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RMD Open Sep 2022Informing an international task force updating the consensus statement on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) selectively...
A systematic literature review informing the consensus statement on efficacy and safety of pharmacological treatment with interleukin-6 pathway inhibition with biological DMARDs in immune-mediated inflammatory diseases.
OBJECTIVES
Informing an international task force updating the consensus statement on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) selectively targeting interleukin-6 (IL-6) pathway in the context of immune-mediated inflammatory diseases.
METHODS
A systematic literature research of all publications on IL-6 axis inhibition with bDMARDs published between January 2012 and December 2020 was performed using MEDLINE, EMBASE and Cochrane CENTRAL databases. Efficacy and safety outcomes were assessed in clinical trials including their long-term extensions and observational studies. Meeting abstracts from ACR, EULAR conferences and results on clinicaltrials.gov were taken into consideration.
RESULTS
187 articles fulfilled the inclusion criteria. Evidence for positive effect of IL-6 inhibition was available in various inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, cytokine release syndrome due to chimeric antigen receptor T cell therapy and systemic sclerosis-associated interstitial lung disease. Newcomers like satralizumab and anti-IL-6 ligand antibody siltuximab have expanded therapeutic approaches for Castleman's disease and neuromyelitis optica, respectively. IL-6 inhibition did not provide therapeutic benefits in psoriatic arthritis, ankylosing spondylitis and certain connective tissue diseases. In COVID-19, tocilizumab (TCZ) has proven to be therapeutic in advanced disease. Safety outcomes did not differ from other bDMARDs, except higher risks of diverticulitis and lower gastrointestinal perforations. Inconsistent results were observed in several studies investigating the risk for infections when comparing TCZ to TNF-inhibitors.
CONCLUSION
IL-6 inhibition is effective for treatment of several inflammatory diseases with a safety profile that is widely comparable to other bDMARDs.
Topics: Adult; Humans; Antirheumatic Agents; Interleukin-6; Ligands; Receptors, Chimeric Antigen; COVID-19 Drug Treatment
PubMed: 36260501
DOI: 10.1136/rmdopen-2022-002359 -
Advances in Therapy Dec 2022In light of the lack of an agreed international standard for how to conduct cost-effectiveness analyses (CEAs), including cost-utility analyses (CUAs) from a societal... (Review)
Review
INTRODUCTION
In light of the lack of an agreed international standard for how to conduct cost-effectiveness analyses (CEAs), including cost-utility analyses (CUAs) from a societal perspective, there is uncertainty regarding to what extent the inclusion of productivity losses/gains in economic evaluations can affect cost-effectiveness results and subsequently decisions on whether to recommend new health technologies. To investigate this, we conducted a systematic review of CEAs and CUAs of drug-based therapies for a set of chronic immune-mediated disorders to understand how cost elements and calculation methods related to productivity losses/gains are used, examine the impact on the incremental cost-effectiveness ratio (ICER) of including productivity costs, and explore factors that affect the inclusion of productivity loss.
METHODS
Databases (MEDLINE In-process, MEDLINE, Embase and Cochrane Library) were searched from January 2010 to October 2020 by two independent reviewers for all CEAs and CUAs in adults with any of the following conditions: ankylosing spondylitis, chronic idiopathic urticaria, Crohn's disease, fibromyalgia, juvenile idiopathic arthritis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis. Relevant study data were extracted and evidence was synthesized for both qualitative and quantitative analysis. Productivity cost elements including absenteeism, presenteeism, unemployment/early retirement, premature mortality and informal care were extracted, along with the method used to determine them. A multivariate analysis was performed to identify factors associated with the inclusion of productivity loss.
RESULTS
Our searches identified 5016 records, culminating in 198 unique studies from 234 publications following screening. Most of the studies investigated rheumatoid arthritis (37.0%) or psoriasis (32.0%). The majority were CUAs, with some including both a CEA and a CUA (73.0%). Most studies used a payer perspective only (28.5%) or a societal perspective only (21.0%). Of the 49 studies incorporating productivity losses/gains, 42 reported the type of cost element used; all of these used patient absenteeism, either alone or in addition with other elements. Only 16 studies reported the method used to value productivity changes, of which eight used a human capital approach, four used a friction cost approach and four used both approaches. Twenty-eight of the 49 studies (57.1%) reported inclusion of productivity losses/gains as contributing to more favourable cost-effectiveness outcomes and ICERs, while 12 (24.5%) reported no substantial impact. On the basis of a multivariate analysis, rheumatoid arthritis as the target disease had a statistically significant association with the inclusion of productivity loss compared with psoriasis and inflammatory bowel disease.
