Clinical Disease Activity Research Articles

Vitamin D as a predictor of severe course of inflammatory bowel diseases in children

Background. Inflammatory bowel diseases (IBD) develop in childhood more often, last throughout life, and their frequency is rapidly increasing in industrialized countries. Most researchers identify vitamin D (VD) as a key regulator of gastrointestinal homeostasis, an innate immune response and a biomarker for the activity and severity of IBD. The purpose was to determine the frequency of vitamin D deficiency and its relationship with the course of inflammatory bowel diseases in children. Materials and methods. The study included 36 patients: 13 with IBD (main group) and 23 children of the comparison group with irritable bowel syndrome and functional abdominal pain. The average age of children was 13.09 ± 2.28 years, with a median of 14.5 years; 63.6 % were boys. Patients with IBD were evaluated for clinical disease manifestations, disease localization (Paris Classification) and disease activity (PCDAI/PUCAI). Irritable bowel syndrome and functional abdominal pain were diagnosed based on the Rome IV Criteria. Serum 25-hydroxyvitamin D (25(OH)D) was assessed by the electrochemiluminescence method (Elecsys Vitamin D total, Cobas). Results. Severe IBD prevailed among the examined children (61.5 %). There was no significant difference in overall body weight and height between the groups, which may be due to the short duration of IBD. However, children with IBD showed a tendency to lower physical development indicators. Significant differences in hemoglobin, erythrocyte sedimentation rate, C-reactive protein, number of platelets, fecal calprotectin were observed among the studied groups (p < 0.05). The concentration of VD in the blood of the examined children ranged from 39.9 to 10.8 ng/ml, with an average of 21.8 ± 5.8 ng/ml. In 76.9 % of patients with IBD, blood concentration of VD reduced, while only 21.7 % children in the comparison group had its level below the norm. Children with IBD were characterized by significantly lower levels of VD in the blood (average of 16.7 ng/ml). Lower levels of VD were associated with female sex, Chron’s disease (CD) and ulcerative colitis (UC), as well as disease duration of more than 3 years and disease severity. There was an inverse correlation between VD and the degree of IBD activity (CD: r = –0.33; p = 0.01; UC: r = –0.38; p = 0.01) and the severity of the course (CD: r = –0.35; p = 0.01; UC: r = –0.36; p = 0.01), the levels of C-reactive protein (CD: r = –0.39; p = 0.01; UC: r = –0.37; p = 0.01) and fecal calprotectin (CD: r = –0.42; p = 0.01; UC: r = –0.46; p = 0.01). Conclusions. In most children (76.9 %) with inflammatory bowel diseases, the concentration of VD in the blood is significantly lower than in those with functional gastrointestinal disorders. Lower vitamin D levels were associated with female sex, Crohn’s disease, and ulcerative colitis, as well as disease duration of more than 3 years, activity level, and severity, supporting the role of vitamin D as a possible predictor of severity of these diseases in childhood.

Clinical usefulness of hypoxia imaging colonoscopy for the objective measurement of ulcerative colitis disease activity

Background and AimsColonic mucosal hypoxia is associated with mucosal inflammation in ulcerative colitis (UC). We aimed to assess the clinical usefulness of hypoxia imaging colonoscopy for the assessment of clinical, endoscopic, and histologic disease activities of UC. MethodsThis was a retrospective cohort study comprised of 100 consecutive UC patients who underwent hypoxia imaging colonoscopy between September 2022 and September 2023 at the University of Tsukuba Hospital. We measured colonic tissue oxygen saturation (StO2) at the biopsy sites and compared StO2 values between different disease activities. We used receiver operating characteristic (ROC) analysis to calculate the area under the ROC curve (AUROC). ResultsWe identified a significant correlation between rectal StO2 and the Simple Clinical Colitis Activity Index, with moderate accuracy to predict bowel urgency at a 40.5% cutoff (AUROC 0.74, 95% CI 0.62-0.87). Our analysis of 490 images showed median StO2 values for Mayo endoscopic subscores (MES) 0, 1, 2, and 3 as 52% (IQR 48%-56%), 47% (IQR 43%-52%), 42% (IQR 38.8%-47%), and 39.5% (IQR 37.3%-41.8%), respectively. Differences for all pairs were significant. Median StO2 was 49% (IQR 44%-54%) for Geboes scores 0-2, significantly higher than histologically active disease (Geboes score ≥ 3). At a colonic StO2 cutoff of 45.5%, AUROCs for endoscopically and histologically active diseases were 0.79 (95% CI 0.74-0.84) and 0.72 (95% CI 0.66-0.77), respectively. ConclusionsStO2 obtained by hypoxia imaging colonoscopy is useful for assessing clinical, endoscopic, and histologic activities of UC, suggesting StO2 may be a novel and objective endoscopic measurement.

