Pub Date : 2024-10-30DOI: 10.1016/j.semarthrit.2024.152572
Omar Al Tabaa , Sophie Hecquet , Marion Thomas , Sandrine Carvès , Alice Combier , Corinne Miceli-Richard , Anna Molto , Olivier Fogel , Yannick Allanore , Jérôme Avouac
Objective
To evaluate the effectiveness and tolerability of JAK inhibitors (JAKi) in patients with difficult-to-treat rheumatoid arthritis (D2TRA) in clinical practice.
Methods
We included RA patients initiating a JAKi between 2018 and 2022. Patients meeting EULAR criteria for D2TRA were compared to active non-D2TRA patients. Efficacy was evaluated at the first visit (FV) (6 months following JAKi initiation) and the last available visit (LV) up to December 2022.
Results
45 patients with D2TRA, all presenting signs of disease activity (imaging, CRP levels), were compared to 29 active non-D2TRA. DAS28 and DAS28-CRP reduction from baseline to FV was significant and similar between both groups, before and after adjusting for several factors including the number and exposure duration to previous targeted therapies. DAS28 and DAS28-CRP remained stable in both groups between FV and LV. The proportion of responders and patients achieving remission or low disease activity at FV and LV was similar in both groups. Thirty-five patients (42 %) discontinued JAKi over a mean observation period of 20±10 months, with no significant difference in discontinuation rates between groups (p = 0.36). Discontinuations due to inefficacy and side effects were evenly distributed. Frequency of infections, herpes zoster, myocardial infarctions, and venous thromboembolism was similar between groups, with a higher likelihood in patients aged ≥65 years and/or with at least one cardiovascular risk factor (30/39, 77 %).
Conclusion
JAKi effectively reduced disease activity in D2TRA patients with the same extent as active non-D2TRA patients. Tolerability profiles were comparable, with outcomes largely dependent on the presence of age and/or cardiovascular risk factors. Haut du formulaire.
{"title":"Real-world assessment of the efficacy and tolerability profile of JAK inhibitors in difficult-to-treat rheumatoid arthritis","authors":"Omar Al Tabaa , Sophie Hecquet , Marion Thomas , Sandrine Carvès , Alice Combier , Corinne Miceli-Richard , Anna Molto , Olivier Fogel , Yannick Allanore , Jérôme Avouac","doi":"10.1016/j.semarthrit.2024.152572","DOIUrl":"10.1016/j.semarthrit.2024.152572","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the effectiveness and tolerability of JAK inhibitors (JAKi) in patients with difficult-to-treat rheumatoid arthritis (D2TRA) in clinical practice.</div></div><div><h3>Methods</h3><div>We included RA patients initiating a JAKi between 2018 and 2022. Patients meeting EULAR criteria for D2TRA were compared to active non-D2TRA patients. Efficacy was evaluated at the first visit (FV) (6 months following JAKi initiation) and the last available visit (LV) up to December 2022.</div></div><div><h3>Results</h3><div>45 patients with D2TRA, all presenting signs of disease activity (imaging, CRP levels), were compared to 29 active non-D2TRA. DAS28 and DAS28-CRP reduction from baseline to FV was significant and similar between both groups, before and after adjusting for several factors including the number and exposure duration to previous targeted therapies. DAS28 and DAS28-CRP remained stable in both groups between FV and LV. The proportion of responders and patients achieving remission or low disease activity at FV and LV was similar in both groups. Thirty-five patients (42 %) discontinued JAKi over a mean observation period of 20±10 months, with no significant difference in discontinuation rates between groups (<em>p</em> = 0.36). Discontinuations due to inefficacy and side effects were evenly distributed. Frequency of infections, herpes zoster, myocardial infarctions, and venous thromboembolism was similar between groups, with a higher likelihood in patients aged ≥65 years and/or with at least one cardiovascular risk factor (30/39, 77 %).</div></div><div><h3>Conclusion</h3><div>JAKi effectively reduced disease activity in D2TRA patients with the same extent as active non-D2TRA patients. Tolerability profiles were comparable, with outcomes largely dependent on the presence of age and/or cardiovascular risk factors. Haut du formulaire.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-28DOI: 10.1016/j.semarthrit.2024.152566
Joy Feld , Oshrat E. Tayer-Shifman , Jiandong Su , Melanie Anderson , Zahi Touma
<div><h3>Objectives</h3><div>To systematically review and synthesize literature on: 1) the overall prevalence of primary headaches and specifically migraines, in patients with lupus since previous systematic review published in 2004; 2) the risk factors associated with primary headaches in patients with lupus; 3) the association of primary headaches with structural brain changes; and 4) “lupus headaches”.</div></div><div><h3>Methods</h3><div>This review used (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) PRISMA guidelines and literature searches in four databases: Ovid-based Medline, Embase, PsycINFO, and Cochrane Database of Systematic Reviews from inception until 4/2022. Papers on primary headaches in patients with lupus were identified. Included studies were critically appraised and analyzed. Since a systematic review on this topic was published in 2004, only papers published in 2004 and later were included in this review. Statistical and publication bias was assessed using funnel plots.</div></div><div><h3>Results</h3><div>A total of 5096 references were identified, 189 were selected for detailed review and 11 papers were included in the final analysis. 1) The pooled prevalence of primary headaches in lupus was 26.8 % (95 %CI 25.1–28.6). The prevalence of primary headaches was similar between patients with lupus and healthy controls, odds ratio (OR) 2.14, 95 %CI 0.97–4.76, p value=0.06, however publication bias was significant according to the Egger test. Lupus patients seem to have a higher prevalence of primary headaches compared to patients with rheumatoid arthritis (RA) and primary Sjogren's syndrome (pSS), OR 2.5, 95 % CI 1.56–4, <em>p</em> < 0.0001. Regarding the prevalence of migraines specifically, no difference was found between patients with lupus compared to healthy controls and patients with RA or pSS. 2) Primary headaches seem to be associated with depression and impaired health related quality of life rather than lupus activity or damage. There is insufficient data to conclude whether specific lupus treatments affected primary headaches in lupus, however, one study did suggest hydroxychloroquine reduced the frequency of primary headaches. Raynaud phenomenon was associated with migraines. 3) One study which examined MRI scans of patients with lupus compared to healthy controls did suggest that larger gray matter volumes reduced the odds for headaches in general (OR 0.98, <em>p</em> = 0.048) and for migraines in particular (OR 0.95, <em>p</em> = 0.004), and larger white matter volumes increased the odds for migraine (OR 1.04, <em>p</em> = 0.007). However, these findings might reflect disease activity or damage, therefore further studies are required to clarify this issue. 4) The only study which specifically addressed the prevalence of “lupus headaches” is Hanly's study from 2013 of the SLICC cohort. In this large cohort, only 1.5 % of patients had "lupus headaches", as defined by SLE Disease Activity Inde
