Rheumatology and Therapy最新文献

{"title":"Effectiveness and Safety of Tofacitinib Up to 36 Months in Canadian Patients with Rheumatoid Arthritis: Final Results from the CANTORAL Study.","authors":"Boulos Haraoui, Denis Choquette, Cristina Sciortino, Corina Galos, Patrice Roy, David Gruben, Julie Vaillancourt, John S Sampalis, Majed Khraishi","doi":"10.1007/s40744-026-00854-1","DOIUrl":"10.1007/s40744-026-00854-1","url":null,"abstract":"<p><strong>Introduction: </strong>We present the final results of the CANadian TOfacitinib for Rheumatoid Arthritis observationaL (CANTORAL) study, which investigated tofacitinib effectiveness, safety, and persistence to month (M) 36 in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>Patients with RA initiating tofacitinib in Canada (October 2017-June 2022) were enrolled in a multicenter, prospective, observational study. Coprimary effectiveness outcomes were Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA) and remission at M6. Secondary and additional outcomes included Disease Activity Score in 28 joints using erythrocyte sedimentation rate/C-reactive protein (DAS28-4[ESR/CRP])-defined LDA and remission, and change from baseline (CFB) in Health Assessment Questionnaire Disability Index (HAQ-DI). Safety was evaluated to M36.</p><p><strong>Results: </strong>Overall, 505 and 507 patients were included in the effectiveness and safety analysis sets, respectively; 59.2% were biologic disease-modifying antirheumatic drug-naïve, 79.2% were ≥ 50 years, 38.6% were ≥ 65 years, and 56.0% were current/former smokers. 59.6% discontinued the study. LDA/remission rates at M36 were: CDAI, 71.0% (n/N = 66/93)/35.5% (n/N = 33/93); DAS28-4(ESR), 69.6% (n/N = 32/46)/52.2% (n/N = 24/46); DAS28-4(CRP), 79.7% (n/N = 47/59)/66.1% (n/N = 39/59); 66.1% (n/N = 82/124) patients had HAQ-DI CFB ≥ 0.22. Treatment-emergent adverse events (TEAEs), TEAEs of special interest, and deaths were reported in 69.8% (n/N = 354/507), 46.5% (n/N = 236/507), and 1.2% (n/N = 6/507) of patients, respectively. For patients with major adverse cardiovascular events and malignancies (excluding nonmelanoma skin cancer), proportions of current/former smokers and patients ≥ 65 years were higher than in the whole population.</p><p><strong>Conclusions: </strong>Tofacitinib provided early and sustained improvement of disease signs and symptoms in patients with RA in Canada. Safety was consistent with the RA clinical program and the established tofacitinib clinical profile. Results were consistent with the interim analysis.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"843-853"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147676269","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":"Treatment Patterns in Hospitalized Hip Fracture Patients: An Interrupted Time-Series Analysis Around the New Fee for Secondary Fracture Prevention in Japan.","authors":"Saeko Fujiwara, Hiroshi Hagino, Satoshi Soen, Noriaki Yamamoto, Takeshi Sawaguchi, Takashi Matsushita, Akiho Terasawa, Izumi Mishiro, Jen Timoshanko, Ryuta Saito","doi":"10.1007/s40744-026-00841-6","DOIUrl":"10.1007/s40744-026-00841-6","url":null,"abstract":"<p><strong>Introduction: </strong>Despite high risk of secondary fracture, osteoporosis treatment rates following hip fracture remain low globally. In April 2022, Japan implemented a reimbursement policy for secondary fracture prevention in patients with hip fracture. We evaluated the impact of this policy on treatment patterns during acute hospitalization.</p><p><strong>Methods: </strong>We conducted an interrupted time-series analysis using the Medical Data Vision database for patients aged ≥ 50 years hospitalized with hip fractures from April 2020 to March 2024. Primary outcome was osteoporosis medication treatment rate during hospitalization. Secondary outcomes included drug class distribution and use of medications categorized as recommended or proposed in preventing fractures according to Japanese guidelines. Segmented regression models were used to evaluate level and trend changes associated with policy implementation.