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RMD Open Jan 2024To evaluate the prevalence of symptoms and factors associated with irritable bowel syndrome (IBS) in axial spondyloarthritis (ax-SpA). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the prevalence of symptoms and factors associated with irritable bowel syndrome (IBS) in axial spondyloarthritis (ax-SpA).
METHODS
In a cross-sectional multicentric study, consecutive patients with ax-SpA treated with biologics in five rheumatology departments were asked for IBS Rome IV criteria. Demographic data, lifestyle behaviours and disease characteristics were recorded. Second, a systematic literature review and meta-analysis were performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
Of the 500 patients with ax-SpA included, 124 reported IBS symptoms (25%). Female gender, unemployment, higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and worse Bath Ankylosing Spondylitis Functional Index scores, multiple lines of biologics, fibromyalgia, anxiety, depression and lower physical activity were associated with IBS symptoms. In multivariate model, the risk of IBS was associated with anxiety and physical inactivity. From the literature review, the prevalence of IBS in patients with SpA was 15.4% (8.8% to 23.3%). Meta-analysis of the five studies comparing the presence of IBS in patients with SpA (323/7292) and healthy controls (484/35587) showed a significant increase of IBS in patients with SpA (OR=1.59 (1.05 to 2.40)).
CONCLUSION
The prevalence of IBS symptoms was high in the ax-SpA population and should therefore be considered in the presence of gastrointestinal disorders. The presence of IBS symptoms was associated with anxiety and low physical activity in multivariate analysis. Patients with IBS symptoms tended to have more difficult to manage disease characterised by higher activity, worse functional score and multiple lines of treatment in univariate analysis.
Topics: Humans; Female; Irritable Bowel Syndrome; Cross-Sectional Studies; Spondylitis, Ankylosing; Spondylarthritis; Biological Products
PubMed: 38216286
DOI: 10.1136/rmdopen-2023-003836 -
Medicine Jan 2024This systematic literature review and meta-analysis aimed to assess the accuracy, sensitivity, and specificity of dual-energy computed tomography (DECT) of the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This systematic literature review and meta-analysis aimed to assess the accuracy, sensitivity, and specificity of dual-energy computed tomography (DECT) of the sacroiliac joint. Bone marrow edema (BME) of the sacroiliac joint is an early manifestation of some diseases, such as ankylosing spondylitis, and is usually examined by nuclear magnetic resonance imaging (MRI); however, MRI can be intolerable for some patients; hence, numerous studies have analyzed DECT examinations.
METHODS
We searched PUBMED, CNKI, and EMBASE in 2023 for articles containing the following terms (DECT) or (DE-CT) or (dual-energy CT) or "dual-energy CT" or (dual-energy computed tomography) and ((sacroiliac joint) or (ankylosing spondylitis) or (sacroiliac arthritis) or (sacroiliitis)). An initial search identified 444 articles, of which 7 met the criteria. Data were extracted to calculate the sensitivity, specificity, and diagnostic odds for analysis using R software.
RESULTS
Out of 291 patients and 577 sacroiliac joints, 429 (74.35%) exhibited BME. All studies used magnetic resonance as the control group. The overall sensitivity and specificity of DECT were 79%, and 92%, respectively, with positive prediction rate of 92.55% and negative prediction rate of 83.73%.
CONCLUSION
DECT appears to be a promising diagnostic tool for detecting BME in the sacroiliac joint and can be used as an alternative examination method for patients in whom MRI is contraindicated.
Topics: Humans; Sacroiliac Joint; Spondylitis, Ankylosing; Bone Marrow; Edema; Tomography
PubMed: 38181261
DOI: 10.1097/MD.0000000000036708 -
Advances in Therapy Feb 2024Immune-mediated inflammatory diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial... (Review)
Review
Safety of Upadacitinib in Immune-Mediated Inflammatory Diseases: Systematic Literature Review of Indirect and Direct Treatment Comparisons of Randomized Controlled Trials.
INTRODUCTION
Immune-mediated inflammatory diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondylarthritis (nr-axSpA), atopic dermatitis (AD), ulcerative colitis (UC), and Crohn's disease (CD) pose a substantial burden on patients and their quality of life. Upadacitinib is an orally administered, selective, and reversible Janus kinase inhibitor indicated for seven conditions, but data on its safety versus other active treatments are limited. A systematic literature review of indirect and direct treatment comparisons of randomized controlled trials (RCTs) was conducted to assess the safety profile of upadacitinib.
METHODS
MEDLINE, Embase, and Cochrane Library databases were searched for indirect and direct treatment comparisons of RCTs that (1) included licensed upadacitinib dosages; (2) studied any of the seven conditions; (3) reported any adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, major adverse cardiovascular event, venous thromboembolism, malignancies, infections or serious infections, and death; and (4) were published between January 2018 and August 2022.