{"title":"Primary headache in SLE –systematic review and meta-analysis","authors":"Joy Feld , Oshrat E. Tayer-Shifman , Jiandong Su , Melanie Anderson , Zahi Touma","doi":"10.1016/j.semarthrit.2024.152566","DOIUrl":"10.1016/j.semarthrit.2024.152566","url":null,"abstract":"<div><h3>Objectives</h3><div>To systematically review and synthesize literature on: 1) the overall prevalence of primary headaches and specifically migraines, in patients with lupus since previous systematic review published in 2004; 2) the risk factors associated with primary headaches in patients with lupus; 3) the association of primary headaches with structural brain changes; and 4) “lupus headaches”.</div></div><div><h3>Methods</h3><div>This review used (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) PRISMA guidelines and literature searches in four databases: Ovid-based Medline, Embase, PsycINFO, and Cochrane Database of Systematic Reviews from inception until 4/2022. Papers on primary headaches in patients with lupus were identified. Included studies were critically appraised and analyzed. Since a systematic review on this topic was published in 2004, only papers published in 2004 and later were included in this review. Statistical and publication bias was assessed using funnel plots.</div></div><div><h3>Results</h3><div>A total of 5096 references were identified, 189 were selected for detailed review and 11 papers were included in the final analysis. 1) The pooled prevalence of primary headaches in lupus was 26.8 % (95 %CI 25.1–28.6). The prevalence of primary headaches was similar between patients with lupus and healthy controls, odds ratio (OR) 2.14, 95 %CI 0.97–4.76, p value=0.06, however publication bias was significant according to the Egger test. Lupus patients seem to have a higher prevalence of primary headaches compared to patients with rheumatoid arthritis (RA) and primary Sjogren's syndrome (pSS), OR 2.5, 95 % CI 1.56–4, <em>p</em> < 0.0001. Regarding the prevalence of migraines specifically, no difference was found between patients with lupus compared to healthy controls and patients with RA or pSS. 2) Primary headaches seem to be associated with depression and impaired health related quality of life rather than lupus activity or damage. There is insufficient data to conclude whether specific lupus treatments affected primary headaches in lupus, however, one study did suggest hydroxychloroquine reduced the frequency of primary headaches. Raynaud phenomenon was associated with migraines. 3) One study which examined MRI scans of patients with lupus compared to healthy controls did suggest that larger gray matter volumes reduced the odds for headaches in general (OR 0.98, <em>p</em> = 0.048) and for migraines in particular (OR 0.95, <em>p</em> = 0.004), and larger white matter volumes increased the odds for migraine (OR 1.04, <em>p</em> = 0.007). However, these findings might reflect disease activity or damage, therefore further studies are required to clarify this issue. 4) The only study which specifically addressed the prevalence of “lupus headaches” is Hanly's study from 2013 of the SLICC cohort. In this large cohort, only 1.5 % of patients had \"lupus headaches\", as defined by SLE Disease Activity Inde","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-28DOI: 10.1016/j.semarthrit.2024.152575
Junghee Yoon , Soo-Bin Lee , Soo-Kyung Cho , Yoon-Kyoung Sung
Objective
This review aimed to map the existing the information and communication technology (ICT)-based patient education for autoimmune inflammatory rheumatic diseases and identify key effectiveness factors and guidelines for professionals.
Methods
A scoping review systematically reviewed PubMed, Cochrane library, EMBASE and Web of Science. We designed search strategies to identify ICT-based patient education for autoimmune inflammatory rheumatic diseases focused on rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus, published between January 2011 and October 2023. Data extraction was independently screened by two reviewers according to the eligibility criteria.
Results
Of 13,861 records, 18 met the eligibility criteria. Most studies were randomized controlled trials, primarily conducted in the USA, focusing on rheumatoid arthritis. ICT-based interventions included web-based platforms, aiming to improve self-management, medication adherence, with most interventions showing significant improvements. Digital tools such as websites, chatbots were common. Five groups representing the ICT functions were identified: digital self-management tools, multimedia learning materials, personalized educational sessions, behavior change and empathy games, and interactive online communities and peer support. Most studies lacked theoretical frameworks, or guidelines for developing patient education.
Conclusion
ICT-based patient education has significant potential for enhancing self-management and behavior changes in patients with autoimmune inflammatory rheumatic diseases.
{"title":"Information and communication technology-based patient education for autoimmune inflammatory rheumatic diseases: A scoping review","authors":"Junghee Yoon , Soo-Bin Lee , Soo-Kyung Cho , Yoon-Kyoung Sung","doi":"10.1016/j.semarthrit.2024.152575","DOIUrl":"10.1016/j.semarthrit.2024.152575","url":null,"abstract":"<div><h3>Objective</h3><div>This review aimed to map the existing the information and communication technology (ICT)-based patient education for autoimmune inflammatory rheumatic diseases and identify key effectiveness factors and guidelines for professionals.</div></div><div><h3>Methods</h3><div>A scoping review systematically reviewed PubMed, Cochrane library, EMBASE and Web of Science. We designed search strategies to identify ICT-based patient education for autoimmune inflammatory rheumatic diseases focused on rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus, published between January 2011 and October 2023. Data extraction was independently screened by two reviewers according to the eligibility criteria.</div></div><div><h3>Results</h3><div>Of 13,861 records, 18 met the eligibility criteria. Most studies were randomized controlled trials, primarily conducted in the USA, focusing on rheumatoid arthritis. ICT-based interventions included web-based platforms, aiming to improve self-management, medication adherence, with most interventions showing significant improvements. Digital tools such as websites, chatbots were common. Five groups representing the ICT functions were identified: digital self-management tools, multimedia learning materials, personalized educational sessions, behavior change and empathy games, and interactive online communities and peer support. Most studies lacked theoretical frameworks, or guidelines for developing patient education.</div></div><div><h3>Conclusion</h3><div>ICT-based patient education has significant potential for enhancing self-management and behavior changes in patients with autoimmune inflammatory rheumatic diseases.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To comprehensively assess and present the evidence for treatments used in the management of the gastrointestinal manifestations of SLE.