</p><p><strong>Results: </strong>Among 71,632 eligible patients with hip fracture (mean age 84, 76% female), the interrupted time-series analysis revealed a significant immediate increase in treatment rates (level change [β₂] = 16%, 95% CI 13-19%, p < 0.001) following policy implementation, with continued monthly growth thereafter (sustained positive slope change [β₃] = 1% per month, p < 0.001). Use of medications both proposed and recommended in the guideline increased significantly for both (level change = 13%, p < 0.001 and level change = 8%, p < 0.001, respectively). Between 2020/21 and 2023/24, the use of bisphosphonates and active vitamin D₃ as monotherapy both increased, from 12% to 29% for each. Nevertheless, overall use of osteoporosis medications, especially non-bisphosphonate drugs, with proven fracture-prevention efficacy and those recommended by clinical guidelines remained low.</p><p><strong>Conclusion: </strong>Japan's secondary fracture prevention reimbursement policy successfully improved in-hospital initiation of osteoporosis treatment among patients with hip fracture. Nevertheless, actual usage of osteoporosis medications with robust evidence for fracture prevention remains suboptimal. Effective prevention of secondary fractures and improved patient outcomes require appropriate medication selection, potentially facilitated by supportive policy measures.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"701-717"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147514472","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":"Comparative Effectiveness of Upadacitinib vs. Other JAK Inhibitors in Patients With Rheumatoid Arthritis in a Global Real-World Setting.","authors":"Peter C Taylor, Aditi Kadakia, Jack Milligan, Ana Romero, Oliver Howell, Pankaj A Patel, Sophie Barlow, Roberto Caporali","doi":"10.1007/s40744-026-00855-0","DOIUrl":"10.1007/s40744-026-00855-0","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to compare the real-world effectiveness of upadacitinib vs. other Janus kinase inhibitors (JAKis) in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>Data were extracted from the Adelphi RA Disease Specific Programme™ (DSP), a cross-sectional survey administered to rheumatologists and their patients in the EU, UK, Japan, Canada, and the US from July 2021 to February 2022. Patients receiving upadacitinib 15 mg or other JAKis, including tofacitinib, baricitinib, or peficitinib, for ≥ 6 months were included in the study. Data captured at treatment initiation and follow-up (≥ 6 months) included physician-evaluated pain rating and Disease Activity Score in 28 joints (DAS28). Fatigue and medication adherence were recorded at follow-up only. Inverse-probability-weighted regression adjustment was used to compare clinical outcomes at follow-up between patients treated with upadacitinib vs. other JAKis.</p><p><strong>Results: </strong>Of 1440 total patients with RA, 1205 patients received upadacitinib and 235 received other JAKis. At study initiation, the majority of patients in both treatment groups had moderate/high disease activity (upadacitinib: 63.5%, other JAKis: 51.3%). At the most recent follow-up, after adjusting for differences in clinical characteristics between groups, patients treated with upadacitinib were significantly more likely to have attained physician-reported remission (54.3% vs. 44.1%, P = 0.030), have no pain (43.4% vs. 32.8%, P = 0.016), and have complete medication adherence (59.5% vs. 49.0%, P = 0.025) compared with patients treated with other JAKis. Of patients treated with upadacitinib, 42.5% were reported as having no fatigue compared with 36.1% of patients receiving other JAKis (P = 0.173).</p><p><strong>Conclusions: </strong>This real-world study of patients with RA showed that greater proportions of patients who received upadacitinib attained physician-reported DAS28 remission, absence of pain, and complete adherence to medication compared with patients receiving other JAKis.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"799-812"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691834","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":"Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN).","authors":"Dara K Shahrokh, Ronald B Vender, Charles W Lynde, Jaggi Rao, Waqqas Afif, A Hillary Steinhart, Neeraj Narula, Evelyn Sutton, Carter Thorne, Louis Bessette","doi":"10.1007/s40744-026-00846-1","DOIUrl":"10.1007/s40744-026-00846-1","url":null,"abstract":"<p><strong>Introduction: </strong>Injection site pain (ISP) is a frequent concern with subcutaneous adalimumab therapy and may negatively affect treatment adherence and patient satisfaction. AVT02 is a high-concentration, low-volume (40 mg/0.4 mL), citrate-free biosimilar of reference product (RP) adalimumab (40 mg/0.8 mL; citrate-containing). The EASE PAIN study evaluated the real-world impact of switching from adalimumab RP or another biosimilar to AVT02 on ISP and patient-reported outcomes over 180 days.