Arthritis Care & Research最新文献

{"title":"List of Reviewers","authors":"","doi":"10.1002/acr.25477","DOIUrl":"https://doi.org/10.1002/acr.25477","url":null,"abstract":"","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"76 12","pages":"1751-1754"},"PeriodicalIF":3.7,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749194","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}

{"title":"Not So Patient Friendly: Patient Education Materials in Rheumatology and Internal Medicine Fall Short of Nationally Recommended Readability Benchmarks in the United States","authors":"Yazmin Rustomji,&nbsp;Ugochukwu C. Nweke,&nbsp;Sobia Hassan,&nbsp;Usama Ahmad,&nbsp;Meenakshi Jolly","doi":"10.1002/acr.25473","DOIUrl":"10.1002/acr.25473","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Patient education materials (PEMs) can help promote health literacy (HL) among patients. However, their use depends on how easily patients can read and comprehend the information. Several national organizations recommend that text be written at a sixth- to eighth-grade level. Herein, we assess and compare the readability and comprehension (RC) of PEMs for rheumatologic and general medical conditions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We used six standardized RC metrics including the well-known Flesch Kincaid Readability Ease and Flesch Kincaid Grade Level to evaluate the RC of PEMs (n = 175) on the American College of Rheumatology (ACR) (n = 86) and the Journal of the American Medical Association (JAMA) (n = 89) websites. Two-sided <i>t</i>-tests compared RC between the two resources. <i>P</i> ≤ 0.05 was considered significant.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>On all six standardized metrics used, the mean reading level of all PEMs ranged from high school to college level. For example, the mean ± SD of Simple Measure of Gobbledygook Index was 10.89 ± 1.88, corresponding to a 10th-grade education, and the mean ± SD of Gunning Fog Score was 14.39 ± 2.49, corresponding to a 14th-grade education required to understand the text. JAMA PEMs had significantly more difficult RC levels compared to ACR PEMs based on five of the six indices used (<i>P</i> &lt; 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>PEMs available on the ACR and JAMA websites do not align with national organizations’ recommendations for RC levels. To enhance patient understanding and promote HL, existing PEMs must be modified in line with these recommendations.</p>\u0000 \u0000 <div>\u0000 <figure>\u0000 <div><picture>\u0000 <source></source></picture><p></p>\u0000 </div>\u0000 </figure>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"676-684"},"PeriodicalIF":3.7,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749828","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}

{"title":"Integrating patient advocacy groups in the development of clinical practice guidelines: comment on the article by Johnson et al","authors":"Nishant Gupta,&nbsp;Steven E. Carsons,&nbsp;Nancy L. Carteron,&nbsp;Robert Hal Scofield,&nbsp;Augustine S. Lee,&nbsp;Donald E. Thomas,&nbsp;Teng Moua,&nbsp;Kamonpun Ussavarungsi,&nbsp;E. William St Clair,&nbsp;Richard Meehan,&nbsp;Kieron Dunleavy,&nbsp;Matt Makara,&nbsp;Katherine Morland Hammitt","doi":"10.1002/acr.25474","DOIUrl":"10.1002/acr.25474","url":null,"abstract":"","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"685-686"},"PeriodicalIF":3.7,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738158","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}

