To evaluate the association between the healthy lifestyle score (HLS) and metabolic syndrome (MetS) among Japanese male workers. This cross-sectional study included 940 participants aged 20-63 years. The longitudinal analysis included 744 participants without MetS at baseline who completed at least one follow-up examination between 2013 and 2019. The HLS was derived from ten lifestyle-related factors: body mass index, smoking, alcohol consumption, current physical activity, sleep quality, weight change, meal skipping, snacking, eating speed, and family history of non-communicable diseases. MetS was defined according to the Japanese criteria. In the cross-sectional analysis, multivariable logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for MetS, after adjusting for potential confounders. In the longitudinal analysis, generalized estimating equations were used to estimate ORs and 95% CIs for incident MetS during follow-up per 1-point increase in baseline HLS, with adjustment for potential confounders. In the cross-sectional analysis, HLS was inversely associated with MetS (p < 0.001). Consistent findings were observed in the longitudinal analysis, in which each 1-point increase in baseline HLS was associated with lower odds of MetS during follow-up (OR: 0.676, 95% CI: 0.600-0.762; p < 0.001). These cross-sectional and longitudinal findings suggest that adherence to healthy lifestyle factors may help prevent MetS among Japanese male workers. The online version contains supplementary material available at 10.1007/s40200-026-01985-6.
Plasmalogens (Pls), a subclass of glycerophospholipids, are bioactive lipids that exert neuroprotective functions by mitigating oxidative stress and regulating neuroinflammatory signaling. The depletion of Pls has been strongly implicated in the pathogenesis of neurodegenerative disorders. However, data on the systematic quantification of Pls in dietary and biological sources remain limited. in this study, we comprehensively profiled Pls species in the breast milk of 159 Japanese mothers by LC-MS/MS. Pls concentrations varied significantly with dietary and sociodemographic factors, including age at pregnancy, dietary composition, alcohol intake, gestational duration, and household income. Notably, younger mothers exhibited significantly higher levels of C18-acyl chain Pls species compared with older mothers. Pls concentrations were positively correlated with gestational period, while higher fish consumption increased ω-3 Pls species and decreased ω-6 Pls species in breast milk. This is the first comprehensive study to characterize the relationship between maternal lifestyle determinants and Pls composition in Japanese breast milk.
Gene expression in immune cells varies greatly among healthy individuals and may be influenced by the genetic background, age and other factors. However, the molecular mechanisms underlying immune diversity at the single-cell level are not well understood. Here, we generate a single-cell multi-omics dataset of peripheral blood from 105 Japanese individuals. We focus on age-related changes in cellular populations and gene expression levels. In our dataset, age-associated population changes are most pronounced in naïve T cells, memory B cells, and CD56bright NK cells, which are associated with the initial immune responses of the respective cell lineages. Conversely, monocytes display prominent epigenomic changes that often precede those in the transcriptome, particularly among immune response genes. This dataset, which represents an underrepresented Japanese population in single-cell research, provides an invaluable resource for future studies.
Japanese encephalitis (JE) is a mosquito-borne disease caused by JE virus (JEV) infection, detected for the first time in south-eastern Australia in 2022. In New South Wales (NSW), detections of JEV in mosquitoes and animal hosts, human JE cases, and climate and environmental considerations have informed which areas are considered high risk for JEV and which populations are eligible for vaccination (funded by Australian states and territories). However, early evidence indicates slower-than-expected uptake in these high-risk areas. We aimed to explore how community members and healthcare professionals (HCPs), including general practitioners (GPs), pharmacists, and nurses, perceive and have responded to JEV risk through vaccination and personal mosquito-bite prevention practices. Tamworth is classified as high-risk for JEV by NSW Health. Semi-structured interviews with community participants (n = 15), GPs (n = 7), nurses (n = 3), and pharmacists (n = 3). An interpretative qualitative study. Data were analysed using an inductive thematic approach. Three themes were identified: (1) Risk awareness shaped by experience, not policy: "I didn't realise Tamworth was identified as an area as well, I just was totally unaware," (2) Vaccine eligibility does not translate into uptake: "There isn't really much promotion at the moment," and (3) Building community-level preparedness through communication: "Messaging that the whole community knows about." Despite early public health efforts, awareness of JE and uptake of preventive measures remained limited in a high-risk regional setting. Supporting trusted healthcare providers with clear, consistent communication is critical to optimising JE vaccine uptake.
