Rheumatology and Therapy最新文献

{"title":"Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years.","authors":"Christina Charles-Schoeman, Jon T Giles, Nancy E Lane, Ernest Choy, Daniel E Furst, Jiří Vencovský, Anthony G Wilson, Gerd R Burmester, Derek Coombs, Sara K Penn, Nasser Khan, Jillian B Yee, Kassim Rahawi, Iain B McInnes","doi":"10.1007/s40744-023-00624-3","DOIUrl":"10.1007/s40744-023-00624-3","url":null,"abstract":"<p><strong>Introduction: </strong>Upadacitinib (UPA) is a Janus kinase inhibitor that has demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA) with an acceptable safety profile. We investigated laboratory parameter changes in UPA RA clinical trials.</p><p><strong>Methods: </strong>Pooled data from six randomized trials in the SELECT phase 3 program were included. Key laboratory parameters and safety data were measured for UPA 15 and 30 mg once daily (QD), adalimumab (ADA) 40 mg every other week + methotrexate (MTX), and MTX monotherapy. Exposure-adjusted event rates (EAERs) of adverse events were calculated.</p><p><strong>Results: </strong>A total of 3209 patients receiving UPA 15 mg QD (10 782.7 patient-years [PY]), 1204 patients receiving UPA 30 mg QD (3162.5 PY), 579 patients receiving ADA + MTX (1573.2 PY), and 314 patients receiving MTX monotherapy (865.1 PY) were included, representing up to 6.5 years of total exposure. Decreases in mean levels of hemoglobin, neutrophils, and lymphocytes, and increases in mean levels of liver enzymes and creatinine phosphokinase were observed with UPA, with grade 3 or 4 changes observed in some patients. Mean low- and high-density lipoprotein cholesterol ratios remained stable for patients receiving UPA 15 mg QD. EAERs of anemia and neutropenia occurred at generally consistent rates between UPA and active comparators (3.1-4.3 and 1.7-5.0 events [E]/100 PY across treatment groups, respectively). Rates of hepatic disorder were higher with MTX monotherapy, UPA 15 mg and UPA 30 mg (10.8, 9.7, and 11.0 E/100 PY, respectively) versus ADA + MTX (6.4 E/100 PY). Rates of lymphopenia were highest with MTX monotherapy (3.2 E/100 PY). Treatment discontinuations due to laboratory-related events were rare, occurring in 1.1% and 2.2% of patients treated with UPA 15 and 30 mg QD, respectively.</p><p><strong>Conclusions: </strong>The results of this integrated long-term analysis of laboratory parameters continue to support an acceptable safety profile of UPA 15 mg QD for moderate-to-severe RA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"157-175"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139098563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis.","authors":"Jeffrey R Curtis, Paul Emery, Bryan Downie, Yan Zhong, Jinfeng Liu, Ling Han, Rachael E Hawtin, Gerd Rüdiger Burmester","doi":"10.1007/s40744-023-00619-0","DOIUrl":"10.1007/s40744-023-00619-0","url":null,"abstract":"<p><strong>Objectives: </strong>To assess cigarette smoking's effects on efficacy of the preferential Janus kinase (JAK) 1 inhibitor filgotinib and drug persistence in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>Efficacy in non-smokers, former smokers, and current smokers from phase 3 filgotinib trials was analyzed, including patients with inadequate response (IR) to methotrexate (MTX) or biologic disease-modifying antirheumatic drugs (bDMARDs) or who were MTX-naïve. Proportions achieving Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP]) ≤ 3.2 were compared using logistic regression. Retrospective claims-based switching data were reviewed.</p><p><strong>Results: </strong>Week 12 (W12) DAS28(CRP) ≤ 3.2 was achieved by 50, 61, and 62% of MTX-IR non-smokers, former smokers, and current smokers taking filgotinib 200 mg (FIL200) + MTX vs. 23, 16, and 32% taking placebo + MTX (p < 0.001, < 0.001, and 0.001) and 50, 34, and 33% taking adalimumab + MTX (p = 0.97, 0.013, and 0.006 vs. FIL200 + MTX). W12 DAS28(CRP) ≤ 3.2 was achieved by 46, 48, and 32% of bDMARD-IR non-smokers, former smokers, and current smokers taking FIL200 + conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) vs. 16, 23, and 5% taking placebo + csDMARD (p < 0.001, 0.077, and 0.051); 57, 58, and 59% of respective MTX-naïve smoking groups achieved W12 DAS28(CRP) ≤ 3.2 with FIL200 + MTX vs. 28, 37, and 18% with MTX (p < 0.001, 0.026, and < 0.001). Claims data showed former/current smokers were likelier than non-smokers to switch from adalimumab to other biologics or JAK inhibitors.