No excess mortality in contemporary undifferentiated arthritis, in contrast to rheumatoid arthritis: a study with a follow-up of at least 10 years.
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ABSTRACT:
SUBMITTER: Verstappen M
PROVIDER: S-EPMC7615882 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
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No excess mortality in contemporary undifferentiated arthritis, in contrast to rheumatoid arthritis: a study with a follow-up of at least 10 years.
Verstappen Marloes M Huizinga Tom Wj TW van der Helm-van Mil Annette Hm AH
Annals of the rheumatic diseases 20220302 8
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Project description:BackgroundThis research describes the incidence and factors associated with opportunistic infections in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs).MethodsA retrospective longitudinal study was carried out from 2007 to 2018. We included RA patients treated with a tumor necrosis factor (TNF)-targeted bDMARD or non-TNF-targeted bDMARD from the start of bDMARDs. An independent variable was the development of an indicator of opportunistic infection after biological (IOIb) treatment. Secondary variables included sociodemographic, clinical, and treatments. We used survival techniques to estimate the incidence of IOIb, per 1000 patient-years (95% CI). We performed a Cox multivariate regression analysis model to compare the risk of IOIb. Results were expressed as a hazard ratio (HR).ResultsA total of 441 RA patients were included, that started 761 different courses of bDMARDs. A total of 81% were women with a mean age at first bDMARD of 57.3 ± 14 years. A total of 71.3% of the courses were TNF-targeted bDMARDs and 28.7% were non-TNF-targeted bDMARDs. There were 37 IOIb (25 viral, 6 fungal, 5 bacterial, 1 parasitic). Nine of these required hospitalization and one died. The global incidence of IOIb was 23.2 (16.8-32). TNF-targeted bDMARDs had 25 IOIb, incidence 20.5 (13.9-30.4), and non-TNF-targeted bDMARDs had 12 IOIb, incidence 31.7 (18-55.9). In the multivariate analysis, glucocorticosteroids (HR 2.17, p = 0.004) and lower lymphocyte count increased the risk for IOIb (HR 0.99, p = 0.005).ConclusionsThe incidence of IOIb due to bDMARDs was 23 cases per 1000 patient-years. Close monitoring should be taken in the RA patients treated with bDMARDs and glucocorticosteroids, mainly in elderly patients and those with a low total lymphocyte count at the beginning of bDMARD treatment.
| S-EPMC6783660 | biostudies-literature
Project description:We aimed at analyzing important predictive factors for experienced negative emotional and social effects of rheumatoid arthritis (RA) two years after diagnosis in patients aged 18-65 years. The first group included 41 participants, who had psychosocial problems (PSP) already at diagnosis, and who received an intervention by a medical social worker to improve coping capacity and social situation. The second group included 54 patients (NPSP) without such problems at diagnosis. All completed a questionnaire mapping their social situation, the Hospital Anxiety and Depression Scale (HADS), the Sense of Coherence Scale (SOC) and the General Coping Questionnaire (GCQ) at diagnosis and after 24 months. The most pronounced predictive factor for a strong impact of the disease was high scores on HADS depression scale. After 24 months, PSP participants had a more strained life situation, with higher scores on anxiety and depression and lower on SOC, in comparison with NPSP. NPSP participants improved their coping strategies regarding self-trust, cognitive revaluation, protest and intrusion, but deteriorated regarding problem focusing and social trust. PSP patients kept their initial coping strategies, except for intrusion decreasing over time, and seemed to have a more rigid coping pattern. However, the experienced negative impact of the disease increased over time in both groups despite improvement in sickness related data. Mostly influenced areas were economy, leisure time activities and social life. We conclude that psychosocial consequences of RA are more connected to emotional and social vulnerability than are RA-related clinical factors.
