Rheumatology and Therapy最新文献

{"title":"Golimumab for the Treatment of Rheumatoid Arthritis: A Narrative Review of Pivotal Randomized Trials and Real-World Studies.","authors":"Uta Kiltz, Yi-Ming Chen, Andrea Rubbert-Roth, Sergio Fonseca, José Antunes, Arun Singh, Richard Milek, Jordan Wu, Jeffrey A Sparks","doi":"10.1007/s40744-026-00849-y","DOIUrl":"https://doi.org/10.1007/s40744-026-00849-y","url":null,"abstract":"<p><p>Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease characterized by progressive joint involvement. The disease is associated with reduced health-related quality of life, functional ability, work productivity, and daily activity, in addition to pain, fatigue, and inflammation-induced structural damage. RA emerges through a complex interplay of multiple factors, including the release of inflammatory cytokines. One such cytokine is tumor necrosis factor (TNF), which is inhibited by golimumab, an approved treatment for the disease. Golimumab is produced using a recombinant cell line that originated from genetically modified mice immunized with human TNF. This narrative review presents the efficacy and safety outcomes from the golimumab pivotal randomized controlled trials (RCTs) that evaluated the subcutaneous and intravenous formulations. Across the RCTs, treatment was associated with an American College of Rheumatology ≥ 20% improvement. A majority of participants reported at least one AE and the most frequent were upper respiratory infection, nasopharyngitis, and bronchitis. The review also presents data from post hoc analyses and real-world studies, which demonstrated benefits that included improvements in health-related quality of life and daily productivity, prolonged drug survival, and reduced fatigue, pain, disease activity, and structural damage. Lastly, data from meta-analyses, including RCTs and real-world studies, demonstrated that golimumab had an adverse event pattern similar to other TNF inhibitors. Collectively, these studies demonstrated that golimumab is an effective and safe treatment for RA when used according to the approved indication.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147842204","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}

{"title":"Prospective Quantification of Glucocorticoid Toxicity Across Dosage Ranges in Systemic Lupus Erythematosus: Insights from the Glucocorticoid Toxicity Index.","authors":"Jiaying Zhang, Dai Gao, Yong Fan, Zhuoli Zhang","doi":"10.1007/s40744-026-00857-y","DOIUrl":"https://doi.org/10.1007/s40744-026-00857-y","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the European Alliance of Associations for Rheumatology (EULAR) recommendation to minimize glucocorticoid (GC) use in systemic lupus erythematosus (SLE), prospective data quantifying toxicity across low-dose ranges are lacking. This study aimed to assess toxicity using the GC toxicity index (GTI) in SLE patients and compare toxicity profiles among dose-defined subgroups.</p><p><strong>Methods: </strong>Patients from the STAR cohort (May 2023-May 2024) were prospectively followed up for 1 year. Stratified by average daily prednisone (PDN) dose, toxicity was assessed using GTI comprising the aggregate improvement score (AIS) and the cumulative worsening score (CWS) at baseline and 1 year. Three pre-planned stepwise comparisons used dose thresholds of 7.5 mg, 5 mg, and 2.5 mg, with a Bonferroni-corrected significance level of P < 0.0167 (α = 0.05/3). Quantile regression evaluated the association between average daily PDN dose and CWS/AIS.</p><p><strong>Results: </strong>Of 302 patients, the PDN ≤ 7.5 mg/day group (n = 223) showed statistically lower median CWS [0 (IQR 0-19) vs. 48 (IQR 19-84), P < 0.001] and AIS [0 (IQR - 19-10) vs. 40 (IQR 9-74), P < 0.001] compared to the PDN > 7.5 mg/day group (n = 79). Within the low-dose group, patients with 5 < PDN ≤ 7.5 mg/day (n = 52) exhibited higher median CWS [10.5 (IQR 0-29) vs. 0 (IQR 0-19), P = 0.002] and wider AIS interquartile range [0 (IQR - 18.75-29) vs. 0 (IQR - 20-0), P = 0.010] than the PDN ≤ 5 mg/day subgroup (n = 171). No significant differences in CWS or AIS were observed between the PDN ≤ 2.5 mg/day (n = 90) and 2.5 < PDN ≤ 5 mg/day (n = 81) subgroups. Quantile regression indicated that each 1 mg/day increase in PDN dose raised median CWS by 3.33 points and median AIS by 3.42 points.</p><p><strong>Conclusions: </strong>To our knowledge, this study provided the first prospective and quantitative evidence using the GTI to demonstrate that PDN dose reduction to ≤ 5 mg/day was linked to reduced toxicity. Moreover, we found that no dose was entirely safe, which strongly supported the EULAR strategy of rigorous GC minimization.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147779694","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}