</p><p><strong>Conclusions: </strong>Greater proportions of MTX-IR current/former smokers responded to FIL200 + MTX vs. adalimumab + MTX. In non-smoking MTX-IR, bDMARD-IR, and MTX-naïve patients with RA, FIL200 + MTX demonstrated increased response vs. controls. Current/former smokers were likelier to discontinue adalimumab vs. non-smokers in real-world clinical settings.</p><p><strong>Trial registration: </strong>NCT02889796, NCT02873936, NCT02886728.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"177-189"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138499334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epidemiology of Sjögren's: A Systematic Literature Review.","authors":"Eleanor Thurtle, Alice Grosjean, Monia Steenackers, Katharina Strege, Giovanna Barcelos, Pushpendra Goswami","doi":"10.1007/s40744-023-00611-8","DOIUrl":"10.1007/s40744-023-00611-8","url":null,"abstract":"<p><strong>Introduction: </strong>Primary Sjögren's is a multi-system autoimmune disease affecting patients' physical, mental, and emotional wellbeing. The epidemiology of Sjögren's is not well understood, and up-to-date epidemiological evidence is needed to improve knowledge and awareness of Sjögren's among patients and healthcare professionals, and to ascertain the global burden of disease. The objective of this research was to conduct a de novo systematic literature review (SLR) to identify and synthesise evidence on global epidemiology of primary Sjögren's.</p><p><strong>Methods: </strong>This SLR was conducted in May 2021 by searching MEDLINE and Embase databases, relevant conference proceedings, websites of registries, and health technology assessment agencies and databases. Publications were systematically screened for English language articles reporting on the incidence, prevalence, age at symptom onset, and age at diagnosis for people with primary Sjögren's.</p><p><strong>Results: </strong>Of 3510 records identified, 68 publications were included, representing 62 unique studies. Studies reported on age at symptom onset (16/62; 25.8%) and age at diagnosis (43/62; 69.4%) more frequently than incidence (7/62; 11.3%) and prevalence (9/62; 14.5%). Primary Sjögren's was found to have the highest incidence and prevalence in females and in older age groups (incidence: ≥65 years; prevalence: ≥75 years). Average age at onset and diagnosis of primary Sjögren's ranged between 34-57 years and 40-67 years, respectively.</p><p><strong>Conclusions: </strong>This SLR identified a paucity of incidence and prevalence data for primary Sjögren's, highlighting a need for further epidemiological studies. The global Sjögren's community must work together to follow the defined classification criteria of primary Sjögren's and reporting guidelines for incidence and prevalence data to allow for meaningful epidemiological comparisons across studies, settings, and countries.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1-17"},"PeriodicalIF":2.9,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72015246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-Sectional and Longitudinal Associations of Comorbidities with Knee Symptoms and Radiographic Abnormalities of Osteoarthritis.","authors":"Xiaoxi Li, Feng Pan, Rui Zhu, Liru Ge, Xiaoyue Zhang, Xiangrui Wen, Jiantao Zhou, Jiale Cheng, Faming Pan, Guoqi Cai","doi":"10.1007/s40744-023-00625-2","DOIUrl":"10.1007/s40744-023-00625-2","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate the associations of comorbidities with knee symptoms and radiographic abnormalities of osteoarthritis (OA).