| S-EPMC3948188 | biostudies-literature
Project description:ObjectiveSarilumab is a human monoclonal antibody that blocks IL-6 from binding to membrane-bound and soluble IL-6 receptor-α. We assessed the long-term safety of sarilumab in patients from eight clinical trials and their open-label extensions.MethodsData were pooled from patients with rheumatoid arthritis who received at least one dose of sarilumab in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; combination group) or as monotherapy (monotherapy group). Treatment-emergent adverse events (AEs) and AEs and laboratory values of special interest were assessed.Results2887 patients received sarilumab in combination with csDMARDs and 471 patients received sarilumab monotherapy, with mean exposure of 2.8 years and 1.7 years, maximum exposure 7.3 and 3.5 years, and cumulative AE observation period of 8188 and 812 patient-years, respectively. Incidence rates per 100 patient-years in the combination and monotherapy groups, respectively, were 9.4 and 6.7 for serious AEs, 3.7 and 1.0 for serious infections, 0.6 and 0.5 for herpes zoster (no cases were disseminated), 0.1 and 0 for gastrointestinal perforations, 0.5 and 0.2 for major adverse cardiovascular events, and 0.7 and 0.6 for malignancy. Absolute neutrophil counts <1000 cells/mm3 were recorded in 13% and 15% of patients, respectively. Neutropenia was not associated with increased risk of infection or serious infection. Analysis by 6-month interval showed no signal for increased rate of any AE over time.ConclusionThe long-term safety profile of sarilumab, either in combination with csDMARDs or as monotherapy, remained stable and consistent with the anticipated profile of a molecule that inhibits IL6 signalling.
| S-EPMC7571482 | biostudies-literature
Project description:ObjectiveThe objective of this study was to investigate the safety and effectiveness of disease activity-guided dose optimization of TNF inhibitors in RA over 10 years.MethodsThe study involved an observational long-term extension of a randomized study of participants who completed the 3-year extension of the DRESS-study. After the randomized phase (months 0-18), disease activity-guided dose optimization was allowed for all. The main outcomes were mean time-weighted DAS28-CRP; biologic and targeted synthetic DMARD (b/tsDMARD) use per year, as proportion of daily defined dose; proportion of patients reaching discontinuation; durability and effectiveness of subsequent dose reduction attempts; and radiographic progression between years 3 and 10 using the Sharp-van der Heijde score.ResultsA total of 170 patients were included, of whom 127 completed the 10-year follow-up. The mean disease activity remained low (DAS28-CRP 2.13, 95% CI 2.10-2.16), while the b/tsDMARD dose reduced from 97% at baseline (95% CI 96-99%, n = 170) to 56% at year 10 (95% CI 49-63%, n = 127). Of 161 participants with an optimization attempt, 119 (74%) reached discontinuation with a median duration of 7 months (interquartile range 3-33 months), and 25 participants never had to restart their b/tsDMARD (21%, 95% CI 14-29%). The mean dose reduction after dose optimization was 48% (n = 159) for the first optimization attempt, and 33% for a subsequent attempt (n = 86). Of the 86 participants, 41 (48%) had radiographic progression exceeding the smallest detectable change (5.7 units), and progression was associated with disease activity, not b/tsDMARD use.ConclusionLong-term disease activity-guided dose optimization of TNF inhibitors in RA, including discontinuation and multiple tapering attempts, remains safe and effective.
| S-EPMC11781578 | biostudies-literature
Project description:We studied emotional health in patients with diabetes mellitus (n = 89) or rheumatoid arthritis (n = 100) aged 18-65 years, at the time of diagnosis and after 24 months. Predictors for depression or anxiety according to the Hospital Anxiety and Depression scale after 2 years were assessed by logistic regression, with psychosocial factors and coping as dependent factors. There were many similarities between patients with diabetes mellitus or rheumatoid arthritis. Having children at home, low score on the Sense of Coherence scale, and high score on the coping strategy "protest" were important risk factors for depression and anxiety after 2 years.
| S-EPMC5193320 | biostudies-literature
Project description:ObjectivesIdentifying patients that will develop RA among those presenting with undifferentiated arthritis (UA) remains a clinical dilemma. Although MRI is helpful according to EULAR recommendations, this has only been determined in UA patients not fulfilling 1987 RA criteria, while some of these patients are currently considered as RA because they fulfil the 2010 criteria. Therefore, we studied the predictive value of MRI for progression to RA in the current UA population, i.e. not fulfilling RA classification criteria (either 1987 or 2010 criteria) and not having an alternate diagnosis. Additionally, the value of MRI was studied in patients with a clinical diagnosis of UA, regardless of the classification criteria.MethodsTwo UA populations were studied: criteria-based UA as described above (n = 405) and expert-opinion-based UA (n = 564), i.e. UA indicated by treating rheumatologists. These patients were retrieved from a large cohort of consecutively included early arthritis patients that underwent contrast-enhanced MRI scans of hand and foot at baseline. MRIs were scored for osteitis, synovitis and tenosynovitis. Patients were followed for RA development during the course of 1 year. Test characteristics of MRI were determined separately for subgroups based on joint involvement and autoantibody status.ResultsAmong criteria-based UA patients (n = 405), 21% developed RA. MRI-detected synovitis and MRI-detected tenosynovitis were predictive for progression to RA. MRI-detected tenosynovitis was independently associated with RA progression (odds ratio (OR) 2.79; 95% CI 1.40, 5.58), especially within ACPA-negative UA patients (OR 2.91; 95% CI 1.42, 5.96). Prior risks of RA development for UA patients with mono-, oligo- and polyarthritis were 3%, 19% and 46%, respectively. MRI results changed this risk most within the oligoarthritis subgroup: positive predictive value was 27% and negative predictive value 93%. Similar results were found in expert-opinion-based UA (n = 564).ConclusionThis large cohort study showed that MRI is most valuable in ACPA-negative UA patients with oligoarthritis; a negative MRI could aid in preventing overtreatment.