Methods
A systematic search of the literature from January 1990 to June 2022 was performed using the following databases: MEDLINE, EMBASE, PubMed and Cochrane. Key words relating to the gastrointestinal system, SLE, and treatment were used. Where there was sufficient evidence for the treatment of a manifestation, we excluded case series with <10 cases and case reports. However, for rarer manifestations with insufficient higher-level evidence, smaller case series and case reports were included.
Results
A total of 29 studies including 767 patients were included in the review; six cohort studies, 11 case-control studies, and 11 case series. Specific gastrointestinal manifestations included enteritis (5 studies), mesenteric vasculitis (3 studies), acute pancreatitis (5 studies), chronic pancreatitis (1 study), intestinal pseudo-obstruction (IPO) (2 studies), hepatitis (4 studies), protein-losing enteropathy (PLE) (6 studies), acute acalculous cholecystitis (2 studies), and Budd-Chiari Syndrome (1 study). Evidence for the treatment of Ascites (13 case reports), peritonitis (3 case reports), and miscellaneous GI manifestations (11 case reports) are included as a supplemental file. Most studies demonstrated a benefit from pulsed intravenous methylprednisolone (IVMP) in severe or life-threatening manifestations, and oral prednisolone for less severe manifestations. However, the quality of evidence was low, with a high risk of bias in all studies.
Conclusion
This review highlights the need for standardised disease definitions and terminology, as well as consideration of including gastrointestinal manifestations in disease scoring systems. There is a significant need for high-quality clinical trials in the treatment of the gastrointestinal manifestations of SLE, which will likely need to be multi-centre. We hope that this review will promote awareness of the gastrointestinal manifestations of SLE, and serve as a practical guide for evidence-based treatment.
{"title":"Systematic review of treatments for the gastrointestinal manifestations of systemic lupus erythematosus","authors":"Luke Williamson , Yanjie Hao , Chamara Basnayake , Shereen Oon , Mandana Nikpour","doi":"10.1016/j.semarthrit.2024.152567","DOIUrl":"10.1016/j.semarthrit.2024.152567","url":null,"abstract":"<div><h3>Objectives</h3><div>To comprehensively assess and present the evidence for treatments used in the management of the gastrointestinal manifestations of SLE.</div></div><div><h3>Methods</h3><div>A systematic search of the literature from January 1990 to June 2022 was performed using the following databases: MEDLINE, EMBASE, PubMed and Cochrane. Key words relating to the gastrointestinal system, SLE, and treatment were used. Where there was sufficient evidence for the treatment of a manifestation, we excluded case series with <10 cases and case reports. However, for rarer manifestations with insufficient higher-level evidence, smaller case series and case reports were included.</div></div><div><h3>Results</h3><div>A total of 29 studies including 767 patients were included in the review; six cohort studies, 11 case-control studies, and 11 case series. Specific gastrointestinal manifestations included enteritis (5 studies), mesenteric vasculitis (3 studies), acute pancreatitis (5 studies), chronic pancreatitis (1 study), intestinal pseudo-obstruction (IPO) (2 studies), hepatitis (4 studies), protein-losing enteropathy (PLE) (6 studies), acute acalculous cholecystitis (2 studies), and Budd-Chiari Syndrome (1 study). Evidence for the treatment of Ascites (13 case reports), peritonitis (3 case reports), and miscellaneous GI manifestations (11 case reports) are included as a supplemental file. Most studies demonstrated a benefit from pulsed intravenous methylprednisolone (IVMP) in severe or life-threatening manifestations, and oral prednisolone for less severe manifestations. However, the quality of evidence was low, with a high risk of bias in all studies.</div></div><div><h3>Conclusion</h3><div>This review highlights the need for standardised disease definitions and terminology, as well as consideration of including gastrointestinal manifestations in disease scoring systems. There is a significant need for high-quality clinical trials in the treatment of the gastrointestinal manifestations of SLE, which will likely need to be multi-centre. We hope that this review will promote awareness of the gastrointestinal manifestations of SLE, and serve as a practical guide for evidence-based treatment.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142507452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/j.semarthrit.2024.152571
Sofia Ramiro , Cédric Lukas , Michael J Nissen , Baojin Zhu , Khai Jing Ng , Mohamed Sheesh , Gabriel Doridot , Soyi Liu-Leage , Antoni Chan , Ying Fang , James Cheng-Chung Wei
Introduction
Spinal pain at night is a major contributor to the patient burden of radiographic axial spondyloarthritis (r-axSpA), resulting in substantial functional limitations and impairment of health-related quality of life (QoL). Ixekizumab (IXE), an interleukin-17A inhibitor, has shown efficacy in patients with r-axSpA.
Objective
To assess spinal pain at night improvement up to week (W) 52 in COAST-V and to determine if clinically important improvement in spinal pain at night at W16 is associated with improvement in disease activity and other patient-reported outcomes (PROs) at W16 and W52.
Methods
The 52 W phase 3 COAST-V trial investigated the efficacy of IXE in patients with r-axSpA that were naïve to biological disease-modifying anti-rheumatic drug (bDMARD). Patients were randomised to IXE every two weeks (Q2W), IXE every four weeks (Q4W), adalimumab (ADA) Q2W, or placebo up to W16. Patients were categorised as achieving or not achieving a ≥3-point improvement, considered a clinically important improvement (CII), in spinal pain at night at W16. Associations between achieving CII in spinal pain at night at W16 and change from baseline in disease activity (ASDAS, ASAS40), Fatigue severity NRS, JSEQ, WPAI and the SF-36 survey, were tested using analysis of covariance (continuous variables) and logistic regression (binary variables).