</p><p><strong>Methods: </strong>Participants were from the Osteoarthritis Initiative. Comorbidities were identified at baseline using the modified Charlson Comorbidity Index. For both knees, symptoms were assessed annually from baseline to 48 months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores (rescaled range 0-100), and radiographic abnormalities using the Kellgren-Lawrence (KL, 0-4) grades. The presence of significant pain and functional disability was defined as a WOMAC score of ≥ 25 and ≥ 22, respectively, and radiographic OA (ROA) as KL ≥ 2. An increase of ≥ 9 in WOMAC scores and ≥ 1 in KL grades were defined as symptomatic and radiographic progression, respectively.</p><p><strong>Results: </strong>Of 3337 participants, 28% and 9% had one and ≥ 2 comorbidities, respectively. The number of comorbidities was associated with the presence of significant functional disability (odds ratios [ORs] 1.15; 1.46) and predicted the progression of both knee pain and functional disability (ORs 1.11; 1.51). For the type of comorbidities, non-OA musculoskeletal diseases were associated with the presence of ROA and significant functional disability (ORs 1.63; 1.82) and showed a trend to predict incident ROA (OR 1.84, 95% confidence interval 1.00-3.38 p = 0.051). Diabetes and kidney diseases were associated with symptomatic progression of OA (ORs 1.38; 2.72).</p><p><strong>Conclusions: </strong>Having more comorbidities, especially diabetes and kidney diseases, is associated with symptomatic progression of knee OA. Moreover, non-OA musculoskeletal diseases may be associated with the presence and onset of ROA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"129-142"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138047883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Burden of Immunosuppressant-Treated Lupus Nephritis: A German Claims Database Analysis.","authors":"Elena Garal-Pantaler, Michael Schultze, Mary Elizabeth Georgiou, Marc Pignot, Kerry Gairy, Jacob N Hunnicutt","doi":"10.1007/s40744-023-00623-4","DOIUrl":"10.1007/s40744-023-00623-4","url":null,"abstract":"<p><strong>Introduction: </strong>This retrospective cohort study (GSK213737) aimed to characterize treatment patterns, healthcare resource utilization (HCRU), and costs in patients with lupus nephritis (LN) initiating immunosuppressant therapy in clinical practice in Germany, to better understand the full picture of the real-world burden of LN.</p><p><strong>Methods: </strong>Adult patients with LN who initiated mycophenolate mofetil (MMF), intravenous cyclophosphamide (CYC), azathioprine (AZA), tacrolimus, cyclosporin A, or rituximab therapy in 2011-2017 (index therapy) were identified from the Betriebskrankenkassen German Sickness Fund database. Treatment patterns, including immunosuppressant discontinuations, and therapy switches, were assessed (maximum follow-up 4 years). Corticosteroid use, HCRU, and total economic costs were also evaluated. HCRU and costs were compared with matched controls (individuals without systemic lupus erythematosus [SLE]/LN matched by age, sex, and baseline Charlson Comorbidity Index).</p><p><strong>Results: </strong>Among 334 patients with LN, the median (interquartile range) duration of index immunosuppressant therapy use was 380.5 (126, 1064) days. Of those patients with 4 years complete enrollment, 70.8% had ≥ 1 discontinuation and 28.8% switched therapy. While most patients (71.2%) received only one immunosuppressant, gaps in treatment were common. After 1 year of follow-up, 41.6% of patients had a prednisone-equivalent corticosteroid dose of ≥ 7.5 mg/day. Patients with LN had greater HCRU use for most categories assessed and increased mean total costs per person-year versus controls (€15,115.99 versus €4,081.88 in the first year of follow-up).</p><p><strong>Conclusions: </strong>This real-world analysis demonstrated the considerable burden of immunosuppressant-treated LN in Germany, with a high rate of discontinuations, frequent use of high-dose corticosteroids, and substantial HCRU/costs.