Drugs - Real World Outcomes最新文献

{"title":"Real-World Effectiveness and Safety of Ofatumumab in Relapsing Multiple Sclerosis: Comparison of Treatment-Naïve Patients and Switchers in a Multicenter Cohort.","authors":"Vincenzo Mangialardi, Giuseppe Macchitella, Rita Vitobello, Antonella Teofilo, Nicola Cavalli, Caterina Lapucci, Marco Vercellino, Elisa Idini, Jessica Frau, Pietro Iaffaldano, Paola Cavalla, Matilde M Inglese, Eleonora Cocco, Damiano Paolicelli","doi":"10.1007/s40801-026-00558-6","DOIUrl":"10.1007/s40801-026-00558-6","url":null,"abstract":"<p><strong>Background: </strong>Ofatumumab (OFA) is a fully human anti-CD20 monoclonal antibody approved for the treatment of relapsing multiple sclerosis (RMS). Real-world data on its effectiveness and safety remain limited.</p><p><strong>Objective: </strong>To assess the effectiveness and safety of OFA in a large Italian RMS cohort and to examine the impact of prior treatment exposure on clinical, radiological, and safety outcomes in routine clinical practice.</p><p><strong>Methods: </strong>This retrospective, multicenter study included adults with RMS who initiated OFA and had at least one follow-up visit. Patients were classified as treatment-naïve, switching from moderate-efficacy therapies (MET), or switching from high-efficacy therapies (HET). Outcomes included annualized relapse rate (ARR), magnetic resonance imaging (MRI) activity, disability measures (including confirmed disability worsening and improvement), no evidence of disease activity (NEDA-3), and adverse events (AEs).</p><p><strong>Results: </strong>A total of 424 patients were analyzed, with a mean follow-up of 1.32 (± 0.61) years: 101 (23.8%) treatment-naïve and 323 (76.2%) switchers, of whom 113 were previously treated with MET and 210 with HET. During treatment, ARR decreased significantly from 0.486 to 0.027 (94.5% reduction; p < 0.001), with comparable relative reduction observed across all subgroups. MRI activity was significantly diminished, and at 12 months, 79.3% of evaluable patients achieved NEDA-3, with no significant differences between naïve, MET, and HET subgroups. Overall, OFA was well tolerated, with predominantly mild injection-related reactions and low discontinuation rates, mainly related to pregnancy planning with favorable outcomes. Infections were the only safety outcome that differed significantly among groups, occurring in 0.9% of naïve patients, 1.7% of MET switchers, and 9.5% of HET switchers (p = 0.001). Prior exposure to HET was the only independent predictor of infections.</p><p><strong>Conclusions: </strong>These findings support OFA as an effective and generally safe option for RMS across various treatment sequences, while suggesting enhanced infection monitoring in patients switching from HETs.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"279-287"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148137029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence, Clinical Characteristics, and Factors Associated with Capecitabine-Induced Hand-Foot Syndrome in Patients with Cancer: Evidence from Sudan.","authors":"Ola K Obeid, Bashir A Yousef, Yousif B Hamadalneel, Mawahib A Mustafa, Amani Abdelaziz Mahmoud, Elkhanssa Abdelhameed Ahmed Elhag","doi":"10.1007/s40801-026-00549-7","DOIUrl":"10.1007/s40801-026-00549-7","url":null,"abstract":"<p><strong>Background: </strong>Hand‒foot syndrome (HFS) is a common cutaneous toxicity of capecitabine that can impair treatment continuity and quality of life. This study aimed to assess the prevalence, clinical characteristics, and factors associated with capecitabine-induced HFS.</p><p><strong>Methods: </strong>A cross-sectional analytical study was conducted at Khartoum Oncology Hospital, Sudan (June-October 2022), among adult patients with cancer receiving capecitabine monotherapy. Hand‒foot syndrome was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events and a modified Black Patient Scale. Multivariable logistic regression was used to identify factors associated with HFS, with adjusted odds ratios (aORs) and 95% confidence intervals (CIs) reported. Data analysis was performed using SPSS version 27.</p><p><strong>Results: </strong>A total of 135 patients were included in the analysis, 90 (66.7%) of whom were female and 52 (38.5%) were aged 56-70 years. The most common cancer type was breast cancer (n = 56) [41.5%]. The overall prevalence of HFS was 74 (54.8%), with 37 (50.0%) involving the hands only and 28 (37.8%) involving both the hands and feet. Onset occurred within 7-21 days in 47 (63.5%) patients. Pain was reported by 41 (30.4%), predominantly moderate by 20 (48.8). Grade I was the most frequent by National Cancer Institute criteria (n = 33) [44.5%] and the Black Patient Scale (n = 33) [44.5%]. Hand‒foot syndrome was more prevalent in female patients (n = 58) [64.4%, p = 0.001], patients with breast cancer (n = 35) [62.5%] (p = 0.049), and those receiving > 6 cycles (n = 6) [75%] (p = 0.006). After adjustment, female sex (aOR = 0.224, 95% CI 0.074-0.681; p = 0.008), patients without concomitant diseases (aOR = 2.389, 95% CI 1.011-5.646; p = 0.047), and patients receiving 4-6 cycles compared with those receiving 1-3 cycles (aOR = 0.359, 95% CI 0.155-0.828; p = 0.016) were independent predictors.