Results
At W16, 63.0 % (n=51), 46.7 % (n=42), and 32.2 % (n=28) of patients treated with IXE Q4W, ADA Q2W, and placebo, respectively, had reached a CII in spinal pain at night. Of those who were treated with IXE Q4W and achieved a CII in spinal pain at night at W16, 58.8 % and 66.7 % achieved an ASDAS <2.1 at W16 and W52 while 25.5 % and 29.4 % of patients also achieved ASDAS <1.3 at W16 and W52, respectively. Results at W16 and W52 show an improvement in disease activity, functioning, and health related QoL for patients who achieved a CII in spinal pain at night at W16.
Conclusion
A larger proportion of patients treated with IXE Q4W achieved rapid and clinically meaningful improvement in spinal pain at night versus placebo, with improvements maintained up to W52. Achieving a CII in spinal pain at night at W16 was associated with improved disease activity, functioning, PROs, and QoL at W16 and W52.
{"title":"Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial","authors":"Sofia Ramiro , Cédric Lukas , Michael J Nissen , Baojin Zhu , Khai Jing Ng , Mohamed Sheesh , Gabriel Doridot , Soyi Liu-Leage , Antoni Chan , Ying Fang , James Cheng-Chung Wei","doi":"10.1016/j.semarthrit.2024.152571","DOIUrl":"10.1016/j.semarthrit.2024.152571","url":null,"abstract":"<div><h3>Introduction</h3><div>Spinal pain at night is a major contributor to the patient burden of radiographic axial spondyloarthritis (r-axSpA), resulting in substantial functional limitations and impairment of health-related quality of life (QoL). Ixekizumab (IXE), an interleukin-17A inhibitor, has shown efficacy in patients with r-axSpA.</div></div><div><h3>Objective</h3><div>To assess spinal pain at night improvement up to week (W) 52 in COAST-V and to determine if clinically important improvement in spinal pain at night at W16 is associated with improvement in disease activity and other patient-reported outcomes (PROs) at W16 and W52.</div></div><div><h3>Methods</h3><div>The 52 W phase 3 COAST-V trial investigated the efficacy of IXE in patients with r-axSpA that were naïve to biological disease-modifying anti-rheumatic drug (bDMARD). Patients were randomised to IXE every two weeks (Q2W), IXE every four weeks (Q4W), adalimumab (ADA) Q2W, or placebo up to W16. Patients were categorised as achieving or not achieving a ≥3-point improvement, considered a clinically important improvement (CII), in spinal pain at night at W16. Associations between achieving CII in spinal pain at night at W16 and change from baseline in disease activity (ASDAS, ASAS40), Fatigue severity NRS, JSEQ, WPAI and the SF-36 survey, were tested using analysis of covariance (continuous variables) and logistic regression (binary variables).</div></div><div><h3>Results</h3><div>At W16, 63.0 % (<em>n</em>=51), 46.7 % (<em>n</em>=42), and 32.2 % (<em>n</em>=28) of patients treated with IXE Q4W, ADA Q2W, and placebo, respectively, had reached a CII in spinal pain at night. Of those who were treated with IXE Q4W and achieved a CII in spinal pain at night at W16, 58.8 % and 66.7 % achieved an ASDAS <2.1 at W16 and W52 while 25.5 % and 29.4 % of patients also achieved ASDAS <1.3 at W16 and W52, respectively. Results at W16 and W52 show an improvement in disease activity, functioning, and health related QoL for patients who achieved a CII in spinal pain at night at W16.</div></div><div><h3>Conclusion</h3><div>A larger proportion of patients treated with IXE Q4W achieved rapid and clinically meaningful improvement in spinal pain at night versus placebo, with improvements maintained up to W52. Achieving a CII in spinal pain at night at W16 was associated with improved disease activity, functioning, PROs, and QoL at W16 and W52.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov NCT02696785</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-11DOI: 10.1016/j.semarthrit.2024.152570
Edward Lovering , Chanakya Kodishala , Roslin Jose George , Rakesh Kumar , Cynthia S Crowson , Ryan J Lennon , John M Davis III , Elena Myasoedova
Objective
To examine the role of cardiovascular disease (CVD) as a mediator in the pathway between rheumatoid arthritis (RA) and Alzheimer's disease and related dementias (ADRD).
Methods
This retrospective population-based study included patients over 50 years of age with incident RA, who met the 1987 ACR criteria in 1980–2014. This cohort was matched 1:1 on age, sex and index year to comparators without RA. Information on CVD events was manually extracted from electronic health records. The relationships between RA, CVD and ADRD were examined using Cox proportional hazard models. Time dependent mediation analysis was used to examine the role of CVD as a mediator between RA and ADRD.
Results
1754 individuals were included (877 persons with RA and 877 comparators without RA). During follow-up, 105 patients with RA and 102 individuals without RA developed ADRD; 444 patients with RA and 375 individuals without RA developed CVD. There was a non-significant association between RA and ADRD both without (aHR 1.27, 95 % CI 0.96, 1.69) and with (aHR 1.27, 95 % CI 0.95,1.68) CVD as a time dependent mediator. The mediation effect of any CVD on ADRD risk was not significant (p = 0.84). We found a significant interaction between RA and CVD on the risk of ADRD (aHR 1.95, 95 % CI 1.11, 3.42; p = 0.021).
Conclusions
The risk of ADRD in RA appears to be increased mainly in the presence of CVD. CVD was not a significant mediator on the risk of ADRD in RA. There was a significant synergistic effect of RA and CVD on ADRD risk.