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"113-127"},"PeriodicalIF":2.9,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138434856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endovascular Interventional Procedure is a Significant Risk Factor of Postsurgical Gout: A Retrospective Cohort Study.","authors":"Shunjie Hu, Zitao Wang, Peiyu Zhang, Huaxiang Wu, Xiaoyong Lu","doi":"10.1007/s40744-023-00617-2","DOIUrl":"10.1007/s40744-023-00617-2","url":null,"abstract":"<p><strong>Introduction: </strong>Surgery is a risk factor for flares in people with gout. However, gout flares after endovascular interventional procedures are not well understood. The aim of this study was to evaluate the clinical features and risk factors for gout flare that develop during the postsurgical period including endovascular procedures.</p><p><strong>Methods: </strong>We enrolled 222 patients with gout who developed postsurgical gout and 196 controls who had histories of gout but did not develop gout flares after surgery within 20 days. Clinical characteristics of patients who developed a postsurgical gout flare were compared with the controls.</p><p><strong>Results: </strong>The rate of endovascular interventional procedures was higher (38.74% vs. 13.48%, P < 0.001) in the flare group than in the no-flare group and lower in orthopedic surgery (13.96% vs. 41.84%, P < 0.001). The Cox model showed that endovascular interventional procedures (HR, hazard ratio 1.752; 95% CI, confidence interval 1.126-2.724, P = 0.013) and presurgical uric acid levels of ≥ 7 mg/dl (HR 1.489; 95% CI 1.081-2.051, P = 0.015) were significantly associated with increased risks of postsurgical gout flare, and taking colchicine before surgery were significantly associated with decreased risk of postsurgical gout flare (HR 0.264; 95% CI 0.090-0.774, P = 0.015). There was no significant difference in the types of endovascular interventional procedures between the flare group and the no-flare group.</p><p><strong>Conclusions: </strong>Patients with a history of gout should be more alert to recurrence gout flares after endovascular interventional procedures. Adequate presurgical control of serum uric acid levels and/or prophylactic treatment with colchicine will help prevent gout flares during the postsurgical period.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"51-60"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71485541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Patients with Rheumatic Diseases and Serum Antibody Changes Post-Omicron Variant Infection.","authors":"Xiaowei Zhang, Yifei Li, Chunqing Dai, Yaya Chu, Chaoqi Luan, Guihong Wang","doi":"10.1007/s40744-023-00630-5","DOIUrl":"10.1007/s40744-023-00630-5","url":null,"abstract":"<p><strong>Introduction: </strong>The purpose of this study was to investigate whether the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has a similar effectiveness and safety profile in patients with rheumatic and musculoskeletal diseases (RMDs) and healthy controls (HCs).</p><p><strong>Methods: </strong>Between August 10, 2021 and September 30, 2021, 134 HCs and 269 patients with RMDs were recruited. All participants who tested negative for COVID-19 were vaccinated with SARS-CoV-2 inactivated vaccine. Next, 150 patients with RMDs and 30 HCs infected with the SARS-CoV-2 Omicron variant within the previous 12 weeks were recruited between February 20, 2023 and March 1, 2023. Serum samples were collected from each participant, and the serum immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody titers against SARS-CoV-2 were determined using a chemiluminescence assay.</p><p><strong>Results: </strong>No statistically significant difference was found in the titer of anti-SARS-CoV-2 IgG and IgM antibodies, or in the incidence of vaccination-related adverse events between the RMD and HC groups (P = 0.183, P = 0.903, and P = 0.27, respectively). Serum IgG titers of SARS-CoV-2 neutralizing antibodies were significantly higher in patients who received two or more doses of inactivated vaccine than in patients who were unvaccinated or had received one dose of vaccine (244.36 ± 109.79 vs. 66.20 ± 82.50; P < 0.001).