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Die ambulante Rheumatologie hat sich in den vergangenen Jahren zu einer der wichtigsten Saulen in der rheumatologischen Versorgung entwickelt. Die besseren diagnostischen Moglichkeiten, die fundierte Ausbildung der Rheumatologen und die diversen Leitlinien haben dazu gefuhrt, dass immer mehr Patienten ambulant diagnostiziert und nach den modernsten Moglichkeiten auch ambulant therapiert werden konnen. Dennoch sind auch der ambulanten Rheumatologie Grenzen gesetzt. Die aktuelle Arbeit soll verdeutlichen, wo zum jetzigen Zeitpunkt die Grenzen der ambulanten Rheumatologie sind und durch wen sie gesetzt werden. Die Darstellung der Einschrankungen soll allen Beteiligten des Gesundheitssystems helfen, falsche Erwartungen und Frustration zu vermeiden. Auf der anderen Seite konnen bei der entsprechenden Motivation auch Grenzen versetzt oder uberwunden werden. Das langfristige Ziel soll eine noch weitere Verbesserung der Interaktion von ambulanter und stationarer Rheumatologie und damit der rheumatologischen Versorgung unserer Patienten sein. Die medizinischen Grenzen der ambulanten Rheumatologie sind relativ klar und uberwiegend unstrittig, die ungerechtfertigte Einweisung in den stationaren Bereich ist z. B. eher selten ein Problem. Einige wenige, theoretisch ambulant mogliche Interventionen werden eher aus logistischen Grunden im stationaren Bereich durchgefuhrt. Groser sind die gesundheitspolitischen und rechtlichen Einschrankungen der ambulant tatigen rheumatologischen Einrichtungen. Trotz weiterer Einschrankungen der ambulanten Rheumatologie stellen unsere Fachrichtung und die ambulante Tatigkeit immer noch eine spannende, moderne und nicht zuletzt auch sehr befriedigende Tatigkeit dar, fur die hiermit geworben wird.

Digitalization in medicine is of major interest since the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. This article tries to present the induced changes and technical solutions with respect to the different parts in the patient journey. Symptom checkers, new health applications, digital appointment management etc. are described. Apart from the technical and digital possibilities, the changes in the quality of communication additionally have to be mentioned. There is an urgent need for further technical standardization including the interfaces. In many cases further studies must confirm the equivalence of digital applications in comparison to analogue techniques.

ZusammenfassungDie Durchführung von Videosprechstunden wird seit mehreren Jahren als ergänzende Form der medizinischen Versorgung in Ergänzung zu einem persönlichen Arzt-Patienten-Kontakt angesehen und teilweise auch gefördert. Die COVID-19-Pandemie hat der Nutzung von Videosprechstunden ungeahnte Aktualität und Aufmerksamkeit verschafft. Die Kassenärztliche Bundesvereinigung beschloss Sonderregelungen im Rahmen der COVID-19-Pandemie, die bisherige Hindernisse für den Einsatz von Telemedizin und Videosprechstunden (und auch teilweise der herkömmlichen Telefonie) reduziert. Die vorliegende Stellungnahme der DGRh zum Einsatz von Videosprechstunden soll einen Überblick darüber geben, in welcher Form und mit welchen Limitierungen die Videosprechstunde in der Rheumatologie in Deutschland anwendbar ist. Die Stellungnahme skizziert einen Ausblick, wie die Videosprechstunde welche Funktionen zukünftig in der rheumatologischen Versorgung übernehmen kann.

Even in the era of modern guidelines, the treatment of rheumatic diseases is only as good as the framework of rheumatological care within which the treatment is carried out. The access to high-quality medical treatment for all patients is therefore essentially decisive for the prognosis of the patients. This article describes the current state of outpatient treatment in rheumatology and demonstrates which quality projects, such as treatment contracts, outpatient specialized medical treatment (ASV), digitalization and training as specialized rheumatological assistant (RFA), have been created in order to ensure the treatment of our patients. Furthermore, standards are defined that can guarantee a contemporary and guideline-conform treatment in outpatient rheumatological units. As an example it is an affirmation of the Professional Association of German Rheumatologists (BDRh) for ensuring optimal care for all rheumatology patients through early or emergency rheumatology clinics, treat to target, appropriate delegation of medical duties and diversification of treatment, thus an assurance of the quality and comprehensive treatment in rheumatology. The important topic of safeguarding the next generation of rheumatologists, which is indispensable for this, is also discussed.

BackgroundShared decision making, a cornerstone of RA management1, allows physicians and their patients to make informed decisions about their treatment goals and choice of care. As new treatments become available, it is important to understand rheumatologists’ reasons for choosing JAKi.ObjectivesThis survey evaluated rheumatologists’ clinical and patient centric reasons for choosing JAKi, in addition to exploring alignment between rheumatologists and RA patients in terms of treatment choice and satisfaction.MethodsThe Adelphi RA Disease Specific Programme™2 is a large, multinational, point-in-time survey conducted amongst rheumatologists and their consulting patients with RA in Europe (Belgium, France, Germany, Italy, Spain, UK) between January and October 2020. Physicians completed record forms for up to 10 consecutive RA patients, collecting demographic, clinical and treatment data, and reasons for current treatment choice. Patients were invited to complete a patient questionnaire to assess their satisfaction with ongoing treatment (5-point scale), and perceptions of shared decision making for the current treatment.Results316 rheumatologists provided data for 3121 patients, of whom 1130 (36.2%) completed patient reported questionnaires. Overall, 67% were female, mean age was 53 years (SD 14), 23% had moderate-high disease activity score (DAS28: >3.2). 68% of patients were currently receiving either a biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD; defined here as advanced therapy, AT), 72% were on first line AT. Overall, physicians and their patients were aligned that a conversation took place about a treatment decision (n=855, 79% net alignment), and this was a shared treatment decision (n=814, 75% net alignment). 15% of patients not taking an AT were reported to have a clinical condition warranting one; reasons for not taking AT included patients’ concerns about infection (24%), conventional synthetic DMARDs were tolerable and safe in the patient (18%), and patient dislike of infusions/injections (17%). Of 2143 patients receiving AT, 19% were prescribed JAKi; 57% as monotherapy, 43% as combination therapy. For physician stated reasons for choice of JAKi, factors were driven by both perceptions of clinical efficacy and onset of action, as well as factors relating to patient acceptability such as method of delivery and ease of use (Table 1). With respect to JAKi treatment (n=135 patient-physician pairs), 62% of physicians and their patients were aligned on satisfaction, however 30% of patients reported less satisfaction than their consulting physician (Figure 1).Table 1.Physician stated clinical and patient centric reasons for prescribing a JAKi in their patients with RA (data are percentage of patients; n=397)Reasons for prescribing JAKiPatients (%)Top 5 clinical reasonsStrong overall efficacy74Fast onset of action49Inhibition of disease progression42Strong efficacy as monotherapy39Achievement of clinical remission37Top 5 patient centric reasonsAcceptability of method of delivery for the patient39Enabling patient to perform everyday tasks/activities36Ease of product use (for the patient)33Improvement or maintenance of quality of life30Improving patient’s mood/state of mind14ConclusionCommunicating the choice of pharmacological therapy to patients with RA has become increasingly complex for physicians with expansion of approved treatments. In this subgroup of patients on JAKi, the drug attributes considered as reasons for prescribing were driven by clinical factors as well as by patient centric attributes. Although communications between patients and physicians were largely aligned, better understanding of patient expectations might serve to improve messaging about treatment options and resulting satisfaction.References[1]Smolen JS et al. Ann Rheum Dis 2017;76.[2]Anderson P et al. Curr Med Res Opin 2008;24(11):3063–72.AcknowledgementsThe study was funded by Galapagos NV (Mechelen, Belgium). We thank the physicians and patients who participated in this survey. Medical writing support was provided by Gary Sidgwick, PhD (Adelphi Real World, Bollington, UK) and publications management was provided by Aspire Scientific Ltd, (Bollington, UK), funded by Galapagos NV.Disclosure of InterestsPeter C. Taylor Consultant of: AbbVie, Biogen, Bristol Myers Squibb, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Nordic Pharma, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: Celgene and Galapagos, Bruno Fautrel Consultant of: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, Sobi, and UCB, Grant/research support from: AbbVie, Lilly, MSD, and Pfizer, Yves Piette Consultant of: AbbVie, Galapagos, Grünenthal, Novartis, Janssen, and Sandoz, Susana Romero-Yuste Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Grunenthal, Janssen, Kern Pharma, Lilly, Roche, Sandoz, Sanofi, and UCB, Consultant of: AbbVie, Bristol, Biogen, Fresenius, Galapagos, Gebro, Janssen, and Lilly, Grant/research support from: Bristol Myers Squibb, MSD, Novartis, and Pfizer, Jasper Broen Consultant of: Galapagos, Gilead, UCB, and Novartis, Martin Welcker Speakers bureau: AbbVie, Aescu, Amgen, Biogen, BMS, Berlin Chemie, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Riemser, Sanofi, and UCB, Consultant of: AbbVie, Boehringer, BMS, Celgene, Galapagos, Gilead, GSK, Medac, Mylan, Novartis, Pfizer, Sanofi, and UCB, Grant/research support from: AbbVie, Actelion, Boehringer, Galapagos, Gilead, GSK, Hexal, Novartis, and UCB, Elizabeth Holdsworth Employee of: Adelphi Real World, Monia Zignani Employee of: Galapagos NV, Katrien Van Beneden Shareholder of: Galapagos NV, Employee of: Galapagos NV, Roberto Caporali Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Galapagos, Gilead, Lilly, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB, Consultant of: Galapagos, Gilead, Janssen, Lilly, and MSD, Rieke Alten Consultant of: AbbVie, Amgen, Biogen, BMS, Celltrion, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and Roche

