Patients with axial spondyloarthritis reported willingness to use remote care and showed high adherence to electronic patient-reported outcome measures: an 18-month observational study.

Remote monitoring using electronic patient reported outcomes (ePROs) in axial spondyloarthritis (axSpA) may improve self-management and reduce the need for consultations. However, knowledge regarding patients' willingness to use remote care and adherence to reporting ePROs is scarce. The objective of this study was to assess axSpA patients' willingness to use remote care and adherence to reporting of ePROs. The study was part of a three-armed randomized controlled trial testing digital follow-up strategies (The ReMonit study, NCT: 05031767). AxSpA patients in low disease activity were randomized to usual care, remote monitoring, or patient-initiated care. Demographics, clinical data, and patients' willingness to use remote care were collected at baseline. EPROs were reported either monthly or quarterly by the remote monitoring- and patient-initiated care group over 18 months, respectively. Adherence to reporting was calculated as number of ePROs completed divided by the total number requested. Mixed model logistic regression was utilized to assess factors associated with adherence to reporting of ePROs. In total 242 patients (median age 43 years, 75% males) were included. The majority (96%) reported high willingness to use remote care. Adherence to reporting ePROs remained high over 18 months by remote monitoring and patient-initiated care groups [median (IQR): 88% (77-100) vs. 83% (66-100)]. No patient characteristics were significantly associated with adherence to reporting of ePROs. The high degree of willingness and adherence to reporting ePROs over time indicates that the majority of axSpA patients with low disease activity are motivated to use remote care.

Comparative Effectiveness and Persistence of SB4 and Reference Etanercept in Patients With Psoriatic Arthritis in Norway.

OBJECTIVE: We aim to compare drug effectiveness and persistence between the reference etanercept (ETN) and ETN biosimilar SB4 in patients with psoriatic arthritis (PsA) naive to ETN and to investigate drug effectiveness and persistence in those undergoing a mandatory nonmedical switch from ETN to SB4. METHODS: We used a retrospective comparative database study including 1,138 patients with PsA treated with ETN or SB4 (years 1999-2021) in Norway. Disease activity score in 28 joints (DAS28) and drug persistence were compared between unmatched ETN (n = 644) and SB4 (n = 252) cohorts and in matched analyses (n = 144, both cohorts) at baseline using a propensity score (PS) to adjust for confounders. Drug persistence was analyzed with the Kaplan-Meier method. RESULTS: In unmatched analyses, difference in change from baseline between ETN (n = 140) and SB4 (n = 132) for DAS28 at one year was mean 0.67 (95% confidence interval [CI] 0.38-0.96) in favor of ETN. In PS-matched analyses, the difference in change from baseline between ETN (n = 54) and SB4 (n = 54) was mean 0.09 (95% CI -0.33 to 0.50), and the mean difference assessed with an analysis of covariance model was 0.01 (95% CI -0.38 to 0.40), both within predefined equivalence margin (±0.6). Drug persistence at one year was mean 0.75 (95% CI 0.71-0.78) for ETN, mean 0.58 (95% CI 0.51-0.63) for SB4, hazard ratio (HR) 2.45 (95% CI 2.02-2.97) in unmatched analysis, and mean 0.55 (95% CI 0.46-0.63) for ETN, mean 0.60 (95% CI 0.51-0.67) for SB4, HR 1.29 (95%CI 0.94-1.76) in PS-matched cohorts. CONCLUSION: At one year, outcomes for PsA disease activity and drug persistence were comparable for patients treated with either ETN or SB4. In patients undergoing a mandatory nonmedical switch from ETN to SB4, drug effectiveness was maintained during a two-year period.

Effects of tapering conventional synthetic disease-modifying antirheumatic drugs to drug-free remission versus stable treatment in rheumatoid arthritis (ARCTIC REWIND): 3-year results from an open-label, randomised controlled, non-inferiority trial.

