Accrual of thromboembolic events and antiphospholipid syndrome in new-onset systemic lupus erythematosus: a population-based inception cohort study.

Objective: This population-based study aimed to determine timing and incidence of arterial and venous thromboembolic events (TE) and antiphospholipid syndrome (APS) relative to systemic lupus erythematosus (SLE) onset and assess relationships between TE, APS and anti-phospholipid antibodies (aPL) during follow-up.

Methods: We included all medical-record confirmed new-onset SLE patients in Southeast Norway (population 2.9 million) 2000-2017 who fulfilled the 2019 European Alliance of Rheumatology Associations/American College of Rheumatology classification criteria.

Remote monitoring or patient-initiated care in axial spondyloarthritis: a 3-armed randomised controlled noninferiority trial.

Objectives: This study aimed to determine whether novel follow-up regimen, remote monitoring, or patient-initiated care is noninferior to usual care in maintaining low disease activity, in patients with axial spondyloarthritis (axSpA).

Methods: This is a randomised, controlled, 3-armed, parallel-group, open-label, noninferiority trial. Patients with axSpA in low disease activity on stable treatment with tumour necrosis factor inhibitor were recruited from a Norwegian outpatient clinic.

Incidence of Major Adverse Cardiovascular Events in Patients With Rheumatoid Arthritis Treated With JAK Inhibitors Compared With Biologic Disease-Modifying Antirheumatic Drugs: Data From an International Collaboration of Registries.

Objective: Our objective was to assess the incidence of major adverse cardiovascular events (MACEs) in patients with rheumatoid arthritis (RA) treated with JAK inhibitors (JAKi), tumor necrosis factor inhibitors (TNFi), or biologic disease-modifying antirheumatic drugs with other modes of action (bDMARD-OMA) in a multicountry, real-world population.

Methods: Patients with RA from 15 registries in the JAK-pot collaboration were included. MACE incidence was analyzed using two approaches: a within-registry analysis aggregating country-specific estimates from registers with >25 incident MACEs through meta-analysis and an individual-level data combined analysis.

VR-guided exercise and mindfulness program for people with chronic pain: a randomised controlled cross-over pilot trial.

Background: Physical exercises and mindfulness are important components in the management of chronic pain, but pain may reduce exercise adherence. Virtual reality (VR) can provide cognitive inhibition of the ascending pain signal and may thus be a tool for the delivery of pain management during exercise interventions. In this study we assessed a VR-guided intervention seeking to improve physical fitness in individuals with chronic pain.

Longitudinal risk of serious infections in patients with inflammatory arthritis on immunomodulating therapy compared to controls.

Objectives: To compare the risk of serious infection across time cohorts in patients with inflammatory arthritis (IA) initiating their first biologic/targeted synthetic DMARD (b/tsDMARD), to that of the general population. Secondarily, to compare the development in infection risk during treatment across diagnoses and examine risk dynamics during the course of b/tsDMARD treatment.

Methods: Patients with IA starting their first b/tsDMARD were included from the prospective NOR-DMARD study.

Remission in gout is possible: 5-year follow-up in the NOR-Gout study.

Objective: To compare the performance of remission definitions for gout in an observational treat-to-target patient cohort with 5 years of follow-up.

Methods: Inclusion criteria were crystal proven gout with increased serum urate levels and a flare. Remission was determined according to the 2016 preliminary gout remission definition, a modified preliminary definition with more lenient thresholds for the individual variables pain due to gout and patient global assessment of gout disease activity, and the simplified definition without patient reported outcomes.

Challenge of missing data in observational studies: investigating cross-sectional imputation methods for assessing disease activity in axial spondyloarthritis.

Objectives: We aimed to compare various methods for imputing disease activity in longitudinally collected observational data of patients with axial spondyloarthritis (axSpA).

Methods: We conducted a simulation study on data from 8583 axSpA patients from ten European registries. Disease activity was assessed by the Axial Spondyloarthritis Disease Activity Score (ASDAS) and the corresponding low disease activity (LDA; ASDAS<2.

Can mindfulness have long-term impact on patients with fibromyalgia? A two-year prospective follow-up study of a mindfulness-based intervention.

To examine changes in symptoms and health status in patients with fibromyalgia (FM) 24 months after participating in the mindfulness-based group-program, the Vitality Training (VTP), followed by physical exercise counselling. Seventy-six participants, mean age (range) 43 (26-52), females 69 (91%), diagnosed with FM according to the ACR 2011-criteria received the VTP in a previous randomised controlled trial. Control group participants could receive the VTP after a 12-month observation period, therefore only data from the intervention group were analysed in the present study.

