Objective To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.Design The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.Participants All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).Primary and secondary outcome measures The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.Results ‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) Δ62%) and remission (SDAI Δ25%, CDAI Δ28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.Conclusion Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.Trial registration number NCT03387423.

ObjectiveTo compare the prevalence of childhood trauma, depression, and anxiety disorders between patients with early arthritis (EA) and a control group (CG). We further aimed to explore the influence of these variables on EA diagnosis.Methods and materialsThis monocentric study included 60 prospectively recruited EA patients with at least one inflammatory joint with a symptom duration of 1–12 months. The CG consisted of 60 individuals with no clinical signs of arthritis. The participants underwent a semi-structured interview screening for psychiatric disorders and completed standardized questionnaires, including the Hospital Anxiety and Depression Scale (HADS-A, HADS-D), the Childhood Trauma Questionnaire (CTQ), and the Posttraumatic Diagnostic Scale (PDS). For statistical analysis, we used SPPS© χ2 test, T-test, Mann–Whitney U-test, and binominal regression analysis.ResultsCompared to the CG, patients with EA had significantly higher rates of depression in the interview (41.7% vs. 16.7%; p = 0.03) and PTSD (13.3% vs. 3.3%; p = 0.048), and significantly higher HADS-D and CTQ childhood sexual abuse mean scores (HADS-D: 5.40 ± 4.80 vs. 3.60 ± 3.30; p = 0.047; CTQ sexual abuse: 5.91 ± 2.68 vs. 5.15 ± 1.02; p = 0.042). Binomial regression analysis revealed higher odds ratios for EA for CTQ emotional neglect (p = 0.048, OR = 1.12), CTQ sexual abuse (p = 0.040, OR = 1.4), HADS-D (p = 0.025, OR = 1.12), and lifetime depression (p = 0.040, OR = 4.00).ConclusionThe high rates of depression and PTSD in EA emphasize a potential link between psychiatric disorders and arthritis. The presence of EA might be associated with present and lifetime depressive symptoms, childhood sexual abuse and emotional neglect.

Die Kerndokumentation der Regionalen Kooperativen Rheumazentren erfasst jährlich Versorgungsdaten von Patient:innen mit entzündlich rheumatischen Erkrankungen. Für rheumatoide Arthritis (RA), Psoriasisarthritis (PsA), axiale Spondyloarthritis (axSpA), systemischen Lupus erythematodes (SLE), systemische Sklerose (SSc), Sjögren-Syndrom (SjS), idiopathische inflammatorische Myositiden (IIM), Polymyalgia rheumatica (PMR), Riesenzellerarteriitis (RZA), ANCA-assoziierte Vaskulitiden (AAV), Morbus Behçet (BD), „adult-onset Still’s disease“ (AOSD) und autoinflammatorische Erkrankungen (AIE) werden Daten aus dem Jahr 2023 berichtet. Angaben umfassen u. a. die ärztlich eingeschätzte Krankheitsaktivität auf einer numerischen Ratingskala (NRS) von 0–10, Therapien und patientenberichtete Outcomes. Für ausgewählte Diagnosen werden Entwicklungen von 2010 bis 2023 zu der ärztlichen Einschätzung der Krankheitsaktivität und zu Therapien dargestellt. Aus 14 Einrichtungen wurden 13.884 Patient:innen dokumentiert, am häufigsten RA (5734), PsA (1741) und axSpA (1494). Das mittlere Alter lag zwischen 45 (BD) und 73 Jahren (RZA), die Krankheitsdauer betrug im Median 3 (PMR) bis 16 Jahre (axSpA). Die Krankheitsaktivität war überwiegend niedrig, bei 6