目的研究心血管疾病(CVD)在类风湿性关节炎(RA)与阿尔茨海默病及相关痴呆症(ADRD)之间的路径中作为介质的作用。在年龄、性别和指数年份方面,该队列与无RA的比较者进行了1:1匹配。心血管疾病事件的信息由人工从电子健康记录中提取。采用Cox比例危险模型研究了RA、心血管疾病和ADRD之间的关系。结果1754人被纳入研究(877名RA患者和877名未患RA的对比者)。在随访期间,105 名 RA 患者和 102 名非 RA 患者出现了 ADRD;444 名 RA 患者和 375 名非 RA 患者出现了心血管疾病。在没有(aHR 1.27,95 % CI 0.96,1.69)和有(aHR 1.27,95 % CI 0.95,1.68)心血管疾病作为时间依赖性中介的情况下,RA 与 ADRD 之间的关系均不显著。任何心血管疾病对 ADRD 风险的中介效应均不显著(p = 0.84)。我们发现 RA 和心血管疾病对 ADRD 风险有明显的交互作用(aHR 1.95,95 % CI 1.11,3.42;p = 0.021)。心血管疾病并不是RA患者ADRD风险的重要中介因素。RA和心血管疾病对ADRD风险有明显的协同作用。
{"title":"The impact of cardiovascular and cerebrovascular disease on the risk of dementia in rheumatoid arthritis: A mediation analysis","authors":"Edward Lovering , Chanakya Kodishala , Roslin Jose George , Rakesh Kumar , Cynthia S Crowson , Ryan J Lennon , John M Davis III , Elena Myasoedova","doi":"10.1016/j.semarthrit.2024.152570","DOIUrl":"10.1016/j.semarthrit.2024.152570","url":null,"abstract":"<div><h3>Objective</h3><div>To examine the role of cardiovascular disease (CVD) as a mediator in the pathway between rheumatoid arthritis (RA) and Alzheimer's disease and related dementias (ADRD).</div></div><div><h3>Methods</h3><div>This retrospective population-based study included patients over 50 years of age with incident RA, who met the 1987 ACR criteria in 1980–2014. This cohort was matched 1:1 on age, sex and index year to comparators without RA. Information on CVD events was manually extracted from electronic health records. The relationships between RA, CVD and ADRD were examined using Cox proportional hazard models. Time dependent mediation analysis was used to examine the role of CVD as a mediator between RA and ADRD.</div></div><div><h3>Results</h3><div>1754 individuals were included (877 persons with RA and 877 comparators without RA). During follow-up, 105 patients with RA and 102 individuals without RA developed ADRD; 444 patients with RA and 375 individuals without RA developed CVD. There was a non-significant association between RA and ADRD both without (aHR 1.27, 95 % CI 0.96, 1.69) and with (aHR 1.27, 95 % CI 0.95,1.68) CVD as a time dependent mediator. The mediation effect of any CVD on ADRD risk was not significant (<em>p</em> = 0.84). We found a significant interaction between RA and CVD on the risk of ADRD (aHR 1.95, 95 % CI 1.11, 3.42; <em>p</em> = 0.021).</div></div><div><h3>Conclusions</h3><div>The risk of ADRD in RA appears to be increased mainly in the presence of CVD. CVD was not a significant mediator on the risk of ADRD in RA. There was a significant synergistic effect of RA and CVD on ADRD risk.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142442876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-11DOI: 10.1016/j.semarthrit.2024.152569
Abdelaaziz Bounabe , Siham Elammare , Saadia Janani (Professor of higher education) , Raja Ouabich , Ilham Elarrachi (Associate Professor)
Background
Rheumatoid arthritis (RA) has a considerable negative impact on quality of life (QoL) and represents a significant burden on healthcare systems worldwide. Although patient education (PE) programs are advocated as an integral component of comprehensive RA management, the magnitude and sustainability of their QoL benefits remain unclear. This meta-analysis seeks to assess the efficacy of PE interventions in enhancing QoL among RA patients.
Methods
A comprehensive review of studies from 1985 to 2022 was conducted, incorporating 66 publications (59 randomized controlled trials and 7 non-randomized controlled trials) with a total of 9622 participants. Studies were selected based on predefined inclusion criteria, focusing on adults diagnosed with RA who participated in PE interventions compared to conventional or no interventions. Data were analyzed using fixed-effect and random-effects models, depending on the heterogeneity among studies. Results were reported separately for the initial follow-up and for the final follow-up.
Findings
PE interventions demonstrated a positive impact on QoL. Following the intervention, there is a significant improvement in QoL (SMD = 0·13, 95% CI: 0·08 to 0·17, I² = 43%), with the highest efficacy observed at 7–12 weeks. Modern-era publications and randomized controlled trials offer more consistent results. Subgroups with higher female representation (>85%) and combined intervention approaches show more substantial effects. In the final assessments, QoL improvements are noteworthy, especially within the 0–6 weeks post-intervention period (SMD = 0·39, 95% CI: 0·13 to 0·66, I² = 84%). Younger adults (≤50 years) benefit the most, while longer program durations (>52 weeks) exhibit significant but varied effects.
Interpretation
This meta-analysis underscores the positive effect of PE interventions on QoL among RA patients, highlighting the importance of tailored approaches considering various contextual factors. Standardizing intervention protocols and optimizing delivery methods are recommended to enhance the sustained impact of PE programs in RA management.