Pain sensitization in fibromyalgia. Cross-sectional associations between quantitative sensory testing of pain sensitization and fibromyalgia disease burden.

Background: Whether fibromyalgia burden is related to measures of sensitization, assessed by quantitative sensory testing (QST), is not clear. We examine the associations between sensitization and fibromyalgia disease burden as measured by the polysymptomatic sistress scale (PDS) and the fibromyalgia impact questionnaire (FIQ) (range 0-100).

Materials And Methods: Participants were recruited from referrals to a rheumatology outpatient clinic and the fibromyalgia diagnosis was verified by a rheumatologist.

Humoral and cellular responses to a fifth bivalent SARS-CoV-2 vaccine dose in patients with immune-mediated inflammatory diseases on tumour necrosis factor inhibitors: a prospective cohort study.

Background: As most people now have established hybrid immunity, the need for regular, updated SARS-CoV-2 vaccine boosters in patients with immune-mediated inflammatory diseases (IMIDs) is unclear. The study aim was to assess humoral and cellular immunogenicity of a fifth bivalent vaccine dose in patients with IMID on tumour necrosis factor inhibitors (TNFi).

Methods: In the longitudinal, observational Nor-vaC study, we assessed anti-spike and neutralising antibodies against Wuhan, Omicron BA.

Non-adherence to urate lowering therapy in gout after 5 years is related to poor outcomes: results from the NOR-Gout study.

Objectives: Patients with gout need to adhere to medication over time to achieve good outcomes. We assessed self-reported adherence to medication with urate lowering therapy (ULT) 5 years after a treat-to-target intervention and studied how non-adherence was related to baseline demographic and disease variables.

Methods: Patients in the NOR-Gout observational study were included after a recent gout flare and serum urate >360 µmol/l.

T cell responses to repeated SARS-CoV-2 vaccination and breakthrough infections in patients on TNF inhibitor treatment: a prospective cohort study.

Background: Understanding cellular responses to SARS-CoV-2 immunisations is important for informing vaccine recommendations in patients with inflammatory bowel disease (IBD) and other vulnerable patients on immunosuppressive therapies. This study investigated the magnitude and quality of T cell responses after multiple SARS-CoV-2 vaccine doses and COVID-19 breakthrough infection.

Methods: This prospective, observational study included patients with IBD and arthritis on tumour necrosis factor inhibitors (TNFi) receiving up to four SARS-CoV-2 vaccine doses.

Interstitial Lung Disease in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Initiating Biologics and Controls: Data From 5 Nordic Registries.

Objective: Interstitial lung disease (ILD) is one of the most common pulmonary manifestations of rheumatoid arthritis (RA), but its prevalence has not been investigated in psoriatic arthritis (PsA). The role of methotrexate (MTX) in ILD development remains under debate. This study (1) compares the incidences of ILD in patients with RA or PsA initiating a first biologic disease-modifying antirheumatic drug (bDMARD) to that in the general population, and (2) investigates the role of MTX comedication on ILD incidence.

Effectiveness of secukinumab in radiographic and non-radiographic axial spondyloarthritis: a European routine-care observational study.

Objectives: To compare the treatment effectiveness of secukinumab in radiographic (r) versus non-radiographic (nr) axial spondyloarthritis (axSpA) patients treated in routine care across Europe.

Methods: Prospectively collected data on secukinumab-treated axSpA patients with known radiographic status were pooled from nine countries.Remission rates based on patient-reported outcomes (PROs; Numeric Rating Scale (0-10), for example, pain ≤2/Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤2 and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ID) <1.

Ultrasound evaluation contrasts clinical disease activity evaluation in rheumatoid arthritis patients with concomitant anxiety or depression.

Objectives: To compare disease activity as assessed by ultrasonography (US) between rheumatoid arthritis (RA) patients with and without anxiety or depression, and to compare clinical disease activity and sociodemographic measures between these patient groups.

Methods: Anxious or depressed patients were identified by EuroQoL-5D-3L question "I am not/moderately/extremely anxious or depressed." US assessments of 36 joints and 4 tendons were performed and power Doppler (PD) and grey scale (GS) sum scores calculated (both range 0-120).