In bats using CF-FM echolocation calls, CF component frequencies vary among colonies, across geographic regions, and between sexes. In this study, we investigated frequency changes of the second harmonic of the CF component (CF2), which is the dominant harmonic in the multi-harmonic echolocation calls, that occur following the mixed housing of resident and wild-caught populations of greater Japanese horseshoe bats (Rhinolophus nippon). By focusing on individual-level frequency adjustments in the context of colony mixing, we tracked CF2 frequencies in a total of 101 individuals across 15 capture events over a one-month period. CF2 frequencies initially differed between the resident and wild-caught populations. These intergroup frequency differences gradually decreased after mixing, accompanied by a reduction in overall variability within the colony. This convergence was achieved asymmetrically, such that bats with lower CF2 frequencies adjusted their frequencies upward, while bats with higher CF2 frequencies individuals showed little or no change. No systematic changes were observed when initial frequencies did not differ between two groups. Echolocation in group contexts would be expected to suffer from severe acoustic interference caused by overlapping calls from conspecifics; however, CF bats instead tend to converge on a shared CF frequency. Because this convergence was primarily driven by individuals using lower frequencies, it may be interpreted as a strategy to allow individuals to share a "silent spectral window" above the CF2 frequency, which is critical for Doppler-based detection. In other words, for CF bats, in which the use of Doppler information is fundamentally important, frequency convergence may function as a strategy for avoiding acoustic interference.
Multiple studies have revealed a potential role for integrin α4 (ITGA4) in the pathogenesis of SARS-CoV-2/HIV/SIV infection, but its role in flavivirus infection remains elusive. Here, we used Japanese encephalitis virus (JEV) as a model, aiming to dissect the regulatory role of ITGA4 in flavivirus infection. We found that JEV infection activates vitamin A metabolism, which in turn induces the upregulation and activation of ITGA4. ITGA4 triggers cytoskeletal reorganization enhancing early viral replication in monocytes via the ITGA4-HSP70-pFAK-Rac1 signaling axis, and reinforces interactions between immune cells and brain microvascular endothelial cells, reducing the expression of tight junction proteins (ZO-1 and Occludin) and increasing blood-brain barrier permeability, thereby enabling viral neuroinvasion and inflammatory cell infiltration. Genetic knockdown of ITGA4 markedly reduces viral load, mitigates neuronal damage, and improves survival in JEV-infected mice. Moreover, ITGA4 enhances the replication of multiple flaviviruses (JEV, dengue virus serotype 2, Zika virus) in monocytes, highlighting a conserved pro-viral function. Collectively, this is the first report demonstrating that ITGA4 as a pivotal host factor orchestrating flavivirus pathogenesis, uncovering the novel dual mechanism through which ITGA4 links vitamin A metabolism, cytoskeletal remodeling, and blood-brain barrier (BBB) disruption to promote flaviviral neuroinvasion.
The phase 3 SURMOUNT-J clinical trial showed that Japanese adults with obesity disease achieved clinically meaningful body weight loss with once-weekly tirzepatide for 72 weeks. The primary objective of the present study was to explore participants' experiences with tirzepatide during SURMOUNT-J and body weight changes after the trial. Secondary objectives were to explore participant experiences with other weight loss treatments and body weight management after the trial, and to understand the healthcare provider support needs related to obesity disease treatment. This was a cross-sectional, non-interventional, semi-structured, qualitative exit interview study conducted in Japan. Tirzepatide-treated participants in SURMOUNT-J who completed the 72-week study were recruited for this study. Participants completed a web-based interview about their experience during and after SURMOUNT-J. Twenty-nine participants completed the interviews. During SURMOUNT-J, 75.9% of participants experienced appetite loss, 72.4% experienced conscious eating habit changes, 62.1% had positive feelings associated with body weight loss, and 75.9% expressed willingness to continue drug therapy. Additionally, 58.6% experienced joy being able to choose new clothes, and 51.7% experienced lighter body movements. After SURMOUNT-J ended, 51.7% of participants maintained their changes in eating behavior, 44.8% were not able to maintain their changes in exercise/physical activity, and 65.5% experienced poor appetite control. The interviews revealed a potential unmet need to provide information to people with obesity disease and to connect them with appropriate medical interventions. Study participants who received tirzepatide treatment reported that they were able to maintain their changes in eating behaviors but not exercise habits after SURMOUNT-J. Three-quarters of participants expressed a desire to continue drug therapy for obesity disease treatment.