{"title":"Relationship Between Number of Different Lower-Limb Resistance Exercises Prescribed in a Program and Exercise Outcomes in People With Knee Osteoarthritis: A Systematic Review With Meta-Regression","authors":"Belinda J. Lawford,&nbsp;Kim L. Bennell,&nbsp;Libby Spiers,&nbsp;Alexander J. Kimp,&nbsp;Andrea Dell'Isola,&nbsp;Alison R. Harmer,&nbsp;Martin Van der Esch,&nbsp;Michelle Hall,&nbsp;Rana S. Hinman","doi":"10.1002/acr.25476","DOIUrl":"10.1002/acr.25476","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>We determine whether there is a relationship between the number of different lower-limb resistance exercises prescribed in a program and outcomes for people with knee osteoarthritis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We used a systematic review with meta-regression. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase up to January 4, 2024. We included randomized controlled trials that evaluated land-based resistance exercise for knee osteoarthritis compared with nonexercise interventions. We conducted meta-regressions between number of different exercises prescribed and standardized mean differences (SMDs) for pain and function. Covariates (intervention duration, frequency per week, use of resistance exercise machine[s], and comparator type) were applied to attempt to reduce between-study heterogeneity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Forty-four trials (3,364 participants) were included. The number of resistance exercises ranged from 1 to 12 (mean ± SD 5.0 ± 3.0). Meta-regression showed no relationship between the number of prescribed exercises and change in pain (slope coefficient: −0.04 SMD units [95% confidence interval {95% CI} −0.14 to 0.05]) or self-reported function (SMD −0.04 [95% CI −0.12 to 0.05]). There was substantial heterogeneity and evidence of publication bias. However, even after removing 31 trials that had overall unclear/high risk of bias, there was no change in relationships.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>There was no relationship between the number of different lower-limb resistance exercises prescribed in a program and change in knee pain or self-reported function. However, given that we were unable to account for all differences in program intensity, progression, and adherence, as well as the heterogeneity and overall low quality of included studies, our results should be interpreted with caution.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"594-603"},"PeriodicalIF":3.7,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749830","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}

{"title":"Incidence of Side Effects Associated With Acetaminophen in People Aged 65 Years or More: A Prospective Cohort Study Using Data From the Clinical Practice Research Datalink","authors":"Jaspreet Kaur,&nbsp;Georgina Nakafero,&nbsp;Abhishek Abhishek,&nbsp;Christian Mallen,&nbsp;Michael Doherty,&nbsp;Weiya Zhang","doi":"10.1002/acr.25471","DOIUrl":"10.1002/acr.25471","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>The main objective of this study is to examine the safety of oral acetaminophen at its therapeutic dose in adults aged ≥65 years.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This population-based cohort study used the Clinical Practice Research Datalink-Gold data. Participants were aged ≥65 years registered with a UK general practice for at least 12 months between 1998 and 2018. Acetaminophen exposure was defined as at least two acetaminophen prescriptions within six months of the first acetaminophen prescription, the first prescription date being the index date. Acetaminophen nonexposure was defined as the absence of two acetaminophen prescriptions within six months over the study period. We calculated propensity score (PS) for acetaminophen prescription and undertook inverse probability treatment weighting using PS and PS-matched analyses to account for confounding. Missing data were handled using multiple imputation. The adjusted hazard ratio (aHR) and 95% confidence interval (95% CI) were calculated using the Cox proportional hazards regression model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 180,483 acetaminophen exposed and 402,478 unexposed participants were included in this study. Acetaminophen exposure was associated with an increased risk of perforation or ulceration or bleeding (aHR 1.24; 95% CI 1.16–1.34), uncomplicated peptic ulcers (aHR 1.20; 95% CI 1.10–1.31), lower gastrointestinal bleeding (aHR 1.36; 95% CI 1.29–1.46), heart failure (aHR 1.09; 95% CI 1.06–1.13), hypertension (aHR 1.07; 95% CI 1.04–1.11), and chronic kidney disease (aHR 1.19; 95% CI 1.13–1.24).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Despite its perceived safety, acetaminophen is associated with several serious complications. Given its minimal analgesic effectiveness, acetaminophen as the first-line oral analgesic option for long-term conditions in older people requires careful reconsideration.</p>\u0000 \u0000 <div>\u0000 <figure>\u0000 <div><picture>\u0000 <source></source></picture><p></p>\u0000 </div>\u0000 </figure>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"666-675"},"PeriodicalIF":3.7,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/acr.25471","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708965","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}

{"title":"Introduction to the Special Theme Issue: Environmental and Geographic Factors and Rheumatic Disease","authors":"Kelli D. Allen,&nbsp;S. Sam Lim","doi":"10.1002/acr.25472","DOIUrl":"10.1002/acr.25472","url":null,"abstract":"","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 1","pages":"1-2"},"PeriodicalIF":3.7,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708967","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}

