ImmunotherapyPub Date : 2026-10-11DOI: 10.1080/1750743X.2026.2738332
A Dodi, G Mazzaschi, F Pecci, P Tamarozzi, L Moron Dalla Tor, P Bordi, G Iovane, M Manini, M Peroni, F Trentini, S D'agnelli, G Martines, M Pluchino, M Verzè, R Minari, F Perrone, A Leonetti, F Quaini, N Sverzellati, M Tiseo
{"title":"Baseline circulating immunophenotype as a predictor of immune-related adverse events in NSCLC patients treated with immune checkpoint inhibitors.","authors":"A Dodi, G Mazzaschi, F Pecci, P Tamarozzi, L Moron Dalla Tor, P Bordi, G Iovane, M Manini, M Peroni, F Trentini, S D'agnelli, G Martines, M Pluchino, M Verzè, R Minari, F Perrone, A Leonetti, F Quaini, N Sverzellati, M Tiseo","doi":"10.1080/1750743X.2026.2738332","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2738332","url":null,"abstract":"<p><strong>Background: </strong>Immune-related adverse events (irAEs) represent a challenge in non-small cell lung cancer (NSCLC) patients receiving immune checkpoint inhibitors (IO). Baseline circulating immunophenotype may identify patients at increased irAEs risk.</p><p><strong>Methods: </strong>This observational study included patients with advanced NSCLC receiving IO alone or with chemotherapy. Baseline clinicopathological data and blood samples were prospectively analyzed to investigate the association of clinicopathological characteristics, circulating immune cells and cytokines, with irAEs onset, severity, timing, and type.</p><p><strong>Results: </strong>178 patients were included; 52.2% (<i>n</i> = 93) developed irAEs, more frequently involving those with good ECOG PS, first-line treatment, favorable LIPI, higher albumin. These patients showed higher baseline lymphomonocytes and lower CD4<sup>+</sup>CD25<sup>+</sup>Foxp3<sup>+</sup> T cells (<i>p</i> = 0.05 and 0.04, respectively). Logistic regression confirmed lymphocyte enrichment as independently associated and Tregs as protective (<i>p</i> = 0.05 for both). High-grade and early-onset irAEs were associated with increased PD-1+ T and NK cells, cytotoxic/proliferative T-cell markers, and reduced inhibitory signals (i.e. sPD-L1). Distinctive immune profiles outlined gastrointestinal and cutaneous toxicities.</p><p><strong>Conclusions: </strong>Baseline circulating immunophenotype showed exploratory association with irAE risk, severity, timing, and pattern in this setting. No association retained statistical significance after false discovery rate (FDR) adjustment. These findings should be considered hypothesis-generating and require independent external validation.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-15"},"PeriodicalIF":2.3,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Real-world efficacy and safety of neoadjuvant immunochemotherapy in patients with triple-negative breast cancer.","authors":"Ruoxi Xu, Pinchao Fan, Yiqiu Liu, Chengjun Zhu, Dandan Wang, Fang Yang, Xiaoxiang Guan","doi":"10.1080/1750743X.2026.2746875","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2746875","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the real‑world efficacy and safety of adding programmed cell death protein 1 (PD-1) inhibitors to neoadjuvant chemotherapy in Chinese patients with triple‑negative breast cancer (TNBC).</p><p><strong>Patients and methods: </strong>This single-center retrospective study enrolled 218 TNBC patients receiving neoadjuvant therapy, including 116 in the neoadjuvant chemotherapy (NAC) cohort and 102 in the neoadjuvant immunochemotherapy (NAIC) cohort. Clinical, biological, pathological and therapeutic data were collected. Primary endpoints were pathological complete response (pCR) and event-free survival (EFS).</p><p><strong>Results: </strong>Multivariate analysis showed Ki-67 >30% (<i>p</i> = 0.003) and PD-1 inhibitor addition (<i>p</i> < 0.001) were independently associated with higher pCR. NAIC significantly reduced recurrence (7.8% vs. 25.0%, <i>p</i> < 0.001). Miller-Payne grades 2-4 were independent prognostic factors for improved EFS compared with grade 1 (all <i>p</i> < 0.05); grade 5 was excluded due to collinearity with pCR. Except for immune-related adverse events (irAEs), the incidence of other adverse events (AEs) showed no significant differences between the two groups (all <i>p</i> > 0.05).</p><p><strong>Conclusions: </strong>Compared with NAC alone, NAIC significantly improves the pCR rate and reduces the recurrence risk in TNBC patients, with generally manageable toxicity in this real-world cohort, which supports its favorable clinical application value.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-12"},"PeriodicalIF":2.3,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-10-09DOI: 10.1080/1750743X.2026.2744059
Sha Liu, Junjun Lu, Zhaojie Lyu, Zhengmao Lu, Yunmei Liu, Ruiying Zhang, Wentao Xu, Guoping Sun, Yingying Du, Lei Huang