Objectives This analysis aimed to evaluate the effect of depressive symptoms on treatment outcomes in patients with axial spondyloarthritis (axSpA), focusing on low disease activity (LDA) and inactive disease (ID) at 3 and 6 months after the start of a new systemic therapy.Methods This analysis used data from the longitudinal, observational RABBIT-SpA register. Depressive symptoms were assessed using the WHO-5 Well-Being Index, with scores below 29 indicating moderate-to-severe symptoms. The treatment outcomes LDA and ID, based on the Axial Spondyloarthritis Disease Activity Score with C-reactive protein, were evaluated after 3 and 6 months. Logistic regression models adjusted for confounding variables, selected via a directed acyclic graph, were used to assess the relationship between baseline depressive symptoms and treatment outcomes. Multiple imputation was used to handle missing data.Results A total of 1755 patients with axSpA were included in the analysis. Moderate-to-severe depressive symptoms were present in 29% of patients at baseline. Fewer patients with moderate-to-severe depressive symptoms reached LDA or ID at 3 months and 6 months compared with those with no or mild symptoms. Logistic regression analysis showed that depressive symptoms were associated with lower odds of reaching LDA or ID at both time points.Conclusion Depressive symptoms have a significant and independent negative effect on treatment response in patients with axSpA, particularly in achieving LDA and ID. These findings highlight the importance of routine mental health screening and treatment of depressive symptoms in axSpA management to optimise disease outcomes.

Background Digital health applications (DHA) became indispensable patient companions accelerated by the current COVID pandemic [1]. In 2020, for the first time worldwide, a regulatory framework to reimburse DHA was established in Germany. To get listed as a DHA, preliminary evidence needs to be generated – next to fulfilling highest standards in quality and safety. The DHA ABATON RA consists of two parts; 1) digital shared-decision-making (SDM) including choosing an appropriate electronic patient reported outcome (ePRO) instrument and the respective ePRO target for the next visit, 2) remote patient monitoring and ePRO tracking by the patient. Hereby, ABATON RA supports a digitally guided Treat-to-Target (T2T) approach. Objectives The objective of this study is to evaluate a potentially beneficial effect for the patient by using ABATON RA. Methods Three-armed, partially blinded multicenter trial (RCT) including RA patients who regularly use a smartphone. Patients attend 3 visits, 3 months apart (T0, T3, T6), with one follow-up visit (T9). Intervention group (IG): Patients use ABATON RA. Via SDM patients and rheumatologists choose a specific ePRO and respective treatment target for the next visit in three months, e.g. RAID ≤4. Control group (CG): Standard of care treatment (no DHA). Placebo group (PG): Usage of a placebo version of ABATON RA providing only Regensburger Insomnie Skala (RIS) and Epworth Sleepiness Scale (ESS) as ePROs. No SDM is conducted and ePRO results are not presented to HCP. Results This interim analysis evaluated the first 38 patients that completed T3. IG: 13 patients (Av. age 55.9, 61.5% females); PG: 12 (Av. age 50.7, 66.7% females); CG: 13 (Av. age 56.1, 76.9% females). We observe a significant improvement in the mean over time in a pairwise comparison within the intervention group for the following: Pt-GA mean difference of 2.98 (p = 0.025, partial η 2 = 0.353), pain mean difference of 1.46 (p = 0.049, partial η 2 = 0.286) whereas all pairwise comparisons for the two parameters were non-significant in PG and CG. The patient reactions assessment (PRA) score, measuring patient perceived quality of the patient-provider relationship, increased by a mean of 4.15 points in IG, compared to a slight decrease of 1.92 for PG and 2.77 for CG. Conclusion These preliminary findings show beneficial differences among the groups in favor of IG: 1) for quality of life and 2) the physician-patient-relationship. A digitally enhanced therapy is non-inferior to the gold-standard of exclusive in-person treatment. Patients seem willing and able to get involved in an enhanced treat-to-target and shared decision-making approach. References [1]Kernder A, Morf H, Klemm P, Vossen D, Haase I, Mucke J, et al. Digital rheumatology in the era of COVID-19: results of a national patient and physician survey. RMD Open. 2021;7:e001548. Disclosure of Interests Johannes Knitza Consultant of: ABATON GmbH, Vila Health, Grant/research support from: ABATON GmbH, Manuel Grahammer Shareholder of: ABATON GmbH, Employee of: ABATON GmbH, Sebastian Boeltz: None declared, Judith Lang: None declared, Markus Detert: None declared, Maram Bader Employee of: ABATON GmbH, Arnd Kleyer: None declared, David Simon: None declared, Gerhard Krönke: None declared, Georg Schett: None declared, Jacqueline Detert: None declared