</p><p><strong>Conclusions: </strong>Capecitabine-induced HFS affects more than half of patients and generally occurs early in onset. After adjustment, female patients and those who received 4-6 chemotherapy cycles were less likely to experience HFS, whereas the absence of concomitant diseases was associated with a greater likelihood of developing HFS. Early monitoring and proactive supportive care remain essential to optimize treatment continuity.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"299-306"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disease Burden in Transfusion-Dependent β-Thalassemia (TDT) Patients and Caregivers in Italy: Results of a Cross-Sectional Descriptive Online Survey.","authors":"Marcella Contieri, Francesca Gatta, Maria Colonnese, Annamaria Pasanisi, Filomena Longo, Giovanni Battista Ferrero, Antonio Giulio Piga, Roberto Lisi, Domenico Roberti, Chiara Baiano, Gabriella Santangelo, Angelo Perrotta, Gelsomina Simeone, Silverio Perrotta, Immacolata Tartaglione","doi":"10.1007/s40801-026-00545-x","DOIUrl":"10.1007/s40801-026-00545-x","url":null,"abstract":"<p><strong>Background: </strong>Patients with transfusion-dependent thalassemia (TDT) require lifelong blood transfusions; data on the psychosocial and economic impact on patients and their caregivers remain limited. The study aims to address this gap by describing the burden of TDT on pediatric, young, and adult patients, as well as their caregivers, within real-world settings in Italy.</p><p><strong>Methodology: </strong>This is a cross-sectional, descriptive study conducted between May and December 2021. TDT patients and their caregivers from Italian sites were invited to complete an online survey with the Ratip and Modell questionnaire (1996) and another bespoke questionnaire. All subjects signed an online informed consent before responding to the questionnaires.</p><p><strong>Results: </strong>Seventy-nine subjects completed the survey: 59 patients (43 adults and 16 children) and 20 caregivers (the majority of adult patients were aged 41-50 years). The age at diagnosis differed between adults and pediatric patients, being earlier in the latter (0-2 months in 43.8%). Nearly half of patients received more than one transfusion/month. More than half of the patients experienced blood shortages, particularly during the summer. School absenteeism was reported as a major issue.</p><p><strong>Conclusion: </strong>TDT continues to impose a significant burden, negatively impacting daily life, work, education, and social interactions. The availability of blood resources remains a critical issue, particularly in high-prevalence regions. The study highlights the need for ongoing research, innovative approaches, and enhanced support to ensure improved well-being for TDT patients and their caregivers.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"289-298"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147527762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient‑Reported Satisfaction in Relapsing-Remitting Multiple Sclerosis: Advantages of At‑Home Self‑Administered Subcutaneous Ofatumumab Versus Other High‑Efficacy Therapies.","authors":"Francesco Pastore, Emanuela Domenicone, Patrizia DellOro, Charlotte Lefort","doi":"10.1007/s40801-026-00553-x","DOIUrl":"10.1007/s40801-026-00553-x","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis is an immune-mediated disorder characterized by demyelination and neurodegeneration. Disease-modifying therapies are available with a range of mechanisms of action, efficacies, safety profiles, places and routes of administration, and degrees of patient autonomy; however, comprehensive evaluations of satisfaction with high-efficacy therapies in patients with multiple sclerosis are lacking.</p><p><strong>Objective: </strong>We aimed to evaluate satisfaction of patients treated with high-efficacy therapies for relapsing-remitting multiple sclerosis and identify factors influencing preferences and acceptance, focusing on the perceived impact of administration routes on quality of life, daily activities, and treatment burden.</p><p><strong>Methods: </strong>We conducted a cross-sectional survey of 208 adults diagnosed with relapsing-remitting multiple sclerosis who were receiving high-efficacy therapies for at least 6 months between February and April 2025 at Italian MS centers. Data were collected using a structured questionnaire designed for this study. Domains included: (I) Temporal and Organizational Burden of Therapy, (II) Perceived Impact of Therapy, (III) Therapy Administration Experience, and (IV) Decision-Making Involvement Experience.</p><p><strong>Results: </strong>A non-parametric analysis revealed that more favorable scores on the domains of (I) Temporal and Organizational Burden of Therapy, (II) Perceived Impact of Therapy, and (III) Therapy Administration Experience were associated with treatment with subcutaneous ofatumumab (n = 90), compared to the other high-efficacy therapies such as natalizumab (n = 55), ocrelizumab (n = 59), and alemtuzumab (n = 4) [all n = 118, p < 0.001]. Fewer than one in four patients recalled being offered the possibility of self-administering high-efficacy therapies at home.