated, mean age 59 years, disease duration 13 years, average number of comorbidities 2.9. Home monitoring data demonstrated high platform adherence. Evaluations yielded predominantly positive feedback: The innovative dashboard-like design offering time-efficient data visualization, comprehension, and personalization was well accepted, i.e., patients rated the platform "overall" as 2.3 (1.1) (mean (SD), Likert scales 1-6) and clinicians recommended further platform use for 93% of their patients. They managed 86% of patients' visits using the clinician dashboard. Dashboards were valued for a broader view of health status and patient-physician interactions. Platform use contributed to improved disease and comorbidity management (i.e., in 70% physicians reported usefulness to assess patients' diseases and in 33% potential influence on treatment decisions; risk manager was used in 59%) and empowered patients (i.e., 48% set themselves new health-related goals, 92% stated easier patient-physician communications). CONCLUSION: Comprehensive aggregation of clinical data from distributed sources in a modern, GDPR-compliant cloud platform can improve physicians' and patients' knowledge of the disease status and comorbidities as well as patients' management. It empowers patients to monitor and positively contribute to their disease management. Effects on patients' outcome, behavior, and changes in the health care systems should be explored by implementing ICT-based platforms enriched by upcoming Artificial Intelligence features where possible. TRIAL REGISTRATION: DRKS-German Clinical Trials Register, DRKS00013637 , prospectively registered. 17 January 2018.

What are the topics you care about making trials in lupus more effective? Results of an Open Space meeting of international lupus experts.

Despite promising candidates for new therapeutic options in the treatment of systemic lupus erythematosus (SLE), many clinical trials have failed in the past few years. The disappointing results have been at least partly be attributed to trial designs. With the aim of stimulating new developments in SLE trial design, an international open space meeting was held on occasion of the European Lupus Meeting 2018 in Duesseldorf, Germany about 'What are the topics you care about for making trials in lupus more effective?'. The Open Space is a participant-driven technology, where the discussion topics and schedule are selected during the meeting by all participants and discussion rounds are led by the people attending encouraging active contributions. Eleven topics were selected for further discussion, of which 6 were voted to be more intensively discussed in two consecutive rounds. Major topics were the optimal handling of glucocorticoids in clinical trials, the improvement of outcome measures, reducing or controlling the placebo response and the identification of biomarkers and stratification parameters. Further, the importance of local and international networks was emphasised. By networking, collaborations are facilitated, patient recruitment is more efficient and treatment can be harmonised thus lead to more successful SLE trials. Further discussions are needed to substantiate the results and develop new trial designs.

[Annual meeting of the German Society for Rheumatology going virtual-successfully defying the pandemic]. / Deutscher Rheumatologiekongress virtuell ­ erfolgreich tagen trotz Pandemie.

BACKGROUND: In 2020 the COVID-19 pandemic led to the annual meeting of the German Society for Rheumatology (DGRh) being conducted as the virtual German Rheumatology Congress. AIM: How is the virtual German Rheumatology Congress accepted and what are the possibilities of optimization for the future? MATERIAL AND METHOD: The registered participants were asked to take part in an online congress evaluation. RESULTS: Of 2566 congress attendees, 721 participated in the evaluation. The majority (80.2%) were (very) satisfied with the event overall. Compared to the traditional format collegial exchange was perceived as worse using the virtual approach. The technology platform was predominantly described as easy to use and easily accessible. The selected topics of the congress met the expectations of 89% of the participants. The presented contents were estimated to be relevant for their professional activities by 85.2% of the participants. The majority of participants (85.3%) would welcome the congress contents to be permanently available on demand. DISCUSSION: Overall, the participants appreciated the virtual format of the German Rheumatology Congress. Optimization aspects could be shown and these could be considered in the implementation of further (digital) congresses. The results of this work provide suggestions for improvement on how the DGRh can meet and exceed the needs of participants in organizing a virtual or hybrid conference in the future.

Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management.

BACKGROUND: Mobile medical applications (Apps) offer innovative solutions for patients' self-monitoring and new patient management opportunities. Prior to routine clinical application feasibility and acceptance of disease surveillance using an App that includes electronic (e) patient-reported outcome measures (PROMs) warrant evaluation. Therefore, we performed a proof-of-concept study in which rheumatoid arthritis (RA) patients used an App (RheumaLive) to document their disease. METHODS: Accurate PROM reporting via an App in comparison to paper-based versions was investigated to exclude media bias. Sixty participants recruited from 268 consecutive RA outpatients completed paper-based and electronic PROMs (Hannover Functional Questionnaire/derived HAQ; modified RA disease activity index) using the App at baseline and follow-up visits. Between visits, patients used their App on their own smartphone according to their preferences. The equivalence of PROM data and user experiences from patients and physicians were evaluated. RESULTS: Patients' (78.3% female) mean (SD) age was 50.1 (13.1) years, disease duration 10.5 (9.1) years, and paper-based HAQ 0.78 (0.59). Mean confidence in Apps scored 3.5 (1.1, Likert scale 1 to 6). ePROMs' scores obtained by patients' data entry in the App were equivalent to paper-based ones and preferred by the patients. After 3 months, the App retention rate was 71.7%. Patients' overall satisfaction with the App was 2.2 (0.9, Likert scale 1 to 6). Patients and physicians valued the App, i.e., for patient-physician interaction: 87% reported that it was easier for them to document the course of the disease using the App than "only" answering questions about their current health during routine outpatient visits. Further App use was recommended in 77.3% of the patients, and according to physicians, in seven patients, the App use contributed to an increased adherence to therapy. CONCLUSION: Our study provides an essential basis for the broader implementation of medical Apps in routine care. We demonstrated the feasibility and acceptance of disease surveillance using a smartphone App in RA. App use was convincing as a reliable option to perform continuous, remote monitoring of disease activity and treatment efficacy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02565225 . Registered on September 16, 2015 (retrospectively registered).