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Project description: Not available
| S-EPMC7581623 | biostudies-literature
Project description:Bone marrow mononuclear cells (BMMCs) have been evaluated for their ability to improve cardiac repair and benefit patients with severe ischemic heart disease and heart failure. In our single-center trial in 2006-2011 we demonstrated the safety and efficacy of BMMCs injected intramyocardially in conjunction with coronary artery bypass surgery. The effect persisted in the follow-up study 5 years later. In this study, we investigated the efficacy of BMMC therapy beyond 10 years. A total of 18 patients (46%) died during over 10-years follow-up and 21 were contacted for participation. Late gadolinium enhancement cardiac magnetic resonance imaging (CMRI) and clinical evaluation were performed on 14 patients, seven from each group. CMRIs from the study baseline, 1-year and 5-years follow-ups were re-analyzed to enable comparison. The CMRI demonstrated a 2.1-fold larger reduction in the mass of late gadolinium enhancement values between the preoperative and the over 10-years follow-up, suggesting less scar or fibrosis after BMMC treatment (- 15.1%; 95% CI - 23 to - 6.7% vs. - 7.3%; 95% CI - 16 to 4.5%, p = 0.039), compared to placebo. No differences in mortality or morbidity were observed. Intramyocardially injected BMMCs may exert long-term benefits in patients with ischemic heart failure. This deserves further evaluation in patients who have received BMMCs in international clinical studies over two decades.
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Project description:BackgroundTimely, high-quality care is critical to rheumatoid arthritis (RA) management. In Alberta, thousands of individuals with RA are waiting for care due to the resource-intensive nature of lifelong follow-ups and rheumatologist shortages. With 20-50% of routine follow-ups not leading to treatment changes or raising new concerns, many appointments may be avoidable if care were restructured. Patient-initiated models extend rheumatologist follow-up intervals beyond 12 months where appropriate, which can reduce inefficiencies and improve care access. To address provincial RA care challenges, we co-developed a theory of change (TOC) for patient-initiated follow-up care.MethodsA TOC serves to define health services interventions and their intended impact prior to implementation testing. We worked with 35 healthcare leaders, implementation experts, and patient partners to co-develop a TOC for patient-initiated RA follow-up care. During the scoping phase, we held discussions with healthcare leaders and reviewed evidence on patient-initiated follow-up models to assess their implementation potential. During the development phase, we drafted a TOC map using scoping phase findings and clinical and patient expertise. During the refinement phase, feedback was collected to optimize the TOC. Meetings were recorded, transcribed, and analyzed using deductive qualitative content analysis alongside anonymous poll results and informal feedback to guide TOC refinement.ResultsThe scoping phase identified challenges in RA care, including long waitlists and unnecessary appointments, which patient-initiated follow-up models have the potential to address. TOC discussions highlighted two intended impacts: (1) efficient and effective care for patients when needed, and (2) a sustainable model for RA care. Feedback in the refinement phase covered 4 topics: (1) preference for an interdisciplinary flare clinic, (2) patient selection, (3) patient education, and (4) patient monitoring. Tools and strategies were co-developed with partners to support patients (e.g., decision tool for patient-provider discussions) and the health system (e.g., monthly meetings to monitor burden). The final TOC for patient-initiated follow-up in RA details the care pathway, key resources and considerations, and evaluation outcomes.ConclusionsA patient-centered, context-specific patient-initiated RA follow-up care model was co-developed with patient and healthcare partners. An implementation pilot will test its ability to address RA care challenges.Clinical trial registrationNot applicable.
| S-EPMC11899900 | biostudies-literature
Project description:ObjectivesTo determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.DesignTwo year randomised controlled trial extended to six years.SettingRheumatology outpatient department in teaching hospital.Participants209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).Main outcome measuresClinical outcomepain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.ResultsParticipants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).ConclusionsOver six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.
| S-EPMC544988 | biostudies-literature