BACKGROUND: Tapering of disease-modifying antirheumatic drugs (DMARDs) to drug-free remission is an attractive treatment goal for patients with rheumatoid arthritis, although long-term effects of tapering and withdrawal remain unclear. We compared 3-year risks of flare between three conventional synthetic DMARD treatment strategies in patients with rheumatoid arthritis in sustained remission. METHODS: In this open-label, randomised controlled, non-inferiority trial, we enrolled patients aged 18-80 years with rheumatoid arthritis who had been in sustained remission for at least 1 year on stable conventional synthetic DMARD therapy. Patients from ten hospitals in Norway were randomly assigned (2:1:1) with centre stratification to receive stable conventional synthetic DMARDs, half-dose conventional synthetic DMARDs, or half-dose conventional synthetic DMARDs for 1 year followed by withdrawal of all conventional synthetic DMARDs. The primary endpoint of this part of the study was disease flare over 3 years, analysed as flare-free survival and risk difference in the per-protocol population with a non-inferiority margin of 20%. This trial is registered with ClinicalTrials.gov (NCT01881308) and is completed. FINDINGS: Between June 17, 2013, and June 18, 2018, 160 patients were enrolled and randomly assigned to receive stable-dose conventional synthetic DMARDs (n=80), half-dose conventional synthetic DMARDs (n=42), or half-dose conventional synthetic DMARDs tapering to withdrawal (n=38). Four patients did not receive the intervention and 156 patients received the allocated treatment strategy. One patient was excluded due to major protocol violation and 155 patients were included in the per-protocol analysis. 104 (67%) of 156 patients were women and 52 (33%) were men. 139 patients completed 3-years follow-up without major protocol violation; 68 (87%) of 78 patients in the stable-dose group, 36 (88%) of 41 patients in the half-dose group and 35 (95%) of 37 patients in the half-dose tapering to withdrawal group. During the 3-year study period, 80% (95% CI 69-88%) were flare-free in the stable-dose group, compared with 57% (41-71%) in the half-dose group and 38% (22-53%) in the half-dose tapering to withdrawal group. Compared with stable-dose conventional synthetic DMARDs, the risk difference of flare was 23% (95% CI 6-41%, p=0·010) in the half-dose group and 40% (22-58%, p<0·0001) in the half-dose tapering to withdrawal group, non-inferiority was therefore not shown. Adverse events were reported in 65 (83%) of 78 patients in the stable-dose group, 36 (90%) of 40 patients in the half-dose group, and 36 (97%) of 37 patients in the half-dose tapering to withdrawal group. One death occurred in the stable-dose conventional synthetic DMARD group (sudden death considered unlikely related to the study medication). INTERPRETATION: Two conventional synthetic DMARD tapering strategies were associated with significantly lower rates of flare-free survival compared with stable conventional synthetic DMARD treatment, and the data do not support non-inferiority. However, drug-free remission was achiveable for a significant subgroup of patients. This trial provides information on risk and benefits of different treatment strategies important for shared decision making. FUNDING: Research Council of Norway and South-Eastern Norway Regional Health Authority.

Decreasing incidence of cervical spine fractures in patients with ankylosing spondylitis: a population-based study in Southeast Norway.

BACKGROUND CONTEXT: Individuals diagnosed with ankylosing spondylitis (AS) face an increased risk of spine fractures, specifically cervical spine fractures (CS-Fxs). In the past two decades, biological disease-modifying antirheumatic drugs (bDMARDs) have provided considerable relief from pain and an enhanced sense of wellbeing for a large segment of AS patients. Despite these improvements, it remains unclear whether extended use of bDMARDs can indeed reduce the risk of spine fractures. PURPOSE: In this study, we aimed to investigate the evolving patterns and epidemiology of traumatic CS-Fxs in both AS and non-AS populations. We hypothesized that the risk of CS-Fxs among AS patients would show a decreasing trend over time, while the risk among non-AS patients would remain constant. STUDY DESIGN/SETTING: Retrospective cohort study based on a prospective database. PATIENT SAMPLE: A total of 3,598 consecutive patients with CS-Fxs were treated at Oslo University Hospital over an 8-year period. OUTCOME MEASURES: CS-Fxs in AS patients were contrasted with non-AS-related CS-Fxs in terms of temporal trends, age, sex, injury mechanism, associated cervical spinal cord injury (cSCI), need for surgical fixation, and 30-day mortality. METHODS: Data regarding all CS-Fxs diagnosed between 2015 and 2022 were extracted from the Southeast Norway population-based quality control database for traumatic CS-Fxs. Categorical data were summarized using frequencies, and continuous data were summarized using medians. The Wilcoxon rank-sum test was used to compare continuous variables, and the chi-squared test and Fischer exact test were used to compare categorical variables. To investigate the trend in the incidence of fractures, two different Poisson models were fitted with the number of non-AS and AS fractures as dependent variables and the year as the explanatory variable. RESULTS: Over an 8-year period, we registered 3,622 CS-Fxs in 3598 patients, with AS patients accounting for 125 of these fractures. Relative to their non-AS counterparts, AS patients presented a 9-fold and 8-fold higher risk of initial and subsequent CS-Fxs, respectively. We observed a declining trend in AS-related CS-Fxs with an annual linear decrease of 8.4% (p=.026), whereas non-AS-related CS-Fxs showed an annual linear increase of 3.7% (p<.001). AS patients sustaining CS-Fxs were typically older (median age 70 vs 63 years), predominantly male (89% vs 67%), and more frequently experienced injuries due to falls (82% vs 57%). They also exhibited a higher prevalence of subaxial CS-Fxs (91% vs 62%), fewer C0-C2 CS-Fxs (14% vs 44%), a higher rate of associated cSCI (21% vs 11%), and a greater tendency for surgical fixation (66% vs 21%). We observed a 30-day mortality rate of 11% in AS patients and 5.4% in non-AS patients (p=.005). CONCLUSIONS: The results of this study confirm the elevated risk of CS-Fxs among AS patients, although this risk appears to show a decreasing trend. The most plausible explanation for this risk reduction is the widespread application of bDMARDs.