Although pelvic landmarks have traditionally been used to estimate the femoral head center (FC), their reliability may be limited in patients with developmental dysplasia of the hip (DDH). In contrast, femoral-based reference methods have been insufficiently investigated. This study aimed to evaluate the feasibility and clinical utility of estimating the FC location in DDH using a three-dimensional model derived from trochanteric landmarks. We retrospectively analyzed 128 femurs from 84 female patients with DDH (mean age, 36.9 years) who underwent curved periacetabular osteotomy (CPO) from April 1, 2010, to September 30, 2020, and had no symptoms involving the spine or knee. The FC was estimated using multiple regression models based on the three-dimensional coordinates (x, y, and z) of the greater and lesser trochanter tips. Differences between the estimated and actual FC positions were assessed along all three axes. Correlation coefficients between the estimated and actual FC ranged from 0.725 to 0.875 across the three directions. The mean absolute error was 2-3 mm, with greater errors observed in the anteroposterior direction than in the craniocaudal direction. An estimation error within 3 mm may be considered relatively small in the context of clinically acceptable ranges reported in previous studies for restoring femoral offset and leg length during total hip arthroplasty (THA), supporting the practical applicability of this method in preoperative planning. The accuracy of the present approach was comparable to that reported in healthy populations and exceeded that of previous pelvic landmark-based regression techniques. This trochanter-based three-dimensional method enables clinically acceptable estimation of the FC in patients with DDH and may serve as a useful adjunct for planning of the femoral component when the native FC is difficult to identify.
This paper aims to promote international collaboration among air medical organizations and provide an overview of the Japanese Society for Aeromedical Services (JSAS) Annual Congress. In 2025, the 32nd Annual Congress of the JSAS was held in Numazu City from November 13 to 15 under the theme "Toward a Shared Vision: A New Era in Aeromedical Care." The congress included 220 presentations and was attended by 980 participants. It remains the only national conference in Japan dedicated exclusively to air medical care. The meeting provided a comprehensive overview of current air medical services and future directions. Key topics included the status of helicopter emergency medical services in Europe, lifesaving cases involving Japan's doctor-helicopter (DH) system, helicopter underwater escape training, international air medical evacuation, and operations of the US Air Force Critical Care Air Transport Team. Sessions also addressed challenges related to prehospital blood product administration, ventilator requirements, safety management, and aircraft maintenance systems. Additional discussions focused on the standardization of clinical protocols, dispatch criteria, and flight physician education, as well as the development of quality indicators through multidisciplinary collaboration. The program further highlighted nationwide public awareness initiatives, nursing practices in air medical settings, responses to large-scale disasters, activities of related organizations, and international air medical evacuation. We believe that the face-to-face relationships fostered through the JSAS Annual Congress play a vital role in strengthening collaboration among DH teams and other aerospace-related organizations.
To determine a cutoff score for the Social Connectivity of Mothers with People in the Community Scale (SCMPCS) and revalidate the scale using additional psychosocial indicators. A cross-sectional analysis used baseline data from one arm of a randomized trial including 259 mothers with children under 3 years of age in Sapporo City, Japan. Reliability and structural validity were reassessed using Cronbach's alpha and confirmatory factor analysis. Parenting isolation was operationally defined as the absence of support from informal, community-based, and formal sources and used as the reference classification for ROC analysis. Predictive validity was examined using logistic regression adjusted for maternal age, educational attainment, daycare use, and perceived economic status. Criterion-related validity was evaluated using Mann-Whitney U tests. The SCMPCS showed good internal consistency (α = 0.85) and acceptable model fit (CFI = 0.90, RMSEA = 0.073). ROC analysis identified a cutoff of 30 or lower with moderate discriminatory ability (AUC = 0.73; sensitivity = 0.92; specificity = 0.50). Mothers at or below the cutoff had higher odds of meeting the operational reference classification of parenting isolation (OR = 11.94, 95% CI: 2.74-52.03) and reported lower self-efficacy and capacity to receive support, greater loneliness, and poorer well-being. The SCMPCS demonstrated stable psychometric performance, and the validated cutoff may support broad preventive screening to identify mothers who may need further assessment and early follow-up. Rather than serving as a diagnostic threshold, this cutoff may help maternal and child health services provide timely preventive support.
