Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-05-05DOI: 10.1007/s40744-026-00849-y
Uta Kiltz, Yi-Ming Chen, Andrea Rubbert-Roth, Sergio Fonseca, José Antunes, Arun Singh, Richard Milek, Jordan Wu, Jeffrey A Sparks
{"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":"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":"899-930"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407820/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-05-23DOI: 10.1007/s40744-026-00859-w
Janet E Pope, Jayeshkumar Patel, Christopher D Saffore, Siran Fang, Al Rasymas, Dalinda Liazoghli, Olga Ziouzina
{"title":"Real-World Upadacitinib Persistence and Clinical Outcomes Among Canadian Patients with Inflammatory Arthritis from a Patient Support Program: The UPRAISE Study.","authors":"Janet E Pope, Jayeshkumar Patel, Christopher D Saffore, Siran Fang, Al Rasymas, Dalinda Liazoghli, Olga Ziouzina","doi":"10.1007/s40744-026-00859-w","DOIUrl":"10.1007/s40744-026-00859-w","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) impact quality of life. Medication persistence is a key determinant of long-term effectiveness in chronic inflammatory diseases. This study evaluated treatment persistence, function, and program satisfaction among Canadian patients with RA, PsA, and axSpA receiving upadacitinib enrolled in the AbbVie Care patient support program (PSP).</p><p><strong>Methods: </strong>Data were collected from adults with RA, PsA, or axSpA enrolled in the Canadian PSP between January 2020 and July 2025. Demographic characteristics, first prescription fill rates, medication persistence, Health Assessment Questionnaire Disability Index (HAQ-DI) scores, and patient satisfaction with the PSP (subset of RA patients) were assessed.</p><p><strong>Results: </strong>A total of 16,075 patients enrolled in the PSP were assessed (RA: N = 11,449; PsA: N = 2751; axSpA N = 1875). Over 90% of all patients filled their first upadacitinib prescription within 7 days. Among patients with RA, medication persistence was 73%, 63%, 56%, and 51% at 12, 24, 36, and 48 months, respectively. In PsA, persistence was 68%, 54%, and 47% at 12, 24, and 36 months, and with axSpA, persistence was 63% and 50% at 12 and 24 months. Patients with RA had a mean reduction from baseline in HAQ-DI of - 0.40 (N = 777; SD: 0.77; P < .001) and most patients (62%) achieved minimal clinically important difference (MCID; improvement ≥ 0.22[RA] or ≥ 0.35[PsA]), with 28% having normative values (HAQ-DI ≤ 0.25). Among patients with PsA, the mean reduction from baseline in HAQ-DI was - 0.65 (N = 153; SD: 0.66; P < 0.001); 73% of patients achieved MCID and 26% had normative values. Among 200 RA patients surveyed, nearly 90% were extremely/very satisfied with the PSP.</p><p><strong>Conclusions: </strong>High first prescription fill and long-term persistence rates were observed in patients with RA, PsA, and axSpA enrolled in a single national PSP, along with substantial improvements in physical function.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1075-1089"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148006408","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-06-13DOI: 10.1007/s40744-026-00866-x
Lianzhi Chen, Jun Yuan, Jun Lu, Gengmin Zhou, Mingxi Gu, Yuting Yang, Chao Chen, Jintao Chen, Qingwen Wang
{"title":"Protective Effects of Apolipoprotein A and High-Density Lipoprotein Cholesterol Against Interstitial Lung Disease in Rheumatoid Arthritis: The Mediating Role of Systemic Inflammation.","authors":"Lianzhi Chen, Jun Yuan, Jun Lu, Gengmin Zhou, Mingxi Gu, Yuting Yang, Chao Chen, Jintao Chen, Qingwen Wang","doi":"10.1007/s40744-026-00866-x","DOIUrl":"10.1007/s40744-026-00866-x","url":null,"abstract":"<p><strong>Introduction: </strong>Interstitial lung disease (ILD) is a progressive fibrotic condition that markedly reduces survival and increases mortality in patients with rheumatoid arthritis (RA). Dysregulated lipid metabolism is associated with the progression of both RA and ILD. However, its relationship with the risk of ILD in the RA population remains uncertain. This study aimed to determine the association between lipid traits and incident ILD in an RA population, as well as the mediating role of systemic inflammation.</p><p><strong>Methods: </strong>This prospective cohort study included 4229 UK Biobank participants with RA and no baseline ILD. Cox proportional-hazards models were used to investigate the association between six lipid traits and ILD risk. Systemic inflammation was estimated using the INFLA-score. Generalized structural equation modeling was employed to investigate the mediating effect of the INFLA-score on the relationship between lipid traits and ILD incidence.