BackgroundIn patients with arthritis, psychological co-morbidities are very common. Previous studies have found a relatively high prevalence of depression, anxiety, and post-traumatic stress disorder (PTSD), especially in long-term disease. Recent research has begun to study psychiatric co-morbidities not just as an outcome, but also as a probable risk factor, evaluating patients in the early disease stages. [1] Furthermore, some sources suggest that childhood adversities could impact the autoimmune process in adulthood. [2]ObjectivesTo compare the prevalence of depression, anxiety, PTSD, and childhood trauma in a prospective early arthritis cohort to a healthy age- and gender-matched control group. Moreover, to explore whether these factors may contribute to the early arthritis development.MethodsThis selective data analysis of prospective single-centre, observational study included 60 patients with an early arthritis and 60 healthy controls. The control group was defined as no inflammatory joint pain and further subdivided into 2 subgroups, differentiating 24 patients with arthralgia and 36 with no arthralgia and not from the outpatient consultation. Early arthritis was defined as the presence of at least one inflammatory joint from 4 weeks to 12 months, independent of rheumatic diagnosis. For the assessment of current and prior psychological co-morbidities, included patients underwent semi-structured interview and received the standardized questionnaires for depression/anxiety (Hospital Anxiety and Depression Scale (HADS)), childhood trauma (Childhood Trauma Questionnaire (CTQ)) and PTSD (Posttraumatic Diagnostic Scale (PDS)) respectively. Differences among the groups were analyzed with Chi Square and Mann-Whitney U tests. A backwards binominal logistic regression model in reference to the healthy patients was performed to identify the significant factors for the early arthritis group.ResultsThe mean age of the total group was 47.4 ± 16.0 (♀ 58.3%, mean symptom duration 4.5±3.3 months). Depression rate of 41.7% according to interview was significantly higher in early arthritis group compared to 16.7% in healthy patients (p=0.03). Regarding arthralgia subgroup, depression was also high with 34%. HADS-D score was also significantly higher in early arthritis (5.4±4.8) to healthy cohort (3.6±3.3) (p=0.047). Compared to 3.3% in healthy patients, PTSD rate of 13.3% was also significantly higher in the arthritis group (p=0.048). We could not detect a significant difference between these two groups using the U test while evaluating CTQ dimensions. We performed a subsequent subgroup analysis and found that childhood trauma dimensions were relevant in arthralgia group, as 25% presented with high emotional abuse score. The logistic regression model showed that emotional neglect, sexual abuses in childhood as well as HADS-D were significant covariates for early arthritis. (p=0,048 OR=1.2; p=0.040 OR=1.4, p=0.025 OR=1.2 respectively).ConclusionAs the rates of depression and PTSD, as well as HADS-D score were significantly higher in the early arthritis cohort compared to healthy individuals, our findings suggest a potential link between psychiatric outcomes and inflammation. According to our regression model certain childhood adversities and depression are significant factors for an early arthritis group. Arthralgia group had similar aberrant scores regarding childhood trauma, implying that early-life stress might be an important factor in understanding this condition.References[1]Vallerand IA et al. Depression as a risk factor for the development of rheumatoid arthritis: a population-based cohort study. RMD Open.2018; 4(2)[2]Dube SR et al. Cumulative childhood stress and autoimmune diseases in adults. Psychosom Med. 2009; 71(2):p.243-50.Disclosure of InterestsNone declared