</p><p><strong>Conclusions: </strong>SARS-CoV-2 inactivated vaccines have similar protective effects in HCs and patients with RMDs, with an appreciable safety profile. Fully vaccinated patients with RMDs infected with the Omicron variant were able to produce effective neutralizing antibody concentrations.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"191-200"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy, Safety and the Lymphocyte Subset Changes of Low-Dose IL-2 in Patients with Autoimmune Rheumatic Diseases: A Systematic Review and Meta-Analysis.","authors":"Qinyi Su, Xinmiao Wang, Yongzhi Li, Jiexiang Zhang, Cairui Bai, Xuechun Wang, Liu Yang, Jingting Zhang, Sheng-Xiao Zhang","doi":"10.1007/s40744-023-00620-7","DOIUrl":"10.1007/s40744-023-00620-7","url":null,"abstract":"<p><strong>Introduction: </strong>Current therapies for autoimmune rheumatic diseases (ARDs) have limited efficacy in certain patients, highlighting the need for the development of novel treatment approaches. This meta-analysis aims to assess the efficacy and safety of low-dose interleukin-2 (LD-IL-2) and evaluate the alterations in lymphocyte subsets in various rheumatic diseases following administration of different dosages of LD-IL-2.</p><p><strong>Methods: </strong>A comprehensive search was conducted in PubMed, Web of Science, the Cochrane Library, Embase databases and CNKI to identify relevant studies. A total of 31 trials were included in this meta-analysis. The review protocols were registered on PROSPERO (CRD42022318916), and the study followed the PRISMA guidelines.</p><p><strong>Results: </strong>Following LD-IL-2 treatment, patients with ARDs exhibited a significant increase in the number of Th17 cells and Tregs compared to their pre-treatment levels [standardized mean difference (SMD) = 0.50, 95% confidence interval (CI) (0.33, 0.67), P < 0.001; SMD = 1.13, 95% CI (0.97, 1.29), P < 0.001]. Moreover, the Th17/Tregs ratio showed a significant decrease [SMD = - 0.54, 95% CI (- 0.64, - 0.45), P < 0.001]. In patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), LD-IL-2 injection led to a significant increase in Treg numbers, and the Th17/Tregs ratio and disease activity scores, including Disease Activity Score-28 joints (DAS28), Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), were all significantly reduced. No serious adverse events were reported in any of the included studies. Additionally, 54.8% of patients with lupus nephritis achieved distinct clinical remission following LD-IL-2 treatment. Injection site reactions and fever were the most common side effects of LD-IL-2, occurring in 33.1% and 14.4% of patients, respectively.</p><p><strong>Conclusion: </strong>LD-IL-2 treatment showed promise and was well tolerated in the management of ARDs, as it effectively promoted the proliferation and functional recovery of Tregs.</p><p><strong>Trial registration: </strong>Retrospectively registered (CRD42022318916, 21/04/2022).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"79-96"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138047884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis.","authors":"Andrea Rubbert-Roth, Adriana M Kakehasi, Tsutomu Takeuchi, Marc Schmalzing, Hannah Palac, Derek Coombs, Jianzhong Liu, Samuel I Anyanwu, Ralph Lippe, Jeffrey R Curtis","doi":"10.1007/s40744-023-00621-6","DOIUrl":"10.1007/s40744-023-00621-6","url":null,"abstract":"<p><strong>Introduction: </strong>This article aims to describe malignancies in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSpA) treated with upadacitinib (UPA) or active comparators.</p><p><strong>Methods: </strong>This integrated safety analysis includes data from 11 phase 3 UPA trials across RA (6 trials), PsA (2 trials), AS (2 trials; one phase 2b/3), and nr-axSpA (1 trial). Treatment-emergent adverse events (TEAEs) were summarized for RA (pooled UPA 15 mg [UPA15], pooled UPA 30 mg [UPA30], adalimumab 40 mg [ADA], methotrexate monotherapy [MTX]), PsA (pooled UPA15, pooled UPA30, ADA), AS (pooled UPA15), and nr-axSpA (UPA15). TEAEs were reported as exposure-adjusted event rates (events/100 patient-years).