RESULTS
A total of 25 studies were eligible for inclusion. SAEs, AEs leading to discontinuation, and any AEs were commonly studied. RA was the most studied condition, followed by AD and UC. Most studies (16/25, 64%) reported no statistically significant difference in the studied safety outcomes between upadacitinib and other active treatments (e.g., tumor necrosis factor blockers, interleukin receptor antagonists, integrin receptor antagonists, T cell co-stimulation modulator), or placebo (placebo ± methotrexate or topical corticosteroids). Other studies (9/25, 36%) reported mixed results of no statistically significant difference and either statistically higher (8/25, 32%) or lower rates (1/25, 4%) on upadacitinib.
CONCLUSION
Most studies suggested that upadacitinib has no statistically significant difference in the studied safety outcomes compared to active treatments or placebo in patients with RA, PsA, AS, AD, UC, and CD. A few studies reported higher rates, but findings were inconsistent with limited interpretation.
Topics: Humans; Arthritis, Psoriatic; Arthritis, Rheumatoid; Colitis, Ulcerative; Heterocyclic Compounds, 3-Ring; Methotrexate; Randomized Controlled Trials as Topic; Spondylitis, Ankylosing
PubMed: 38169057
DOI: 10.1007/s12325-023-02732-6 -
Frontiers in Pharmacology 2023To evaluate efficacy and safety of iguratimod (IGU) in the treatment of rheumatic and autoimmune diseases. Databases such as Pubmed, Embase, Sinomed were searched (as...
To evaluate efficacy and safety of iguratimod (IGU) in the treatment of rheumatic and autoimmune diseases. Databases such as Pubmed, Embase, Sinomed were searched (as of July 2022) to collect randomized controlled trials (RCTs) of IGU in the treatment of rheumatic and autoimmune diseases. Two researchers independently screened the literature, extracted data, assessed the risk of bias of the included literature, and performed meta-analysis using RevMan 5.4 software. A total of 84 RCTs and 4 types of rheumatic and autoimmune diseases [rheumatoid arthritis (RA), ankylosing spondylitis (AS), primary Sjögren's syndrome (PSS) and Autoimmune disease with interstitial pneumonia]. Forty-three RCTs reported RA and showed that IGU + MTX therapy can improve ACR20 (RR 1.45 [1.14, 1.84], = 0.003), ACR50 (RR 1.80 [1.43, 2.26], < 0.0000), ACR70 (RR 1.84 [1.27, 2.67], = 0.001), DAS28 (WMD -1.11 [-1.69, -0.52], = 0.0002), reduce ESR (WMD -11.05 [-14.58, -7.51], < 0.00001), CRP (SMD -1.52 [-2.02, -1.02], < 0.00001), RF (SMD -1.65 [-2.48, -0.82], < 0.0001), and have a lower incidence of adverse events (RR 0.84 [0.78, 0.91], < 0.00001) than the control group. Nine RCTs reported AS and showed that IGU can decrease the BASDAI score (SMD -1.62 [-2.20, -1.05], < 0.00001), BASFI score (WMD -1.07 [-1.39, -0.75], < 0.00001), VAS (WMD -2.01 [-2.83, -1.19], < 0.00001), inflammation levels (decreasing ESR, CRP and TNF-α). Thirty-two RCTs reported PSS and showed that IGU can reduce the ESSPRI score (IGU + other therapy group: WMD -1.71 [-2.44, -0.98], < 0.00001; IGU only group: WMD -2.10 [-2.40, -1.81], < 0.00001) and ESSDAI score (IGU + other therapy group: WMD -1.62 [-2.30, -0.94], < 0.00001; IGU only group: WMD -1.51 [-1.65, -1.37], < 0.00001), inhibit the inflammation factors (reduce ESR, CRP and RF) and increase Schirmer's test score (IGU + other therapy group: WMD 2.18 [1.76, 2.59], < 0.00001; IGU only group: WMD 1.55 [0.35, 2.75], = 0.01); The incidence of adverse events in IGU group was also lower than that in control group (IGU only group: RR 0.66 [0.48, 0.98], = 0.01). Three RCTs reported Autoimmune disease with interstitial pneumonia and showed that IGU may improve lung function. Based on current evidence, IGU may be a safe and effective therapy for RA, AS, PSS and autoimmune diseases with interstitial pneumonia. : (CRD42021289489).
PubMed: 38143490
DOI: 10.3389/fphar.2023.1189142 -
BMJ Open Dec 2023External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to...
OBJECTIVES
External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).
DESIGN
Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.
DATA SOURCES
Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.
ELIGIBILITY CRITERIA
Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.
DATA EXTRACTION AND SYNTHESIS
Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.
RESULTS
Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.
CONCLUSIONS
Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.