The doses of lenvatinib for patients with hepatocellular carcinoma (HCC) are determined using the Child-Pugh classification and body weight. Because lenvatinib is highly bound to plasma albumin (98.6%), patients with low plasma albumin levels and hepatic lenvatinib clearance may exhibit a high unbound fraction and/or concentration of lenvatinib in the plasma to alter efficacy and toxicity. This study exploratorily and prospectively examined the effects of baseline albumin-bilirubin (ALBI) on systemic exposure to unbound lenvatinib and lenvatinib clinical responses in patients with HCC. Patients with HCC who received lenvatinib were enrolled. Total- and unbound-base dose-normalized area under the plasma concentration-time curve (AUCt/dose and AUCu/dose, respectively) were determined. Progression-free survival (PFS) and toxicities were evaluated. Forty-one patients were enrolled between May 2020 and January 2024. AUCu/dose, but not AUCt/dose, was significantly negatively correlated with ALBI score (P = 0.00699). Patients with ALBI grade ≥ 2b had significantly higher AUCu/dose than those with < 2b (mean ± SD, 0.00602 ± 0.00268 vs. 0.00390 ± 0.00168 h/L, P = 0.0131). Child-Pugh class was associated with AUCu/dose (P = 0.0312); however, among Child-Pugh classification components, albumin only was associated with the AUCu/dose. Multivariate Cox proportional hazards analysis identified ALBI grade ≥ 2b as risk factor for shorter PFS (P = 0.0000521; hazard ratio 9.43; 95% confidence interval 3.18-28.0). ALBI grade ≥ 2b, but not Child-Pugh class, showed a significantly higher incidence of lenvatinib-induced toxicity grades ≥ 2 than ALBI grade < 2b (87.0 vs. 55.6%, P = 0.0357). The study exploratorily found that baseline ALBI grade was associated with lenvatinib AUCu/dose and clinical responses. UMIN000057138 (registered on February 27, 2025).
As the life expectancy of individuals with hemophilia increases, arterial thrombotic disease has emerged as an important clinical issue. Accurate risk stratification for primary prevention is increasingly critical, since managing arterial events is complex in hemophilia owing to bleeding risk. However, current prospective data on event incidence and risk prediction for hemophilia remain limited. We analyzed 5-year follow-up data from ADVANCE Japan-a nationwide prospective registry of Japanese adults aged ≥40 years with hemophilia. Participants with prior arterial thrombosis were excluded. Five-year arterial event risk was estimated using the Hisayama model, the Suita score, and QRISK3. Model performance was evaluated using sensitivity, specificity, and observed-to-expected event comparisons. Among the 599 participants (median age: 59 years; 83% hemophilia A, 63% severe disease), 28 first arterial events occurred over 5 years (4.67%). The sensitivity and specificity for identifying events were 70.5% and 68.0% for the Hisayama model, 73.3% and 61.2% for the Suita score, and 71.4% and 57.7% for QRISK3, respectively. The observed incidence was 2.93 events per 100 participants over 5 years, closely matching predictions by the Hisayama model and Suita score, whereas QRISK3 substantially overestimated the risk. Incorporating hemophilia-related clinical factors did not improve predictive performance beyond established scores. Arterial event incidence in Japanese adults with hemophilia was comparable to that expected in the Japanese general population. The Japanese population-based risk models-the Hisayama model-may support the development of primary prevention strategies for Japanese adults with hemophilia. This trial was registered with the Japan Registry of Clinical Trials (jRCT1030190046).
The FIGO scoring system is a well-established method for classifying patients with gestational trophoblastic neoplasia (GTN) worldwide, and the Japanese scoring system is widely employed in Japan. This study aimed to evaluate the clinical outcomes of de-escalated chemotherapy in patients with high-risk GTN, classified as "clinical invasive mole" according to the Japanese scoring system. We retrospectively reviewed 268 patients with GTN who received initial treatment at Nagoya University Hospital between 1991 and 2023. All patients were assessed using the FIGO and Japanese scoring systems, and treatment strategies were determined primarily based on histopathological diagnosis and subsequently guided by the Japanese scoring system. Clinical features and treatment outcomes were analyzed. Among 268 patients, 49 were classified as having high-risk GTN. All patients with FIGO scores of ≥ 9 were classified as "clinical choriocarcinoma" by the Japanese scoring system. In contrast, 17 patients with FIGO scores of 7-8 were divided into the invasive mole group (n = 7) and the choriocarcinoma group (n = 10). All patients in the invasive mole group received de-escalated chemotherapy and achieved complete remission. The proportions of patients with age ≥ 40 years (p = 0.046), antecedent hydatidiform mole (p = 0.021), shorter interval from index pregnancy (p = 0.002), and larger tumor size (p = 0.003) were significantly higher in the invasive mole group than in the choriocarcinoma group. De-escalated chemotherapy may be feasible for select patients with FIGO scores of 7-8, and further refinement of risk stratification is warranted to avoid overtreatment.