</p><p><strong>Methods: </strong>The EASE PAIN study (NCT05913817) was a national, observational, prospective phase IV study with a 6-month follow-up. The study enrolled Canadian patients with gastrointestinal conditions (Crohn's disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]) or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had already decided to switch them from a high-volume RP or alternative adalimumab biosimilar to low-volume AVT02. The study assessed ISP measured via the Visual Analog Scale (VAS), adherence via the compliance rate, patient satisfaction and perception of change in pain via the Likert scale, injection site reactions (ISR) via a checklist (bleeding, burning, erythema, itching, soreness, swelling), quality of life based on EQ-5D-5L, and disease activity via the patient and physician global assessment scores for participants up to day 180 after switching. Healthcare utilization was measured as per the frequency, type, and volume of medical services accessed.</p><p><strong>Results: </strong>The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, mean ISP VAS scores improved by - 19.9 ± 26.1 mm compared with baseline. Adherence rate was 93.4% overall. More than 74.4% of patients reported being mostly or completely satisfied with treatment, and 76.9% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of high-volume adalimumab (124 patients; 42.3%). Quality-of-life scores remained stable throughout follow-up. No clinically meaningful changes were observed in disease activity or healthcare utilization.</p><p><strong>Conclusions: </strong>In this real-world Canadian study, switching from adalimumab RP or alternative biosimilar to AVT02 was associated with reductions in ISP and reactions while maintaining high adherence, patient satisfaction, quality of life, and disease control across multiple indications.</p><p><strong>Trial registration: </strong>This trial is registered with ClinicalTrials.gov: NCT05913817.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"745-765"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654838","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":"Pain Reduction Improves Adherence, Quality of Life, and Work Capacity in Rheumatoid Arthritis Patients Receiving Baricitinib: Czech ATTRA Registry Analysis.","authors":"Karel Pavelka, Ladislav Šenolt, Iva Váchová, Ewa Haladyj, Lenka Klementová, Jana Šilarová, Jakub Závada","doi":"10.1007/s40744-026-00837-2","DOIUrl":"10.1007/s40744-026-00837-2","url":null,"abstract":"<p><strong>Introduction: </strong>Despite achieving targets of inflammation reduction, many patients with rheumatoid arthritis (RA) report persistent pain and reduced quality of life (QoL). Biologic and targeted RA therapies produce similar improvements in disease activity, but varying improvements in pain. Baricitinib is a Janus kinase inhibitor that has demonstrated greater and more pain relief compared to either methotrexate or adalimumab.</p><p><strong>Methods: </strong>This study examines 24-month registry data from real-world patients receiving baricitinib in the Czech Republic. The aim was to determine the impact of baseline pain intensity on treatment survival and its correlation with QoL and work capacity.</p><p><strong>Results: </strong>Data from 392 patients (83.2% women) were analysed, with the majority (75.8%) having prior experience with biologic/targeted therapeutics. At baseline, disease activity (mean Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28-ESR] of 5.6 [± 1.2]) and pain Visual Analogue Scale (VAS) (61.2 [± 22.5] mm) were high. Mean DAS28-ESR decreased to 3.3 (± 1.1) after 3 months and 2.7 (± 1.0) after 24 months; mean pain VAS decreased to 36.4 (± 23.4) mm and 30.8 (± 22.7) mm. We observed negative correlations between baseline pain VAS and treatment survival, and positive correlations between baseline pain VAS and work/activity impairment (strong in all components [ρ = 0.73-0.78] except absenteeism [absence from work, ρ = 0.20]). Pain VAS was also negatively correlated with QoL at all timepoints (p < 0.001).</p><p><strong>Conclusion: </strong>Treatment with baricitinib provided sustained pain reduction and decreased disease activity in patients with RA. Findings highlight the need for pain-focused treatment goals and suggest earlier intervention may enhance persistence and QoL. Work limitations persisted, highlighting the need for flexible employment policies.