Topics: Adult; Humans; Spondylitis, Ankylosing; Pouchitis; Arthritis, Rheumatoid; Psoriasis; Inflammatory Bowel Diseases; Immunomodulating Agents
PubMed: 38070932
DOI: 10.1136/bmjopen-2023-076677 -
RMD Open Nov 2023Axial spondyloarthritis (axSpA) can limit work participation. Our objective was to characterise productivity in patients with axSpA, including changes after 12-16 weeks... (Meta-Analysis)
Meta-Analysis
Work productivity in patients with axial spondyloarthritis initiating biological or targeted synthetic disease-modifying antirheumatic drugs: a systematic literature review and meta-analysis.
BACKGROUND
Axial spondyloarthritis (axSpA) can limit work participation. Our objective was to characterise productivity in patients with axSpA, including changes after 12-16 weeks of treatment with biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
METHODS
A systematic literature review identified studies published from 1 January 2010 to 21 October 2021 reporting work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire in patients with axSpA initiating b/tsDMARDs. Baseline and Week 12-16 overall work productivity, absenteeism, presenteeism and activity impairment scores were used in a random-effects meta-analysis to calculate absolute mean change from baseline for each WPAI-domain.
RESULTS
Eleven studies in patients with axSpA who received either placebo (n=727) or treatment with adalimumab, bimekizumab, etanercept, ixekizumab, secukinumab or tofacitinib (n=994) were included. In working patients initiating a b/tsDMARD, mean baseline overall work productivity impairment, absenteeism and presenteeism scores were 52.1% (N=7 studies), 11.0% and 48.8% (N=6 studies), respectively. At Week 12-16, the pooled mean change from baseline in overall work impairment for b/tsDMARDs or placebo was -21.6% and -12.3%. When results were extrapolated to 1 year, the potential annual reductions in cost of paid and unpaid productivity loss per patient ranged from €11 962.88 to €14 293.54.
CONCLUSIONS
Over 50% of employed patients with active axSpA experienced work impairment, primarily due to presenteeism. Overall work productivity improved at Weeks 12-16 to a greater extent for patients who received b/tsDMARDs than placebo. Work productivity loss was associated with a substantial cost burden, which was reduced with improvements in impairment.
Topics: Humans; Antirheumatic Agents; Spondylitis, Ankylosing; Efficiency; Etanercept; Axial Spondyloarthritis
PubMed: 38035757
DOI: 10.1136/rmdopen-2023-003468 -
RMD Open Nov 2023Summarise the evidence of the performance of the machine learning algorithm in discriminating sacroiliitis features on MRI and compare it with the accuracy of human...
OBJECTIVES
Summarise the evidence of the performance of the machine learning algorithm in discriminating sacroiliitis features on MRI and compare it with the accuracy of human physicians.
METHODS
MEDLINE, EMBASE, CIHNAL, Web of Science, IEEE, American College of Rheumatology and European Alliance of Associations for Rheumatology abstract archives were searched for studies published between 2008 and 4 June 2023. Two authors independently screened and extracted the variables, and the results are presented using tables and forest plots.
RESULTS
Ten studies were selected from 2381. Over half of the studies used deep learning models, using Assessment of Spondyloarthritis International Society sacroiliitis criteria as the ground truth, and manually extracted the regions of interest. All studies reported the area under the curve as a performance index, ranging from 0.76 to 0.99. Sensitivity and specificity were the second-most commonly reported indices, with sensitivity ranging from 0.56 to 1.00 and specificity ranging from 0.67 to 1.00; these results are comparable to a radiologist's sensitivity of 0.67-1.00 and specificity of 0.78-1.00 in the same cohort. More than half of the studies showed a high risk of bias in the analysis domain of quality appraisal owing to the small sample size or overfitting issues.
CONCLUSION
The performance of machine learning algorithms in discriminating sacroiliitis features on MRI varied owing to the high heterogeneity between studies and the small sample sizes, overfitting, and under-reporting issues of individual studies. Further well-designed and transparent studies are required.
Topics: Humans; Sacroiliitis; Magnetic Resonance Imaging; Spondylarthritis; Sensitivity and Specificity; Machine Learning
PubMed: 37996126
DOI: 10.1136/rmdopen-2023-003783 -
Frontiers in Pharmacology 2023Biologics and small-molecule drugs have become increasingly accepted worldwide in the treatment of axial spondyloarthritis (axSpA), including ankylosing spondylitis...