{"title":"Musculoskeletal Ultrasound Practices of Graduates of a Blended-Learning Program: A Survey of Rheumatologists From the United States","authors":"Midori Nishio,&nbsp;Karina D. Torralba,&nbsp;Sonja I. Ziniel,&nbsp;Eugene Kissin,&nbsp;Fawad Aslam,&nbsp;for the Ultrasound School of North American Rheumatologists","doi":"10.1002/acr.25470","DOIUrl":"10.1002/acr.25470","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Not much is known regarding musculoskeletal ultrasound (MSUS) practices of rheumatologists in the United States. We sought to determine the current use of MSUS among past participants of the Ultrasound School of North American Rheumatologists (USSONAR) training program and, by extension, MSUS-practicing rheumatologists and to understand barriers to its MSUS use.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>An online survey was sent to 374 participants in the eight-month USSONAR blended course (Fundamentals in Musculoskeletal Ultrasound and Train the Trainer) between 2009 and 2020. Each respondent had a unique identifier linked to their total number of submitted practice scans and examination scores during training.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The survey response rate was 28.1% (105 of 374), comprising 82% adult and 18% pediatric rheumatologists. Of the respondents, 71% were MSUS certified: 86.7% performed and/or interpreted diagnostic MSUS, 81.0% performed/interpreted procedural MSUS, 59.8% billed for at least 50% of diagnostic studies, and 78.8% billed for at least 50% of procedural studies. The top reasons for not doing diagnostic and procedural ultrasonography were lack of administrative support and limited time, respectively. For 25% of diagnostic ultrasonography and 12.9% of procedural ultrasonography, billing was done &lt;50% of the time. Of the respondents, 78.0% reported that USSONAR training made them better rheumatologists.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Most USSONAR-trained rheumatologists are certified, practicing both diagnostic and procedural MSUS and billing for most of their work. However, a substantial number of studies are not being billed due to time constraints, limited administrative support, and legal liability. Participants agreed that USSONAR training made them better rheumatologists.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"658-665"},"PeriodicalIF":3.7,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692494","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}

{"title":"Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database","authors":"Denis Mongin,&nbsp;Marco Matucci-Cerinic,&nbsp;Ulrich A. Walker,&nbsp;Oliver Distler,&nbsp;Radim Becvar,&nbsp;Elise Siegert,&nbsp;Lidia P. Ananyeva,&nbsp;Vanessa Smith,&nbsp;Juan Jose Alegre-Sancho,&nbsp;Sule Yavuz,&nbsp;Massimiliano Limonta,&nbsp;Gabriela Riemekasten,&nbsp;Elena Rezus,&nbsp;Madelon Vonk,&nbsp;Marie-Elise Truchetet,&nbsp;Francesco Del Galdo,&nbsp;Delphine S. Courvoisier,&nbsp;Michele Iudici,&nbsp;the EUSTAR Collaborators","doi":"10.1002/acr.25469","DOIUrl":"10.1002/acr.25469","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>The objective of this study is to evaluate whether adding oral glucocorticoids to immunosuppressive therapy improves skin scores and ensures safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We performed an emulated randomized trial comparing the changes from baseline to 12 ± 3 months of the modified Rodnan skin score (mRSS: primary outcome) in patients with early dcSSc receiving either oral glucocorticoids (≤20 mg/day prednisone equivalent) combined with immunosuppression (treated) or immunosuppression alone (controls), using data from the European Scleroderma Trials and Research Group. Secondary end points were the difference occurrence of progressive skin or lung fibrosis and scleroderma renal crisis. Matching propensity score was used to adjust for baseline imbalance between groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We matched 208 patients (mean age 49 years; 33% male; 59% anti-Scl70), 104 in each treatment group, obtaining comparable characteristics at baseline. In the treated group, patients received a median prednisone dose of 5 mg/day. Mean mRSS change at 12 ± 3 months was similar in the two groups (decrease of 2.7 [95% confidence interval {95% CI} 1.4–4.0] in treated vs 3.1 [95% CI 1.9–4.4] in control, <i>P</i> = 0.64). Similar results were observed in patients with shorter disease duration (≤ 24 months) or with mRSS ≤22. There was no between-group difference for all prespecified secondary outcomes. A case of scleroderma renal crisis occurred in both groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>We did not find any significant benefit of adding low-dose oral glucocorticoids to immunosuppression for skin fibrosis, and at this dosage, glucocorticoid did not increase the risk of scleroderma renal crisis.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"649-657"},"PeriodicalIF":3.7,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142613804","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}