</p><p><strong>Results: </strong>After a mean follow-up of 14.736 years, 152 incident ILD cases were recorded. High serum levels of apolipoprotein A (ApoA) and high-density lipoprotein cholesterol (HDL-C) were independent protective factors against incident all-cause ILD in RA, associated with a 61.5% and 51.3% risk reduction in ILD per standard deviation (SD) increase in ApoA and HDL-C, respectively (ApoA: HR 0.385, 95% CI 0.189-0.783, p = 0.008; HDL: HR 0.487, 95% CI 0.280-0.847, p = 0.011). These associations were more pronounced in males, relatively young patients and ever-smokers. Systemic inflammation accounted for 88.5% of the association with ApoA and 63.6% with HDL-C, respectively.</p><p><strong>Conclusions: </strong>Elevated ApoA and HDL-C were independently associated with a lower risk of incident all-cause ILD in RA. The associations appear to be largely driven by low-grade systemic inflammation.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1141-1157"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148252847","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-05-18DOI: 10.1007/s40744-026-00860-3
Konstantinos Tsafis, Vasileios Skepastianos, Elpida Skouvaklidou, Dimitrios Deligeorgakis, Maria Boutel, Aikaterini Kontonikola, Nikolaos Papazoglou, George E Fragoulis, Nikolaos Kougkas
{"title":"Cutaneous Manifestations in Psoriatic Arthritis: Phenotypes, Clinical Burden, and Therapeutic Implications.","authors":"Konstantinos Tsafis, Vasileios Skepastianos, Elpida Skouvaklidou, Dimitrios Deligeorgakis, Maria Boutel, Aikaterini Kontonikola, Nikolaos Papazoglou, George E Fragoulis, Nikolaos Kougkas","doi":"10.1007/s40744-026-00860-3","DOIUrl":"10.1007/s40744-026-00860-3","url":null,"abstract":"<p><p>Cutaneous disease is a central component of psoriatic arthritis (PsA), contributing substantially to patient disease burden and influencing therapeutic choices. Beyond plaque psoriasis, specific phenotypes, including nail, scalp, palmoplantar, and inverse involvement, are relatively common in PsA and are frequently associated with greater functional limitation, impaired quality of life, and discordant responses to systemic therapy. Accurate identification of these manifestations is critical for diagnosis, risk stratification, and treatment optimization. This review provides a clinically oriented overview of the dermatologic spectrum of PsA, outlining epidemiology, pathogenic mechanisms linking the skin-joint axis, and the impact of skin disease on outcomes. We summarize evidence for topical therapies, conventional systemic agents, biologics targeting tumour necrosis factor alpha (TNFα), interleukin-17 (IL-17), and interleukin-23 (IL-23), targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), and emerging treatments, with attention to phenotype-specific considerations and multidisciplinary management. The implications of persistent skin activity in complex-to-manage PsA are also discussed. A domain-based, integrated approach to skin and joint care is required to achieve effective control both of musculoskeletal and cutaneous symptoms. Systematic evaluation and treatment of skin involvement should be considered a core component of PsA management rather than an ancillary concern.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"931-949"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974964","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-06-16DOI: 10.1007/s40744-026-00863-0
Jucier Gonçalves Júnior, Jamily Izabel Alves Dos Santos, Samuel Katsuyuki Shinjo
{"title":"Clinically Amyopathic Dermatomyositis: Epidemiology, Clinical Presentation, Pathophysiology, Treatment, and Prognosis: A Systematic Review.","authors":"Jucier Gonçalves Júnior, Jamily Izabel Alves Dos Santos, Samuel Katsuyuki Shinjo","doi":"10.1007/s40744-026-00863-0","DOIUrl":"10.1007/s40744-026-00863-0","url":null,"abstract":"<p><strong>Introduction: </strong>We conducted a systematic review on the epidemiology, clinical presentation, pathophysiology, treatment, and prognosis of clinically amyopathic dermatomyositis (CADM).</p><p><strong>Methods: </strong>A qualitative systematic review was performed from October 1988 to January 2026 according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines, using seven electronic databases: PubMed, Web of Science, EMBASE, Virtual Health Library, PsycInfo, Scopus, and the Cochrane Library. Studies were eligible if at least one combination of search terms appeared in the title, were written in English, Portuguese, or Spanish, and addressed the epidemiology, pathogenesis, diagnosis, or treatment of CADM. Systematic reviews, theses, dissertations, letters, editorials, studies with unclear methodology, and articles addressing classic or paraneoplastic dermatomyositis were excluded.