In recent years outpatient rheumatology has developed into one of the most important pillars of rheumatological care. The better diagnostic possibilities, the well-founded training of rheumatologists and the diverse guidelines have led to increasingly more patients being diagnosed as outpatients and can be treated by the most modern options as outpatients. Nevertheless, limits have also been set for outpatient rheumatology.This article aims to highlight what the limits of outpatient rheumatology currently are and who sets the limits. The presentation of the limitations should help all participants in the healthcare system to avoid false expectations and frustration; however, limits can also be relocated or overcome by appropriate motivation. The long-term target should be a further improvement in the interaction between outpatient and inpatient rheumatology and therefore the rheumatological care of patients.The medical limits of outpatient rheumatology are relatively clear and predominantly uncontroversial, the unjustified referral to the inpatient section is, for example, relatively rarely a problem. Some theoretically possible outpatient interventions are carried out in the inpatient sector more due to logistical problems. The healthcare political and legal limitations of outpatient rheumatological institutions are greater. Despite further limitations of outpatient rheumatology this discipline and the outpatient activity still represents an exciting, modern and last but not least a very satisfying activity, which is promoted here.HINTERGRUND: Die ambulante Rheumatologie hat sich in den vergangenen Jahren zu einer der wichtigsten Säulen in der rheumatologischen Versorgung entwickelt. Die besseren diagnostischen Möglichkeiten, die fundierte Ausbildung der Rheumatologen und die diversen Leitlinien haben dazu geführt, dass immer mehr Patienten ambulant diagnostiziert und nach den modernsten Möglichkeiten auch ambulant therapiert werden können. Dennoch sind auch der ambulanten Rheumatologie Grenzen gesetzt.Die aktuelle Arbeit soll verdeutlichen, wo zum jetzigen Zeitpunkt die Grenzen der ambulanten Rheumatologie sind und durch wen sie gesetzt werden. Die Darstellung der Einschränkungen soll allen Beteiligten des Gesundheitssystems helfen, falsche Erwartungen und Frustration zu vermeiden. Auf der anderen Seite können bei der entsprechenden Motivation auch Grenzen versetzt oder überwunden werden. Das langfristige Ziel soll eine noch weitere Verbesserung der Interaktion von ambulanter und stationärer Rheumatologie und damit der rheumatologischen Versorgung unserer Patienten sein.Die medizinischen Grenzen der ambulanten Rheumatologie sind relativ klar und überwiegend unstrittig, die ungerechtfertigte Einweisung in den stationären Bereich ist z. B. eher selten ein Problem. Einige wenige, theoretisch ambulant mögliche Interventionen werden eher aus logistischen Gründen im stationären Bereich durchgeführt. Größer sind die gesundheitspolitischen und rechtlichen Einschränkungen der ambulant tätigen rheumatologischen Einrichtungen. Trotz weiterer Einschränkungen der ambulanten Rheumatologie stellen unsere Fachrichtung und die ambulante Tätigkeit immer noch eine spannende, moderne und nicht zuletzt auch sehr befriedigende Tätigkeit dar, für die hiermit geworben wird.

Digitalization in medicine is of major interest since the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. This article tries to present the induced changes and technical solutions with respect to the different parts in the patient journey. Symptom checkers, new health applications, digital appointment management etc. are described. Apart from the technical and digital possibilities, the changes in the quality of communication additionally have to be mentioned. There is an urgent need for further technical standardization including the interfaces. In many cases further studies must confirm the equivalence of digital applications in comparison to analogue techniques.Die Digitalisierung in der Medizin steht seit der SARS-CoV-2-Pandemie im Mittelpunkt des Interesses. Der Beitrag versucht die Veränderungen und technischen Lösungen in Bezug auf die unterschiedlichen Teile der „patient journey“ darzustellen. Symptom-Checkers, neue Gesundheitsapplikationen, digitale Terminverwaltung etc. werden beschrieben. Abgesehen von den technischen und digitalen Möglichkeiten muss ergänzend die Veränderung der Qualität in der Kommunikation beachtet werden. Es besteht die dringende Notwendigkeit der weiteren technischen Standardisierung einschließlich der Schnittstellen. Weitere Studien müssen die Gleichwertigkeit der digitalen Anwendungen im Vergleich zur analogen Technik in vielen Fällen erst noch belegen.

The global COVID-19 pandemic has led to drastic changes in the management of patients with rheumatic diseases. Due to the imminent risk of infection, monitoring intervals of rheumatic patients have prolonged. The aim of this study is to present insights from patients, rheumatologists, and digital product developers on the ongoing digital health transition in rheumatology. A qualitative and participatory semi-structured fishbowl approach was conducted to gain detailed insights from a total of 476 participants. The main findings show that digital health and remote care are generally welcomed by the participants. Five key themes emerged from the qualitative content analysis: (1) digital rheumatology use cases, (2) user descriptions, (3) adaptation to different environments of rheumatology care, and (4) potentials of and (5) barriers to digital rheumatology implementation. Codes were scaled by positive and negative ratings as well as on micro, meso, and macro levels. A main recommendation resulting from the insights is that both patients and rheumatologists need more information and education to successfully implement digital health tools into clinical routine.

Background The worldwide burden of musculoskeletal diseases is increasing. The number of newly registered rheumatologists has stagnated. Primary care, which takes up a key role in early detection of rheumatic disease, is working at full capacity. COVID-19 and its containment impede rheumatological treatment. Telemedicine in rheumatology (telerheumatology) could support rheumatologists and general practitioners. Objective The goal of this study was to investigate acceptance and preferences related to the use of telerheumatology care among German rheumatologists and general practitioners. Methods A nationwide, cross-sectional, self-completed, paper-based survey on telerheumatology care was conducted among outpatient rheumatologists and general practitioners during the pre-COVID-19 period. Results A total of 73.3% (349/476) of survey participants rated their knowledge of telemedicine as unsatisfactory, poor, or very poor. The majority of survey participants (358/480, 74.6%) answered that they do not currently use telemedicine, although 62.3% (291/467) would like to. Barriers to the implementation of telemedicine include the purchase of technology equipment (182/292, 62.3%), administration (181/292, 62.0%), and poor reimbursement (156/292, 53.4%). A total of 69.6% (117/168) of the surveyed physicians reckoned that telemedicine could be used in rheumatology. Surveyed physicians would prefer to use telemedicine to communicate directly with other physicians (370/455, 81.3%) than to communicate with patients (213/455, 46.8%). Among treatment phases, 64.4% (291/452) of participants would choose to use telemedicine during follow-up. Half of the participants would choose telecounseling as a specific approach to improve rheumatology care (91/170, 53.5%). Conclusions Before COVID-19 appeared, our results indicated generally low use but high acceptance of the implementation of telerheumatology among physicians. Participants indicated that the lack of a structural framework was a barrier to the effective implementation of telerheumatology. Training courses should be introduced to address the limited knowledge on the part of physicians in the use of telemedicine. More research into telerheumatology is required. This includes large-scale randomized controlled trials, economic analyses, and the exploration of user preferences.

