Drug survival superiority of tumor necrosis factor inhibitors and interleukin-17 inhibitors over Janus kinase inhibitors and interleukin-12/23 inhibitors in German psoriatic arthritis outpatients: retrospective analysis of the RHADAR database.

Objective: Treatment options with disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis (PsA) have evolved over recent years. In addition to Janus kinase inhibitors (JAKi), four classes of biologic DMARDs (bDMARDs; interleukin [IL]-23 inhibitors [IL-23i], IL-12/23 inhibitors [IL-12/23i], tumor necrosis factor inhibitors [TNFi], and IL-17 inhibitors [IL-17i]) are currently approved for moderate to severe PsA treatment. There is minimal evidence of the persistence of these drugs among PsA outpatients in a real-world scenario during the period following the approval of JAKi. Therefore, we aimed to analyze the drug survival rates of biologic and JAKi therapies among German PsA outpatients during routine clinical care. Methods: We retrospectively analyzed PsA patients with a new prescription for a biologic or JAKi in the RHADAR database between January 2015 and October 2023. Kaplan-Meier Curves and Cox regression modelling were used to compare drug survival rates. Results: 1352 new prescriptions with bDMARDs (IL-12/23i [n=50], IL-23i [n=31], TNFi [n=774], IL-17i [n=360]) or JAKi (n=137) were identified. The 5-year drug survival rate was 67.8% for IL-17i, 62.3% for TNFi, 53.3% for JAKi, and 46.0% for IL-12/23i. Discontinuation probabilities for JAKi and IL-12/23i were significantly higher compared with TNFi (JAKi hazard ratio [HR] 1.66, [95% CI 1.23-2.24], p=0.001; IL-12/23i HR 1.54, [95% CI 1.02-2.33], p=0.042) and IL-17i (JAKi HR 1.77, [95% CI 1.27-2.47], p=0.001; IL-12/23i HR 1.64, [95% CI 1.06-2.55], p=0.027). JAKi-treated patients had more severe disease and more osteoarthritis (OA) compared to TNFi and more OA compared to IL-17i. Conclusion: German PsA outpatients might persist longer with TNFi and IL-17i compared with IL-12/23i or JAKi. For TNFi, differences in subgroup characteristics and comorbidities (OA) may have affected drug survival rates. For IL-17i, the longer drug survival might not only be related to less OA compared to JAKi and, therefore, might be affected by other factors.

Radiographic and non-radiographic axial spondyloarthritis are not routinely distinguished in everyday clinical care: an analysis of real-world data from rheumatology practices.

The categorization of axial spondyloarthritis (axSpA) into radiographic (r-axSpA) and non-radiographic (nr-axSpA) subtypes is important in clinical trials but may be of less value in clinical practice. This exploratory cross-sectional, multi-center study evaluated patients with axSpA under routine care at German clinical rheumatology sites (RHADAR real-world database), with a focus on imaging data used for diagnostic classifications. Our analyses included 371 patients with axSpA. The mean (standard deviation [SD]) age was 50.9 (14.0) years, disease duration was 16.4 (13.5) years, and 39.6% were female. Based on the rheumatologist's final assessment, almost half of patients had definite r-axSpA (n = 179; 48.2%), 53 (14.3%) had suspected r-axSpA, 112 (30.2%) had non-radiographic-axSpA (nr-axSpA), and 27 (7.3%) had undefined axSpA. Patients assessed with definite or suspected r-axSpA were more likely to be treated with disease-modifying antirheumatic drugs (DMARDs) (62.0% and 64.2%, respectively) compared with nr-axSpA or undefined axSpA patients (37.5% and 48.1%, respectively). Almost all patients (348/371; 93.8%) had sacroiliac joint imaging data (radiographs or magnetic resonance imaging) documented in their charts, but only 216 (58.2%) had conventional radiographs required for formal diagnosis of r-axSpA by modified New York criteria. Follow-up radiographic imaging in nr-axSpA patients was uncommon (23/216 [25.0%]) but confirmed r-axSpA in 9/23 patients (39.1%). In conclusion, radiographs were available for slightly more than half of axSpA patients. Follow-up imaging was infrequent during rheumatology care in Germany but confirmed r-axSpA in ~ 40% of patients originally considered to have nr-axSpA. The distinction between r-axSpA and nr-axSpA may be ill-defined in routine clinical practice.

[Delegation of medical duties to qualified rheumatology assistants : Effect on depression and anxiety in patients with rheumatoid arthritis]. / Delegation ärztlicher Leistungen an rheumatologische Fachassistenten : Effekte auf Depression und Angst bei Patienten mit rheumatoider Arthritis.

BACKGROUND: At least 1 comorbidity occurs in 80% of patients with rheumatoid arthritis (RA). In addition to cardiovascular comorbidities psychological comorbid conditions are common. The prevalence of depression and anxiety is higher in patients than in the general population. Screening for comorbidities is crucial. A shortage of outpatient specialist care barely allows resources for this. The implementation of team-based care holds the potential to improve the standard of care while simultaneously working against the shortage of care. OBJECTIVE: The aim of the study was to examine the effects of care on the course of depression and anxiety in patients with seropositive RA and active disease. MATERIAL AND METHODS: A multicenter pragmatic randomized controlled trial was conducted over the course of 1 year with 224 patients. After baseline, five more visits followed. In the intervention group (IG), three were initially carried out by qualified rheumatological assistants. Depression, anxiety and patient satisfaction with outpatient care were looked at in detail. RESULTS: In the IG the anxiety symptoms significantly improved over 12 months (p = 0.036). The proportions of patients with anxiety also significantly changed in the IG (p < 0.001), while there was no change in the control group between baseline and month 12. The values of the depression scale did not differ significantly (p = 0.866). In terms of the information dimension of the satisfaction questionnaire, patients in the IG felt significantly better informed after 6 months (p = 0.013) and 12 months (p = 0.003). CONCLUSION: A positive effect of team-based care on the course of depression and anxiety in patients with seropositive RA and active disease could be shown.

Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis.

Spondyloarthritis may contribute to deficits in cognition. The objective of this study was to compare cognitive abilities in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) with matched reference groups. This investigator-initiated, cross-sectional, exploratory study of adults with axSpA or PsA was conducted at two German rheumatology centres (November 2018-September 2019). All data on patient and disease characteristics and cognitive abilities were collected at a single visit. Cognitive function was assessed by the previously validated Memory and Attention Test subscores of selective attention, episodic working memory, and episodic short-term memory and compared with subscores from healthy age-, sex-, and education-matched reference subjects. The mean patient age was 51.1 and 55.8 years in the axSpA (n = 101) and PsA (n = 117) groups, respectively, and mean symptom duration was 13.7 and 10.3 years. Compared with matched reference subjects, axSpA and PsA patients showed significant impairments in selective attention (mean difference of -6.5 and -4.5, respectively, on a 45-point scale; P < 0.001 for both) and no significant differences in episodic working memory. The PsA cohort, but not the axSpA cohort, had significantly better episodic short-term memory subscores compared with matched reference subjects (mean change of 2.0 on a 15-point scale; P < 0.001). Explorative subgroup analyses were unable to identify factors influencing cognitive changes, including disease activity, pain, and function, but may have been underpowered. We conclude that impairments in selective attention may impact the ability of axSpA and PsA patients to process information. These findings warrant additional studies, including longitudinal analyses, in patients with spondyloarthritis.

Outcome of adult patients with JIA treated with the biosimilar Benepali®: results of the biologic register JuMBO.

BACKGROUND: To analyze therapy adherence, safety, and outcome in adult patients with juvenile idiopathic arthritis (JIA) treated with the etanercept biosimilar Benepali® (Biogen Inc, Cambridge, USA). METHODS: Data from the prospective registry, JuMBO (Juvenile arthritis MTX/Biologics long-term Observation), were used for the analysis. JuMBO is a long-term observational cohort study. It follows adult patients with JIA who were formerly included in the national JIA biologic register (BiKeR Registry). Both registries provide individual trajectories of clinical data and outcomes from childhood to adulthood in JIA patients treated with disease-modifying anti-rheumatic drugs (DMARDs). RESULTS: Eighty-three patients from the German JuMBO registry were treated with Benepali®. Of these, 74% had switched from Enbrel® (Pfizer Inc., NYC, USA) the originator of etanercept to Benepali® for cost reasons. Therapy survival of patients treated with Benepali® in comparison to Enbrel® in patients matched by significant parameters was comparable. Adverse events (AE) were reported in 25.3% and serious adverse events (SAE) in 9.6% of patients. Physicians rated no SAE causative related to Benepali®. The majority of SAEs were surgical/medical procedures and there was only one infection. All efficacy parameters (cJADAS-10, Physician Global Assessment, number of joints with active arthritis, patients' overall well-being, pain, and HAQ) demonstrated improvement over 24 months (p-values were not significant). 9.6% of patients permanently discontinued Benepali® because of an AE. CONCLUSIONS: Tolerability and effectiveness of the biosimilar Benepali® were satisfactory and therapy survival was comparable to the originator. Further data on therapy with biologics and biosimilars such as Benepali® must be collected by registries such as BiKeR and JuMBO in order to optimize therapy and patient outcomes and to reduce costs in the health system in the long term.

Prevalence of Depressive Symptoms in Patients With Psoriatic Arthritis: Have Numbers Changed During the COVID-19 Pandemic?

This longitudinal analysis compares the prevalence of depressive symptoms in patients with psoriatic arthritis in the context of the COVID-19 pandemic. Data from a national patient register in Germany were analyzed regarding the Patient Health Questionnaire 2 (PHQ-2) to identify cases suspicious for depression at two time points, i.e., before and during the COVID-19 pandemic. Only patients with complete concurrent information on the Disease Activity in Psoriatic Arthritis Score (DAPSA) were included in the analysis. The frequency of depressive symptoms in psoriatic arthritis patients during the COVID-19 pandemic did not differ from the prevalence rates measured before. In addition, prevalence rates for depressive symptoms did not differ when stratifying the patient sample for DAPSA levels of disease activity measured before the pandemic. These results were confirmed further in a sensitivity analysis, limiting the second PHQ-2 assessment to lockdown periods only. However, longitudinal data on the prevalence of depressive symptoms in patients with rheumatic diseases, in general, and psoriatic arthritis, in particular, are scarce in the context of the COVID-19 pandemic. For a sensible comparison of prevalence rates for depressive symptoms in the future, underlying SARS-CoV-2 infection rates and resulting local healthcare disruptions need to be taken into account, besides the potential use of different depression screening tools to evaluate resulting numbers sensibly and draw corresponding conclusions for patient care.

A Real-World Rheumatology Registry and Research Consortium: The German RheumaDatenRhePort (RHADAR) Registry.

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.

Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial.

OBJECTIVE: To 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. METHODS: A 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. RESULTS: Demographic 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 (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes. CONCLUSION: This 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 NUMBER: DRKS00013055.