Patient-reported outcomes (PRO) represent a cornerstone in the management of patients with rheumatoid arthritis (RA). However, PRO are currently recorded mainly on paper and only during on-site appointments. Electronic PRO (ePRO) enable continuous remote monitoring and could improve shared decision-making (SDM) and implementation of a treat-to-target (T2T) approach. This study aims to investigate patient and physician experiences, perceived drawbacks and benefits of using an ePRO web-app (ABATON RA) to digitally support SDM and T2T. A qualitative study embedded in a multicenter randomized controlled trial (RCT) consisting of interviews with RA patients and physicians that were subsequently analyzed using deductive-inductive qualitative content analysis. Between August 2021 and May 2022, interviews with ten RA patients and five physicians were completed. Three key themes emerged in the analysis: (i) App user experiences; (ii) perceived drawbacks of app-supported rheumatology care; and (iii) perceived benefits of app-supported rheumatology care. Continuous ePRO collection and a high level of standardization strained some RA patients. Certain ePRO seemed outdated and were hard to understand. Patients and physicians appreciated having an improved overview of disease activity, capturing disease flares and continuous remote monitoring. Paper- and time-saving were associated with using ePRO. Physicians feared to become too focused on ePRO data, stressed the lack of ePRO monitoring reimbursement and app interoperability. For RA patients and physicians, benefits seemed to outweigh observed drawbacks of the digitally supported SDM using ePRO. The software was easy to use and could lead to a better understanding of the individual disease course, resource allocation and treatment of rheumatoid arthritis.

Objective To investigate the efficacy of bDMARDs in patients with RA with RF/ACPA compared with patients without these autoantibodies.Methods Previous systematic literature reviews performed by EULAR RA management task forces were searched for qualifying RCTs. RCTs investigating the efficacy of bDMARDs and including both autoantibody-positive (<= 80% of total population) and -negative RA patients were eligible. For trials comparing bDMARD+csDMARD vs csDMARD, relative risks (RR) comparing two groups (RF+ vs RF-, ACPA+ vs ACPA-) were calculated for efficacy outcomes for each arm. Subsequently, relative risk ratios (RRRs) were computed, as the ratio of RR of the bDMARD-arm and the RR from the non-bDMARD-arm. Pooled effects were obtained with random effect meta-analyses.Results Data from 28 eligible RCTs were analysed, pooling 23 studies in three subgroups: six including csDMARD-naive patients, 14 csDMARD-IR and three TNFi-IR patients. In csDMARD-naive and csDMARD-IR patients, seropositivity was not associated with a better response to bDMARDs: pooled 6-month ACR20 RRRs 1.02 (0.88-1.18) and 1.09 (0.90-1.32), respectively. Other outcomes showed no difference between groups either. In TNFi-IR patients, based on three trials, the 6-month ACR20 RRR was 2.28 (1.31-3.95), favoring efficacy in seropositive patients. Other outcomes mostly showed no significant difference between the groups. Based on the mode of action, efficacy was comparable between RF-positive and RF-negative patients for both TNFi and non-TNFi treatment and also for the individual bDMARDs.Conclusion The effect of bDMARDs is generally comparable in patients with and without RF/ACPA, regardless of the patient population, the mechanism of action or individual drug used.

OBJECTIVE:To identify patient characteristics associated with responsiveness to tumour necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA). MATERIALS AND METHODS:Individual patient data from 29 randomised controlled trials (RCTs) evaluating the efficacy of a TNFi versus placebo or conventional therapy were obtained. Response to treatment was assessed in subgroups according to the following baseline characteristics: smoking status, physical activity, sex, age, body mass index, autoantibody profile, disease duration, high initial disease activity defined by Disease Activity Score on 28 joints (DAS28)(C reactive protein (CRP)) >5.1. The primary outcome was the between-treatment group difference in DAS28(CRP) change from baseline to 6 months. The secondary endpoints were the between-treatment group difference in final DAS28(CRP) measured until 6 months and EULAR response criteria until 6 months. Data from each RCT were then pooled by the Mantel-Haenszel method using a random effects model. A linear metaregression was also carried out on two data-sharing platforms separately to support the results. RESULTS:Individual data of 11 617 patients from 29 RCTs were analysed. Until 6 months, a significantly higher EULAR non-response rate was observed in obese patients (OR 0.52 vs 0.36 for non-obese, p=0.01). A multivariable regression model performed on 7457 patients indicated that patients treated by TNFi had a final DAS28(CRP) decreased by 0.02 for each year of disease duration (p<0.001), and a 0.21 decreased for patients with a baseline DAS28(CRP) >5.1 (p<0.001). CONCLUSIONS:In RA, patients who are more responsive to TNFi are those who are non-obese, have a long disease duration and have a high initial disease activity.