CONCLUSIONS
The results of our review suggest that incorporating productivity cost elements may positively affect cost-effectiveness outcomes in evaluations of therapeutics for immune-mediated disorders. Our work highlights the continued need for clarity when reporting how CEAs and CUAs in this disease area are conducted, in order to better inform healthcare decision-making.
Topics: Adult; Humans; Cost-Benefit Analysis; Efficiency; Arthritis, Rheumatoid; Absenteeism; Psoriasis
PubMed: 36205907
DOI: 10.1007/s12325-022-02321-z -
Frontiers in Microbiology 2022Spondyloarthritis (SpA) is a group of rheumatic diseases that cause joint inflammation. Accumulating studies have focused on the metabolomic profiling of SpA in recent... (Review)
Review
Spondyloarthritis (SpA) is a group of rheumatic diseases that cause joint inflammation. Accumulating studies have focused on the metabolomic profiling of SpA in recent years. We conducted a systematic review to provide a collective summary of previous findings on metabolomic profiling associated with SpA. We systematically searched PubMed, Medline, Embase and Web of Science for studies on comparisons of the metabolomic analysis of SpA patients and non-SpA controls. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of the included articles. From 482 records identified, 31 studies were included in the analysis. A number of metabolites were differentially distributed between SpA and non-SpA cases. SpA patients showed higher levels of glucose, succinic acid, malic acid and lactate in carbohydrate metabolism, higher glycerol levels and lower fatty acid (especially unsaturated fatty acid) levels in lipid metabolism, and lower levels of tryptophan and glutamine in amino acid metabolism than healthy controls. Both conventional and biological therapy of SpA can insufficiently reverse the aberrant metabolism state toward that of the controls. However, the differences in the results of metabolic profiling between patients with SpA and other inflammatory diseases as well as among patients with several subtypes of SpA are inconsistent across studies. Studies on metabolomics have provided insights into etiological factors and biomarkers for SpA. Supplementation with the metabolites that exhibit decreased levels, such as short-chain fatty acids (SCFAs), has good treatment prospects for modulating immunity. Further studies are needed to elucidate the role of disordered metabolic molecules in the pathogenesis of SpA.
PubMed: 36118235
DOI: 10.3389/fmicb.2022.965709 -
Frontiers in Medicine 2022Previous studies showed conflicting results regarding peripheral vitamin D levels in ankylosing spondylitis (AS). We performed this systemic review and meta-analysis to...
OBJECTIVES
Previous studies showed conflicting results regarding peripheral vitamin D levels in ankylosing spondylitis (AS). We performed this systemic review and meta-analysis to explore whether vitamin D may influence AS process.
METHODS
Articles published until March 2022 were searched in databases as follows: PubMed, Web of Science, and Google Scholar. The present study included cross-sectional and case-control studies regarding vitamin D levels in patients with AS. Studies were excluded according to the following exclusion criteria: (1) we excluded studies which did not provide sufficient information regarding the comparison of vitamin D levels in AS patients and healthy controls (HC). Vitamin D levels in the two group studies should be reported or could be calculated in included studies; (2) meta-analysis, reviews and case reports. STATA 12.0 software was used to make a meta-analysis. Standard mean differences (SMDs) and 95% confidence intervals (CIs) were computed as effect size.
RESULTS
The present meta-analysis showed no significant difference in peripheral 1,25-dihydroxyvitamin D3 (1,25OHD) levels between AS and healthy controls (HCs) in Caucasians with a random effects model [SMD: -0.68, 95% CI (-1.90, 0.54)]. Patients with AS had lower peripheral 25-hydroxyvitamin D (25OHD) levels compared with HC with a random effects model [SMD: -0.45, 95% CI: (-0.70, -0.20)]. Patients with AS had higher peripheral C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels compared with HC in Caucasian population with random effects models [CRP: SMD: 1.08, 95% CI: (0.78, 1.37); ESR: SMD: 0.86, 95% CI: (0.39, 1.34)]. However, no significant difference in alkaline phosphatase (ALP), parathyroid hormone (PTH) or calcium levels were indicated between AS and HC in Caucasian with random effects models [ALP: SMD: 0.07, 95% CI: (-0.41, 0.55); PTH: SMD: -0.15, 95% CI: (-0.56, 0.26); calcium: SMD: -0.06, 95% CI: (-0.39, 0.26)].