Real-world data are crucial to continuously improve the management of patients with rheumatic and musculoskeletal diseases (RMDs). The German RheumaDatenRhePort (RHADAR) registry encompasses a network of rheumatologists and researchers in Germany providing pseudonymized real-world patient data and allowing timely and continuous improvement in the care of RMD patients. The RHADAR modules allow automated anamnesis and adaptive coordination of appointments regarding individual urgency levels. Further modules focus on the collection and integration of electronic patient-reported outcomes in between consultations. The digital RHADAR modules ultimately allow a patient-centered adaptive approach to integrated medical care starting as early as possible in the disease course. Such a closed-loop system consisting of various modules along the whole patient pathway enables comprehensive and timely patient management in an unprecedented manner.

BackgroundDuring the COVID-19 pandemic telemedicine tools rapidly and widely gained acceptance as indispensable management tools for the continuum of clinical care in rheumatic diseases. They have been adopted in position papers and guidelines for the management of rheumatic diseases in adult patients.ObjectivesEvaluation of the use of video consultation as one form of telemedicine before and during the COVID-19 pandemic and associated lockdowns among Rheumatology physicians in Germany. The survey results are expected to support the optimization and implementation of video consultation (VC) into routine clinical practice in rheumatology, providing long-term benefits for both parties, patients and their treating rheumatologists.MethodsCross-sectional nationwide online survey among German rheumatologists and rheumatologists in training. The survey was promoted by newsletters sent by means of mail and Twitter posts to members of the German Society for Rheumatology (n=1,650) and German Professional Society for Rheumatology (n=527).ResultsReported data refer to 205 participants. The majority of respondents was male (59%), older than 40 years (90%) and specialized in internal medicine/rheumatology (85%).They were divided into two groups: ‘digital users’ (38%) and ‘digital non-users’ (62%). Users employing telemedicine (TM) but never VC were defined as ‘TM-users’ (10%). Those using TM and VC were classified as ‘VC-users’ (27%). ‘Non-users’ negated the use of VC and TM respectively.Knowledge on telemedicine was self-rated as 4 (median on a Likert Scale 1 (very high) to 6 (very low)) with a significant difference between user (VC-user 2.7±1.2, TM-user 3.2±1.1) and non-user (4.4±1.3).The Figure 1 shows a significant increase in the use of VC during the lockdown periods. Even between the lockdown phases, VC use was higher than in the pre-pandemic phase.Figure 1.Grouped patient numbers seen via VC during the pandemic wavesReasons for VC non-use in TM-user and non-user 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%).Based on the experience gained, physicians considered the following clinical situations to be particularly suitable for VC: follow-up visits (VC-user 79%, TM-user 62%, non-user 47%), emergency consultations (VC-user 20%, TM-user 33%, non-user 20%), and patients presenting for the first time (VC-user 11%, TM-user 19%, non-user 8%).Table 1.Evaluation of the VC in comparison to other patient interaction (VC-user) on a Likert Scale with 1 (I agree completely) to 6 (I do not agree at all)VC isMean ± standard deviation (median)… comparable to a face to face meeting (n=52)4.3 ± 1.3 (4.5)… comparable to a telephone consultation (n=51)3.3 ± 1.3 (3.0)… suitable as an additional means of communication with the patient (n=51)2.3 ± 1.5 (2.0)ConclusionDespite the fact that the current pandemic situation, with social distancing and several lockdowns, provides an ideal environment for the implementation of new remote care forms such as VC, their use and acceptance remained below expectations. Given the reported decline in physician face-to-face consultations during the pandemic, these findings are even more concerning. The identified reasons for non-utilization should be addressed by policy makers, payers and medical societies to provide better foundations for future innovative care models.Disclosure of InterestsJoana Reiter: None declared, Gamal Chehab: None declared, Peer Aries: None declared, Felix Muehlensiepen Speakers bureau: Novartis Pharma GmbH, Grant/research support from: Novartis Pharma GmbH & AbbVie Deutschland GmbH & Co. KG, Martin Welcker: None declared, Anna Voormann: None declared, Matthias Schneider Speakers bureau: Astra-Zeneca; Biogen; BMS; Celgene; Chugai; GSK; Janssen-Cilag; Lilly; Pfizer; UCB, Paid instructor for: Lilly, Consultant of: Abbvie; Astra-Zeneca; Boehringer-Ingelheim; GSK; Lilly; Novartis; Pfizer; Protagen; Roche; Sanofi-Aventis; UCB, Grant/research support from: Abbvie; Astra-Zeneca; GSK; UCB, Christof Specker: None declared, Jutta G. Richter: None declared

ZusammenfassungDer Ausbruch der COVID-19-Pandemie geht mit tief greifenden Einschnitten im Alltag und im Berufsleben einher – sowohl gesamtgesellschaftlich als auch speziell im Gesundheitswesen. Im Fokus der Pandemieeindämmung haben sich vielerorts rheumatologische Routineabläufe verändert. Um den entsprechenden Infektionsschutz der Patienten und des medizinischen Personals gewährleisten zu können, wurde hier verstärkt Telemedizin (insbesondere Telefon- und Videosprechstunde) eingesetzt. Weiterhin stehen durch die Digitale-Gesundheitsanwendungen-Verordnung (DiGAV) voraussichtlich in den kommenden Monaten neue, abrechnungsfähige telemedizinische Anwendungsmöglichkeiten wie Apps und Wearables zur Verfügung. Der Artikel soll einen Überblick über telemedizinische Versorgungsmöglichkeiten in der Rheumatologie (mit besonderem Fokus auf die Videosprechstunde) geben. Weiterhin wird Bezug auf die vorhandene Evidenzlage sowie Chancen und Limitation der Telemedizin im Fachgebiet genommen.

Even in the era of modern guidelines, the treatment of rheumatic diseases is only as good as the framework of rheumatological care within which the treatment is carried out. The access to high-quality medical treatment for all patients is therefore essentially decisive for the prognosis of the patients. This article describes the current state of outpatient treatment in rheumatology and demonstrates which quality projects, such as treatment contracts, outpatient specialized medical treatment (ASV), digitalization and training as specialized rheumatological assistant (RFA), have been created in order to ensure the treatment of our patients. Furthermore, standards are defined that can guarantee a contemporary and guideline-conform treatment in outpatient rheumatological units. As an example it is an affirmation of the Professional Association of German Rheumatologists (BDRh) for ensuring optimal care for all rheumatology patients through early or emergency rheumatology clinics, treat to target, appropriate delegation of medical duties and diversification of treatment, thus an assurance of the quality and comprehensive treatment in rheumatology. The important topic of safeguarding the next generation of rheumatologists, which is indispensable for this, is also discussed.Auch im Zeitalter moderner Leitlinien ist die Behandlung rheumatischer Erkrankungen nur so gut wie die rheumatologische Versorgung, in deren Rahmen die Behandlung erfolgt. Der Zugang zu einer qualitativ hochwertigen Medizin für alle Patienten entscheidet daher wesentlich über die Prognose der Patienten. Die vorliegende Arbeit beschreibt den aktuellen Stand der ambulanten Versorgung in der Rheumatologie und zeigt auf, welche Qualitätsprojekte, wie z. B. Versorgungsverträge, ambulante spezialärztliche Versorgung (ASV), Digitalisierung, Ausbildung zur rheumatologischen Fachassistentin (RFA) u. a., geschaffen wurden, um die Versorgung unserer Patienten zu sichern. Darüber hinaus definiert sie Standards, welche in ambulanten rheumatologischen Einheiten eine zeitgemäße und leitliniengerechte Behandlung sicherstellen können. Als Leitbild ist sie ein Bekenntnis des BDRh zur Versorgungssicherheit aller rheumatologischer Patienten durch Früh- bzw. Notfallsprechstunden, Treat-to-Target, angemessener Delegation ärztlicher Leistungen und Verbreiterung der Versorgung, also einer Sicherung der Qualität und umfassenden Versorgung in der Rheumatologie. Auch auf das wichtige Thema der Sicherung des rheumatologischen Nachwuchses, welches dafür unabdingbar ist, wird eingegangen.