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"581-593"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147390889","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 and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study.","authors":"Caifeng Li, Junmei Zhang, Haiguo Yu, Meiping Lu, Sirui Yang, Cuihua Liu, Ping Zeng, Bo Zhao, Xiaoqing Li, Wenjie Zheng, Yue Du, Wei Zhang, Zhihui Li, Xiufen Hu, Jianming Lai, Qian Xu, Xu Zhang, Xianyang Wang, Palasaiti Adili, Wei Qu","doi":"10.1007/s40744-026-00830-9","DOIUrl":"10.1007/s40744-026-00830-9","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic juvenile idiopathic arthritis (sJIA) is an autoinflammatory disorder that impacts children aged ≤ 16 years. This study evaluated the efficacy and safety of firsekibart, a fully human anti-IL-1β monoclonal antibody, in children with active sJIA.</p><p><strong>Methods: </strong>This multicenter, randomized, open-label, active-controlled phase 2 study (NCT05925452) enrolled participants aged 2- < 18 years with active sJIA across 14 sites in China. Participants were randomized (1:1:1) to firsekibart 3.0 mg/kg or 4.0 mg/kg subcutaneously every 4 weeks, or tocilizumab intravenously every 2 weeks, for 24 weeks. The primary endpoint was modified JIA American College of Rheumatology Pediatric criteria (ACR Pedi) 30 response at day 28. Secondary endpoints included ACR Pedi 30/50/70/90 responses, corticosteroid tapering, immunogenicity, and safety.</p><p><strong>Results: </strong>Fifty participants were randomized (firsekibart 3.0 mg/kg: n = 17; 4.0 mg/kg: n = 16; tocilizumab: n = 17). At day 28, ACR Pedi 30 response rates were 94.1% (95% CI 71.3-99.9), 75.0% (47.6-92.7) and 82.4% (56.6-96.2) in the firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab groups, respectively. Firsekibart 3.0 mg/kg achieved numerically higher ACR Pedi 70/90 responses. By the end of treatment, successful corticosteroid tapering occurred in 75.0%, 63.6%, and 62.5% of patients receiving firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab, respectively. No MAS events or anti-drug or neutralizing antibodies were detected. Treatment-emergent adverse events (TEAEs) occurred in 70.6%, 93.8%, and 94.1% of participants in the firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab groups, respectively. Grade ≥ 3 TEAEs were absent in the 3.0 mg/kg group. Common TEAEs mainly included infections and laboratory abnormalities.</p><p><strong>Conclusions: </strong>Firsekibart demonstrated rapid clinical improvement, steroid-sparing effects, and an acceptable safety profile. The 3.0 mg/kg dose provided the most favorable benefit-risk balance, with efficacy and safety outcomes comparable to tocilizumab, supporting further evaluation as a convenient once-every-4-weeks IL-1β-targeted option in future phase 3 trials.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05925452.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"595-610"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147435012","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":"Prevalence and Risk of Falls and Fractures in the Idiopathic Inflammatory Myopathies: A Cross-Sectional Study of 470 Patients.","authors":"Dhruv Nandakumar, Abhiram R Bhashyam, Manuel Lubinus, Lynn Wilson, Jerry Williams, Salman Bhai","doi":"10.1007/s40744-026-00829-2","DOIUrl":"10.1007/s40744-026-00829-2","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with idiopathic inflammatory myopathies (IIMs) can develop marked muscle weakness, which predisposes them to falls and injuries. We examined the prevalence of falls and associated fractures, assistive device use, and bone-protective therapy use among those reporting a fracture history. This analysis focuses on secondary prevention strategies in a high-risk population.</p><p><strong>Methods: </strong>A cross-sectional survey was developed and distributed by Myositis Support and Understanding, a patient-led advocacy organization, to members of its group. Patients aged ≥ 18 years with a diagnosis of an IIM (dermatomyositis, antisynthetase syndrome, polymyositis, inclusion body myositis [IBM], immune-mediated necrotizing myopathy, or overlap myositis [OM]) were eligible to participate. Ordinal logistic regression was utilized to identify variables independently associated with falls.