18F-Sodium fluoride PET-CT visualizes disease activity in chronic nonbacterial osteitis in adults.

Chronic nonbacterial osteitis (CNO) is a rare disease spectrum, which lacks biomarkers for disease activity. Sodium fluoride-18 positron emission tomography/computed tomography ([18F]NaF-PET/CT) is a sensitive imaging tool for bone diseases and yields quantitative data on bone turnover. We evaluated the capacities of [18F]NaF-PET/CT to provide structural and functional assessment in adult CNO. A coss-sectional study was performed including 43 adult patients with CNO and 16 controls (patients referred for suspected, but not diagnosed with CNO) who underwent [18F]NaF-PET/CT at our expert clinic. Structural features were compared between patients and controls, and maximal standardized uptake values (SUVmax [g/mL]) were calculated for bone lesions, soft tissue/joint lesions, and reference bone. SUVmax was correlated with clinical disease activity in patients. Structural assessment revealed manubrial and costal sclerosis/hyperostosis and calcification of the costoclavicular ligament as typical features associated with CNO. SUVmax of CNO lesions was higher compared with in-patient reference bone (mean paired difference: 11.4; 95% CI: 9.4-13.5; p < .001) and controls (mean difference: 12.4; 95%CI: 9.1-15.8; p < .001). The highest SUVmax values were found in soft tissue and joint areas such as the costoclavicular ligament and manubriosternal joint, and these correlated with erythrocyte sedimentation rate in patients (correlation coefficient: 0.546; p < .002). Our data suggest that [18F]NaF-PET/CT is a promising imaging tool for adult CNO, allowing for detailed structural evaluation of its typical bone, soft-tissue, and joint features. At the same time, [18F]NaF-PET/CT yields quantitative bone remodeling data that represent the pathologically increased bone turnover and the process of new bone formation. Further studies should investigate the application of quantified [18F]NaF uptake as a novel biomarker for disease activity in CNO, and its utility to steer clinical decision making.

68 Ga]Ga-FAPI-04 PET/CT may be a predictor for early treatment response in rheumatoid arthritis

BackgroundThe identification of biomarkers predicting the treatment response of rheumatoid arthritis (RA) is important. [68 Ga]Ga-FAPI-04 showed markedly increased uptake in the joints of patients with RA. The purpose of this study is to investigate whether [68 Ga]Ga-FAPI-04 PET/CT can be a predictor of treatment response in RA. ResultsNineteen patients diagnosed with RA in the prospective cohort study were finally enrolled. Both total synovitis uptake (TSU) and metabolic synovitis volume (MSV) in [68 Ga]Ga-FAPI-04 and [18F]FDG PET/CT of the responders were significantly higher than those in non-responders according to Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) response criteria at 3-months’ follow-up (P < 0.05). The PET joint count (PJC) detected in [68 Ga]Ga-FAPI-04 and [18F]FDG PET/CT were also significantly higher in CDAI responders than non-responders (P = 0.016 and 0.045, respectively). The clinical characteristics of disease activity at baseline did not show significant difference between the responders and non-responders, except CRP (P = 0.035 and 0.033 in CDAI and SDAI response criteria, respectively). The baseline PJCFAPI, TSUFAPI and MSVFAPI > cutoff values in [68 Ga]Ga-FAPI-04 PET/CT successfully discriminated CDAI and SDAI responders and non-responders at 3-months’ follow-up. Conclusion[68 Ga]Ga-FAPI-04 uptake at baseline were significantly higher in early responders than those in non-responders.Trial registration ClinicalTrials. NCT04514614. Registered 13 August 2020, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000A4PN&selectaction=Edit&uid=U0001JRW&ts=2&cx=-x9t7cp

Increased vascular inflammation on PET/CT in psoriatic arthritis patients in comparison with controls

BackgroundPatients with psoriatic arthritis (PsA) have an increased risk of cardiovascular disease, possibly due to a chronic inflammatory state.ObjectivesThe main objective of this study was to investigate the difference in...