Male patients with inflammatory joint diseases are less likely than controls to be childless: results from a Norwegian population-based cohort study of 10 865 patients.

OBJECTIVES: To investigate the number of children per man and the proportion of childless men as a proxy of fertility in a national cohort of men with inflammatory joint diseases (IJDs), compared with matched controls from the general population. METHODS: This is a nationwide, population-based retrospective cohort study. Male patients with IJDs (n = 10 865) in the Norwegian Arthritis Registry were individually matched 1:5 on birth year and county of residence with men without IJDs obtained from the National Population Register (n = 54 325). Birth data were obtained from the Medical Birth Registry of Norway. We compared the mean number of children per man and the proportion of childless men and analysed the impact of age and year of diagnosis. RESULTS: The mean number of children per man in the patient group was 1.80 versus 1.69 in the comparison group (p <0.001), and 21% of the patients in the patient group were childless versus 27% in the comparison group (p <0.001). The finding of less childlessness and higher number of children per man remained consistent across age at diagnosis, except for those diagnosed at age 0-19 years. The difference in childlessness was most pronounced for men diagnosed after year 2000, especially when diagnosed at 30-39 years of age (22% vs 32%, p<0.001). CONCLUSION: In this large cohort study we found that patients with IJD have a higher number of children and are less likely to be childless compared with controls. Factors associated with developing or having an IJD might influence fertility and this requires further investigation.

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. Remote monitoring or self-monitoring may provide a more personalized follow-up, but there is limited research on how these follow-up strategies perform in maintaining low disease activity, patient satisfaction, safety, and cost-effectiveness. OBJECTIVE: The Remote Monitoring in Axial Spondyloarthritis (ReMonit) study aimed to assess the effectiveness of digital remote monitoring and self-monitoring in maintaining low disease activity in patients with axial spondyloarthritis. METHODS: The ReMonit study is a 3-armed, single-site, randomized, controlled, open-label noninferiority trial including patients with axial spondyloarthritis with low disease activity (Ankylosing Spondylitis Disease Activity Score <2.1) and on stable treatment with a tumor necrosis factor inhibitor. Participants were randomized 1:1:1 to arm A (usual care, face-to-face visits every sixth month), arm B (remote monitoring, monthly digital registration of patient-reported outcomes), or arm C (patient-initiated care, self-monitoring, no planned visits during the study period). The primary end point was disease activity measured with the Ankylosing Spondylitis Disease Activity Score, evaluated at 6, 12, and 18 months. We aimed to include 240 patients, 80 in each arm. Secondary end points included other measures of disease activity, patient satisfaction, safety, and cost-effectiveness. RESULTS: The project is funded by the South-Eastern Norway Regional Health Authority and Centre for the treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Norway. Enrollment started in September 2021 and was completed with 242 patients by June 2022. The data collection will be completed in December 2023. CONCLUSIONS: To our knowledge, this trial will be among the first to evaluate the effectiveness, safety, and cost-effectiveness of remote digital monitoring and self-monitoring of patients with axial spondyloarthritis compared with usual care. Hence, the ReMonit study will contribute important knowledge to personalized follow-up strategies for patients with axial spondyloarthritis. These results may also be relevant for other patient groups with inflammatory joint diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT05031767; hpps://www.clinicaltrials.gov/study/NCT05031767. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52872.