</p><p><strong>Conclusions: </strong>Subcutaneous ofatumumab treatment, a therapy self-administered at home, was associated with more favorable experiences compared to other high-efficacy therapies, highlighting the importance of shared decision making and organizational and logistical factors when selecting therapies for multiple sclerosis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"241-252"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component.","authors":"Sandesh Sahebrao Patil, Brijesh Jerambhai Patel, Bhavsar Neel Mahendrabhai, C L Nawal, B Valya, K Sanjeev Kumar, Pandurang Wattamwar, Rana Kaushikkumar Ramanlal, Swagat Shah, Mandodari Rajurkar, Supriya Sonowal, Dipak Patil, Pravin Ghadge, Suyog Mehta","doi":"10.1007/s40801-026-00543-z","DOIUrl":"10.1007/s40801-026-00543-z","url":null,"abstract":"<p><strong>Background and objective: </strong>Nearly two-thirds of patients with acute low back pain progress to chronic low back pain (CLBP). It is likely to be due to the involvement of both nociceptive and neuropathic pain mechanisms. Therefore, this study evaluated the safety and effectiveness of a fixed-dose combination (FDC) of pregabalin prolonged release (PR) and etoricoxib in patients with CLBP with a neuropathic component.</p><p><strong>Methods: </strong>This single-arm, phase IV study was conducted at nine hospitals across India. Patients with CLBP received an FDC of pregabalin PR 75 mg and etoricoxib 60 mg. The primary endpoint was safety, evaluated by the incidence of adverse events (AEs) and serious AEs. The secondary endpoint was effectiveness, assessed by change in the numeric rating scale (NRS), Roland-Morris Disability Questionnaire (RDQ) and visual analog scale (VAS) scores, and proportion of patients using rescue medication.</p><p><strong>Results: </strong>Of 231 screened patients, 185 met eligibility criteria and were enrolled. During the 8-week study, four patients were lost to follow-up, and one withdrew consent. Out of the 19 AEs reported, 18 were treatment-emergent AEs (TEAEs), which occurred in 13 (7.18%) patients. Dizziness, cough, pruritus, and rash were the most common TEAEs. All TEAEs were mild or moderate, and no serious TEAEs or discontinuations due to TEAEs occurred in the study. Statistically significant improvements were observed at week 8 compared with baseline in NRS scores (- 3.4 ± 1.69; p < 0.0001), RDQ scores (- 7.3 ± 3.42; p < 0.0001), and VAS scores (- 32.1 ± 15.33; p < 0.0001). The need for rescue medication decreased over time, with only 34 (18.89%) patients requiring it at week 8 compared with 121 (66.85%) at baseline.</p><p><strong>Conclusion: </strong>The FDC of pregabalin PR and etoricoxib was found to be safe, well tolerated, and effective in reducing pain intensity and improving quality of life in patients with CLBP with a neuropathic component. Thus, this FDC can be a potential alternative for managing CLBP with a neuropathic component.</p><p><strong>Trial registration number: </strong>CTRI/2022/05/042521 [Registered on: May 12, 2022] https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njg1ODg=&Enc=&userName.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"307-316"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147431500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First Real-World Data of Olaparib Combination Treatment with Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC): Descriptive Analysis of 154 Patients Enrolled in the Early Access Program in France.","authors":"Louis Marie Dourthe, Aline Guillot, Cécile Vassal, Eyad Kazan, David Coeffic, Christine Rebischung, Delphine Suau, Amir Lahouegue, Sofia Aboulabbes, Amélie Falabrègues, Hassiba Ould Lahsen","doi":"10.1007/s40801-026-00551-z","DOIUrl":"10.1007/s40801-026-00551-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Olaparib, a poly ADP-ribose polymerase inhibitor, was approved by the European Commission in December 2022 and for which the Health for technology Assessment (HtA body) issued a favorable opinion for reimbursement in France on 5 April, 2023, following the results of the PROpel phase III clinical trial, for the first-line treatment of metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone in adult men for whom chemotherapy is not clinically indicated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This publication aimed to report the first real-world data of patients with metastatic castration-resistant prostate cancer who received a combination of first-line olaparib with abiraterone, plus prednisone or prednisolone in the funded Early Access (fEA) for olaparib in France, from 30 March, 2023, to 25 September, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Eligible patients were adult men with first-line metastatic castration-resistant prostate cancer. Olaparib 300-mg twice-daily tablets was given in combination with abiraterone plus prednisone or prednisolone regardless of the homologous recombination repair gene mutation