{"title":"Circulating and tumor microenvironment immunomarkers associate with immunotherapy efficacy in advanced bladder urothelial carcinoma: an exploratory multicenter study integrating genomic and immunophenotypic profiling.","authors":"Sha Liu, Junjun Lu, Zhaojie Lyu, Zhengmao Lu, Yunmei Liu, Ruiying Zhang, Wentao Xu, Guoping Sun, Yingying Du, Lei Huang","doi":"10.1080/1750743X.2026.2744059","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2744059","url":null,"abstract":"<p><strong>Aims: </strong>To elucidate the efficacy-predictive values of immunomarkers in both peripheral blood and tumor tissue in patients with advanced bladder-urothelial-carcinoma (aBUC) undergoing first-line immunotherapy.</p><p><strong>Patients and methods: </strong>In previously untreated aBUC, T-cell subclusters and PD-L1 expression were determined using immunohistochemistry, and genetic profiling was conducted using cSMART 2.0 sequencing. Peripheral blood immunomarkers were assessed both at baseline and prior to the second immunotherapy cycle for dynamic analysis.</p><p><strong>Results: </strong>Lower baseline neutrophil-to-lymphocyte ratio (NLR) was associated with better disease-control (<i>p</i> = 0.048) and improved overall survival (<i>p</i> = 0.028), and NLR was an independent predictive factor (HR = 3.40, 95%-CI = 1.10-10.49, <i>p</i> = 0.034). Patients with better disease-control had lower monocyte-to-lymphocyte ratio (MLR) (<i>p</i> = 0.020). An early-decrease in platelet-to-lymphocyte ratio (PLR) at the second immunotherapy-cycle in patients with inferior baseline-PLR was linked to a longer progression-free survival (<i>p</i> = 0.040). Patients with higher NLR at Cycle 1 or 2 of immunotherapy had lower CD8+ lymphocyte level or tumor-mutation-burden (TMB), and those with higher PLR had higher PD-L1 expression in the tumor-microenvironment. A significant negative correlation was identified between NLR and TMB in primary tumors (<i>r</i> = -0.919, <i>p</i> = 0.027).</p><p><strong>Conclusions: </strong>Circulating immunomarkers at baseline and/or second cycle of immunotherapy were linked to the microenvironment immunomarkers, and exploratorily showed associations with disease control and/or survival in aBUC undergoing first-line immunotherapy.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-15"},"PeriodicalIF":2.3,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-10-08DOI: 10.1080/1750743X.2026.2743429
Xiaoyue Ren, Lijie Zhang, Linli Zhou, Shuqi Zhao
{"title":"Liquid-liquid phase separation-related gene can predict prognosis and influence immune microenvironment in acute myeloid leukemia.","authors":"Xiaoyue Ren, Lijie Zhang, Linli Zhou, Shuqi Zhao","doi":"10.1080/1750743X.2026.2743429","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2743429","url":null,"abstract":"<p><strong>Aims: </strong>Acute myeloid leukemia (AML) is a hematopoietic malignant tumor whose growth and metastasis have been found to be closely correlated with Liquid-liquid phase separation (LLPS); however, the molecular mechanisms underlying and the immunological value of LLPS in AML have not been reported.</p><p><strong>Methods: </strong>In this study, we aimed to develop a precise prognostic risk model based on LLPS-associated key genes in AML. We analyzed differentially expressed genes from AML versus control samples (GSE9476), intersected these with LLPS genes to identify differentially expressed LLPS-related genes, and used univariate Cox regression to find those linked to prognosis. Candidate genes were identified by overlapping prognostic differentially expressed LLPS-related genes with inter-subtype differentially expressed genes.</p><p><strong>Results: </strong>We used the least absolute selection and shrinkage operator to pinpoint three key genes-SLC4A1, SCRN1, and HOPX-for the prognostic risk model, which proved effective in assessing AML prognosis. A nomogram incorporating risk score, age, and AML risk category was developed showing promising potential for clinical utility. Immune analysis revealed variations in certain immune cells across risk groups. Drug sensitivity tests highlighted significant differences in the efficacy of several drugs among these groups.</p><p><strong>Conclusion: </strong>This model integrating the three key genes offers a novel insight into AML prognosis prediction.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-13"},"PeriodicalIF":2.3,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-10-08DOI: 10.1080/1750743X.2026.2742742
Yueqi Wang, Siqi Wang, Huijuan Fan, Wenjun Sun, Yanmei Fa, Yuxian Yang, Ronghua Chen, Kang Du, Shanshan Wu