CONCLUSION
In conclusion, the study showed an inverse association between 25OHD and AS, which suggests that vitamin D may have a protective effect on AS. ESR and C-reactive protein (CRP) are important biomarkers for AS.
PubMed: 36091702
DOI: 10.3389/fmed.2022.972586 -
Frontiers in Physiology 2022Balneotherapy and exercise are potential factors influencing sleep through several physiological pathways and relaxing effects. This review aims to assess whether...
Balneotherapy and exercise are potential factors influencing sleep through several physiological pathways and relaxing effects. This review aims to assess whether balneotherapy can improve sleep quality in concomitance or not with exercise. The research was conducted on , , , and databases. The current review followed PRISMA reporting guidelines and involves twenty-one articles grouped into four sections based on the characteristics of the balneotherapy protocol: 1.a (five studies); 1.b (six studies); 2.a (eight studies); 2.b (three studies). Apart from healthy or sub-healthy subjects, patients recruited in the studies were affected by fibromyalgia, ankylosing spondylitis, osteoarthritis, musculoskeletal pain, subacute supraspinatus tendinopathy, and mental disorders. Duration, number of sessions, and study protocols are very different from each other. Only one study objectively evaluated sleep, whereas the others used subjective sleep assessment methods. Eight studies considered sleep as a primary outcome and ten as secondary. Sixteen out of twenty-one studies described improvements in self-perceived sleep quality. Thus, balneotherapy associated with other spa treatments and physical exercise seems to be effective in improving self-perceived sleep quality. However, the miscellany of treatments makes it difficult to discern the isolated effects of balneotherapy and physical exercise. Future studies should consider using an objective sleep assessment method and describing the pathways and physiological mechanisms that could provoke sleep changes during balneotherapy treatments.
PubMed: 36035468
DOI: 10.3389/fphys.2022.964232 -
RMD Open Jun 2022The objectives of this review were to collect and summarise evidence on therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and... (Review)
Review
Therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal disease: a systematic literature review informing EULAR points to consider.
The objectives of this review were to collect and summarise evidence on therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases and to inform the EULAR Task Force for the formulation of evidence-based points to consider. A systematic literature review (SLR) was performed, covering technical aspects and (clinical) utility of TDM, to answer 13 research questions. MEDLINE, Embase and Cochrane were searched until July 2020. American College of Rheumatology and EULAR abstracts were also considered for inclusion. Data were extracted in evidence tables and risk of bias assessment was performed. For the search on technical aspects, 678 records were identified, of which 22 papers were selected. For the clinical utility search, 3846 records were identified, of which 108 papers were included. Patient-related factors associated with biopharmaceutical blood concentrations included body weight, methotrexate comedication and disease activity. The identification of a target range was hampered by study variability, mainly disease activity measures and study type. Evidence was inconsistent for multiple clinical situations in which TDM is currently applied. However, for some particular scenarios, including prediction of future treatment response, non-response to treatment, tapering and hypersensitivity reactions, robust evidence was found. There is currently no evidence for routine use of proactive TDM, in part because published cost-effectiveness analyses do not incorporate the current landscape of biopharmaceutical costs and usage. This SLR yields evidence in favour of TDM of biopharmaceuticals in some clinical scenarios, but evidence is insufficient to support implementation of routine use of TDM.
Topics: Antirheumatic Agents; Arthritis, Rheumatoid; Biological Products; Drug Monitoring; Humans; Methotrexate
PubMed: 35980738
DOI: 10.1136/rmdopen-2022-002216 -
Frontiers in Immunology 2022To evaluate the randomized controlled trials (RCTs) of Curcumin and Curcuma longa Extract in the treatment of autoimmune diseases. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the randomized controlled trials (RCTs) of Curcumin and Curcuma longa Extract in the treatment of autoimmune diseases.