Preliminary Exploration of Al18F-NOTA-FAPI-04 PET/CT in the Management of Ankylosing Spondylitis: A Prospective Clinical Study

Background Ankylosing spondylitis (AS) is characterized by inflammation and osteoblastic changes in the sacroiliac joint. As a potential imaging method for the early assessment of AS, positron emission tomography (PET) can quantify systemic disease activity, which is conducive to monitoring the progression of disease activity and assisting in evaluating the efficacy of the treatment. Objective The study was to evaluate the diagnostic value of aluminium-[18F]fuoride(Al18F)-labelled fibroblast activation protein inhibitor (FAPI) PET/computed tomography (CT) in AS and to investigate its ability to assess disease activity during the development of AS. Material and Methods Twenty AS participants who met the Assessment of SpondyloArthritis international Society criteria and were in an active disease stage were included in this study from May 2022 to April 2023. Sixteen healthy controls were also inrolled. All participants underwent Al18F-NOTA-FAPI-04 PET/CT imaging after collecting clinical assessment and laboratory results. The correlation between positive joint count (PJC) and systemic joint standard uptake value ratio (SUVR, the mean SUVmax of the 5 highest joints/SUVmax of the uninvolved sacrum) on PET and clinical disease activity assessment and various laboratory tests were analyzed. Results A total of 2820 joints were observed in 20 participants (median age 34.5,[21-61]range, 15 men), with a PJC of 1300 (46.7%), and 39 positive uptakes were found in 40 sacroiliac joints (97.5%). PET/CT images revealed FAPI-04 uptake in both sacroiliac joints in 2 participants without radiographic sacroiliitis in the early stages of AS and varying degrees of uptake in the sacroiliac joints and spinal joints in the remaining participants. PJC and SUVR were positively correlated with most clinical assessments and laboratory findings ( P &lt; .05), and SUVR of the sacroiliac joint was positively correlated with C-reactive protein (CRP) (mg/L; r = 0.498, P = .026). Conclusion Al18F-NOTA-FAPI-04 PET/CT was highly sensitive to systemic arthritic changes in AS participants and correlated with clinical disease activity and laboratory tests.

Food-Related Quality of Life Is Impaired in Latinx and Non-Latinx Patients With Inflammatory Bowel Disease

Anxiety over food choices and symptoms related to food consumption diminish quality of life (QoL) in inflammatory bowel disease (IBD) patients. However, the specific factors that impact QoL among IBD patients remain unclear. In this study, we analyzed the relationships of demographic and disease factors with food-related QoL (FRQoL) in a large, diverse US cohort of IBD patients. In this cross-sectional analysis of 1108 IBD patients aged ≥18 years, we measured FRQoL with the 29-item Food-Related Quality of Life Questionnaire (FR-QoL-29) and disease activity with the Harvey-Bradshaw index in Crohn's disease (CD) patients or the Simple Clinical Colitis Activity Index in ulcerative colitis (UC) patients. Latinx immigrants completed a Spanish translation of the FR-QoL-29. A subset of patients had colonoscopy and inflammatory marker data available. We used univariate, multivariate, and subgroup analyses to examine the factors that influence FRQoL. In our cohort, 55% of IBD patients self-identified as Latinx. Latinx and non-Latinx patients had similar FR-QoL-29 scores. Female patients had significantly lower FRQoL than male patients (P= .001). Increasing age and IBD duration correlated with higher FRQoL (P < .0001). In UC patients, higher Simple Clinical Colitis Activity Index scores (P < .0001), higher Mayo scores (P= .0009), and longer disease duration (P= .03) predicted significantly lower FRQoL. Disease activity and FRQoL were not significantly related in CD patients. This is the largest study to date to examine FRQoL in American IBD patients, and the first to include Latinx patients. Disease-related factors had a greater impact on FRQoL than ethnicity. Clinical and endoscopic disease activity had a more detrimental impact on FRQoL in UC than in CD. Diet intervention studies are needed to alleviate symptoms and improve FRQoL in the IBD population.

Опыт применения ингибитора янус-киназ упадацитиниба у детей с ревматическими болезнями