{"title":"Effectiveness of patient education on the quality of life of patients with rheumatoid arthritis: A systematic review and meta-analysis","authors":"Abdelaaziz Bounabe , Siham Elammare , Saadia Janani (Professor of higher education) , Raja Ouabich , Ilham Elarrachi (Associate Professor)","doi":"10.1016/j.semarthrit.2024.152569","DOIUrl":"10.1016/j.semarthrit.2024.152569","url":null,"abstract":"<div><h3>Background</h3><div>Rheumatoid arthritis (RA) has a considerable negative impact on quality of life (QoL) and represents a significant burden on healthcare systems worldwide. Although patient education (PE) programs are advocated as an integral component of comprehensive RA management, the magnitude and sustainability of their QoL benefits remain unclear. This meta-analysis seeks to assess the efficacy of PE interventions in enhancing QoL among RA patients.</div></div><div><h3>Methods</h3><div>A comprehensive review of studies from 1985 to 2022 was conducted, incorporating 66 publications (59 randomized controlled trials and 7 non-randomized controlled trials) with a total of 9622 participants. Studies were selected based on predefined inclusion criteria, focusing on adults diagnosed with RA who participated in PE interventions compared to conventional or no interventions. Data were analyzed using fixed-effect and random-effects models, depending on the heterogeneity among studies. Results were reported separately for the initial follow-up and for the final follow-up.</div></div><div><h3>Findings</h3><div>PE interventions demonstrated a positive impact on QoL. Following the intervention, there is a significant improvement in QoL (SMD = 0·13, 95% CI: 0·08 to 0·17, <em>I²</em> = 43%), with the highest efficacy observed at 7–12 weeks. Modern-era publications and randomized controlled trials offer more consistent results. Subgroups with higher female representation (>85%) and combined intervention approaches show more substantial effects. In the final assessments, QoL improvements are noteworthy, especially within the 0–6 weeks post-intervention period (SMD = 0·39, 95% CI: 0·13 to 0·66, <em>I²</em> = 84%). Younger adults (≤50 years) benefit the most, while longer program durations (>52 weeks) exhibit significant but varied effects.</div></div><div><h3>Interpretation</h3><div>This meta-analysis underscores the positive effect of PE interventions on QoL among RA patients, highlighting the importance of tailored approaches considering various contextual factors. Standardizing intervention protocols and optimizing delivery methods are recommended to enhance the sustained impact of PE programs in RA management.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study aimed to systematically evaluate the efficacy of plasma exchange (PLEX) in patients with idiopathic inflammatory myositis (IIM) complicated by interstitial lung disease (ILD).
Method
We conducted a comprehensive literature search in Medline and EMBASE from their inception to August 2023, focusing on randomized controlled trials, cohort studies, and case-control studies involving IIM patients with ILD treated with PLEX compared to those treated with standard therapies. The primary outcome was the one-year survival rate. All the statistical analyses were performed using RevMan version 4.12.0.
Results
Out of 438 retrieved studies, 16 were selected for full-text review. Six cohort studies involving 148 patients with anti-melanoma differentiation-associated gene 5 (MDA5)-positive dermatomyositis or antisynthetase syndrome-related dermatomyositis with rapidly progressive ILD refractory to standard treatments (including glucocorticoids, immunosuppressive agents, or intravenous immunoglobulin) met the inclusion criteria. Patients receiving PLEX in addition to other therapies demonstrated a greater one-year survival rate (relative risk [RR] 1.59, 95 % CI 0.96–2.65, I2 52 %) than did patients in the non-PLEX group. Significance was reached in a sensitivity analysis after excluding one outlier (RR 1.71, 95 % confidence intervals [CI] 1.30–2.25; I2 0 %). Additionally, there was a trend suggesting that PLEX improved lung function, radiographic outcomes, and key serum biomarkers, such as Krebs von den Lungen-6 and ferritin. Funnel plot asymmetry suggested publication bias due to the lack of reporting of negative trials. All studies had a low risk of bias.
Conclusions
As an adjunctive therapy, PLEX improved one-year survival in IIM patients with rapidly progressive ILD who were unresponsive to standard treatments.
{"title":"One-year survival benefit of plasma exchange in idiopathic inflammatory myositis patients with progressive interstitial lung disease-a systemic review and meta-analysis","authors":"Bunyarak Tangborwornweerakul , Nattharadee Phutthinart , Supparerk Disayabutr , Wanruchada Katchamart","doi":"10.1016/j.semarthrit.2024.152564","DOIUrl":"10.1016/j.semarthrit.2024.152564","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to systematically evaluate the efficacy of plasma exchange (PLEX) in patients with idiopathic inflammatory myositis (IIM) complicated by interstitial lung disease (ILD).</div></div><div><h3>Method</h3><div>We conducted a comprehensive literature search in Medline and EMBASE from their inception to August 2023, focusing on randomized controlled trials, cohort studies, and case-control studies involving IIM patients with ILD treated with PLEX compared to those treated with standard therapies. The primary outcome was the one-year survival rate. All the statistical analyses were performed using RevMan version 4.12.0.</div></div><div><h3>Results</h3><div>Out of 438 retrieved studies, 16 were selected for full-text review. Six cohort studies involving 148 patients with anti-melanoma differentiation-associated gene 5 (MDA5)-positive dermatomyositis or antisynthetase syndrome-related dermatomyositis with rapidly progressive ILD refractory to standard treatments (including glucocorticoids, immunosuppressive agents, or intravenous immunoglobulin) met the inclusion criteria. Patients receiving PLEX in addition to other therapies demonstrated a greater one-year survival rate (relative risk [RR] 1.59, 95 % CI 0.96–2.65, I<sup>2</sup> 52 %) than did patients in the non-PLEX group. Significance was reached in a sensitivity analysis after excluding one outlier (RR 1.71, 95 % confidence intervals [CI] 1.30–2.25; I<sup>2</sup> 0 %). Additionally, there was a trend suggesting that PLEX improved lung function, radiographic outcomes, and key serum biomarkers, such as Krebs von den Lungen-6 and ferritin. Funnel plot asymmetry suggested publication bias due to the lack of reporting of negative trials. All studies had a low risk of bias.</div></div><div><h3>Conclusions</h3><div>As an adjunctive therapy, PLEX improved one-year survival in IIM patients with rapidly progressive ILD who were unresponsive to standard treatments.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-11DOI: 10.1016/j.semarthrit.2024.152568
Luis Alonso González , Guillermina B. Harvey , Rosana Quintana , Guillermo J. Pons-Estel , Manuel F. Ugarte-Gil , Gloria Vásquez , Luis J Catoggio , Mercedes A. García , Eduardo F. Borba , Nilzio A. Da Silva , João C. Tavares Brenol , Marlene Guibert Toledano , Loreto Massardo , Oscar Neira , Virginia Pascual-Ramos , Mary-Carmen Amigo , Leonor A. Barile-Fabris , Ignacio García De La Torre , José Alfaro-Lozano , María I. Segami , Bernardo A. Pons-Estel
Objective
To examine the predictors of the occurrence of severe thrombocytopenia and its impact on damage accrual and mortality in SLE patients.