</p><p><strong>Results: </strong>Of 470 respondents, 79.8% reported falling once since diagnosis, and 57.0% fell within the past year. Fall-related fractures since diagnosis were reported by 121 participants (25.7%), of whom 61 (50.4%) experienced ≥ 2 fractures and 39 (32.2%) required surgical treatment. Among those with fall-related fractures, nearly half (47.9%) reported not receiving any dietary supplements or pharmacologic therapies (e.g., calcium, vitamin D, or bisphosphonates) to reduce bone loss or prevent future fractures. Use of braces/splints or mobility aids was reported by 18.2% and 77.7% of participants with fall-related fractures, respectively. Regression analyses identified mobility aid usage as being associated with a significantly increased fall risk (odds ratio [OR], 3.1; P < 0.001). Relative to dermatomyositis, fall risk was significantly higher among participants with IBM (OR, 2.5; P = 0.002) and polymyositis (OR, 2.0; P = 0.037) and lower for participants with antisynthetase syndrome (OR, 0.5; P = 0.038).</p><p><strong>Conclusions: </strong>All IIMs can lead to marked weakness, with varying individual risks of falls. Multidisciplinary care, with an emphasis on primary and secondary prevention of falls and fractures, is critical to improving outcomes and preserving quality of life in these patient populations.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"677-689"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147494261","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":"Characterizing Adherence to a Mobile Health App for Patient-Reported Outcomes in Rheumatoid Arthritis.","authors":"Zeynep Serra Tuzun, Leah Santacroce, Hilde S Ørbo, Sho Fukui, Sara K Tedeschi, Daniel H Solomon","doi":"10.1007/s40744-026-00843-4","DOIUrl":"10.1007/s40744-026-00843-4","url":null,"abstract":"<p><strong>Introduction: </strong>Adoption of mobile health applications (\"apps\") that collect patient-reported outcomes (PROs) into clinical practice remains limited, and studies about patient usage preferences are lacking. Our aim was to characterize adherence to a PRO app designed for patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>We performed a post hoc analysis of a non-randomized trial of a PRO app for patients with RA seen at an academic medical center. The 12-month trial enrolled 149 participants with RA. The app collected one of four PROs every other day. We calculated adherence using two methods: (1) percent of PROs completed, and (2) time until app non-use. These calculations used different intervals for PRO completion and different periods of non-use to define adherence. We also investigated the association of potential predictors on the outcome using multivariable regression models.</p><p><strong>Results: </strong>The percentage of completed PROs was 43.5% (standard deviation, SD = 27.8) using a 2-day interval between PROs; this included all possible PRO questionnaires. Adherence was 68.0% (SD = 34.0) for any completion in an 8-day interval, and 77.3% (SD = 30.9) for a 32-day interval. In survival analyses, describing time until app non-use, the mean number of days until cessation was 153.8 days (SD = 94.1), defining non-use as ≥ 32 days without PRO completion and 152.3 days (SD = 95.8) for ≥ 64 days. We observed that older age and more frequent physician engagement with the PROs data were associated with greater adherence and increased time until cessation.</p><p><strong>Conclusions: </strong>Adherence to longitudinal PRO symptom reporting through an app was moderate and varied depending on how it was measured; the 8-day interval (approximately 1 week) is likely the most realistic expectation for patient completion of PRO symptoms. Adherence correlates with patient and physician factors.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"731-743"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147532630","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":"Frequency and Impact of Serious Infections in Hospitalised Patients with Sjögren's Disease: A Longitudinal Cohort Study.","authors":"Johannes C Nossent, Charles A Inderjeeth","doi":"10.1007/s40744-026-00850-5","DOIUrl":"10.1007/s40744-026-00850-5","url":null,"abstract":"<p><strong>Introduction: </strong>As little is known about the risk, type and severity of infections in patients with Sjögren's disease (SjD), we compared the frequency and impact of serious infections (SI) between hospitalised patients with SjD and controls (Co).