ZusammenfassungDie Digitalisierung im Gesundheitswesen ist für die Rheumatologie eine ebenso große Herausforderung wie für andere medizinische Fachgebiete. Die Deutsche Gesellschaft für Rheumatologie e. V. (DGRh) will diesen Prozess aktiv gestalten und davon profitieren. Mit der Gründung der Kommission Digitale Rheumatologie hat sie ein Gremium geschaffen, das die damit verbundenen Aufgaben bearbeitet, die DGRh zu Fragestellungen berät und sich positioniert. Für die DGRh berührt dies verschiedenste Bereiche der Digitalisierung in Medizin und Rheumatologie. Dieses Positionspapier legt die aktuell von der Kommission bearbeiteten Themengebiete, Entwicklungen und identifizierten Aufgaben dar.

Digitalization in the healthcare system is a great challenge for rheumatology as for other medical disciplines. The German Society for Rheumatology (DGRh) wants to actively participate in this process and benefit from it. By founding the commission on digital rheumatology, the DGRh has created a committee that deals with the associated tasks, advises the DGRh on questions and positions associated with digital health. For the DGRh, this affects the most diverse areas of digitalization in medicine and rheumatology. This position paper presents the topics and developments currently handled by the commission and the tasks identified.

Background:There is some evidence that neuropsychiatric changes occur in systemic lupus(1) and rheumatoid arthritis(2). However, little is known regarding a possible disease-related impairment of cognitive abilities in axial spondyloarthritis (axSpA).Objectives:To evaluate patients with axSpA regarding cognitive impairments.Methods:Patients with axSpA attending two rheumatology practices were routinely evaluated by rheumatologists and underwent a computer-based memory and attention test (MAT) (3, 4) with subscale scores ranging from 0 (worst) to 15 (best). The results of short-term memory and working memory were compared to an age-, sex- and education-matched control group of healthy subjects. Descriptive results are presented as median (IQR) for interval data and n (%) for nominal data if not stated otherwise. Two-tailed Wilcoxon signed-rank tests including Bonferroni-Holm adjustment for multiple tests were conducted to investigate the magnitude of potential differences in cognitive abilities.Results:101 consecutive patients were tested (Table 1). After multiple testing adjustment for two subscales, Wilcoxon signed-rank tests returned significant findings for working memory (V = 539.5, p = 0.006, |r| = 0.204) but not for short-term memory (V = 1075, p = 0.351, |r| = 0.078). Regarding the scales’ anchors, descriptive results on pairwise differences suggested axSpA patients to have working memory scores that are on average 10.7% lower compared to control participants (mean Δ= -1.64, SD Δ= 5.95).Table 1.Patients and disease characteristicsn%MeanSDMedian25% Quantile75% QuantileAge10110051.111.6524260Age (female)4847.552.611.75444.561Age (male)5352.549.811.5514157< 13 years formal education4746.5≥ 13 years formal education5453.5HLA B27 positive n/N64/9263.4Disease duration (years)10110013.711.712421Disease duration (female, years)4847.511.69.99417.2Disease duration (male, years)5352.515.512.915523BASDAI9291.13.71.73.82.45BASFI9190.132.42.31.24.5BASMI7574.31.92.3103ASDAS98972.30.82.31.82.8Conclusion:The MAT computerized testing is a feasible test and was well accepted by patients. Results regarding working memory suggest that cognitive abilities needed to accomplish everyday tasks may be impaired in axSpA patients. Further work is needed to characterise possible causes of or associations with this cognitive impairment.References:[1]Zabala A, Salgueiro M, Saez-Atxukarro O, Ballesteros J, Ruiz-Irastorza G, Segarra R. Cognitive Impairment in Patients With Neuropsychiatric and Non-neuropsychiatric Systemic Lupus Erythematosus: A Systematic Review and Meta-analysis. J Int Neuropsychol Soc. 2018:1-11.[2]Vitturi BK, Nascimento BAC, Alves BR, de Campos FSC, Torigoe DY. Cognitive impairment in patients with rheumatoid arthritis. J Clin Neurosci. 2019;69:81-7.[3]Adler G, Bektas M, Feger M, Lembach Y. [Computer-based assessment of memory and attention: evaluation of the memory and attention test (MAT)]. Psychiatr Prax. 2012;39(2):79-83.[4]Adler G, Lembach Y. Memory and selective attention in multiple sclerosis: cross-sectional computer-based assessment in a large outpatient sample. Eur Arch Psychiatry Clin Neurosci. 2015;265(5):439-43.Acknowledgements:This study was funded by the RHADAR GbR (A Network of Rheumatologists), Bahnhofstr. 32, 82152 Planegg, Germany. RHADAR GbR has received a grant for this study from Novartis Pharma GmbH.Disclosure of Interests:Stefan Kleinert Consultant of: Novartis, Abbvie, Grant/research support from: Novartis, Praxedis Rapp: None declared., Florian Schuch Speakers bureau: Novartis, Abbvie, Gilead, Consultant of: Novartis, Abbvie, Gilead, Monika Ronneberger: None declared., Joerg Wendler Speakers bureau: Roche, Pharma, JanssenCilag, Novartis, Abbvie, Consultant of: JanssenCilag, Patrizia Sternad: None declared., Florian Popp: None declared., Peter Bartz-Bazzanella: None declared., Cay-Benedict von der Decken: None declared., Kirsten Karberg Speakers bureau: Roche, Sanofi, Abbvie, Lilly, Georg Gauler Speakers bureau: Abbvie, Gilead, Novartis, Lilly, Consultant of: Lilly, Gilead, Abbvie, Patrick Wurth Speakers bureau: Abbvie, Lilly, UCB, Medac, Susanna Spaethling-Mestekemper Speakers bureau: Abbvie, BMS, Celgene, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Christoph Kuhn: None declared., Matthias Englbrecht Speakers bureau: AbbVie, Chugai, Eli Lilly, Novartis, Roche, Sanofi, Mundipharma, Paid instructor for: AbbVie, Chugai, Roche, Consultant of: AbbVie, Novartis, Roche, Sanofi, Grant/research support from: Roche, Chugai, Wolfgang Vorbrüggen: None declared., Georg Adler: None declared., Martin Welcker Speakers bureau: Abbvie, Actelion, Amgen, Biogen,BMS, Berlin Chemie, Celgene, Galapagos, Gilead, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Roche, Sanofi, SOBI, UCB, Grant/research support from: Novartis, Abbvie.