Objective As part of European League against Rheumatism (EULAR)/European Musculoskeletal Conditions Surveillance and Information Network, 20 user-focused standards of care (SoCs) for rheumatoid arthritis (RA) addressing 16 domains of care were developed. This study aimed to explore gaps in implementation of these SoCs across Europe. Methods Two cross-sectional surveys on the importance, level of and barriers (patients only) to implementation of each SoC (0-10, 10 highest) were designed to be conducted among patients and rheumatologists in 50 European countries. Care gaps were calculated as the difference between the actual and maximum possible score for implementation (ie, 10) multiplied by the care importance score, resulting in care gaps (0-100, maximal gap). Factors associated with the problematic care gaps (ie, gap >= 30 and importance >= 6 and implementation<6) and strong barriers (>= 6) were further analysed in multilevel logistic regression models. Results Overall, 26 and 31 countries provided data from 1873 patients and 1131 rheumatologists, respectively. 19 out of 20 SoCs were problematic from the perspectives of more than 20% of patients, while this was true for only 10 SoCs for rheumatologists. Rheumatologists in countries with lower gross domestic product and non-European Union countries were more likely to report problematic gaps in 15 of 20 SoCs, while virtually no differences were observed among patients. Lack of relevance of some SoCs (71%) and limited time of professionals (66%) were the most frequent implementation barriers identified by patients. Conclusions Many problematic gaps were reported across several essential aspects of RA care. More efforts need to be devoted to implementation of EULAR SoCs.

Objectives Hand osteoarthritis (OA) is a condition characterised by cartilage degradation and frequently erosive changes. Analgesics and non-steroidal anti-inflammatory drugs are used for symptomatic relief but are often poorly tolerated or contraindicated. Previous publications suggest hydroxychloroquine (HCQ) as a possible treatment for hand OA. The OA-TREAT study aimed to investigate the efficacy and safety of HCQ in patients with inflammatory and erosive hand OA (EOA). Methods OA-TREAT was an investigator-initiated, multicentre, randomised, double-blind, placebo (PBO)-controlled trial. Patients with inflammatory and EOA, according to the ACR criteria, with radiographically erosive disease were randomised 1:1 to HCQ 200–400 mg/day or PBO for 52 weeks (W52). Both groups received stable standard therapy. The primary endpoint was Australian Canadian Hand Osteoarthritis Index (AUSCAN) for pain and hand disability at W52. Results 75 patients were randomised to HCQ and 78 to PBO. At W52, mean AUSCAN pain was 26.7 in HCQ and 26.5 in PBO patients (p=0.92). Hand disability measured by AUSCAN function (mean) was 48.1 in HCQ and 51.3 in PBO patients (p=0.36). Changes in radiographic scores did not differ significantly (p>0.05) between treatment groups. There were 7 serious adverse events in the HCQ and 15 in the PBO group. Conclusions OA-TREAT is the first large randomised PBO controlled trial focusing on EOA. HCQ was no more effective than PBO for changes in pain, function and radiographic scores in the 52-week period. Overall safety findings were consistent with the known profile of HCQ.