Methods
Factors associated with time to severe thrombocytopenia (platelet count ≤20,000/mm3) occurring from the onset of SLE symptoms were assessed by Cox proportional hazards regressions. The association of severe thrombocytopenia with mortality was evaluated by logistic regression analyses while its impact on damage was by negative binomial regression.
Results
Of 1,217 patients, 33 (2.7%) developed severe thrombocytopenia over a mean (SD) follow-up time of 5.9 (3.6) years. The median time from the onset of SLE symptoms to severe thrombocytopenia occurrence was 22 months (IQR 8.7–62.0). Mestizo (60.6%) was the predominant ethnic group, followed by Caucasian (27.3%), while African Latin American exhibited the lowest frequency (12.1%). By multivariable analysis, Mestizo ethnicity (HR 2.67, 95% CI 1.12–6.37, p = 0.027), and autoimmune hemolytic anemia (AIHA) at baseline (HR 3.99; 95% CI 1.05–15.19, p = 0.042) were associated with a shorter time to the occurrence of severe thrombocytopenia while middle/high socioeconomic status (HR 0.23; 95% CI 0.08–0.69, p = 0.008) was associated with a longer time. Severe thrombocytopenia contributed neither to damage nor to mortality.
Conclusions
Severe thrombocytopenia occurs during the early course of SLE. Mestizo ethnicity and AIHA at baseline emerged as independent predictors of a shorter time to severe thrombocytopenia occurrence while a middle/high socioeconomic status seems to be protective against its occurrence. Damage and mortality did not seem to be impacted by the occurrence of severe thrombocytopenia.
目的研究严重血小板减少症发生的预测因素及其对系统性红斑狼疮患者损伤累积和死亡率的影响:方法:采用Cox比例危险度回归法评估从系统性红斑狼疮症状开始到发生严重血小板减少(血小板计数≤20,000/mm3)的时间相关因素。严重血小板减少症与死亡率的关系通过逻辑回归分析进行评估,而其对损害的影响则通过负二项回归进行评估:在 1217 名患者中,33 人(2.7%)在平均(标度)5.9(3.6)年的随访时间内出现了严重血小板减少症。从出现系统性红斑狼疮症状到出现严重血小板减少症的中位时间为 22 个月(IQR 8.7-62.0)。梅斯蒂索人(60.6%)是主要的种族群体,其次是白种人(27.3%),而非洲裔拉美人的发病率最低(12.1%)。通过多变量分析,梅斯蒂索种族(HR 2.67,95% CI 1.12-6.37,p = 0.027)和基线时的自身免疫性溶血性贫血(AIHA)(HR 3.99;95% CI 1.05-15.19,p = 0.042)与患者的寿命缩短有关。042)与较短的严重血小板减少症发生时间相关,而中/高社会经济地位(HR 0.23;95% CI 0.08-0.69,p = 0.008)与较长的时间相关。严重血小板减少既不会造成损害,也不会导致死亡:结论:严重血小板减少症发生在系统性红斑狼疮的早期。结论:严重血小板减少症发生在系统性红斑狼疮的早期病程中。梅斯蒂索种族和基线时的AIHA是预测严重血小板减少症发生时间缩短的独立因素,而中/高社会经济地位似乎对严重血小板减少症的发生具有保护作用。损害和死亡率似乎不受严重血小板减少症发生的影响。
{"title":"Factors predictive of severe thrombocytopenia and its impact on poor outcomes in Latin American patients with systemic lupus erythematosus: Data from a multiethnic Latin American cohort","authors":"Luis Alonso González , Guillermina B. Harvey , Rosana Quintana , Guillermo J. Pons-Estel , Manuel F. Ugarte-Gil , Gloria Vásquez , Luis J Catoggio , Mercedes A. García , Eduardo F. Borba , Nilzio A. Da Silva , João C. Tavares Brenol , Marlene Guibert Toledano , Loreto Massardo , Oscar Neira , Virginia Pascual-Ramos , Mary-Carmen Amigo , Leonor A. Barile-Fabris , Ignacio García De La Torre , José Alfaro-Lozano , María I. Segami , Bernardo A. Pons-Estel","doi":"10.1016/j.semarthrit.2024.152568","DOIUrl":"10.1016/j.semarthrit.2024.152568","url":null,"abstract":"<div><h3>Objective</h3><div>To examine the predictors of the occurrence of severe thrombocytopenia and its impact on damage accrual and mortality in SLE patients.</div></div><div><h3>Methods</h3><div>Factors associated with time to severe thrombocytopenia (platelet count ≤20,000/mm<sup>3</sup>) occurring from the onset of SLE symptoms were assessed by Cox proportional hazards regressions. The association of severe thrombocytopenia with mortality was evaluated by logistic regression analyses while its impact on damage was by negative binomial regression.</div></div><div><h3>Results</h3><div>Of 1,217 patients, 33 (2.7%) developed severe thrombocytopenia over a mean (SD) follow-up time of 5.9 (3.6) years. The median time from the onset of SLE symptoms to severe thrombocytopenia occurrence was 22 months (IQR 8.7–62.0). Mestizo (60.6%) was the predominant ethnic group, followed by Caucasian (27.3%), while African Latin American exhibited the lowest frequency (12.1%). By multivariable analysis, Mestizo ethnicity (HR 2.67, 95% CI 1.12–6.37, <em>p</em> = 0.027), and autoimmune hemolytic anemia (AIHA) at baseline (HR 3.99; 95% CI 1.05–15.19, <em>p</em> = 0.042) were associated with a shorter time to the occurrence of severe thrombocytopenia while middle/high socioeconomic status (HR 0.23; 95% CI 0.08–0.69, <em>p</em> = 0.008) was associated with a longer time. Severe thrombocytopenia contributed neither to damage nor to mortality.</div></div><div><h3>Conclusions</h3><div>Severe thrombocytopenia occurs during the early course of SLE. Mestizo ethnicity and AIHA at baseline emerged as independent predictors of a shorter time to severe thrombocytopenia occurrence while a middle/high socioeconomic status seems to be protective against its occurrence. Damage and mortality did not seem to be impacted by the occurrence of severe thrombocytopenia.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142507451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-11DOI: 10.1016/j.semarthrit.2024.152561
Qianru Zhang , Gregory C McDermott , Pierre-Antoine Juge , Sung Hae Chang , Kathleen MM Vanni , Grace Qian , Katarina J Bade , Kevin T Mueller , Emily N Kowalski , Alene A Saavedra , Jeffrey A Sparks
Objective
To investigate the association of disease-modifying antirheumatic drugs (DMARDs) and risk of incident interstitial lung disease (ILD) among patients with rheumatoid arthritis (RA) using a systematic literature review and meta-analysis.