Multigene panel testing has become an important component of hereditary cancer evaluation in Western practice. This shift has been driven by advances in next-generation sequencing, declining costs, and the increasing relevance of germline findings to treatment, surveillance, prevention, and cascade testing. In Japan, publication of The Japanese Society for Hereditary Tumors Guidance: Hereditary Cancer Syndromes with Multigene Panel Testing, 2025 Edition provided a timely framework for reconsidering how Western experience should inform domestic implementation. Evidence from the United States and Europe has fostered the view that multigene panel testing has replaced sequential single-gene testing as a first-line approach because of its broader diagnostic yield and growing use in routine care. However, broader detection does not automatically translate into broader clinical benefit. Multigene panel testing is most valuable when the pathogenic variants detected are sufficiently prevalent, highly penetrant, and linked to established surveillance, risk-reducing surgery, targeted therapy, or cascade testing. Broader panels may also increase variants of uncertain significance, psychological burden, and unnecessary management. This review examines why multigene panel testing came to be seen as a first-line approach, distinguishes diagnostic yield from meaningful clinical utility, and considers why Western adoption should inform Japanese practice not as a mandate for indiscriminate expansion, but as support for phased, quality-assured, utility-oriented integration.
Respiratory syncytial virus (RSV) remains a leading cause of medically attended lower respiratory tract disease (MA-LRTD) among infants in Japan. With the approval of maternal immunization (MI) and nirsevimab, a long-acting monoclonal antibody for infant RSV prevention, Japan is transitioning from high-risk - targeted prophylaxis toward broader RSV prevention. This study evaluated the public health and economic impact of alternative MI and nirsevimab strategies within the Japanese National Immunization Program (NIP). A static decision-analytic cohort model, estimated clinical and economic outcomes from birth through the first year of life (and the second RSV season for eligible high-risk infants). Strategies included an NIP-aligned scenario reflecting expected MI and nirsevimab, mixed nirsevimab - MI coverage scenarios (20/80, 50/50, 80/20), and a nirsevimab-only strategy. Outcomes included MA-LRTDs, hospitalizations, costs, quality-adjusted life-years (QALYs), and number needed to immunize (NNI) from payer and societal perspectives. Compared with the NIP-aligned scenario, shifting coverage toward greater nirsevimab use reduced MA-LRTDs by 9.6% to 28.1%. A nirsevimab-only strategy reduced MA-LRTDs by 34.3% and hospitalizations by 33.4%. Under base-case assumptions, strategies with greater nirsevimab use improved outcomes and reduced costs, with lower NNI as coverage increased. Findings were robust in sensitivity analyses. For the Japanese setting, greater nirsevimab use improves outcomes and reduces costs, with nirsevimab-only strategies providing the greatest overall benefit.
Linguistic abnormalities in schizophrenia (SCZ) span morphological, syntactic, semantic, and discourse levels. Converging cross-linguistic evidence suggests that SCZ may involve semantic narrowing alongside reduced syntactic differentiation, yet how these changes co-occur across linguistic domains and whether they represent core, task-general disturbances remains unclear. We applied a multilevel NLP framework to a large Japanese dataset to identify structurally related linguistic markers of SCZ across elicitation contexts. Speech from 104 patients with SCZ and 101 healthy controls was collected through semi-structured interviews. Transcripts from free conversation, storytelling, and picture description were analyzed using GiNZA, Word2Vec, TF-IDF, and SentenceBERT to extract 76 morphosyntactic, semantic, and discourse features. Factor analysis identified representative features independent of diagnosis, which were tested using generalized estimating equations and validated with bootstrap and permutation procedures. Cross-task stability was examined to determine core linguistic markers. In free conversation, reduced Case-particle (Kakujoshi) and Adverb use and increased Mean Pairwise Word Similarity were strongly associated with SCZ (AUC = 0.87, 95% CI: 0.74-0.97). Adverbial, case-particle, and semantic-network measures functioned as cross-task markers. SCZ involves multidimensional language disturbances characterized by a tripartite linguistic phenotype of diminished morphosyntactic explicitness, semantic narrowing, and reduced modification-based contextual modulation in spontaneous discourse. Extending cross-linguistic evidence, our results indicate that lexical-semantic contraction co-occurs with reduced overt marking of argument relations in Japanese, alongside weakened adverbial elaboration and framing - suggesting convergent, largely task-general dimensions of SCZ language pathology, most evident in free conversation.