BACKGROUND Antimalarial medication (AM) plays an important role in the treatment of rheumatic diseases. OBJECTIVE Updated evidence-based recommendations on the safety management of rheumatological treatment with AM are presented. METHODS A systematic literature search in the databases Medline (PubMed) and Cochrane identified 1160 studies on the safety of treatment with AM in rheumatology. In addition, a manual search was carried out and 67 publications considered to be particularly relevant by the authors were analyzed in more detail. These publications served as a basis for consensus-based recommendations. RESULTS Treatment with AM in rheumatology should be carried out with hydroxychloroquine (HCQ) with a dosage not exceeding 5 mg/kg body weight/day. Patients should undergo a basic ophthalmological examination within the first 6 months of AM treatment. Pre-existing maculopathy, renal insufficiency (glomerular filtration rate, GFR 5 mg/kg HCQ or treatment with chloroquine (CQ) show an increased risk for AM-induced retinopathy. These patients should undergo an annual ophthalmological check from the beginning of the treatment, whereas patients with no risk factors are recommended to start this only after 5 years of taking the medication. The ophthalmological examination should comprise at least both an appropriate subjective and an objective method and these are usually an automated visual field test and optical coherence tomography (OCT). A visual field test revealing a parafoveal sensitivity loss and an OCT showing a parafoveal circumscribed loss of the photoreceptor layer or focal interruptions of the structural line of the outer segment are signs of a possible AM retinopathy. Determination of creatine kinase (CK) and lactate dehydrogenase (LDH) in blood is appropriate to screen for cardiomyopathy and myopathy and should be checked before starting the treatment and then ca. every 3 months. The use of cardiac biomarkers, such as brain natriuretic peptide (BNP) or troponin in serum, electrocardiograph (ECG) or cardiac imaging should be considered depending on the situation. An intake of HCQ is safe during pregnancy and breastfeeding according to the current state of knowledge and is protective for mother and child in patients with systemic lupus erythematosus. CONCLUSION The updated recommendations on AM treatment in rheumatology in particular include a more rigorous measuring of doses, risk stratification in monitoring and defined ophthalmological examination methods to detect a possible retinopathy.

BACKGROUND:Antimalarial medication (AM) plays an important role in the treatment of rheumatic diseases. OBJECTIVE:Updated evidence-based recommendations on the safety management of rheumatological treatment with AM are presented. METHODS:A systematic literature search in the databases Medline (PubMed) and Cochrane identified 1160 studies on the safety of treatment with AM in rheumatology. In addition, a manual search was carried out and 67 publications considered to be particularly relevant by the authors were analyzed in more detail. These publications served as a basis for consensus-based recommendations. RESULTS:Treatment with AM in rheumatology should be carried out with hydroxychloroquine (HCQ) with a dosage not exceeding 5 mg/kg body weight/day. Patients should undergo a basic ophthalmological examination within the first 6 months of AM treatment. Pre-existing maculopathy, renal insufficiency (glomerular filtration rate, GFR <60 ml/min), tamoxifen comedication, a daily dose of >5 mg/kg HCQ or treatment with chloroquine (CQ) show an increased risk for AM-induced retinopathy. These patients should undergo an annual ophthalmological check from the beginning of the treatment, whereas patients with no risk factors are recommended to start this only after 5 years of taking the medication. The ophthalmological examination should comprise at least both an appropriate subjective and an objective method and these are usually an automated visual field test and optical coherence tomography (OCT). A visual field test revealing a parafoveal sensitivity loss and an OCT showing a parafoveal circumscribed loss of the photoreceptor layer or focal interruptions of the structural line of the outer segment are signs of a possible AM retinopathy. Determination of creatine kinase (CK) and lactate dehydrogenase (LDH) in blood is appropriate to screen for cardiomyopathy and myopathy and should be checked before starting the treatment and then ca. every 3 months. The use of cardiac biomarkers, such as brain natriuretic peptide (BNP) or troponin in serum, electrocardiograph (ECG) or cardiac imaging should be considered depending on the situation. An intake of HCQ is safe during pregnancy and breastfeeding according to the current state of knowledge and is protective for mother and child in patients with systemic lupus erythematosus. CONCLUSION:The updated recommendations on AM treatment in rheumatology in particular include a more rigorous measuring of doses, risk stratification in monitoring and defined ophthalmological examination methods to detect a possible retinopathy.