{"title":"Immunosuppressive Drugs in Early Systemic Sclerosis and Prevention of Damage Accrual","authors":"Murray Baron,&nbsp;Mandana Nikpour,&nbsp;Dylan Hansen,&nbsp;Susanna Proudman,&nbsp;Wendy Stevens,&nbsp;the Australian Scleroderma Interest Group and the Canadian Scleroderma Research Group,&nbsp;Mianbo Wang","doi":"10.1002/acr.25467","DOIUrl":"10.1002/acr.25467","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Organ damage in patients with systemic sclerosis (SSc) in individual organs such as the lungs may be prevented by receiving immunosuppressive drugs (ISs). A new measure of global organ damage, the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI), has allowed us to investigate whether receiving ISs may reduce global organ damage accrual in patients with early SSc.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This was a retrospective study of patients with two or less years of disease duration in Canadian and Australian cohorts with SSc. Patients with either limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc) were observed separately and divided into groups who were either ever or never exposed to ISs. The SCTC-DI was the outcome, and inverse probability of treatment weighting (IPTW) was used to balance the study groups and to fit a marginal structural generalized estimating equation model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the cohort with lcSSc, there were 210 patients, of whom 34% were exposed to ISs at some time. Exposure to ISs was associated with lower damage scores. In the cohort with dcSSc, there were 192 patients, of whom 76% were exposed to ISs at some time. Exposure to ISs was not associated with damage scores.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>In this retrospective observational cohort study, using IPTW to adjust for confounders, we found a protective effect of receiving ISs on damage accrual in patients with lcSSc. We were unable to determine such an effect in patients with dcSSc, but unknown confounders may have been present, and prospective studies of patients with dcSSc receiving ISs should include the SCTC-DI to determine the possible effect of ISs on damage accrual.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"640-648"},"PeriodicalIF":3.7,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/acr.25467","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142613784","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}

{"title":"Pharmacokinetics, Efficacy, and Safety of Upadacitinib in Pediatric Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: An Interim Analysis of an Open-Label, Phase 1 Trial","authors":"Hermine I. Brunner,&nbsp;Anna Shmagel,&nbsp;Gerd Horneff,&nbsp;Ivan Foeldvari,&nbsp;Jordi Antón,&nbsp;Athimalaipet V. Ramanan,&nbsp;Yuli Qian,&nbsp;Kristina Unnebrink,&nbsp;Shuai Hao,&nbsp;Heidi S. Camp,&nbsp;Nasser Khan,&nbsp;Wei Liu,&nbsp;Mohamed-Eslam F. Mohamed","doi":"10.1002/acr.25465","DOIUrl":"10.1002/acr.25465","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This work aimed to evaluate the pharmacokinetics, efficacy, and safety of upadacitinib, an oral selective JAK inhibitor, in pediatric patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In an open-label, phase 1 study (SELECT-YOUTH), enrolled patients, aged 2 to &lt;18 years with pcJIA, received body weight–based upadacitinib doses using a twice-daily oral solution or once-daily extended-release tablet based on their body weight and ability to swallow tablets. The study included a 7-day pharmacokinetic assessment, followed by a long-term efficacy and safety evaluation for up to 156 weeks, including an additional long-term safety cohort. This interim analysis included available pharmacokinetic and safety data and efficacy data collected through week 48.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 57 patients received upadacitinib. The median time to maximum upadacitinib concentration was approximately three hours and one hour for the tablet and oral solution regimens, respectively; the harmonic mean functional half-life was approximately five hours and two hours, respectively. Juvenile idiopathic arthritis American College of Rheumatology 30, 50, 70, 90, and 100 responses at week 12 were 91.8%, 89.8%, 69.4%, 49.0%, and 32.7%, respectively. Efficacy was generally maintained through week 48, and improvement in additional efficacy end points was also observed. At a median exposure duration of 412 days, 52 of 57 patients reported adverse events; of these, 6 experienced serious adverse events. Adverse events were predominately mild to moderate in severity and consistent with the known safety profile of upadacitinib.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This interim analysis demonstrates that the bodyweight-based dosing regimen of upadacitinib was well tolerated and efficacious in pediatric patients with pcJIA.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":"77 5","pages":"584-593"},"PeriodicalIF":3.7,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/acr.25465","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142613806","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}