Background:Although seronegative RA patients often present with substantial disease burden [1], patients are underrepresented in research cohorts or clinical trials. Consequently, less knowledge about this subgroup has been accumulated.Objectives:To describe outcome of seronegative vs. seropositive RA patients treated with sarilumab in regular care in Germany.Methods:The prospective, observational, 24-month single-arm PROSARA study (SARILL08661) is currently running in Germany at 96 sites, aiming to enroll up to 750 RA patients treated with sarilumab. RA patients are prospectively selected at physician’s discretion according to label, and medical history is documented before treatment. This interim analysis included patients with data available up to 24 months. Here we focus on sustained treatment response after 6 and 12 months, respectively. Patients were stratified according to serostatus (RF- AND ACPA- as seronegative or RF+ AND/OR ACPA+ as seropositive). All analyses are descriptive only.Results:To date 473 patients were included in the study, of which 22.2% (n=105) were seronegative and 59.0% (n=279) were seropositive (Table 1). For 89 patients (18.8%) serostatus was not specified.Table 1.Baseline data regarding patient characteristics, prior treatment and disease activityseronegativeseropositivepatients [n] (%)105(22.2)279(59.0)patient characteristicsSex female [n] (%)81(77.1)207(74.2)Age mean [years] (SD)56.6(12.5)59.6(10.9)BMI mean (SD) [kg/m2]29.2(6.7)28(6.0)Smoking history current/former [%]22.1/11.525.5/20.4Time since diagnosis of RA mean [years] (SD)7.9(7.6)11.5(9.9)prior RA treatmentcsDMARD [n] (%)102(97.1)273(97.8)bDMARD (TNFi) [n] (%)54(51.4)167(59.9)bDMARD (non-TNFi) [n] (%)32(30.5)83(29.7)tsDMARD (JAKi) [n] (%)25(23.8)57(20.4)disease activityCRP [mg/l] (SD)12.9(30.9)14.2(31.0)ESR [mm/h] (SD)23.7(20.5)25.3(22.4)SJC mean (SD)5.3(5.5)4.6(4.8)TJC mean (SD)10.2(8.2)7.2(6.6)HAQ-DI mean (SD)1.4(0.7)1.2(0.7)DAS28-ESR mean (SD)5.0(1.5)4.6(1.5)CDAI mean (SD)27.7(14.7)23.0(12.9)Fatigue [VAS] (SD)64.0(25.5)51.1(28.1)The mean time since diagnosis of RA was shorter in seronegative than in seropositive patients (7.9±7.6 years vs. 11.5±9.9 years) (Table 1).At baseline, CDAI score was 27.7±14.7 (n=104) and 23.0±12.9 (n=272) in seronegative and seropositive patients, respectively. After 12 months of sarilumab treatment, CDAI improved to 15.6±12.3 (n=38) and 9.1±8.7 (n=101) in seronegative and seropositive, respectively, for patients with post-baseline data available. At that time, remission/low disease activity according to CDAI was reached by 5.3% (n=2/38) / 39.5% (n=15/38) of seronegative patients, respectively and by 26.7% (n=27/101) / 68.3% (n=69/101) of seropositive patients, respectively (Fig. 1A, B).Figure 1.CDAI (A, B) and HAQ-DI (C) outcomes in seronegative and seropositive patientsPhysical function, assessed by HAQ-DI, was slightly more impaired in seronegative patients (1.4±0.7) than in seropositive patients (1.2±0.7) at baseline. HAQ-DI improved over 12 months to 0.9±0.7 in seropositive patients (n=90) but showed no change in seronegative patients (1.4±0.7; n=37) (Fig. 1C).Safety was consistent with the anticipated profile of IL-6-R-inhibition and no new safety signals occurred. Adverse events and serious adverse events were described in 61.7% and 12.8% of seronegative patients, respectively and in 55.2% and 13.7% of seropositive patients, respectively.Conclusion:Sarilumab treatment ameliorated CDAI in both seronegative (ΔCDAI -17.0±16.5) and seropositive (ΔCDAI -15.4±14.3) patients to the same extent over the course of 12 months, with a higher remission rate in seropositive patients. Functional capacity improved meaningfully in the seropositive cohort but had no significant impact in seronegative patients. The safety profile was consistent with data reported from controlled clinical trials.References:[1]Choi S-T et al. (2018) PLoS ONE 13(4): e0195550.Acknowledgements:We thank Cornelia Kühne (Haldensleben) for substantial contribution to patient recruitment in PROSARA.Disclosure of Interests:Harald Burkhardt Speakers bureau: Sanofi, Pfizer, Roche, Abb- vie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scribb, Janssen, and Novartis, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Grant/research support from: Pfizer, Roche, Abbvie, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, Peer-Malte Aries Speakers bureau: Abbvie, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Consultant of: Abbvie, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Silke Zinke: None declared, Klaus Krueger Speakers bureau: Sanofi, Jonas Ahlers Employee of: Sanofi, Rolf Hecker Employee of: Sanofi, Inka Albrecht Employee of: Sanofi, Stefanie Kalus Consultant of: Sanofi, Oliver Bley Employee of: Sanofi, Patrizia Sternad: None declared, Ann-Dörthe Holst: None declared, Niklas Thomas Baerlecken: None declared, Thilo Klopsch: None declared, Martin Welcker Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Consultant of: Abbvie, Actelion, Aescu, Amgen, Cel- gene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Eugen Feist Speakers bureau: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Consultant of: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi

Polyglandular autoimmune syndromes encompass several endocrine and nonendocrine autoimmune disorders with variable onset and phenotype. Rheumatoid and gastroenterological symptoms in patients with autoimmune polyglandular syndromes are suggestive of additional rheumatoid gastrointestinal and hepatological autoimmune diseases. Autoimmune gastritis, celiac disease, autoimmune hepatitis, rheumatoid arthritis, Sjogren syndrome, and systemic Lupus erythematodus are of particular clinical relevance. In addition, unspecific rheumatoid and gastrointestinal attendant symptoms of the existing autoimmune endocrinopathy must be considered. Furthermore, certain disorders of polyglandular autoimmune syndromes, e. g., type 1 diabetes are frequently associated with particular gastrointestinal diseases such as small bowel bacterial overgrowth. An optimal patient-centered care of subjects with autoimmune diseases requires a comprehensive differential diagnostic work up and emphasizes the importance of an interdisciplinary cooperation.

Background:Inflammatory rheumatic disorders are very complex and require high medical resources. However, there is a shortage of care for these patients, which results in suboptimal reach of therapy objectives. Nevertheless, these very objectives need to be pursued quickly to prevent permanent joint damage. In order to ensure adequate care, multidisciplinary teams which include clinical nurse specialists are required. These clinical nurse specialists play an important role in improving standard-of-care in addition to the rheumatologist. The current standard of care ensures that essential medical provision remains intact, however, psychological, social, rehabilitative and educational needs are often skipped due to time constraints. While studies from e.g. the UK and Denmark have already supported the non-inferiority of nurse-led care (NLC)1, no such studies have yet been published in Germany.Objectives:To demonstrate the non-inferiority of NLC to the current standard-of-care, rheumatologist-led care (RLC), for patients with seropositive rheumatoid arthritis (RA) with induction, escalation or change of therapy regarding disease activity as well as different patient reported outcomes (PROs).Methods:This trial was conducted as a prospective multi-centered RCT with a non-inferiority design over the course of 12 months. Based on power calculations, 236 adults with RA were included in the study and randomized to either NLC or RLC. The primary outcome measure is disease activity (DAS28), assessed at baseline (T0), 6 weeks (T1), 3,6, 9, and 12 months (T3, T6, T9, T12). Secondary measures are health related quality of life (RAID), functionality (FFbH) and depression (PHQ9).Results:There are no significant differences between intervention group (IG) (n=117) and control group (CG) (n=119) at baseline. The mean age of the IG is 58.80 years (SD=12.09) and of the CG 58.34 years (SD=11.72). 72.4% of the IG and 78.1% of the CG are female. The mean duration of symptoms was 147 months (SD=144.63) for the IG and 116 months (108.89) for the CG. The mean DAS28 for the IG is 4.36 (SD=1.24) and 4.51 (SD=1.24) for the CG.A mixed one-way repeated measures ANOVA showed that the DAS28 improves significantly over time, Huyn-FeldtF(4.42, 751.72) = 105.701,p< .001, partialη2= 0.383, but the interaction of the DAS28 and the randomization is not significant, Huyn-FeldtF(4.42, 751.72) = 1.464,p= 0.260, partialη2= 0.009. No main effect for randomization was found, meaning that the IG and CG did not differ significantly,F(1, 170) = 1.005,p= 0.317, partialη2= 0.006.The Mann-Whitney-Test showed that the change of the secondary outcomes does not depend on the randomization FFbHU= 4978.50,Z= -.755,p=.450. RAIDU= 5121.00,Z= -.539,p=.590. PHQ9U= 4800.50,Z= -1.281,p=.200. The secondary outcomes improve significantly over time, as shown by a Wilcoxon Signed Rank test for the FFbHZ= -5.589,p< .001, the RAIdZ= -9.884,p< .001 and the PHQ9Z= -7.960,p< .001.Conclusion:The results support the non-inferiority of NLC in the management of RA regarding the primary and secondary outcome measures and provide first evidence that NLC could improve care and help carry the doctors’ workflow.Figure 1.Figure 2.References:[1]de Thurah A, Esbensen BA, Roelsgaard IK, et al. Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis. RMD Open 2017;3:e000481.Disclosure of Interests:Juliana R Hoeper: None declared, Georg Gauler Consultant of: Abbvie, Lilly, MSD, Speakers bureau: Abbvie, Celgene, Novartis, Sanofi,, Dirk Meyer-Olson Grant/research support from: Novartis, Sandoz Hexal, Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Chugai, Lilly, Mylan, Novartis, Sandoz Hexal, Sanofi, Speakers bureau: Abbvie, Bristol Myers Squibb, Chugai, Lilly, Novartis, Pfizer, Sandoz Hexal, Sanofi, Karin Rockwitz Consultant of: Janssen Cilag, Speakers bureau: Janssen Cilag, Patricia Steffens-Korbanka Consultant of: Abbvie, Chugai, Novartis, Sanofi, Mylan, Lilly, Speakers bureau: Abbvie, Chugai, Novartis, Sanofi, Lilly, Carsten Stille: None declared, Jochen Walter Consultant of: Pfizer, Speakers bureau: AbbVie, Frauenhofer Institut, Gilead, Janssen-Cilag, Medac, Novartis, Pfizer, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Joerg Wendler Consultant of: Janssen, AbbVie, Sanofi, Speakers bureau: Roche, Chugai, Janssen, AbbVie, Novartis, Jan Zeidler: None declared, Kirsten Hoeper Consultant of: AbbVie, Celgene,, Speakers bureau: Abbvie, Chugai, Novartis, Lilly, Celgene, Sandoz Hexal