METHODS
Databases such as Embase, Web of Science, PubMed and The Cochrane Library were searched from the database establishment to February 2022 to collect RCTs of Curcumin and Curcuma longa Extract in the treatment of autoimmune diseases. Then the literature was screened and the data were extracted. Meta-analysis was performed using RevMan 5.3 software.
RESULTS
A total of 34 records were included, involving 31 RCTs and 10 types of autoimmune disease. Among them, ankylosing spondylitis (AS) involves one RCT, Behcet 's disease (BD) involves one RCT, Crohn 's disease involves two RCTs, multiple sclerosis (MS) involves two RCTs, oral lichen planus involves six RCTs, psoriasis involves two RCTs, rheumatoid arthritis (RA) involves five RCTs, systemic lupus erythematosus (SLE) involves two RCTs, arteritis involves one RCT, ulcerative colitis (UC) involves nine RCTs. Among them, most of the RCTs of ulcerative colitis (UC), oral lichen planus, RA showed that curcumin and curcumin extracts improved clinical or laboratory results. Crohn ' s disease, MS, SLE, psoriasis included two RCTs; they all showed improvements (at least one RCT reported improvements in clinical outcomes). AS, BD and arteritis included only one RCT, and the clinical results showed improvement. However, due to the small number of RCTs and the small number of patients involved in each disease, there is still a need for more high-quality RCTs.
CONCLUSION
Curcumin and Curcuma longa Extract had good clinical efficacy in the treatment of Psoriasis, UC and RA, so Curcumin and Curcuma longa Extract could be used in the treatment of the above diseases in the future. The results of Meta-analysis showed that Curcumin and Curcuma longa Extract did not show efficacy in the treatment of oral lichen planus, while Takayasu arteritis, SLE, MS, AS, BD and CD did not report sufficient clinical data for meta-analysis. Therefore, large-sample, multi-center clinical trials are still needed for revision or validation.
Topics: Arteritis; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Curcuma; Curcumin; Humans; Lichen Planus, Oral; Lupus Erythematosus, Systemic; Plant Extracts; Psoriasis; Randomized Controlled Trials as Topic; Spondylitis, Ankylosing
PubMed: 35979355
DOI: 10.3389/fimmu.2022.896476 -
Frontiers in Immunology 2022Modern pharmacological research found that the chemical components of are mainly curcumin and turmeric volatile oil. Several recent randomized controlled trials (RCT)... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Modern pharmacological research found that the chemical components of are mainly curcumin and turmeric volatile oil. Several recent randomized controlled trials (RCT) have shown that curcumin improves symptoms and inflammation in patients with arthritis.
METHODS
Pubmed, Cochran Library, CNKI, and other databases were searched to collect the randomized controlled trials (RCTs). Then, the risk of bias of RCTs were assessed and data of RCTs were extracted. Finally, RevMan 5.3 was utilized for meta-analysis.
RESULTS
Twenty-nine (29) RCTs involving 2396 participants and 5 types of arthritis were included. The arthritis included Ankylosing Spondylitis (AS), Rheumatoid Arthritis (RA), Osteoarthritis (OA), Juvenile idiopathic arthritis (JIA) and gout/hyperuricemia. Curcumin and Curcuma longa Extract were administered in doses ranging from 120 mg to 1500 mg for a duration of 4-36 weeks. In general, Curcumin and Curcuma longa Extract showed safety in all studies and improved the severity of inflammation and pain levels in these arthritis patients. However, more RCTs are needed in the future to elucidate the effect of Curcumin and Curcuma longa Extract supplementation in patients with arthritis, including RA, OA, AS and JIA.
CONCLUSION
Curcumin and Curcuma longa Extract may improve symptoms and inflammation levels in people with arthritis. However, due to the low quality and small quantity of RCTs, the conclusions need to be interpreted carefully.
Topics: Arthritis, Rheumatoid; Curcuma; Curcumin; Humans; Inflammation; Osteoarthritis; Plant Extracts; Randomized Controlled Trials as Topic; Spondylitis, Ankylosing
PubMed: 35935936
DOI: 10.3389/fimmu.2022.891822 -
Health and Quality of Life Outcomes Jul 2022Patients who suffered from ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA) often have poor quality of life (QoL) and there has been a... (Meta-Analysis)
Meta-Analysis Review
The validity and reliability of quality of life questionnaires in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and meta-analysis.