Biologics and small-molecule drugs have become increasingly accepted worldwide in the treatment of axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). However, a quantitative multiple comparison of their efficacy and safety is lacking. This study aims to provide an integrated assessment of the relative benefits and safety profiles of these drugs in axSpA treatment. We included randomized clinical trials that compared biologics and small-molecule drugs in the treatment of axSpA patients. The primary outcomes assessed were efficacy, including the Assessment of SpondyloArthritis International Society (ASAS) improvement of 20% (ASAS20) and 40% (ASAS40). Safety outcomes included treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). We used the surface under the cumulative ranking (SUCRA) curve value and ranking plot to evaluate and rank clinical outcomes and safety profiles of different treatments. The two-dimensional graphs were illustrated to visually assess both the efficacy (horizontal axis) and safety (vertical axis) of each intervention. Our analysis included 57 randomized clinical trials involving a total of 11,787 axSpA patients. We found that seven drugs (TNFRFc, TNFmAb, IL17Ai, IL17A/Fi, IL17RAi, JAK1/3i, and JAK1i) were significantly more effective in achieving ASAS20 response compared to the placebo (PLA). Except for IL17RAi, these drugs were also associated with higher ASAS40 responses. TNFmAb demonstrated the highest clinical response efficacy among all the drugs. Subgroup analyses for AS and nr-axSpA patients yielded similar results. IL17A/Fi emerged as a promising choice, effectively balancing efficacy and safety, as indicated by its position in the upper right corner of the two-dimensional graphs. Our findings highlight TNFmAb as the most effective biologic across all evaluated efficacy outcomes in this network meta-analysis. Meanwhile, IL17A/Fi stands out for its lower risk and superior performance in achieving a balance between efficacy and safety in the treatment of axSpA patients.
PubMed: 37942485
DOI: 10.3389/fphar.2023.1226528 -
Clinical and Experimental Rheumatology Jan 2024The approval of TNF-a inhibitors (TNFi) was a breakthrough in the treatment of ankylosing spondylitis (AS). Although also effective in psoriasis, drug-related adverse... (Review)
Review
OBJECTIVES
The approval of TNF-a inhibitors (TNFi) was a breakthrough in the treatment of ankylosing spondylitis (AS). Although also effective in psoriasis, drug-related adverse events of onset of psoriasiform skin lesions - paradoxical psoriasis (PP) under TNFi have been reported.
METHODS
We performed an electronic data search in MEDLINE via Pubmed and Cochrane library scientific databases from inception to January 2023, following the PRISMA guidelines. We assessed the distinct characteristics and frequency of risks for PP appearance in AS patients treated with different TNFi.
RESULTS
PP was found in 0.5-1% of TNFi-treated AS patients and the latency period was 2-11 months. The safest TNFi in terms of PP induction was certolizumab, whereas the one most commonly associated with PP was infliximab.
CONCLUSIONS
PP is an uncommon adverse reaction to TNFi treatment in AS patients and responds well to drug withdrawal. More large data studies need to be conducted though, to shed light on PP nature and management.
Topics: Humans; Spondylitis, Ankylosing; Tumor Necrosis Factor-alpha; Tumor Necrosis Factor Inhibitors; Infliximab; Psoriasis; Adalimumab
PubMed: 37812484
DOI: 10.55563/clinexprheumatol/rq4k3u -
ARP Rheumatology Aug 2023To collect and summarize the available scientific evidence that evaluates the effects of physical exercise interventions on axial spondyloarthritis (axSpA).
AIM
To collect and summarize the available scientific evidence that evaluates the effects of physical exercise interventions on axial spondyloarthritis (axSpA).
METHODS
A systematic review was conducted in accordance to the guidance of Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) to collect randomized controlled trials on the PubMed, Embase and Web of Science Core Collection databases. The search strategy included terms regarding physical exercise interventions targeted to axSpA participants and all of its variants in multiple combinations adapted to each one of the databases regarding its own special requirements. Several outcomes were defined: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), ASDAS (Ankylosing Spondylitis Disease Activity Score), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), the 36-item short form health survey (SF-36) and the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL). Two independent researchers screened the titles and abstracts followed by full-text analysis when suitable, using EndnoteTM online. Selected articles, according to exclusion/inclusion criteria defined, were submitted to data extraction and bias assessment was performed for each study's outcomes using the Cochrane risk-of-bias tool for randomized trials.
RESULTS
A total of 2063 articles were identified through the electronic databases search. After removal of duplicates, 1435 were eligible for screening, of which 45 articles went through full text evaluation. Only 24 articles met the inclusion/exclusion criteria. Physical exercise contributes for a statistically significant improvement of BASDAI in 13 studies, BASFI in 10, BASMI in 6, ASDAS in 3, CRP in 2, ESR in 1, SF-36 in 2 and ASQoL in 3.No major adverse effects were reported and an overall benefit was noted with the implementation of physical exercise as a treatment modality for axSpA.
CONCLUSION
Physical exercise seems to be an effective non-pharmacological therapy for axSpA, with positive effects in disease activity, physical function, and quality of life.
PubMed: 37728143
DOI: No ID Found