OBJECTIVES:To report the tolerability and effectiveness of certolizumab pegol (CZP) for the treatment of patients with active rheumatoid arthritis (RA) in a routine clinical practice setting.METHODS:FαsT (NCT01069419) was a non-interventional, observational 104-week (wk) study performed at 163 sites in Germany. RA patients were treated according to the treating physician's discretion. Clinical remission (DAS28-CRP<2.6) at wk 104 was the primary endpoint of the study. Remission data based on ESR (DAS28-ESR<2.6) were also assessed. Secondary endpoints included the effect of CZP treatment on pain, physical function and disease activity. Safety data were collected at all study visits.RESULTS:1,117 patients were enrolled in the FαsT study (78% female, mean age: 55 years). Rapid responses were observed at wk 6 (18.7% and 12.9% patients in DAS28-CRP and DAS28-ESR remission, respectively) with improvements sustained over 2 years (20.0% and 13.9% patients achieved DAS28-CRP and DAS28-ESR remission, respectively at wk 104). Anti-TNF naïve patients exhibited greater improvements than anti-TNF experienced patients (mean DAS28-ESR change from baseline [CfB] -1.3, -1.5 and -1.7 for patients with ≥2, 1 and no anti-TNFs, respectively at wk104). Improvements were reported in all secondary endpoint measures. 1,111 patients were exposed to CZP for a total of 1,538 patient-years during the study. 2,000 treatment-emergent adverse events (TEAEs) were reported in 745 patients (67.1%); 9 (0.8%) experienced TEAEs with fatal outcome.CONCLUSIONS:CZP demonstrated efficacy and safety outcomes reflective of those observed in trial settings. Rapid reductions in disease activity and improvements in physical function were maintained up to wk 104.

Zahlreiche Studien und Registerdaten belegen, dass die Depression, häufig verbunden mit Angststörungen, bei Patienten mit einer rheumatoiden Arthritis (RA) sehr häufig zu finden ist. Inwiefern diese psychiatrischen Erkrankungen in einem sehr frühen Erkrankungsstadium bereits relevant sind, ist aktuell noch unzureichend untersucht.

Zahlreiche Fortschritte in der Grundlagenforschung, in der Diagnostik und Therapie in den letzten Jahren führen dazu, dass Patienten mit einer entzündlichen Gelenkerkrankung eine Remission bzw. niedrigstmögliche Krankheitsaktivität, Lebensqualität, einen Erhalt ihrer Arbeitsfähigkeit als auch das Beibehalten der sozialen Integration beibehalten. Diese Erfolge werden schrittweise versucht, auf andere Autoimmunerkrankungen zu übertragen. Es zeigt sich gerade auf dem Gebiet der Medikamentenentwicklung jedoch immer wieder, dass es sich um pathogenetisch unterschiedlich verursachte Erkrankungen handelt und Therapieerfolge nicht immer gleichermaßen erreichbar sind. Jedoch sind inzwischen zahlreiche Medikamente zur Behandlung der entzündlichen Gelenkerkrankungen verfügbar, weitere werden derzeit intensiv in klinischen Studien geprüft bzw. sind zur Zulassungsentscheidung bei den Aufsichtsbehörden registriert. So sind auch in den nächsten Jahren weitere Therapiemöglichkeiten zu erwarten. Die rheumatoide Arthritis ist ein Beispiel dieser Erfolgsgeschichte, so dass inzwischen sogar die Frage diskutiert wird, ob diese Erkrankung präventiv zu behandeln und somit die Manifestation der Erkrankung zu stoppen ist. Diese Übersicht vermittelt eine Auswahl aktueller Forschungsergebnisse und Medikamentenentwicklungen bei entzündlichen Gelenkerkrankungen.

Numerous advances in basic medical and biological research, diagnostics and therapy in recent years have resulted in patients with inflammatory joint disease achieving remission or the lowest possible disease activity, and maintaining quality of life, ability to work and social integration. These successes are being tried to transfer to other autoimmune diseases in a step-by-step approach. In the field of drug development, however, it has been shown repeatedly that these diseases have different pathogenetic causes, and that it is not possible to achieve equal treatment success in all cases. However, a large number of drugs are now available for the treatment of inflammatory joint diseases; others are being studied intensively in clinical trials or are registered with the regulatory authorities. Further therapeutic possibilities are to be expected in the coming years. Rheumatoid arthritis is an example of this success story, so there are discussions ongoing on whether or not it would be possible to treat this disease preventively, thereby stopping its manifestation in the first place. This overview provides a selection of current research results and drug developments in inflammatory joint diseases.