</p><p><strong>Methods: </strong>Population-level observational study of patients with SjD (n = 692, 87.9% female, age 67 years) identified in the Hospital Morbidity Data Collection (HDMC) in Western Australia (WA) between 1980 and 2015 by diagnostic codes (ICD-9 CM 710.2, ICD10-AM M35.0) and age- and gender-matched controls free of rheumatic disease (n = 3737, 87.5% female, age 67 years). SI were defined by a validated algorithm and primary SjD, as the absence of other autoimmune rheumatic disease. Odds ratios (OR), incidence rates (IR) per 100 person-years (PY) and IR ratios (IRR) with 95% CI for SI were estimated. HDMC data were linked to WA Death Registry to evaluate the impact of SI on mortality rates (MR) per 100 PY and Kaplan-Meier survival estimates.</p><p><strong>Results: </strong>Serious infections occurred more in patients with SjD (OR 1.87, CI 1.59, 2.21, p < 0.01) with a fourfold higher IR for SI (IRR 4.28, CI 4.02-4.56) and increased IRR for pneumonia (4.01, CI 3.50-4.60), urogenital (3.06, CI 2.73-3.43), skin/soft tissue (5.22, CI 4.60-5.90), opportunistic infections (6.93, CI 5.77-8.32) and sepsis (6.15, CI 4.87-7.74) (all p < 0.01). The MR for patients with SjD with SI was almost twice that for Co with SI (MR ratio 1.89, CI 1.65-2.16). Patients with associated SjD (n = 270, 39%) had increased OR (2.05, CI 1.49-2.82) and IRR (1.61, CI 1.44-1.79) for SI compared to patients with primary SjD (n = 422, 61%). Few differences in SI existed between patients with SjD associated with rheumatoid arthritis (n = 197) or SLE (n = 79).</p><p><strong>Conclusions: </strong>SI occurred at a higher rate in all patients with SjD and was associated with increased long-term mortality. These results emphasize the increased susceptibility to and impact of SI for both patients with primary and secondary SjD.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"785-797"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147663018","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":"Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study.","authors":"Megan E B Clowse, Radboud J E M Dolhain, Stephanie Finzel, Frauke Förger, Cornelia Glaser, Andrea Pluma, Laura Shaughnessy, Jagdev Sidhu, Jemma Greenin, Kathy Rice, Gauri Utturkar, Joao N Duarte, Marie Teil","doi":"10.1007/s40744-026-00853-2","DOIUrl":"10.1007/s40744-026-00853-2","url":null,"abstract":"<p><strong>Introduction: </strong>Control of chronic inflammatory diseases (CIDs) during pregnancy is essential for maternal and foetal health; however, the impact of pregnancy on the pharmacokinetics (PK) of CID therapies is unknown. This study investigated the impact of pregnancy on the PK of certolizumab pegol (CZP), a tumour necrosis factor inhibitor (TNFi), in women with CIDs.</p><p><strong>Methods: </strong>CHERISH (NCT04163016) was a multicentre, longitudinal, open-label phase 1B study evaluating the impact of pregnancy on the PK of CZP in women with CIDs. Pregnant participants on a stable CZP regimen were enrolled at ≤ 10 weeks of gestation. The primary variable was pre-dose and post-dose plasma CZP concentrations throughout pregnancy and postpartum in patients who received ≥ 1 dose. Treatment-emergent adverse events (TEAEs) were recorded.</p><p><strong>Results: </strong>Of 21 enrolled participants (CZP 200 mg every 2 weeks [Q2W], n = 15; CZP 400 mg Q2W, n = 1; CZP 400 mg Q4W, n = 5), 16 completed the study. Relative to postpartum, pre-dose plasma CZP concentrations were modestly reduced across trimesters 1-3, with no clear pattern in post-dose concentrations. TEAEs occurred in 81.0% of participants, with 'infections and infestations' being most common; only 1 (4.8%) was considered treatment related. Five participants (23.8%) experienced serious TEAEs; none were considered treatment-related. One serious TEAE of foetal death in a high-risk twin pregnancy, one spontaneous abortion was reported in an enrolled participant before their first dose of CZP in the study, and no infant illnesses were reported.</p><p><strong>Conclusions: </strong>CZP plasma concentrations were modestly lower during pregnancy versus postpartum, were consistent across trimesters, and were within the range observed in studies of non-pregnant individuals with CIDs. Safety was consistent with the established profile of CZP and the patient population. Findings support maintenance of CZP dosing regimens during pregnancy.</p><p><strong>Trial registration: </strong>ClinicialTrials.gov identifier: NCT04163016.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"813-828"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147779705","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}