{"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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biologic Therapy Is Associated with Faster Bone Union After the Sauvé-Kapandji Procedure in Patients with Rheumatoid Arthritis.","authors":"Hinako Okabe, Kazuhiro Maeda, Yu Yamashita, Asami Zenitani, Tetsuro Nishizawa, Mitsuhito Yukawa, Reiji Nishimura, Hideaki Bo, Takeshi Miyawaki, Mitsuru Saito","doi":"10.1007/s40744-026-00847-0","DOIUrl":"https://doi.org/10.1007/s40744-026-00847-0","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is characterized by chronic inflammation and impaired bone quantity and quality, which may delay postoperative bone healing. The Sauvé-Kapandji (SK) procedure is a common surgical strategy for distal radioulnar joint disorders, but the association between RA medications-particularly biologic and targeted synthetic disease-modifying antirheumatic drugs (b/ts DMARDs)-and bone union after SK is unclear. This study aimed to identify patient- and treatment-related factors associated with bone union time, with a special focus on biologic therapy.</p><p><strong>Methods: </strong>We retrospectively analyzed patients with RA who underwent SK. Bone union was assessed using serial wrist radiographs, and union timing was independently evaluated by multiple orthopedic specialists in a blinded manner. Patient characteristics-including demographics, disease activity, medication use, bone mineral density, and biomarkers-were analyzed. Correlations with bone union duration were examined using Pearson's test; intergroup comparisons used t tests, Fisher's exact test, or Wilcoxon tests. Multiple regression identified independent predictors of union time.</p><p><strong>Results: </strong>All patients achieved bone union. Higher matrix metalloproteinase-3 levels and methotrexate (MTX) dose were associated with prolonged healing, whereas biologic agents, specifically tumor necrosis factor (TNF) inhibitors, were associated with significantly shorter union time. Nonsteroidal anti-inflammatory drugs (NSAIDs) use was also linked to delayed healing. Multivariate analysis confirmed that MTX dose, biologic use, and NSAIDs use were independently associated with bone union duration.</p><p><strong>Conclusions: </strong>Biologic therapy was independently associated with faster bone union after SK, whereas higher MTX dosage and NSAIDs use were linked to delayed healing. In current clinical practice, biologic agents are often withheld during the perioperative period because of concerns regarding wound healing; however, our findings suggest that, from the standpoint of bone union, biologic therapy may have a favorable effect. Larger prospective studies are warranted to confirm these findings and clarify the optimal perioperative management of b/ts DMARDs in this setting.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729731","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}

{"title":"Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis: A Systematic Review and Meta-Analysis.","authors":"Xingyun Wan, Xiaolong Wang, Shuang Liang, Qian Wang, Chao Liu, Zheyi Dong","doi":"10.1007/s40744-026-00851-4","DOIUrl":"https://doi.org/10.1007/s40744-026-00851-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;This study evalöuated the clinical efficacy and safety of mizoribine (MZR) in the treatment of lupus nephritis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a systematic review and meta-analysis in accordance with PRISMA 2020 guidelines. Literature searches were performed in PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov up to June 30, 2025. Two investigators independently screened studies, extracted data, and assessed risk of bias. Included studies enrolled patients with biopsy-confirmed lupus nephritis treated with mizoribine-containing regimens, including randomized controlled trials (RCTs), cohort studies, and single-arm designs. Primary and secondary outcomes were renal response rate (The proportion of patients achieving either complete response (CR) and partial response (PR). CR: 24-h urinary protein &lt; 0.5 g/day with normal/stable serum creatinine ≤ 25%. PR: ≥ 50% reduction in proteinuria to &lt; 3.5 g/day with stable serum creatinine ≤ 25%), and adverse reaction rate, 24-h urinary protein, and systemic lupus erythematosus disease activity index (SLEDAI) score, respectively. Data were analyzed in STATA 14.0 using fixed or random-effects models based on heterogeneity (random effects for I&lt;sup&gt;2&lt;/sup&gt; ≥ 25% and P ≤ 0.1). Prespecified subgroup analyses were performed by treatment duration (induction period ≤ 6 months vs. maintenance period &gt; 6 months) and control regimen (glucocorticoid group vs. glucocorticoid and immunosuppressants ).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Nineteen studies (four RCTs, one cohort, 14 single-arm) with 1489 patients were included. Meta-analysis of randomized controlled trials (RCTs) showed no significant differences in renal response rates or adverse reaction rates between MZR and control groups, but a higher SLEDAI score was observed with MZR (WMD = 1.75, 95% CI 0.33-3.16, P &lt; 0.05). Subgroup analysis indicated MZR was associated with a reduced renal response rates (RR = 0.83, 95% CI 0.71-0.97, P &lt; 0.05), elevated proteinuria (WMD = 0.62, 95% CI 0.22-1.03, P &lt; 0.05), and higher SLEDAI scores (WMD = 1.75, 95% CI 0.33-3.16, P &lt; 0.05) versus controls. These negative outcomes, including increased proteinuria (WMD = 0.73, 95% CI 0.11-1.36, P &lt; 0.05) and SLEDAI (WMD = 2.60, 95% CI 1.19-4.01, P &lt; 0.05), were significant only in the induction period use (P &lt; 0.05) and not sustained maintenance period (&gt; 6 months). Single-arm studies reported high response rates (59-100%) but widely variable adverse reaction rates (5-50%). The types of adverse events included hyperuricemia, respiratory tract infection, leukopenia, etc. CONCLUSIONS: Mizoribine demonstrates phased efficacy in lupus nephritis: it is less effective than standard regimens for the induction period (≤ 6 months) but comparable during the maintenance period (&gt; 6 months). Therefore, it is not a first-line induction agent but serves as a practical maintenance option, particularly for patients intolerant of convent","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147717863","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}