The efficacy of JAK-kinase inhibitors in autoimmune diseases is due to the peculiarities of their pathogenesis, the involvement of various cytokines that trigger the cascade of inflammatory reactions, enhance the transcriptional response of disease-induced or disease-associated genes and potentiate the production of proinflammatory cytokines. Only tofacitinib is currently approved for use in pediatric rheumatic diseases. Given the literature data on the efficacy of other JAK-kinase inhibitors in adult rheumatic diseases, we assume the possibility of their use in pediatric patients. Objective. To evaluate the efficacy and safety of selective JAK-kinase inhibitor upadacitinib in children with rheumatic diseases. Patients and methods. Data on 85 pediatric patients with various variants of juvenile idiopathic arthritis (JIA) (n = 64) and systemic connective tissue lesions (SCTL) (n = 21) treated with upadacitinib were included in this retrospective study. Initiation of therapy was carried out on the basis of the rheumatology department of the Research Institute of Pediatric Rheumatology of the Federal State Autonomous Institution "Children's Health Research Center" of the Ministry of Health of Russia (Moscow) in the period from May 2022 to July 2023. Descriptive statistics methods were used to assess the efficacy of upadacitinib therapy, comparative analysis was performed using the Wilcoxon criterion. Therapy outcomes in the group of patients with JIA were evaluated by the percentage of improvement according to pediatric criteria of the American College of Rheumatology, achievement of inactive disease stage according to C.Wallace criteria and JADAS-71 activity index, in the group of patients with SCTL – by the dynamics of clinical and laboratory activity parameters, as well as steroid-saving effect. Results. In patients with JIA without systemic manifestations treated with upadacitinib for 3 months (15/54), 30% improvement in ACR Pedi criteria was recorded in 13/15 (87%), 50% in 12/15 (80%), 70% in 11/15 (73%), and 90% in 10/15 (66%) patients; after 6 months. – 30th; 50th; 70th; 90% improvement in 14/15 (93%), 14/15 (93%), 13/15 (87%), 13/15 (87%) patients, respectively. Inactive disease stage according to C.Wallace criteria after 3 months was achieved in 5/15 (33.3%) patients, after 6 months. – у 11/15 (73,3%). In patients with systemic JIA the efficacy of therapy after 3 months was evaluated in 3/10 patients: 2/3 achieved JADAS remission (1 of them – stage of inactive disease according to C.Wallace criteria), in 1 patient the disease activity increased against the background of hip arthroplasty. After 6 months (assessment of outcomes is available in 3/10 patients): 1 patient achieved JADAS remission, 1 patient achieved 50% improvement according to ACR Pedi criteria, 1 patient showed increased disease activity when attempting to reduce the dose of glucocorticoids (GCS). In the group of patients with SCTL, the majority of patients were able to reduce clinical and laboratory disease activity and the demand for oral GCS. Conclusion. The use of upadacitinib in children in rheumatic diseases is highly effective and safe. In patients with refractory course of the disease it is possible to achieve a decrease in disease activity and remission, to reduce the dose of GCS. Key words: systemic connective tissue lesions, systemic juvenile idiopathic arthritis, upadacitinib, juvenile idiopathic arthritis, Janus kinases

Using a collaborative learning health system approach to improve disease activity outcomes in children with juvenile idiopathic arthritis in the Pediatric Rheumatology Care and Outcomes Improvement Network.

The Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) is a North American learning health network focused on improving outcomes of children with juvenile idiopathic arthritis (JIA). JIA is a chronic autoimmune disease that can lead to morbidity related to persistent joint and ocular inflammation. PR-COIN has a shared patient registry that tracks twenty quality measures including ten outcome measures of which six are related to disease activity. The network's global aim, set in 2021, was to increase the percent of patients with oligoarticular or polyarticular JIA that had an inactive or low disease activity state from 76% to 80% by the end of 2023. Twenty-three hospitals participate in PR-COIN, with over 7,200 active patients with JIA. The disease activity outcome measures include active joint count, physician global assessment of disease activity, and measures related to validated composite disease activity scoring systems including inactive or low disease activity by the 10-joint clinical Juvenile Arthritis Disease Activity Score (cJADAS10), inactive or low disease activity by cJADAS10 at 6 months post-diagnosis, mean cJADAS10 score, and the American College of Rheumatology (ACR) provisional criteria for clinical inactive disease. Data is collated to measure network performance, which is displayed on run and control charts. Network-wide interventions have included pre-visit planning, shared decision making, self-management support, population health management, and utilizing a Treat to Target approach to care. Five outcome measures related to disease activity have demonstrated significant improvement over time. The percent of patients with inactive or low disease activity by cJADAS10 surpassed our goal with current network performance at 81%. Clinical inactive disease by ACR provisional criteria improved from 46% to 60%. The mean cJADAS10 score decreased from 4.3 to 2.6, and the mean active joint count declined from 1.5 to 0.7. Mean physician global assessment of disease activity significantly improved from 1 to 0.6. PR-COIN has shown significant improvement in disease activity metrics for patients with JIA. The network will continue to work on both site-specific and collaborative efforts to improve outcomes for children with JIA with attention to health equity, severity adjustment, and data quality.

Serum Amyloid-A in Behçet’s Disease: Relation to Clinical Manifestations and Disease Activity

Serum Amyloid-A in Behçet’s Disease: Relation to Clinical Manifestations and Disease Activity

Chronic spontaneous urticaria: Evidence of systemic microcirculatory changes.

Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease where activation of endothelial cells (ECs) at sites of skin lesions leads to increased blood flow, leakage of fluid into the skin, cellular infiltration, and vascular remodeling. To understand the disease duration and the sometimes vague systemic symptoms accompanying flares, the objective of this study was to examine if CSU comes with systemic vascular changes at the microcirculatory level. We investigated CSU patients (n=49) and healthy controls (HCs, n=44) for microcirculatory differences by nailfold videocapillaroscopy (NVC) and for blood levels of the soluble EC biomarkers serum vascular endothelial growth factor (VEGF), soluble E-selectin, and stem cell factor (SCF). Patients were also assessed for clinical characteristics, disease activity, and markers of autoimmune CSU (aiCSU). CSU patients had significantly lower capillary density, more capillary malformations, and more irregular capillary dilations than HCs on NVC. Serum levels of VEGF, soluble E selectin and SCF were similar in CSU patients and HCs. CSU patients with higher VEGF levels had significantly more abnormal capillaries. Patients with markers of aiCSU, that is, low IgE levels or increased anti-TPO levels, had significantly more capillaries and less capillary dilations than those without. Our results suggest that CSU comes with systemic microcirculatory changes, which may be driven, in part, by VEGF.

Clinical and structural damage outcomes in axial spondyloarthritis patients receiving NSAIDs or advanced therapies: a description of a real-life cohort.

This study aims to describe the clinical characteristics, disease activity, and structural damage in patients with axial spondyloarthritis (axSpA) who receive chronic treatment with nonsteroideal anti-inflammatory drugs (NSAIDs) or advanced therapies in a clinical setting. Cross-sectional study on axSpA patients consecutively recruited from the outpatient clinic of a tertiary hospital. We collected data on clinical and demographic characteristics, as well as treatment patterns involving NSAIDs and advanced therapies. Structural damage was assessed using mSASSS. Overall, data from 193 axSpA patients (83% ankylosing spondylitis) were gathered, with a mean disease duration of 21.4 years. Of these, 85 patients (44%) were exclusively taking NSAIDs, while 108 (56%) were receiving advanced therapies, with TNF inhibitors being the predominant choice (93 out of 108, 86.1%). Among patients using NSAIDs, 64.7% followed an on-demand dosing regimen, while only 17.6% used full doses. Disease activity was low, with a mean BASDAI of 3.1 and a mean ASDAS-CRP of 1.8. In comparison to patients under chronic NSAID treatment, those taking advanced therapies were primarily male (69.4% versus 51.8%, p = 0.025) and significantly younger (mean age of 49 versus 53.9 years, p = 0.033). Additionally, patients on advanced therapies exhibited lower ASDAS-CRP (p = 0.046), although CRP serum levels and BASDAI scores did not differ between the two groups. In the multivariable analysis, therapy (NSAID versus biological treatment) was not independently associated with ASDAS-CRP, BASDAI or mSASSS. This cross-sectional analysis of a real-world cohort of axSpA patients shows positive clinical and radiological outcomes for both NSAIDs and advanced therapies.

A potential biomarker of disease activity in systemic lupus erythematosus, systemic immune-inflammation index.

Biomarkers using routine laboratory tests accurately presenting systemic lupus erythematosus (SLE) disease activity may have important practical values in clinical settings. The primary purpose of this study was to investigate neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and systemic immune-inflammation index (SII; neutrophil X platelet/lymphocyte) as potential biomarkers of disease activity in cases with SLE. In this case-control observational study, cases with SLE and demographically similar healthy controls were included. For clinical evaluation demographic features, disease duration and drugs were recorded. SLE clinical disease activity was assessed with SLEDAI scores. For laboratory assessments; erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and C3-C4 levels and anti-dsDNA positivity were recorded. Based on the simultaneous complete blood count (CBC) of the participants NLR, PLR and SII were calculated. The correlation between clinical and laboratory data was analyzed. 68 cases with SLE (64 women, 8 men) and 69 controls (65 women, 4 men) were included in this investigation. The demographic features of the cases and controls were similar. ESR, CRP, NLR, PLR and SII scores were statistically higher in cases with SLE than controls (p<0.000). Statistically significant positive correlations between SLEDAI and NLR, PLR and SII scores were demonstrated (p=0.01, r=0.505; 0.414; 0.698, respectively). We determined a cut-off value of SII as 681,3 presenting 77% sensitivity and 76% specificity to discriminate no-mild disease activity and moderate-higher SLE disease activity status. The SII cut-off value was determined as 681,3 presenting 77% sensitivity and 76% specificity (p<0.000, and AUC=0.930). CBC indices were shown to be higher in cases with SLE than healthy controls in our study. By presenting a strong correlation with disease activity and discriminating ability of disease status, SII might serve as a biomarker supporting clinical evaluation in SLE.