BACKGROUND
Patients who suffered from ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA) often have poor quality of life (QoL) and there has been a substantial increase in research on acceptable questionnaires for assessment of QoL. This systematic review aims at examining the validity and reliability of QoL questionnaires in patients with AS/nr-axSpA.
METHODS
Randomized controlled trials (RCTs), cohort trials, and cross-sectional trails were retrieved by searching seven databases. Primary outcomes included test-retest reliability and construct validity. Secondary outcomes included internal consistency, structural validity, responsiveness and so on. Data extraction and analyses were conducted according to the Cochrane standards. The Agency for Healthcare Research and Quality (AHRQ) checklists was used to assess the risk of bias for each included study. We used the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) to assess the methodological quality and measurement property of included instruments. The quality of evidence on pre-specified outcomes were assessed by the Grades of Recommendations, Development and Evaluation (GRADE) approach.
RESULTS
22 publications containing 10 self-rating instruments were included in this study. Most studies were cross-sectional in design and a total of 3,085 participants were enrolled. 19 studies had moderate to high test-retest reliability. Cronbach's alpha (α) Coefficients were generally high (0.79-0.97) for overall scales. The ankylosing spondylitis quality of life (ASQOL) and evaluation of ankylosing spondylitis quality of life (EASi-QoL) questionnaires showed the strongest measurement properties in high-quality studies. The correlation coefficient for test-retest reliability of the ASQOL questionnaire was 0.85 (95% CI 0.80 to 0.89). The pooled Cronbach's α coefficients of the ASQOL questionnaire and the EASi-QoL questionnaire were high. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) were considered as two validity criteria. For the ASQOL and EASi-QoL questionnaire, pooled convergent validity associations with BASDAI and BASFI were low to strong (0.24-0.81).
CONCLUSIONS
This study indicated acceptable reliability and stability of included QoL questionnaires. The ASQOL and the EASi-QoL questionnaires are validated and reliable disease-specific questionnaires for the assessment of QoL in patients with AS/nr-axSpA.
Topics: Axial Spondyloarthritis; Humans; Non-Radiographic Axial Spondyloarthritis; Quality of Life; Reproducibility of Results; Severity of Illness Index; Spondylitis, Ankylosing; Surveys and Questionnaires
PubMed: 35907948
DOI: 10.1186/s12955-022-02026-5 -
Journal of Orthopaedic Surgery and... Jul 2022Ankylosing spondylitis (AS) and spinal fusion (SF) classified as stiff spines have been associated with the increased rate of complications following total hip... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ankylosing spondylitis (AS) and spinal fusion (SF) classified as stiff spines have been associated with the increased rate of complications following total hip arthroplasty (THA). However, the differences between the two cohorts have inconsistent evidence.
METHODS
We searched for studies comparing complications among stiff spine patients, including SF and AS, who underwent THA in PubMed/MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and Scopus until March 2021. Studies detailing rates of mechanical complications, aseptic loosening, dislocation, infection, and revisions were included. We performed network meta-analyses using frequentist random-effects models to compare differences between cohorts. We used P-score to rank the better exposure with the lowest complications.
RESULTS
Fourteen studies were included in the final analysis. A total of 740,042 patients were included in the systematic review and network meta-analysis. Mechanical complications were highest among SF patients (OR 2.33, 95% CI 1.86, 2.92, p < 0.05), followed by AS patients (OR 1.18, 95% CI 0.87, 1.61, p = 0.82) compared to controls. Long Spinal Fusions had the highest aseptic loosening (OR 2.33, 95% CI 1.83, 2.95, p < 0.05), dislocations (OR 3.25, 95% CI 2.58, 4.10, p < 0.05), infections (OR 2.14, 95% CI 1.73, 2.65, p < 0.05), and revisions (OR 5.25, 95% CI 2.23, 12.32, p < 0.05) compared to AS and controls. Our results suggested that SF with longer constructs may be associated with higher complications in THA patients.
CONCLUSIONS
THAs following SFs have higher mechanical complications, aseptic loosening, dislocations, and infections, especially with longer constructs. AS patients may have fewer complications compared to this cohort.
Topics: Arthroplasty, Replacement, Hip; Hip Prosthesis; Humans; Joint Dislocations; Network Meta-Analysis; Reoperation; Retrospective Studies; Spinal Fusion
PubMed: 35842632
DOI: 10.1186/s13018-022-03237-8