</p><p><strong>Results: </strong>Median treatment duration ranged from 1.0 to 4.0 years (with a maximum of 6.6 years in RA). Across treatments and indications, rates of malignancy excluding nonmelanoma skin cancer (NMSC) ranged from 0.2 to 1.1, while NMSC ranged from 0.0 to 1.4. In RA, rates of malignancy excluding NMSC were generally similar between UPA15, UPA30, ADA, and MTX (breast and lung cancer were the most common). In RA and PsA, Kaplan-Meier analyses revealed no differences in event onset of malignancy excluding NMSC with UPA15 versus UPA30 over time. In RA, NMSC rates were higher with UPA30 than UPA15; both UPA15 and UPA30 were higher than ADA and MTX. In PsA, rates of malignancy excluding NMSC and NMSC were generally similar between UPA15, UPA30, and ADA. In AS and nr-axSpA, malignancies were reported infrequently. Few events of lymphoma were reported across the clinical programs.</p><p><strong>Conclusion: </strong>Rates of malignancy excluding NMSC were generally similar between UPA15, UPA30, ADA, and MTX and were consistent across RA, PsA, AS, and nr-axSpA. A dose-dependent increased rate of NMSC was observed with UPA in RA.</p><p><strong>Trial registration: </strong>ClinicaTrials.gov identifier: NCT02706873, NCT02675426, NCT02629159, NCT02706951, NCT02706847, NCT03086343, NCT03104400, NCT03104374, NCT03178487, and NCT04169373.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"97-112"},"PeriodicalIF":3.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138047885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the COVID-19 Pandemic on People Living with Rheumatoid Arthritis: Experiences and Preferences in Accessing Healthcare Across Five Countries","authors":"Alain Saraux, Licia Maria Henrique da Mota, Sanjay Dixit, Allan Gibofsky, Tsukasa Matsubara, Amy Mulvey, Cheryl Koehn, Mahta Mortezavi, Michelle Segovia, Meriem Kessouri","doi":"10.1007/s40744-023-00629-y","DOIUrl":"https://doi.org/10.1007/s40744-023-00629-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>The global coronavirus 2019 (COVID-19) pandemic created many challenges in healthcare provision. This study aimed to evaluate the global impact of the COVID-19 pandemic on people living with rheumatoid arthritis (RA).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The RA Narrative COVID-19 survey was conducted online among people with RA who resided in Brazil, Canada, France, Japan, and the US from August to September 2021. The survey examined disease management, healthcare access and experiences, and participant preferences for interactions with their doctor.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Overall, 500 participants completed the survey: 100 each resided in Brazil, Canada, France, Japan, and the US. Emotional well-being was the aspect of disease management most reported to be negatively impacted by the pandemic (55% of participants); ‘having more anxiety and/or stress’ during the pandemic was the top factor that made controlling RA symptoms more difficult (49% of participants). In comparison, the top factor that made controlling RA symptoms easier was ‘having a less busy schedule’ (35% of participants). More participants had virtual appointments during versus pre-pandemic (53% vs. 13%, respectively) and participants were equally satisfied with the overall quality of care received via virtual and in-person appointments (76% of participants were ‘satisfied’ or ‘very satisfied’ with both). However, participants generally preferred in-person over virtual appointments, except for prescription refills, for which preferences were similar (39% vs. 36%, respectively).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>This survey suggests that the COVID-19 pandemic did negatively impact some aspects of disease management for people living with RA but had positive impacts on the utilization of virtual care. Although participants generally preferred in-person appointments, these results position virtual care as an appropriate means for routine follow-ups.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"6 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139463782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}