Evaluating the influence of a structured nursing protocol on targeted outcomes in rheumatoid arthritis patients

Objective: Rheumatoid arthritis (RA) requires comprehensive management. Structured nursing protocols may enhance outcomes, but evidence is limited. This study evaluated the effect of a structured nursing protocol on RA outcomes. Materials and Methods: In this one-group pre-post study, 30 Egyptian RA patients completed assessments before and after a 12-week nursing protocol comprising education, psychosocial support, and self-management promotion. Assessments included clinical evaluation of joint counts, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) and patient-reported Arthritis Self-Efficacy Scale (ASES), Health Assessment Questionnaire (HAQ), Visual Analog Scale (VAS) for pain, and Hospital Anxiety and Depression Scale (HADS). Results: The study demonstrated significant improvements in both clinical- and patient-reported outcomes. Joint count decreased from 18.4 ± 4.2 to 14.2 ± 3.8 (P &lt; 0.001), ESR from 30.1 ± 6.8 mm/h to 25.5 ± 6.8 mm/h (P &lt; 0.01), and CRP levels from 15.2 ± 3.6 mg/L to 11.8 ± 2.9 mg/L (P &lt; 0.01) postintervention. Patient-reported outcomes showed a marked increase in ASES score from 140 ± 25 to 170 ± 30 (P &lt; 0.001) and reductions in HAQ from 1.6 ± 0.4 to 1.3 ± 0.3 (P &lt; 0.01), VAS pain score from 7.8 ± 1.7 to 6.2 ± 1.2 (P &lt; 0.001), and HADS anxiety and depression scores from 11 ± 3 to 8 ± 2 (P &lt; 0.05) and 10 ± 2 to 7 ± 1 (P &lt; 0.05), respectively. Conclusion: A structured nursing protocol significantly improved clinical disease activity, physical functioning, pain, self-efficacy, and emotional well-being in RA patients. A multifaceted nursing intervention appears beneficial for optimizing RA outcomes.

Comparison of Remission Criteria in Patients with Rheumatoid Arthritis: Results from a Smart System of Disease Management Group.

This study aimed to compare the rates of disease remission evaluated using various remission criteria, including Boolean2.0, Boolean1.0, clinical disease activity index (CDAI), simplified disease activity index (SDAI), and disease activity score using 28 joints based on C-reactive protein (DAS28-CRP) in patients with rheumatoid arthritis (RA). A cross-sectional observational analysis was performed using data from patients with RA enrolled in a smart system of disease management group (SSDM). The clinical remission rates of RA patients estimated using the DAS28-CRP, CDAI, SDAI, Boolean1.0 and Boolean2.0 criteria were investigated. Variables were compared using the t-test, Mann-Whitney U-test, or chi-squared test. The agreement between Boolean remission and the DAS28-CRP, CDAI, or SDAI definitions of remission was assessed using McNemar's test with k coefficient of agreement. A total of 5619 patients were included in the analysis. The mean age of the patients was 56.33 (±13.01) years, with the majority being female (4491, 79.9%). The rates of remission, as assessed by Boolean2.0, Boolean1.0, DAS28-CRP, CDAI, and SDAI, were 16.6%, 9.7%, 35.2%, 9.1%, and 9.4%, respectively. Comparison with Boolean1.0 criteria revealed higher concordance between Boolean2.0 and DAS28-CRP remission and lower concordance with CDAI and SDAI, regardless of whether the analysis was conducted on the entire population or subgroups based on gender, age or disease duration. Additionally, the administration of different medications may have influenced the rate of Boolean2.0 remission. This study demonstrated a higher concordance between Boolean2.0 criteria and DAS28-CRP remission and a lower concordance with CDAI and SDAI when compared with Boolean1.0 remission criteria.