</p><p><strong>Results: </strong>A total of 106 studies comprising 816 patients were included. CADM is more frequent among females and most prevalent in the fifth and sixth decades of life. The most common cutaneous findings were Gottron's signs, heliotrope rash, and the V-neck sign. Interstitial lung disease (ILD) was the most frequent extracutaneous, extramuscular manifestation. Elevated ferritin, lactate dehydrogenase (LDH), and C-reactive protein (CRP) levels were common. The most frequent autoantibodies were anti-MDA-5 (Anti-Melanoma Differentiation-Associated gene 5) and anti-Ro-52. Treatment most often combined pulse glucocorticoids with human immunoglobulin, cyclophosphamide, rituximab, or cyclosporine. Poorer prognosis was associated with higher ferritin, CRP, and LDH levels, and with the presence of ILD.</p><p><strong>Conclusions: </strong>CADM is a serious, complex disease with a distinct clinical and serological profile, requiring further conceptual refinement and multicenter studies to better characterize this DM phenotype.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"997-1053"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407798/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148259570","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-06-18DOI: 10.1007/s40744-026-00867-w
Konstantinos Triantafyllias, Stefanie Liverakos, Khalid K Altamimi, Ann-Kathrin Druck, Svea Gauch, Ioannis Parodis, Dionysis Nikolopoulos, Christian Geber, Muthuraman Muthuraman, Andreas Schwarting
{"title":"Optical Spectral Transmission Imaging in Patients with Osteoarthritis: A Comparative Study with Joint Ultrasound and Clinical Markers.","authors":"Konstantinos Triantafyllias, Stefanie Liverakos, Khalid K Altamimi, Ann-Kathrin Druck, Svea Gauch, Ioannis Parodis, Dionysis Nikolopoulos, Christian Geber, Muthuraman Muthuraman, Andreas Schwarting","doi":"10.1007/s40744-026-00867-w","DOIUrl":"10.1007/s40744-026-00867-w","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the diagnostic performance of optical spectral transmission (OST) in patients with hand osteoarthritis (OA) and to assess its associations with clinical findings, joint ultrasound (US) markers of active OA, and patient- and disease-related characteristics.</p><p><strong>Methods: </strong>In this exploratory pilot study, consecutive patients with OA and healthy controls underwent OST measurements using the HandScan<sup>®</sup> device. Clinical examinations and inflammatory markers (C-reactive protein, erythrocyte sedimentation rate) were obtained. A subset of patients underwent standardized joint US [greyscale (GSUS)/power Doppler (PDUS)]. Correlations between OST and clinical, anthropometric and US parameters were examined, and receiver operating characteristics (ROC) assessed discriminative ability. Linear regression was used to evaluate confounding effects.</p><p><strong>Results: </strong>A total of 2910 joints of 97 patients with OA were examined via OST and compared to 3300 joints of 100 control subjects. OST values were significantly higher in patients with OA than in controls (10.39 ± 1.82 vs. 7.51 ± 3.80; p < 0.001), and this difference remained significant after adjustment for potential confounders (β = 1.698; 95% CI 0.149-3.247; p<sub>adj</sub> = 0.032). OST showed a weak but significant correlation with PDUS when distal interphalangeal (DIP) and proximal interphalangeal (PIP) joints were analysed together (ρ = 0.11, p = 0.014). At the DIP joint level, OST correlated weakly but significantly with both GSUS (ρ = 0.19, p = 0.004) and PDUS (ρ = 0.22, p = 0.001). Moderate correlations with hand size were observed in patients with OA (ρ = 0.36, p < 0.001) and controls (ρ = 0.40, p < 0.001). ROC analysis revealed a moderate discriminative ability [patients vs. controls: area under the curve (AUC) 0.718; 95% CI 0.645-0.792; p < 0.001].</p><p><strong>Conclusion: </strong>OST correlated with US synovitis markers and demonstrated a moderate/significant capacity to distinguish patients with OA from controls. As a rapid, non-invasive and examiner-independent technique, OST may represent a useful adjunctive tool in the diagnostic assessment of hand OA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1159-1172"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148278706","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-05-16DOI: 10.1007/s40744-026-00852-3
Roy M Fleischmann, Vibeke Strand, Eugen Feist, Tatiana Lisitsyna, Jeffrey A Sparks, Evgeny Nasonov, Mikhail Samsonov, Sergey Grishin, Alina Egorova, Sofiya Kuzkina, Josef S Smolen