Methods
We performed a systematic literature review and meta-analysis of studies examining the association of DMARDs with incident RA-ILD. PubMed, Embase, Web of Science, and Cochrane Library were searched from inception to November 2023 for randomized controlled trials (RCTs), observational studies, and post-marketing surveillance studies that investigated adults with RA and compared DMARDs of interest with placebo, no DMARDs, or other DMARDs. The outcome was incident ILD. We summarized the literature on DMARDs and incident RA-ILD risk. Among studies with sufficient quality, we performed meta-analyses to obtain odds ratios (OR) and 95 % confidence intervals (95 %CI) using the Mantel-Haenszel method.
Results
Among 3,612 studies, we identified a total of 40 papers that encompassed 486,465 patients with RA and 3,928 incident ILD outcomes that were included in the final systematic review and meta-analysis. Among the studies, 24 were RCTs, 4 were prospective cohort studies, 9 were retrospective cohort studies, 2 were case-control studies, and 1 was a post-marketing surveillance study. The pooled analysis from RCTs revealed no statistically significant difference in the odds of ILD development for any specific DMARD across all comparisons examined. The largest identified RCT (Oral Surveillance trial) of tofacitinib (n = 2,911) vs. tumor necrosis factor inhibitor (TNFi, n = 1,451) found no relationship with incident ILD (OR 0.94, 95 %CI 0.52 to 1.69, p = 0.828). In 7 observational studies, the use of methotrexate (MTX) yielded a pooled OR for ILD of 0.49 (95 %CI 0.32 to 0.76, p < 0.001) compared to those not using MTX. In a single observational study, tofacitinib users had an OR for ILD of 0.36 (95 %CI 0.15 to 0.87, p = 0.024) compared to TNFi users.
Conclusion
Observational data suggest no increased risk for any DMARD for incident RA-ILD risk, and perhaps a potential protective role of MTX and tofacitinib. However, these studies may be susceptible to bias, and no specific DMARD showed associations with incident RA-ILD in RCTs. Further well-designed prospective studies are warranted for definitive conclusions on the potential relationship between DMARDs and RA-ILD risk.
{"title":"Disease-modifying antirheumatic drugs and risk of incident interstitial lung disease among patients with rheumatoid arthritis: A systematic review and meta-analysis","authors":"Qianru Zhang , Gregory C McDermott , Pierre-Antoine Juge , Sung Hae Chang , Kathleen MM Vanni , Grace Qian , Katarina J Bade , Kevin T Mueller , Emily N Kowalski , Alene A Saavedra , Jeffrey A Sparks","doi":"10.1016/j.semarthrit.2024.152561","DOIUrl":"10.1016/j.semarthrit.2024.152561","url":null,"abstract":"<div><h3>Objective</h3><div>To investigate the association of disease-modifying antirheumatic drugs (DMARDs) and risk of incident interstitial lung disease (ILD) among patients with rheumatoid arthritis (RA) using a systematic literature review and meta-analysis.</div></div><div><h3>Methods</h3><div>We performed a systematic literature review and meta-analysis of studies examining the association of DMARDs with incident RA-ILD. PubMed, Embase, Web of Science, and Cochrane Library were searched from inception to November 2023 for randomized controlled trials (RCTs), observational studies, and post-marketing surveillance studies that investigated adults with RA and compared DMARDs of interest with placebo, no DMARDs, or other DMARDs. The outcome was incident ILD. We summarized the literature on DMARDs and incident RA-ILD risk. Among studies with sufficient quality, we performed meta-analyses to obtain odds ratios (OR) and 95 % confidence intervals (95 %CI) using the Mantel-Haenszel method.</div></div><div><h3>Results</h3><div>Among 3,612 studies, we identified a total of 40 papers that encompassed 486,465 patients with RA and 3,928 incident ILD outcomes that were included in the final systematic review and meta-analysis. Among the studies, 24 were RCTs, 4 were prospective cohort studies, 9 were retrospective cohort studies, 2 were case-control studies, and 1 was a post-marketing surveillance study. The pooled analysis from RCTs revealed no statistically significant difference in the odds of ILD development for any specific DMARD across all comparisons examined. The largest identified RCT (Oral Surveillance trial) of tofacitinib (<em>n</em> = 2,911) vs. tumor necrosis factor inhibitor (TNFi, <em>n</em> = 1,451) found no relationship with incident ILD (OR 0.94, 95 %CI 0.52 to 1.69, <em>p</em> = 0.828). In 7 observational studies, the use of methotrexate (MTX) yielded a pooled OR for ILD of 0.49 (95 %CI 0.32 to 0.76, <em>p</em> < 0.001) compared to those not using MTX. In a single observational study, tofacitinib users had an OR for ILD of 0.36 (95 %CI 0.15 to 0.87, <em>p</em> = 0.024) compared to TNFi users.</div></div><div><h3>Conclusion</h3><div>Observational data suggest no increased risk for any DMARD for incident RA-ILD risk, and perhaps a potential protective role of MTX and tofacitinib. However, these studies may be susceptible to bias, and no specific DMARD showed associations with incident RA-ILD in RCTs. Further well-designed prospective studies are warranted for definitive conclusions on the potential relationship between DMARDs and RA-ILD risk.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142442241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}