ObjectiveTo determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.MethodsA multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.ResultsDemographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (pConclusionThis study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.Trial registration numberDRKS00013055.

Background:The number of rheumatologists in Germany does not cover the minimum medical need [1]. This implies long journeys and waiting periods for patients in the context of rheumatologists’ consultations. International studies suggest that telemedicine could resolve these issues and support health care professionals in rheumatologic care [2, 3]. So far, comprehensive sustainable approaches are still pending in Germany. By addressing the potential users, TeleRheumaBB investigates whether and how telemedicine can support rheumatologic care in Germany. The study is realized from Oct. 2017 until Jun. 2020.Objectives:The objectives of the study are to evaluate the acceptance and willingness of patients and medical practitioners (MP) to implement telemedicine into rheumatological care as well as to understand how telemedical approaches should be designed to be applied in daily practice.Methods:The study design contains a mixed-methods approach, which combines qualitative and quantitative data. In the qualitative part of the study 28 in-depth interviews and 3 focus groups involving patients, rheumatologists, general practitioners and stakeholders were conducted. The quantitative part of the study comprised a questionnaire survey with rheumatologists (n=48) and referrers (n=444) and a second questionnaire survey with patients (n=734).Results:Qualitative Data:The term “telemedicine” is filled with different meanings. Motives to implement telemedicine into daily practice are patient guidance, information, substantial time savings, desire of a modern practice etc. Reported risks of telemedicine are adverse impacts on the doctor-patient-relationship as well as low benefit with high effort.Quantitative Data:62% of the MPs’ surveyed answered that they would like to use telemedical approaches. 81% of the participants supported doctor-doctor communication via telemedicine. Only 47% of the MPs’ surveyed supported doctor-patients communication via telemedicine. MPs’ state that there are barriers which prevent them from implementing telemedicine (89%). These are among others acquisition of technology, administrative expenses and poor remuneration.53% of the patients surveyed stated that they had heard the term telemedicine before. 30% of the participants answered that they would like to try out telemedicine. 38% answered with “no” and 29% with “do not know”. Further results from the patient survey will be available in June 2020.Conclusion:The study results show high acceptance rates of telemedicine regarding doctor-doctor communication. Doctor-patient communication via telemedicine is less accepted. However, MPs’ are reporting obstacles preventing the implementation of telemedicine in rheumatology. In order to implement telemedicine in rheumatological care comprehensively, adequate conditions must be established in the German health care system.References:[1]Zink A, Braun J, Gromnica-Ihle E, Krause D, Lakomek HJ, Mau W, et al. Memorandum der Deutschen Gesellschaft für Rheumatologie zur Versorgungsqualität in der Rheumatologie – Update 2016. Zeitschrift für Rheumatologie. 2017;76(3):195-207.[2]McDougall J, Ferruci E, Glover J, Fraenkel L (2017) Telerheumatologiy: A Systematic Review. Arthritis Care Res (Hoboken); 69(10):1546-1557.[3]Piga M, Cangemi I, Mathieu A, Cauli A (2017) Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda. Semin Arthritis Rheum 47(1):121-128.Disclosure of Interests:Felix Muehlensiepen Grant/research support from: Novartis, Wenke Marquardt Grant/research support from: Novartis, Johannes Knitza Grant/research support from: Research Grant: Novartis, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB

Background:Symptom checkers (SC) promise to reduce diagnostic delay, misdiagnosis and effectively guide patients through healthcare systems. They are increasingly used, however little evidence exists about their real-life effectiveness.Objectives:The aim of this study was to evaluate the diagnostic accuracy, usage time, usability and perceived usefulness of two promising SC, ADA (www.ada.com) and Rheport (www.rheport.de). Furthermore, symptom duration and previous symptom checking was recorded.Methods:Cross-sectional interim clinical data from the first of three recruiting centers from the prospective, real-world, multicenter bETTeR-study (DKRS DRKS00017642) was used. Patients newly presenting to a secondary rheumatology outpatient clinic between September and December 2019 completed the ADA and Rheport SC. The time and answers were recorded and compared to the patient’s actual diagnosis. ADA provides up to 5 disease suggestions, Rheport calculates a risk score for rheumatic musculoskeletal diseases (RMDs) (≥1=RMD). For both SC the sensitivity, specificity was calculated regarding RMDs. Furthermore, patients completed a survey evaluating the SC usability using the system usability scale (SUS), perceived usefulness, previous symptom checking and symptom duration.Results:Of the 129 consecutive patients approached, 97 agreed to participate. 38% (37/97) of the presenting patients presented with an RMD (Figure 1). Mean symptom duration was 146 weeks and a mean number of 10 physician contacts occurred previously, to evaluate current symptoms. 56% (54/96) had previously checked their symptoms on the internet using search engines, spending a mean of 6 hours. Rheport showed a sensitivity of 49% (18/37) and specificity of 58% (35/60) concerning RMDs. ADA’s top 1 and top 5 disease suggestions concerning RMD showed a sensitivity of 43% (16/37) and 54% (20/37) and a specificity of 58% (35/60) and 52% (31/60), respectively. ADA listed the correct diagnosis of the patients with RMDs first or within the first 5 disease suggestions in 19% (7/37) and 30% (11/37), respectively. The average perceived usefulness for checking symptoms using ADA, internet search engines and Rheport was 3.0, 3.5 and 3.1 on a visual analog scale from 1-5 (5=very useful). 61% (59/96) and 64% (61/96) would recommend using ADA and Rheport, respectively. The mean SUS score of ADA and Rheport was 72/100 and 73/100. The mean usage time for ADA and Rheport was 8 and 9 minutes, respectively.Conclusion:This is the first prospective, real-world, multicenter study evaluating the diagnostic accuracy and other features of two currently used SC in rheumatology. These interim results suggest that diagnostic accuracy is limited, however SC are well accepted among patients and in some cases, correct diagnosis can be provided out of the pocket within few minutes, saving valuable time.Figure:Acknowledgments:This study was supported by an unrestricted research grant from Novartis.Disclosure of Interests:Johannes Knitza Grant/research support from: Research Grant: Novartis, Jacob Mohn: None declared, Christina Bergmann: None declared, Eleni Kampylafka Speakers bureau: Novartis, BMS, Janssen, Melanie Hagen: None declared, Daniela Bohr: None declared, Elizabeth Araujo Speakers bureau: Novartis, Lilly, Abbott, Matthias Englbrecht Grant/research support from: Roche Pharma, Chugai Pharma Europe, Consultant of: AbbVie, Roche Pharma, RheumaDatenRhePort GbR, Speakers bureau: AbbVie, Celgene, Chugai Pharma Europe, Lilly, Mundipharma, Novartis, Pfizer, Roche Pharma, UCB, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Timo Meinderink: None declared, Wolfgang Vorbrüggen: None declared, Cay-Benedict von der Decken: None declared, Stefan Kleinert Shareholder of: Morphosys, Grant/research support from: Novartis, Consultant of: Novartis, Speakers bureau: Abbvie, Novartis, Celgene, Roche, Chugai, Janssen, Andreas Ramming Grant/research support from: Pfizer, Novartis, Consultant of: Boehringer Ingelheim, Novartis, Gilead, Pfizer, Speakers bureau: Boehringer Ingelheim, Roche, Janssen, Jörg Distler Grant/research support from: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Paid instructor for: Boehringer Ingelheim, Speakers bureau: Boehringer Ingelheim, Peter Bartz-Bazzanella: None declared, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB

Background:Blockade of IL-6 signaling by sarilumab has been demonstrated to be an effective treatment approach for rheumatoid arthritis. Due to strict inclusion and exclusion criteria, randomized controlled trials may not represent the heterogeneous RA patient population encountered in regular care.Objectives:The current study investigated the safety and effectiveness of sarilumab in the treatment of RA in regular care in Germany.Methods:The prospective, observational, single-arm 24-months PROSARA study (SARILL08661) is currently running in Germany at 79 sites, aiming to include up to 750 RA patients treated with sarilumab. RA patients are selected at physician discretion and treated according to the label. Study objectives include the documentation of safety and various effectiveness outcomes. This interim analysis included patients with data available up to 12 weeks. All analyses are descriptive only.Results:To date 348 patients were included in the study; of which 265 patients had post-baseline data. The mean age of the patients analyzed was 58.6 years (24-83); 76.3% are female. The mean disease duration was 10.3 years; comorbidities were present in 80.7% of patients. At baseline, 32.5% were biologic naïve. Most common pretreatment with b/ts DMARDs included TNF-inhibitors (TNFi, 56.2%), non-TNFi biologics (29.1%) or JAK-inhibitors (JAKi, 17.4%). At baseline, 49% received sarilumab as monotherapy and 29% in combination with conventional DMARDs (not specified for 22%). After 12 weeks of treatment with sarilumab, the mean DAS28-ESR decreased from 5.0±1.46 to 3.0±1.44 and CDAI from 26.7±13.79 to 13.6±11.4, respectively. DAS28-ESR remission/ low disease activity was achieved in 42.8% [n=77/180 patients with valid data on this parameter]/ 59.4% [n=107/180] of patients; 13.6% [n=28/206] and 49% [n=101/206] of patients reached CDAI remission and low disease activity. Boolean remission was observed in 9.5% [n=19/201] of patients at week 12. HAQ-DI improved from 1.3 at baseline to 1.1 at week 12 (n=195). The mean CDAI improvement was similar for autoantibody-positive (RF and/or ACPA; CDAI -12.5 at week 12) compared to -negative patients (CDAI -15.4 at week 12). Patients switching from JAKi to sarilumab (n=32), were more severely affected, had longer disease duration and received more prior treatments than patients switched from another compound. Of note, similar efficacy was observed among patients that switched from JAKi to sarilumab vs patients switched from other DMARDs; disease activity outcome measures including DAS28, CDAI, TJC, SJC and global assessments improved consistently (Figure 1).Safety was consistent with the anticipated profile of IL-6-R-inhibition and no new safety signals occurred. Adverse events and serious adverse events were described in 33.9% and 6.3% of patients, respectively.Conclusion:Sarilumab administered in regular care demonstrated rapid and clinically meaningful improvement in a general RA patient population including patients switching from JAKi. The safety profile was consistent with data reported from controlled clinical trials.Disclosure of Interests:Eugen Feist Consultant of: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Speakers bureau: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Peer-Malte Aries Consultant of: Sanofi, Speakers bureau: Sanofi, Silke Zinke: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Inka Albrecht Employee of: Sanofi, Oliver Bley Employee of: Sanofi, Michael Obermeier: None declared, Patrizia Sternad: None declared, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Cornelia Kühne Grant/research support from: Novartis, Amgen, Roche/Chugai, Pfizer, Celgene, AbbVie, Sanofi, Ann-Dörthe Holst: None declared, Niklas Thomas Baerlecken: None declared, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

Background Medical Applications have the potential to support physicians and patients to document the course of the disease and optimize therapies. We describe the linkage and integration of patient reported outcomes (PROs) into existing medical office software and rheumatologic documentation systems by means of the digital applications RheumaLive and AxSpALive. RheumaLive is certified as medical product class I, and certification for AxSpALive is in preparation. Methods RheumaLive and AxSpALive are applications that can be downloaded free of charge from the common app-stores (Android, Apple) and installed on mobile devices (smartphones, tablets). A freeware version for PCs is also available (Windows- und Mac OS X-Version). A diary functionality allows to document the medication uptake (partially filed, memory-functionality for medication uptake available), validated scores like VAS, SJC, morning stiffness, FFBh (comparable to HAQ), BASDAI, RADAI, etc. and days of sick leave (+/- related to the rheumatic disease). All App-versions are password-protected, which is provided by the treating rheumatologist (relationship patient-physician). The patient reported outcomes are stored locally on the respective device. For the subsequent visit, they can be printed or sent encrypted to the treating physician via internet in a prespecified interval. A specific software allows to integrate the data into the existing medical office software. In daily practise, data entered by patients into RheumaLive can be screened and compared with collected clinical data and laboratory measures, because of it9s certification as medical product. In case of an increasing disease activity the patient can be rapidly contacted and medication can be modified, if necessary. Regular F2F-appointments remain integral part of the medical care, even in case of good controlled disease activity. But in case of F2F-appointments, PROs can be delivered by patients, saving time and resources. The PROs can be made available to rheumatologic documentation systems like RheumaDok via predefined interfaces. Results In a first pilot phase 54 patients in 4 rheumatologic specialised practices were documented. In the next phase the number of patients and participating practices/centres shall be increased. Further studies are necessary to show if the integration of PROs which are collected via electronical application can lead to an improvement of rheumatologic diseases. Conclusions The integration of PROs collected with RheumaLive and AxSpALive into existing rheumalogic documentation systems allows a close monitoring of disease courses and therapies according to the “tight control” principle. Acknowledgements RheumaLive and AxSpALive werde developed by Starhealth GmbH on behalf of UCB Pharma GmbH. Disclosure of Interest M. Feuchtenberger Speakers bureau: UCB, S. Kleinert Speakers bureau: UCB, F. Schuch Speakers bureau: UCB, S. Spahtling-Mestekemper Speakers bureau: UCB, C. Kuhn: None declared, M. Welcker Speakers bureau: UCB

Background The datanetwork Rheuma 4.0 (DNR_4.0) is a consortium of 5 internistic-rheumatologic specialized practices. Patient data that were collected routinely will be pooled pseudonymized (e.g. via RheumaDok) and will be made available to answer numerous healthcare- and scientific research questions. Methods The participating centres document the following data in specific rheumatologic data documentation systems (RheumaDok, Emil, DocuMed.rh). These data will be routed automatically to the data base of the DNR_4.0 via a prespecified interface and can be used for certain research areas: Diagnosis (by rheumatologist (R), anamnesis (R), medication (R), morning stiffness (R, patient (P)), scores like RADAI (R, P), DAS28 (R), BASDAI (P), BASFI (P), quality of life (R, P). Also prespecified laboratory measures (R) like ESR, CRP etc. can be collected automatically. Patient reported Outcomes (PROs) that were entered via mobile applications like RheumaLive and AxSpALive can be collected in certain intervalls and be sent encrypted into the medical office data base. The data entered by patients will be screened by the rheumatologist or nurse and will be stored in the underlying data base. Clinical data that are collected during regular F2F-appointments will be stored together with the PROs according to a specific period of time. Results The datanetwork Rheuma 4.0 (DNR_4.0) is an association of 5 internistic-rheumatologic specialized practices. By the automated documentation of PROs (patient) and medical measures (rheumatologist) in an underlying data base, scientific and health care real worl data can be collected without extra workload or time requirements. These data are specific and different from data collected by other centres. In principal, the extension of the group to increase the number of participating centres is easily possible because the interface is an “open system”. This allows to build an automised collecting, big and representative data base. Now pooled data sets of 18.000 patients are available in the data base. In a first step, quality and the completeness of the existing data sets will be evaluated and the daily documentation routines will be described. Anonymised statistical analysis of the pooled data sets of the rheumatologic centres will allow to gain knowledge in respect to health care research of the own working group and external interested parties like research groups, sick funds, insurance companies and companies. Conclusions The german biologic registry Rabbit and the “Core documentation” data base deliver valid data about the safety and efficacy of rheumatologic medication. The datanetwork Rheuma 4.0 will make a valuable contribution – especially in conjunction with apps of patient9s self management like RheumaLive and AxSpALive – to health care research, therapeutic strategies and clinical questions from daily practice. Acknowledgements RheumaLive and AxSpALive werde developed by Starhealth GmbH on behalf of UCB Pharma GmbH. Disclosure of Interest S. Kleinert Speakers bureau: UCB, F. Schuch Speakers bureau: UCB, S. Spathling-Mestekemper Speakers bureau: UCB, M. Feuchtenberger Speakers bureau: UCB, C. Kuhn: None declared, M. Welcker Speakers bureau: UCB