{"title":"Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials).","authors":"Roy M Fleischmann, Vibeke Strand, Eugen Feist, Tatiana Lisitsyna, Jeffrey A Sparks, Evgeny Nasonov, Mikhail Samsonov, Sergey Grishin, Alina Egorova, Sofiya Kuzkina, Josef S Smolen","doi":"10.1007/s40744-026-00852-3","DOIUrl":"10.1007/s40744-026-00852-3","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis evaluated the effects of olokizumab (OKZ) on patient-reported outcomes (PROs) after up to 106 weeks of treatment in patients with active rheumatoid arthritis (RA) refractory to methotrexate (MTX; MTX-inadequate response [MTX-IR]) or refractory to tumor necrosis factor inhibitor (TNFi; TNFi-inadequate response [TNFi-IR]).</p><p><strong>Methods: </strong>Post-hoc analysis was performed of pooled PROs from phase III, double-blind, placebo-controlled trials (CREDO1/2 MTX-IR; CREDO3 TNFi-IR; NCT02760368/ NCT02760407/NCT03225932) and their open-label extension (OLE; up to 106 weeks) in adults with active RA despite treatment with MTX or TNFi. Patients were treated with OKZ 64 mg every 2 weeks (q2w) or every 4 weeks (q4w) + MTX versus MTX + placebo (weeks 0-24) or active comparator (CREDO2), followed by an OLE (all OKZ). The PROs analyzed were patient global assessment; pain (visual analog scale); Health Assessment Questionnaire Disability Index (HAQ-DI); 36-Item Short Form Health Survey (SF-36); Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (FACIT-F); Work Productivity Survey Rheumatoid Arthritis (WPS-RA) and the European Quality of Life-Five-Dimension Questionnaire (EQ-5D). Changes from baseline at weeks 12, 24 and 106 were analyzed using a mixed model for repeated measures; analyses included percentages of patients reporting improvements ≥ minimal clinically important difference (MCID).</p><p><strong>Results: </strong>By week 12, treatment with OKZ compared to placebo (PBO) resulted in greater numerical and clinically meaningfully changes from baseline in all PROs for patients refractory to MTX: the HAQ-DI was - 0.60 for OKZ q2w, - 0.58 for OKZ q4w and - 0.34 for PBO; pain VAS was - 33.26, - 32.51, - 18.39, respectively; and the FACIT-F was 8.47, 8.42 and 4.69, respectively (p < 0.0001). Similar but less prominent improvements were noted in the patients with TNFi-IR. Post hoc analyses demonstrated a higher proportion of patients receiving OKZ reported improvements ≥ MCID versus those receiving PBO (p < 0.05) in all PROs in both groups at week 12. For patients treated with OKZ, the observed improvements from baseline were maintained and increased in magnitude through week 106.</p><p><strong>Conclusion: </strong>Treatment with OKZ over 106 weeks resulted in sustained numerically greater and clinically meaningful improvements in PROs compared to baseline in both RA patients with MTX-IR and those with TNFi-IR. These findings support the long-term benefit of OKZ on PROs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers NCT02760368, NCT02760407, NCT02760433, NCT03120949.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1055-1074"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407398/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147960219","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":"Effectiveness and Safety of Inebilizumab for IgG4-Related Disease in a Real-World Clinical Setting in Japan: Protocol for a Long-Term Prospective Observational Study (4SigHT Study).","authors":"Yoshiya Tanaka, Yuzo Kodama, Shingo Nakayamada, Atsushi Masamune, Hirokazu Sato, Akiko Takahashi, Junichiro Shibata, Yusuke Takeshima, Mitsuhiro Kawano","doi":"10.1007/s40744-026-00870-1","DOIUrl":"10.1007/s40744-026-00870-1","url":null,"abstract":"<p><strong>Introduction: </strong>IgG4-related disease (IgG4-RD) is a systemic fibroinflammatory condition that can cause irreversible organ dysfunction and life-threatening complications. Although glucocorticoids are the standard first-line therapy, frequent flares necessitate prolonged use, which is in turn associated with toxicity. Inebilizumab, a CD19-targeted antibody approved in Japan in November 2025, demonstrated efficacy in the phase 3 MITIGATE trial. However, the trial's eligibility criteria and controlled environment may not reflect the heterogeneity of the routine clinical setting or the long-term profile in the Japanese population. This study (4SigHT Study) aims to evaluate the long-term effectiveness and safety of inebilizumab in Japan.