This study investigated key-press responses to five spoken Japanese vowels: [ɑ], [i], [ɯ], [e], and [o]. In the first experiment, 30 participants pushed only a single key when they listened to spoken Japanese vowels (response task). In the second experiment, another 29 participants matched the heard vowels with represented vowels by pushing one of five corresponding keys (matching task). The results of the first experiment showed no difference in the response times to the five vowels. In the second experiment, the response times to [i] and [e] were faster than those to [ɯ] and [o]. These results suggest that front vowels promote faster key-press responses than back vowels when the keys corresponding to the heard vowels are consciously selected.
Background Pain Science Education (PSE) aims to improve patients' understanding of pain based on modern pain science, empowering informed care choices and supporting better health outcomes and has demonstrated effectiveness in chronic musculoskeletal conditions. The Knowledge and Attitudes of Pain (KNAP) questionnaire was developed to assess the knowledge and attitudes about pain science in physical therapy students undergoing PSE. In 2022, a Japanese-language version was created that is comprehensible to university students without specialized knowledge of pain. The KNAP is expected to assess changes in patients' knowledge of pain science and attitudes toward pain among those receiving PSE, but its measurement error in patient populations remains unclear. This study aimed to determine the smallest detectable change (SDC) of the Japanese KNAP among female teleworkers with chronic neck/shoulder stiffness, a population with high levels of presenteeism. Methodology This test-retest reliability study was conducted alongside a randomized controlled trial involving female teleworkers with presenteeism related to neck/shoulder stiffness. Participants who completed the final one-year follow-up and who still had neck/shoulder stiffness were invited. The KNAP was administered via a web-based survey twice, with a one-week interval. The SDC was calculated using the intraclass correlation coefficient. Results A total of 101 participants completed two surveys. The mean KNAP total score was 75.6 (standard deviation (SD) 3.7). The SDC was 6.5.  Conclusion The KNAP demonstrated a smallest detectable change of 6.5 points in female teleworkers with chronic neck/shoulder stiffness, indicating the threshold for changes beyond measurement error at the individual level. This finding contributes to the interpretability of the KNAP and may assist in evaluating changes over time, although the clinical importance of such changes remains to be established.
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. 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. 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. The study is registered with the Japan Registry of Clinical Trials (jRCT1031250749).
The aim of this study was to evaluate the clinical outcomes of arthroscopic rotator cuff repair (ARCR) in which intratendinous tears (ITTs) were converted to full-thickness tears and repaired via the suture-bridge technique. Partial-thickness ITTs that were refractory for more than 6 months to conservative treatment were surgically treated using a radiofrequency device to convert the ITTs into full-thickness tears, which were subsequently repaired via the suture-bridge technique. The evaluation parameters included shoulder range of motion (forward elevation and external rotation), Japanese Orthopaedic Association (JOA) scores, Constant-Murley scores, University of California at Los Angeles (UCLA) scores, American Shoulder and Elbow Surgeons (ASES) scores, and retear rates (Sugaya classifications IV and V). Twenty-one patients (8 males, 13 females; mean age: 55.3 ± 14.7 years) out of 25 diagnosed with isolated ITT completed at least 12 months of follow-up after surgery. Significant improvements were observed in the shoulder range of motion (139.5 ± 31.4° preoperatively to 164.5 ± 12.8° postoperatively), external rotation (45.8 ± 15.1° to 54.1 ± 14.7°), and clinical scores including the JOA score (64.4 ± 15.0 to 91.9 ± 7.2), Constant-Murley score (49.1 ± 18.7 to 81.9 ± 16.6), UCLA score (18.1 ± 5.2 to 30.4 ± 6.1), and ASES score (46.9 ± 28.8 to 91.3 ± 9.8). No re-tears were observed (0%). There is no consensus on the optimal surgical approach for ITT. This study demonstrated the favorable clinical outcomes of ARCR via the suture-bridge technique after conversion of ITT to full-thickness tears. Level Ⅳ, retrospective cohort study.