Ein 55-jahriger Patient mit pulmonaler Sarkoidose prasentierte sich mit einer neu aufgetretenen Aphasie, ausgelost durch zerebrale Rundherde. Unter dem Verdacht einer Spondyloarthritis war zuvor – nach Ausschluss einer Tuberkulose – eine TNF-α-Blocker-Therapie eingeleitet worden. Die weiterfuhrende Diagnostik ergab eine Lungentuberkulose mit zerebralen Tuberkulomen, reaktiviert durch das Biologikum auf dem Boden einer vorbestehenden Sarkoidose mit pulmonaler Beteiligung und Sakroiliitis. Trotz eines negativen Tuberkulosescreenings muss differenzialdiagnostisch an atypische Tuberkulosemanifestationen unter TNF-α-Blocker-Therapie gedacht werden.

This article reports the case of a 55-year-old man who presented with aphasia caused by intracerebral lesions and had a history of pulmonary sarcoidosis. Due to nonsteroidal anti-inflammatory drug-resistant spondyloarthritis TNF-alpha inhibitor treatment was started after a negative tuberculosis screening. Subsequently the patient developed pulmonary tuberculosis and cerebral tuberculoma reactivated by the TNF-alpha inhibitor therapy accompanied by pulmonary sarcoidosis with sacroiliitis and oligoarthritis. This case report emphasises the risk of atypical tuberculosis infections under TNF-alpha inhibitors despite negative results of tuberculosis screening.

A case of digital gangrene in a patient with systemic lupus erythematosus without secondary anti-phospholipid syndrome is reported. The acute onset of the necrotizing acrovasculitis occurred without a history of Raynaud's phenomenon. Preceding symptoms of the systemic lupus erythematosus were arthritis, photosensitivity, alopecia and anorexia. Despite the seriousness of the acute episode the patient achieved an excellent outcome.

Background In may 1999 a 57 year old woman presented progressive symmetric arthritis of the hand, fingers and forefoot over a period of more than 6 weeks. Laboratory testing revealed an elevated sedimentation rate, increased C reactive protein levels and secondary signs of inflammation (elevated ferritine, alpha-2-fraction in the serum electrophoreses, etc.). The radiograph showed juxtaarticular osteoporosis without further signs of joint destruction. The x-ray of the chest was normal (performed for reasons of nicotin consumption over years and the intention of methotrexate therapy) without signs of malignancy. Initially the patient was treated as an outpatient. Although the initiated DMARD-therapy with methotrexate was well tolerated at a dose of 15 mg orally per week she was finally admitted to the hospital in December 1999 for reasons of further deteriorating of the arthritis and the general feeling. Symmetrical arthritis and elevated sedimentation rate revealed continuous inflammation. An x-ray control of the hand and feet showed a fine periostal hyperostosis suspective for “osteoarthropathy hypertrophiante pneumonique Pierre Marie Bamberger”. The x-ray of the chest was suspective for a malignant process of the lung, a diagnose that was confirmed by computer tomography. Histological examination revealed an adeno carcinoma of the lung. Consecutive palliative chemotherapy led to improvement of arthritis. Objectives ./. Methods ./. Results ./. Conclusion This is a case of malignant lung disease with the rare initial symptom of symmetric progressive arthritis and periostal hyperostosis, improving after chemotherapy.

Background Juxtaarticular osteoporosis is an early sign of inflammation in conventional radigraphy in Rheumatoid arthritis. Objectives It should be shown weather juxtaarticular osteoporosis can be analysed by dual x-ray adsorption (DXA) and if there is a correlation to general bone loss in inflammatory joint disease. Methods 20 patients with Rheumatoid arthritis and 10 patients with Fibromyalgia were analysed by DXA (Hologic 2000). Regions of interest (ROIs) were the spine, the hip, the forearm and juxtaarticular subregions of the fingers. Results Patients with Rheumatoid arthritis showed decreased bone densities of the spine, the hip, the forearm and the juxtaarticular joint region of the fingers. This was the case in late and early stages (Larsen 0–1) of the disease. The relative loss of juxtaarticular bone density was in these cases comparable to the relative loss of bone density of the spine and the hip. Conclusion DXA revealed loss of juxtaarticular bone density in patients suffering from Rheumatoid arthritis. This could be a method for objective estimation of juxtaarticular osteoporosis in the early course of Rheumatoid arthritis. Infection related rheumatic diseases

Background In february 1999 a 39 year old woman developed progressive swelling of the hands, arthralgias, Raynaud9s phenomenon, dyspepsia and reduced physical strength. For this reasons, positive ANA9s (no anti topoisomerase I antibodies, pathologic oesophagus manometry and clinical signs of lung involvement including typical skin lesions (thickening, necrosis, erythema anulare, etc.) systemic sceloris was diagnosed. In the course of disease DMARDs such as penicillamin and cyclophosphamide showed no efficacy over a period of 18 months. Relatively high doses of methylprednisolone (up to 250 mg/d; not below 20 mg/d) were needed to reduce the clinical signs of the disease. In december 2000 anti-TNF-alpha-antibody therapy (infliximad) was started in a dosage of about 5 mg per kg body weight. After four perfusions (weeks 0, 2, 6, 10) clinical improvement (healing of skin necrosis, reduced dyspepsia and dyspnoe, increased general feeling, reduced VAS from 80 to 20, increased opening of the mouth, increased movement of the hands and fingers) permitted a slow reduction of the daily steroid dose. Objectives ./. Methods ./. Results ./. Conclusion This is a case with positive therapeutic onset of infliximab (remicade) in a case with systemic sclerosis.

Immunoadsorption (IMAD) is a particle extracorporeal therapy in treatment of various autoimmune diseases which differs from plasmapheresis. In the case presented here IMAD was helpful in the therapy of an acute renal failure due to an antiglomerular basement membrane disease. IMAD resulted in a quick recovery and stabilisation of the renal function. In addition to IMAD, the patient was treated with steroids, an immunosuppressive therapy was started immediately after IMAD. Considering the course of this patient's disease, we are convicted that IMAD was a major factor in the therapeutic success. IMAD was well tolerated by the patient, no side effects were seen.

Immunoadsorption is an improvement of extracorporeal therapy which differs from plasmapheresis. After plasma perfusion on a special adsorption filter the patient's plasma is reinfused. Meanwhile more than 270 immunoadsorptions have been performed. 7 patients with SLE and glomerulonephritis as well as 3 patients suffering from Wegener's vasculitis and glomerulonephritis had been treated with combined immunoadsorption and IVIG therapy. After three sessions of immunoadsorption (2-3 1 plasma filtrate) the patients received 10 g 7S-immunoglobulin infusions on three consecutive days. Patients with SLE and end-stage kidney involvement (2 patients) did not show any benefit by the above mentioned treatment regimen. Patients with Wegener's vasculitis and glomerulonephritis showed no significant improvement, except in one of three patients who showed a remarkable decrease in proteinuria. On the other hand, patients with SLE and "moderate" kidney involvement (short course of disease, no fixed structural changes) showed improvement on combined immunoadsorption and IVIG therapy.

A 21–year-old woman suffering from bipolar affective disorder developed systemic lupus erythematosus (SLE) with characteristic laboratory findings, 18 months after starting carbamazepine maintenance treatment. SLE receded after withdrawal of carbamazepine and treatment with anti-inflammatory drugs. Although both the spontaneous occurrence of SLE and the psychosis as a sign of CNS involvement of SLE cannot be excluded, SLE could be considered as an adverse effect of carbamazepine.