Background Early stages of rheumatic diseases are still difficult to diagnose and treatment is delayed often due to the lack of practicing rheumatologists. Therefore, novel ways of diagnostic strategies are urgently needed. Objectives Evaluation of a structured screening system for selecting and treating patients (pts) with rheumatoid arthritis (RA) or rheumatic and musculoskeletal diseases (RMD) with health professional assistants (HPA, trained specialist nurses). Methods 177 pts visited a screening appointment for early arthritis (EA) between February 2015 and July 2016 in a specialised EA clinic. Inclusion criterion was arthritis in ≥one joint for less than one year. Pts had three options for accessing the screening: phone call with qualified HPAs, online questionnaire or attending a walk in clinic (figure 1). Upon screening, all pts filled in a digital questionnaire about their symptoms and comorbidities. In group 1 an HPA performed the joint count and analysed the questionnaire for 116 pts before giving a suspected diagnosis. Subsequently, a rheumatologist saw these pts and also made a suspected diagnosis. 61 pts in group 2 were examined directly by a rheumatologist. In case of a suspected RMD or abnormal laboratory parameters, pts received a new appointment for completing diagnostics, or in acute cases, treatment was started immediately. All pts had the opportunity of a new appointment in case of persistency or worsening of the symptoms. Results Pts had a mean age of 50.9±15.2 years and 135 (76.3%) pts were female. 160 (90.4%) pts had access to the screening by phone call. 10 (5.7%) pts used the online questionnaire, and 7 (3.9%) pts used the walk-in consultation. Pts waited 3.1±1.8 weeks for a screening appointment. According to the digital questionnaire pts had symptoms for 58.1±90.5 weeks at the screening appointment. 34 (56.7%) pts with RMD visited the screening clinic within six months after symptom onset. 2 (1.7%) pts had an RMD that had not been suspected by the HPA upon screening in group 1 and subsequently received conventional disease modifying antirheumatic drugs (cDMARDs) and glucocorticoids (GC). In group 2, 3 (4.9%) pts received cDMARDs although in the screening an RMD had not been initially suspected by the rheumatologist. In total 69 (39.0%) pts finally had an RMD, whereof 43 (24.3%) pts had an RA. 44 (24.9%) pts received therapy with a cDMARDs and 6 (3.4%) had the recommendation for a therapy with cDMARDs but refused treatment. Therapy with cDMARDs started 44.8±41.9 days after screening. 21 (11.9%) pts could already start with GC at the screening appointment. 27 (15.2%) pts without a diagnosed RMD visited the rheumatologist at least twice. Conclusions HPAs can select pts with RMDs efficiently in a structured screening system which leads to treating RMDs at an early stage in times of limited resources. Acknowledgements Abbvie supported the project within the T2T Initiative Germany. Disclosure of Interest None declared

Medication-based strategies to treat rheumatoid arthritis are crucial in terms of outcome. They aim at preventing joint destruction, loss of function and disability by early and consistent inhibition of inflammatory processes. Achieving consensus about evidence-based recommendations for the treatment of rheumatoid arthritis with disease-modifying anti-rheumatic drugs in Germany. Following a systematic literature research, a structured process among expert rheumatologists was used to reach consensus. The results of the consensus process can be summed up in 6 overarching principles and 10 recommendations. There are several new issues compared to the version of 2012, such as differentiated adjustments to the therapeutic regime according to time point and extent of treatment response, the therapeutic goal of achieving remission as assessed by means of the simplified disease activity index (SDAI) as well as the potential use of targeted synthetic DMARDs (JAK inhibitors) and suggestions for a deescalating in case of achieving a sustained remission. Methotrexate still plays the central role at the beginning of the treatment and as a combination partner in the further treatment course. When treatment response to methotrexate is inadequate, either switching to or combining with another conventional synthetic DMARD is an option in the absence of unfavourable prognostic factors. Otherwise biologic or targeted synthetic DMARDs are recommended according to the algorithm. Rules for deescalating treatment with glucocorticoids and-where applicable-DMARDs give support for the management of patients who have reached a sustained remission. The new guidelines set up recommendations for RA treatment in accordance with the treat-to-target principle. Modern disease-modifying drugs, now including also JAK inhibitors, are available in an algorithm.