Real-World Clinical Equivalence of Generic and Branded Tofacitinib: A Prospective Longitudinal Cohort Study in Patients With Rheumatoid Arthritis

ObjectivesTo explore the clinical efficacy and safety of generic tofacitinib vs brand name tofacitinib in patients with rheumatoid arthritis (RA) in a single-center comparative study based on a prospective real-world cohort. MethodsPatients with RA receiving tofacitinib, either generic (Kelejia) or branded (Xeljanz), from March 2017, to December 31, 2022, were enrolled. The primary outcome was the simplified disease activity index (SDAI)–defined remission rate at month 6. Secondary outcomes included the rates of remission and low disease activity defined by other composite scores; European Alliance of Associations for Rheumatology response rate, and ultrasonic synovitis scores at months 1, 3, 6, and 12. Cost-effectiveness was investigated. Propensity score–based inverse probability of treatment weighting was adopted to reduce selection bias. ResultsA total of 204 patients were enrolled: 59 in the generic group and 145 in the branded group. An SDAI-defined remission was achieved in 41.1% and 39.2% of patients in the generic and branded groups, respectively, at month 6 (P=.85). Rates of remission and low disease activity achievement, changes in clinical disease activity scores, and power Doppler and gray scale synovitis scores at months 1, 3, 6, and 12 were comparable between the 2 groups. Similar proportions of patients in the groups achieved moderate/good response at months 1, 3, 6, and 12. Rates of drug retention and adverse effects were also similar in the 2 groups. Both Kelejia and Xeljanz were cost-effective, but Kelejia had a lower average cost-effectiveness ratio. ConclusionGeneric tofacitinib (Keljia) had equivalent clinical efficacy and safety and better cost-effectiveness compared with its originator (Xeljanz).

Uticaj intenziteta bola na funkcionalnu sposobnost pacijenata sa reumatoidnim artritisom

Introduction: Rheumatoid arthritis is a chronic autoimmune inflammatory disease with progressive joint damage, leading to functional impairment of the locomotor system, including disability. Aim: The study aimed to examine the correlation between disease severity, pain intensity and functional capacity of patients with rheumatoid arthritis (RA). Material and methods: An observational, analytical, cross-sectional study that included 30 adult (≥ 18 years) subjects, who had been suffering from RA for two years or more. Data were collected by interviewing subjects, clinical examinations, using available medical documentation and specific questionnaires that are applied in RA. We determined the current disease activity (severity) using the Clinical Disease Activity Index, CDAI. To assess functional (in)capacity, we used the Health Assessment Questionnaire (HAQ). A Visual Analogue Scale (VAS) was used to assess the intensity of pain, which classifies the intensity of pain from 0 to 10. Descriptive statistical methods, methods for testing statistical hypotheses and methods for testing addiction were used for statistical data analysis. Statistical hypotheses were tested at a statistical significance level (alpha level) of 0.05. Results: Out of a total of 30 subjects, 13.3% were male and 86.7% were female. The average age of the subjects was 58.9 ± 8.0 years. In terms of occupation, the majority were retirees, and in terms of education, most subjects had a secondary vocational education. The average duration of the disease was 14 years. Our subjects most often had low and moderate disease activity (33.3% each). Regarding pain intensity, most participants experienced moderate pain (43.3%), the fewest had mild pain (26.7%), and 30.0% of participants reported severe pain. The VAS pain score median of all subjects was 5. The most common was a moderate to severe disturbance of functional ability (56.7%). It was found that there was a statistically significant association between pain intensity and functional disability (rs = 0.618; p = 0.001). There was also a statistically significant association between the degree of disease activity (CDAI) and functional disability (HAQ) (rs = 0,377; p = 0,040). No statistically significant correlation was shown between the duration of the disease and the degree of functional disability (rs = -0.037; p = 0.845). Conclusion: It is necessary to pay special attention to the treatment of pain in patients with RA, because its presence and intensity are closely related to the degree of functional disability.

Correlation between Ankylosing Spondylitis Disease Activity Score and MRI Scoring in Patients with Ankylosing Spondylitis: A Cross-sectional Study