{"title":"Efgartigimod in the treatment of severe Guillain-Barre syndrome with overlapping autoantibody syndrome: a case report and updated clinical review.","authors":"Yueqi Wang, Siqi Wang, Huijuan Fan, Wenjun Sun, Yanmei Fa, Yuxian Yang, Ronghua Chen, Kang Du, Shanshan Wu","doi":"10.1080/1750743X.2026.2742742","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2742742","url":null,"abstract":"<p><p>Guillain-Barre syndrome (GBS) is an immune-mediated acute inflammatory polyradiculoneuropathy, with intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) established as standard first-line treatments. A subset of severe overlapping GBS patients carrying multiple pathogenic anti-ganglioside immunoglobulin G (IgG) antibodies typically exhibits poor therapeutic responses to IVIG. Efgartigimod, a neonatal Fc receptor (FcRn) antagonist, accelerates the clearance of circulating pathogenic IgG, conferring theoretical therapeutic value for IgG-driven autoimmune neurological disorders. Herein, we present a 51-year-old female patient with severe multi-antibody-positive overlapping GBS who failed full-course standard IVIG treatment; sequential salvage Efgartigimod administration induced progressive recovery of limb muscle strength. We further performed a systematic literature review pooling 15 previously published cases of efgartigimod-treated GBS to synthesize global clinical evidence. Our pooled analysis suggests that Efgartigimod could act as a salvage therapeutic candidate for IVIG-refractory severe GBS complicated by multiple anti-ganglioside antibody positivity. Nevertheless, the definitive efficacy and optimal timing of intervention remain to be validated by large‑sample randomized controlled trials.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-7"},"PeriodicalIF":2.3,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-10-04DOI: 10.1080/1750743X.2026.2742727
Xiaohan Hu, Amin Haiderali, Yezhou Sun, Wilbur Pan
{"title":"Real-world utilization of immune checkpoint inhibitors in medicare-eligible patients with triple-negative breast cancer in the United States.","authors":"Xiaohan Hu, Amin Haiderali, Yezhou Sun, Wilbur Pan","doi":"10.1080/1750743X.2026.2742727","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2742727","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to characterize real-world treatment patterns among patients in the United States with triple-negative breast cancer (TNBC) eligible for pembrolizumab treatment, including patients eligible for Medicare (aged ≥65 years).</p><p><strong>Materials and methods: </strong>This retrospective study analyzed treatment utilization among patients with TNBC using two United States (US)-based electronic health record (EHR) databases (Flatiron Health Research Database and N-Power Medicine's Breast Analytical Dataset). Patients were stratified by Medicare insurance status or age ≥65 years. Treatment uptake was analyzed in cohorts of patients with a metastatic diagnosis on or after 1 January 2021, and defined by FDA-approved pembrolizumab indications in TNBC.</p><p><strong>Results: </strong>Overall, 133 patients with metastatic TNBC (mTNBC) and 392 patients with early-stage TNBC (esTNBC) were included; 33.9-39.1% were Medicare-eligible. Programmed Death-Ligand 1 (PD-(L)1) inhibitors were the most used therapy class across all Medicare-eligible cohorts with TNBC (79.0-85.0%). Use of pembrolizumab-containing regimens was observed across TNBC cohorts (77.0-85.0%). Treatment patterns in Medicare-eligible patients were consistent with the overall population.</p><p><strong>Conclusions: </strong>This real-world analysis demonstrates high uptake of PD-(L)1 inhibitors, including pembrolizumab, among Medicare-eligible patients with TNBC. These findings provide real-world insights into how regulatory approvals in TNBC have shaped clinical practice in the US.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-10"},"PeriodicalIF":2.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cost-effectiveness analysis of penpulimab plus anlotinib versus sorafenib as first-line therapy for advanced hepatocellular carcinoma.","authors":"Zhiwei Zheng, Lisheng Huang, Yuling Zhang, Huide Zhu, Ling Fang","doi":"10.1080/1750743X.2026.2743426","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2743426","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to assess the cost-effectiveness of penpulimab plus anlotinib therapy relative to sorafenib for advanced hepatocellular carcinoma (HCC) from the Chinese healthcare system perspective.</p><p><strong>Methods: </strong>The study utilized a partitioned survival model to evaluate the cost-effectiveness of anlotinib plus penpulimab over a 10-year time horizon with a cycle period of 3 weeks for advanced HCC. The cost analysis considered direct costs. The willingness-to-pay (WTP) threshold was set at three times China's 2025 per capita gross domestic product (GDP), amounting to 41,876.05 USD per quality-adjusted life year (QALY). Sensitivity analyses were conducted to assess the impact of parameter variations on the study outcomes.</p><p><strong>Results: </strong>The first-line treatment with penpulimab plus anlotinib resulted in an incremental 0.66 QALYs gained and incremental costs of 39,421.98 USD compared with sorafenib. The combination therapy of penpulimab plus anlotinib was determined to have an incremental cost-effectiveness ratio (ICER) of 59,730.27 USD per QALY. Sensitivity analysis confirmed the robustness of our findings to variations in key parameters.</p><p><strong>Conclusion: </strong>Penpulimab combined with anlotinib is not a cost-effective first-line treatment strategy for patients with advanced HCC relative to sorafenib at the current WTP threshold in China.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-11"},"PeriodicalIF":2.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-10-01DOI: 10.1080/1750743X.2026.2738337