</p><p><strong>Methods: </strong>This multicenter, prospective, observational study plans to enroll 100 patients with definite or probable IgG4-RD who are initiating inebilizumab at up to 40 sites in Japan. The study runs from March 1, 2026 to March 31, 2032. It includes up to 14 scheduled visits over a maximum duration of 312 weeks and reflects real-world decisions without mandated interventions. Comprehensive baseline assessments capture disease characteristics, comorbidities, vaccination history, and clinical history, including the frequency and nature of flares over the preceding 52 weeks. Longitudinal data are collected via an electronic data capture system. To ensure data robustness, the study employs a rigorous adjudication process. Suspected flares treated by investigators are adjudicated by an independent data and safety monitoring board using standardized organ-specific flare criteria.</p><p><strong>Planned outcomes: </strong>The primary outcome is the proportion of participants with an adjudicated clinical flare through week 52. Secondary outcomes include treatment-free complete remission, glucocorticoid-free complete remission, time to clinical flare, annual clinical flare rate, proportion of patients who initiate additional treatment, time to treatment initiation for new or worsening symptoms, and cumulative glucocorticoid dose. Furthermore, the study evaluates the long-term safety of inebilizumab over 6 years.</p><p><strong>Trial registration: </strong>The study is registered with the Japan Registry of Clinical Trials (jRCT1031250749).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1191-1202"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148302937","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}
Rheumatology and TherapyPub Date : 2026-08-01Epub Date: 2026-06-25DOI: 10.1007/s40744-026-00869-8
Övgü Özenli Yağcı, Çisem Yıldız, Deniz Gezgin Yıldırım, Emre Bilgin, Sevcan A Bakkaloğlu
{"title":"Comparison of Systemic Corticosteroid Therapy Practices Between Pediatric and Adult Rheumatologists: A Multicenter Survey Study.","authors":"Övgü Özenli Yağcı, Çisem Yıldız, Deniz Gezgin Yıldırım, Emre Bilgin, Sevcan A Bakkaloğlu","doi":"10.1007/s40744-026-00869-8","DOIUrl":"10.1007/s40744-026-00869-8","url":null,"abstract":"<p><strong>Introduction: </strong>The indications, dosage, and duration of systemic corticosteroid treatment may vary among pediatric rheumatologists (PRs) and adult rheumatologists (ARs) in daily clinical practice. This study aims to evaluate and compare practices, perceptions, and attitudes of PRs and ARs regarding the use of systemic corticosteroids.</p><p><strong>Methods: </strong>An online survey was administered to rheumatologists in Türkiye to assess their use of systemic corticosteroids in the management of rheumatic diseases. The questionnaire addressed preferred corticosteroid formulations, dosing and tapering strategies, monitoring and preventive measures for adverse effects, and vaccination practices.</p><p><strong>Results: </strong>Sixty PRs and 40 ARs participated in the study. Prednisolone was most commonly preferred by PRs while almost all ARs used methylprednisolone. Weight-based dosing was favored by PRs whereas ARs preferred fixed-dose regimens. PRs more frequently preferred longer pulse corticosteroid therapy, whereas ARs most commonly used a 3-day pulse regimen. In contrast, ARs reported significantly longer durations of bridging and maintenance therapy. Delirium was reported significantly more often by ARs as a complication (p = 0.026). In pre-treatment evaluation, PRs more commonly assessed peripheral blood smear (p < 0.001) whereas ARs more frequently screened for hepatitis serology (p = 0.014). As preventive strategies, PRs were significantly more likely to request ophthalmologic examination (p = 0.005). Immunization assessment for meningococcal, measles-mumps-rubella, and varicella vaccines was significantly more common among PRs (p > 0.005, for all).</p><p><strong>Conclusion: </strong>Significant heterogeneity exists between PRs and ARs in systemic corticosteroids practices, highlighting the need for age-specific standardized protocols for dosing, preventive strategies, and complication monitoring. Graphical abstract available for this article.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1173-1190"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148318806","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}
Rheumatology and TherapyPub Date : 2026-06-01Epub Date: 2026-04-12DOI: 10.1007/s40744-026-00845-2
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
{"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":"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":"767-784"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198592/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}