Introduction: Ankylosing Spondylitis (AS) is an inflammatory disorder of unknown cause that primarily affects the axial skeleton, peripheral joints, and extra-articular structures. Typically, the condition starts in the second or third decade. Lower back pain lasting longer than three months, morning stiffness lasting more than 30 minutes, relieved by daily activities, are signs of disease onset. Aim: To establish a correlation between disease severity score Ankylosing Spondylitis Disease Activity Score (ASDAS) and Magnetic Resonance Imaging (MRI) scoring in patients with AS. Materials and Methods: This cross-sectional study was conducted on 66 patients attending the Medicine Emergency/ Outpatient Department (OPD)/ward of ESIPGIMSR and ESI Hospital, Basaidarapur, New Delhi, India, who were diagonsed with AS based on the modified New York Criteria. Clinical assessments included ASDAS based on Erythrocyte Sedimentation Rate (ESR) and C-reactive Protein (CRP), while MRI disease activity scores were determined using the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scoring. The sample size was calculated with a coefficient limit of 10% and a confidence level of 95%. Data analysis was performed using Statistical Packages for Social Sciences (SPSS) version 21.0, a widely used statistical computing and graphics tool. Pearson’s correlation coefficients were computed to explore relationships between variables, including age, disease duration, ASDAS-ESR, and MRI changes. Results: In present study, a total of 66 patients were included, out of which 51 (77.3%) were males and 15 (22.7%) were females. The age group of patients included in present study was 33 years to 44 years with a mean of 37.96 years. In present study, the disease duration ranged from a minimum of two years to a maximum of 10 years with a mean of 5.4 years. The mean ASDAS CRP was 3.687 (minimum-2.80, maximum-4.60), and the disease activity as assessed by MRI score (SPARCC) had a minimum value of 8.85 and a maximum value of 26.2 with a mean of 16.359. In present study, the X-ray grading of sacroiliitis revealed that 19.7% of the subjects were classified as Grade-2, 60.6% as Grade-3, and 19.7% as Grade-4. Conclusion: The clinical disease activity index may not always reflect active inflammation, which is detectable by MRI. Incorporating MRI into diagnostic and treatment strategies for AS is crucial for the accurate assessment of disease severity and better patient outcomes.

Femoral bone mineral density as a tool of personalized medicine for rheumatoid arthritis: Interleukin-6 inhibitors for patients with low density whereas tumor necrosis factor inhibitor for patients with preserved density?

There is a lack of indicators to distinguish between interleukin-6 inhibitors responders and tumor necrosis factor inhibitors responders in the treatment of rheumatoid arthritis. Osteoporosis is a complication of rheumatoid arthritis and is closely related to inflammatory pathology. The purpose of this study was to evaluate whether bone mineral density can distinguish interleukin-6 inhibitors responders from tumor necrosis factor inhibitors responders in rheumatoid arthritis. Either interleukin-6 inhibitors or tumor necrosis factor inhibitors was introduced as the first biologics to patients naïve to both corticosteroid and osteoporosis treatment. Correlations between baseline bone mineral density and Clinical Disease Activity Index after 3 months were analyzed. The subjects were 26 rheumatoid arthritis patients with a median age of 60 years old, disease duration of 1.4 years, Clinical Disease Activity Index of 13.7, and C-reactive protein of 1.69 mg/dL. The subjects were divided into two groups (high (H) and low (L)) according to their femoral bone mineral density with a cutoff of young adult mean of 80%. Six in group H and 11 in group L received interleukin-6 inhibitors, and nine in group H received tumor necrosis factor inhibitors. Clinical Disease Activity Index remission rate by interleukin-6 inhibitors was significantly greater in group L (8/11 (72.7%)) than in group H (1/6 (16.7%); p < 0.05). In the whole group H, significantly more patients obtained Clinical Disease Activity Index remission by tumor necrosis factor inhibitors (7/9, 77.8%) than by interleukin-6 inhibitors (1/6 (16.7%); p = 0.04). In patients with rheumatoid arthritis, interleukin-6 inhibitors may be more beneficial for patients with low femoral bone mineral density, whereas tumor necrosis factor inhibitors may be advantageous for those with preserved bone mineral density.

Rheumatoid arthritis: remission without biotherapy? The experience of Burkina Faso (West Africa)

the objective of this study was to evaluate the therapeutic response of patients treated with disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA). descriptive and analytical single-center cross-sectional study conducted in Burkina Faso from January 2019 to December 2021 in patients with RA meeting American Rheumatism Association/European League against rheumatism criteria. Therapeutic response was assessed according to the criteria of the European League Against Rheumatism, the clinical disease activity index and the simplified disease activity Index after at least six months of treatment. one hundred and three patients, including 85 women were included. The average age of the patients was 50.14 years ± 15.04 years. Eighty-seven patients (84.47%) were ACPA positive and 50 patients (48.54%) had radiological damage at inclusion. The mean DAS28-CRP, CDAI and SDAI were 5.17, respectively; 32.16 and 35.48 at inclusion compared to 2.53; 7.83 and 8.76 after at least six months of treatment (p<0.0001). Ninety-six patients (93.20%) were treated with methotrexate. According to the criteria of the European League Against Rheumatism, 89 patients (86.41%) were good responders, 62 patients (60.19%) were in remission. Major improvement was observed in 53 patients (51.46%) as assessed by the Clinical Disease Activity Index and the Simplified Disease Activity Index. despite the unavailability of biotherapies in sub-Saharan Africa, remission of RA can be obtained by optimizing treatment with DMARDs and "tight control".