Calogera Claudia Spagnolo, Irene Campo, Elena Fassi, Francesco Nucera, Paolo Ruggeri, Paola Muscolino, Carla Infurna, Antonio Ieni, Vanesa Gregorc, Chiara Lazzari, Mariacarmela Santarpia
{"title":"Beyond PD-L1: emerging clinical and molecular biomarkers of response to immune checkpoint inhibitors in non-small cell lung cancer.","authors":"Calogera Claudia Spagnolo, Irene Campo, Elena Fassi, Francesco Nucera, Paolo Ruggeri, Paola Muscolino, Carla Infurna, Antonio Ieni, Vanesa Gregorc, Chiara Lazzari, Mariacarmela Santarpia","doi":"10.1080/1750743X.2026.2738337","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2738337","url":null,"abstract":"<p><p>Immune checkpoint inhibitors (ICIs) have radically changed the treatment landscape of non-small cell lung cancer (NSCLC) and significantly improved patients' prognosis in many settings of the disease. Nevertheless, clinical outcomes remain highly heterogeneous, and a substantial proportion of patients do not achieve meaningful and/or durable benefit from immunotherapy. This variability in treatment response has highlighted the need to identify more robust predictive biomarkers that integrate, beyond established biomarkers such as programmed cell death ligand 1 (PD-L1) expression, additional clinical, genomic, immunologic, and microenvironmental features to better identify the biological determinants underlying sensitivity and resistance to ICIs. In this review, we will analyze the current evidence supporting established predictive biomarkers, including PD-L1 expression, while highlighting their major limitations. We will also discuss and summarize emerging clinical and molecular biomarkers and integrative predictive approaches aimed at improving the stratification of patients with NSCLC, to identify those most likely to benefit from ICI therapy and ultimately refine personalized treatment strategies.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-20"},"PeriodicalIF":2.3,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ImmunotherapyPub Date : 2026-09-22DOI: 10.1080/1750743X.2026.2735709
Hiroe Suzuki-Chiba, Atsushi Miyawaki
{"title":"Addressing socioeconomic barriers to immunotherapy access for non-small cell lung cancer in Japan.","authors":"Hiroe Suzuki-Chiba, Atsushi Miyawaki","doi":"10.1080/1750743X.2026.2735709","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2735709","url":null,"abstract":"","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-3"},"PeriodicalIF":2.3,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149016471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Injection-based safety of aqueous venom immunotherapy during venom extract shortage: impact of forced depot-to-aqueous switching.","authors":"Gökten Bulut, Rukiye Demiralp, Şefika Karabaş, Fidan Coşkun","doi":"10.1080/1750743X.2026.2722552","DOIUrl":"10.1080/1750743X.2026.2722552","url":null,"abstract":"<p><strong>Background: </strong>Venom immunotherapy (VIT) is the only disease-modifying treatment for Hymenoptera venom allergy. Nationwide shortages of depot venom extracts necessitated transition to aqueous preparations, but real-world safety data on this switch remain limited.</p><p><strong>Objective: </strong>To evaluate the injection-based safety of aqueous VIT and the impact of forced depot-to-aqueous switching on systemic reactions (SRs).</p><p><strong>Methods: </strong>This retrospective single-center cohort included 31 aqueous VIT courses in 30 adults treated between January 2023 and January 2026. Patients initiated aqueous VIT or were compulsorily switched from depot preparations. SRs were assessed at treatment-course and injection levels. Predictors were evaluated using Firth penalized logistic regression.</p><p><strong>Results: </strong>SRs occurred in 10/31 courses (32.3%) and in 28/504 injections (5.6%): 6.3% during buildup and 4.6% during maintenance. Most were mild to moderate, with no Grade 4-5 reactions. Comorbid disease independently predicted SRs (adjusted OR 5.87, 95% CI 1.07-38.42; <i>p</i> = 0.042). Forced switching showed higher odds of SRs but was not independently significant (adjusted OR 6.84, 95% CI 0.84-88.76; <i>p</i> = 0.072).</p><p><strong>Conclusions: </strong>Aqueous VIT remained feasible during the depot extract shortage despite a higher-than-previously-reported SR rate. Comorbid disease predicted SRs, while forced switching may identify patients requiring closer monitoring.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"917-925"},"PeriodicalIF":2.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}