Cut-Offs for Disease Activity States in Axial Spondyloarthritis With Ankylosing Spondylitis Disease Activity Score (ASDAS) Based on C-Reactive Protein and ASDAS Based on Erythrocyte Sedimentation Rate: Are They Interchangeable?

Objective: Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is recommended over ASDAS based on erythrocyte sedimentation rate (ASDAS-ESR) to assess disease activity in axial spondyloarthritis (axSpA). Although ASDAS-CRP and ASDAS-ESR are not interchangeable, the same disease activity cut-offs are used for both. We aimed to estimate optimal ASDAS-ESR values corresponding to the established ASDAS-CRP cut-offs (1.

Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy: identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study.

Objectives: To assess incidence, severity and predictors of COVID-19, including protective post-vaccination levels of antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD), informing further vaccine strategies for patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive medication.

Methods: IMIDs on immunosuppressives and healthy controls (HC) receiving SARS-CoV-2 vaccines were included in this prospective observational study. COVID-19 and outcome were registered and anti-RBD antibodies measured 2-5 weeks post-immunisation.

Participatory Development of a Virtual Reality Exercise Program for People with Chronic Pain.

By describing how a participatory process led to changes in the design of a study of a virtual reality (VR)-guided exercise and mindfulness intervention tailored to people with chronic musculoskeletal pain, this article makes the case for including end user at an early stage when planning research within this field. A multidisciplinary panel including end-user representatives, researcher, clinicians, and VR developers participated in a 1-day workshop to design a randomized study and a VR-guided intervention. Through the participatory process, changes were made to the original study design with respect to experimental design, duration, content of VR interventions and mode of delivery.

Dynamics of SARS-CoV-2 immunity after vaccination and breakthrough infection in rituximab-treated rheumatoid arthritis patients: a prospective cohort study.

Background: SARS-CoV-2 vaccination in rheumatoid arthritis (RA) patients treated with B cell-depleting drugs induced limited seroconversion but robust cellular response. We aimed to document specific T and B cell immunity in response to vaccine booster doses and breakthrough infection (BTI).

Methods: We included 76 RA patients treated with rituximab who received up to four SARS-CoV-2 vaccine doses or three doses plus BTI, in addition to vaccinated healthy donors (HD) and control patients treated with tumor necrosis factor inhibitor (TNFi).

Patient-reported outcomes in axial spondyloarthritis and psoriatic arthritis patients treated with secukinumab for 24 months in daily clinical practice.

Objectives: In patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) initiating secukinumab, we aimed to assess and compare the proportion of patients achieving 6-, 12- and 24-month patient-reported outcomes (PRO) remission and the 24-month retention rates.

Patients And Methods: Patients with axSpA or PsA from 16 European registries, who initiated secukinumab in routine care were included. PRO remission rates were defined as pain, fatigue, Patient Global Assessment (PGA) ≤2 (Numeric Rating Scale (NRS) 0-10) and Health Assessment Questionnaire (HAQ) ≤0.

Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial.

Background: Patients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist health care to maintain low disease activity. The follow-up has been organized as prescheduled face-to-face visits, which are time-consuming for both patients and health care professionals. Technology has enabled the remote monitoring of disease activity, allowing patients to self-monitor their disease and contact health care professionals when needed.

Developing and externally validating multinomial prediction models for methotrexate treatment outcomes in patients with rheumatoid arthritis: results from an international collaboration.

Objectives: In rheumatology, there is a clinical need to identify patients at high risk (>50%) of not responding to the first-line therapy methotrexate (MTX) due to lack of disease control or discontinuation due to adverse events (AEs). Despite this need, previous prediction models in this context are at high risk of bias and ignore AEs. Our objectives were to (i) develop a multinomial model for outcomes of low disease activity and discontinuing due to AEs 6 months after starting MTX, (ii) update prognosis 3-month following treatment initiation, and (iii) externally validate these models.

Definition of rheumatoid arthritis flare based on SDAI and CDAI.

Objective: To develop and validate definitions for disease flares in rheumatoid arthritis (RA) based on the quantitative Simplified and Clinical Disease Activity Indices (SDAI, CDAI).

Methods: We analysed RA treatment courses from the Norwegian disease-modifying antirheumatic drug registry (NOR-DMARD) and the Vienna RA cohort. In a receiver operating curve analysis, we determined flare definitions for absolute changes in SDAI and CDAI based on a semiquantitative patient anchor.