{"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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Achievement and Maintenance of Remission with Upadacitinib in Patients with Moderate-to-Severe Rheumatoid Arthritis in Italy: 1-Year Data from UPHOLD, a Prospective Real-World Observational Study.","authors":"Caterina Baldi, Eleonora Celletti, Serena Bugatti, Marcello Govoni, Massimiliano Cazzato, Andrea Picchianti Diamanti, Marco Fornaro, Giuliana Guggino, Luca Navarini, Maria Antonietta D'Agostino, Luca Quartuccio, Francesco Ciccia, Lorenzo Dagna, Paolo Stobbione, Massimo Triggiani, Ombretta Viapiana, Annarita Giardina, Gianluca Moroncini, Roberto Caporali, Chiara Bazzani, Enrico Tirri, Claudia Lomater, Sara Di Fino, Francesca Morello, Carlo Selmi","doi":"10.1007/s40744-026-00845-2","DOIUrl":"https://doi.org/10.1007/s40744-026-00845-2","url":null,"abstract":"<p><strong>Introduction: </strong>Upadacitinib (UPA) is approved for moderate-to-severe rheumatoid arthritis (RA) based on SELECT trials, but data on real-world effectiveness are limited. UPHOLD is a multicountry study of patients with RA receiving UPA 15 mg.</p><p><strong>Methods: </strong>The present interim analysis was based on the Italian cohort performed across 28 centers. Co-primary endpoints were (i) the proportion of patients receiving UPA who achieved DAS28(CRP) remission (< 2.6) at 6 months and (ii) the proportion of patients achieving DAS28(CRP) remission at 6 months who continued to receive UPA and maintained remission (or had no more than a 0.6-point increase in DAS28[CRP]) at 12 months, analyzed by modified non-responder imputation (mNRI) and as observed (AO). Modified full analysis sets (mFAS1 and mFAS2) included patients completing 6 and 12 months, respectively. Safety analysis included reporting of adverse events and treatment-emergent adverse events (TEAEs), as exposure-adjusted event rates (EAERs; events per 100 patient-years [E/100PY]).</p><p><strong>Results: </strong>Among 270 patients, 74 (27.4%) discontinued by 12 months because of lack of efficacy (13.7%) or adverse events (8.1%). In mFAS1 (N = 168), 50.6% (mNRI) and 62% (AO) achieved DAS28(CRP) remission at 6 months. In mFAS2 (N = 55), 80% (mNRI) and 91.7% (AO) maintained DAS28(CRP) remission at 12 months. CDAI and SDAI remission rates at 12 months were 31.3%. Patients on UPA monotherapy at 12 months showed remission rates of 49.5% (DAS28[CRP]), 27.2% (CDAI), and 27.4% (SDAI). Significant improvements in patient-reported pain and physical function were also observed. A total of 278 TEAEs were reported (80.8 E/100PY), including herpes zoster, liver disorders, and serious infections with EAERs of 2.0, 1.5, and 1.2 E/100PY, respectively.</p><p><strong>Conclusion: </strong>UPA 15 mg was observed to effectively treat moderate-to-severe RA in the real-world setting, with ≥ 80% maintaining DAS28(CRP) remission at 12 months, showing a favorable benefit-risk profile.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04497597.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147676331","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}

{"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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}