status. Characteristics of the population, treatment duration, reasons for discontinuation, and safety data were collected during the fEA period. Patients could continue to receive olaparib after the end of the fEA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 84 physicians spread over 72 hospitals in metropolitan France requested a fEA for 176 patients, 154 (87.5%) of whom were eligible to be included in the early access program. In total, 118 (76.6%) patients had an unknown homologous recombination repair status. Half of the patients (76, 49.7%) had very aggressive cancer with a Gleason score of 8 while 11 (7.2%) of them had a low-grade cancer with a Gleason score of 6 at the diagnosis. The most common metastatic sites were bone (107 patients, 69.5%) and distant (60, 39.0%) or regional (42, 27.3%) lymph nodes. Among the 154 patients, 84 (54.5%) had medical history, 47 (56.0%) of whom had arterial hypertension. All included patients had received at least one prior treatment prior to the metastatic castration resistance stage. Most patients (145, 94.2%) had received androgen suppression and 70 (45.5%) had been treated with androgen receptor pathway inhibitors. Of the 154 patients, 153 (99.4%) had at least one concomitant treatment with abiraterone and prednisone or prednisolone. Data confirming administration of olaparib treatment were provided for 149 patients (exposed patients), of whom 140 (94.0%) received olaparib at initiation at the dose of 300 mg twice daily. Fifty-seven patients experienced a total of 60 adverse events (36 serious adverse events and 24 non-serious adverse events). Over this period, three fatal and five life-threatening events were reported. The three fatal adverse events were one death assessed as a suspected adverse reaction (pancytopenia) ","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"211-224"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From Genomic Testing to Olaparib Treatment: Real-World Utilization and Outcomes in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.","authors":"Dianne Bosch, Kim J M van der Velden, Aart Beeker, Hendrik P van den Berg, André M Bergman, Maarten J van der Doelen, Alfons J M van den Eertwegh, Mathijs P Hendriks, Thomas M A Kerkhofs, Addy C M van de Luijtgaarden, Niven Mehra, Reindert J A van Moorselaar, Metin Tascilar, Walter L Vervenne, Nir I Weijl, Carin A Uyl-de Groot, Peter F A Mulders, Malou C P Kuppen, Inge M van Oort","doi":"10.1007/s40801-026-00548-8","DOIUrl":"10.1007/s40801-026-00548-8","url":null,"abstract":"<p><strong>Background: </strong>In November 2020, olaparib became the first approved poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi) for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations (BRCAm) in the Netherlands. As randomized clinical trials include fitter patients, their findings may not fully reflect real-world outcomes.</p><p><strong>Objective: </strong>The aim was to evaluate genomic testing practice and subsequent use and outcomes of olaparib monotherapy in a real-world BRCAm mCRPC population.</p><p><strong>Methods: </strong>Data were derived from ten hospitals in the Dutch CAPRI-3 registry, including mCRPC patients diagnosed between 2016 and 2021. Those receiving olaparib in standard-of-care treatment after its national approval (from November 2020) were analyzed and grouped as taxane-naïve (TN) or post-taxane (PT). The primary endpoint was overall survival (OS).</p><p><strong>Results: </strong>Among 1996 mCRPC patients, genomic analysis (somatic and/or germline) was performed in 23.4% (range 3.8-63.2% across hospitals), identifying BRCAm in 11.3% of patients. Tested patients differed significantly in age, comorbidities, and prior treatment. Among 35 eligible BRCAm patients, 27 (77.1%) received olaparib. TN patients (8/27) were significantly older and initiated olaparib at an earlier line of therapy. Median OS was 28.7 months (95% confidence interval (CI) not reached) in TN versus 10.5 months (95% CI 9.6-11.5) in PT patients (p = 0.003). Limitations include the retrospective design and small subgroups.</p><p><strong>Conclusions: </strong>Genomic testing application remained limited and uneven across centers. Most eligible patients received olaparib; TN patients seemed to benefit most.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"183-192"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Effectiveness of Intravenous Belimumab in Patients with Systemic Lupus Erythematosus in South Korea: A Multicentre, Observational, Real-World Study.","authors":"Sang-Bae Yoo, Jung-Eun Cho, Da-Jung Baek, Eun-Bin Lee, Sung-Hwan Park, Sang-Hyon Kim, Eun Young Lee, Yeon-Ah Lee, Sang-Cheol Bae","doi":"10.1007/s40801-026-00556-8","DOIUrl":"10.1007/s40801-026-00556-8","url":null,"abstract":"<p><strong>Background: </strong>In South Korea, belimumab is indicated for patients with systemic lupus erythematosus (SLE), including paediatric patients aged ≥ 5 years, and for adults with lupus nephritis, based on clinical trial evidence; however, real-world data in this population remain limited.</p><p><strong>Objective: </strong>To assess the real-world safety and effectiveness of intravenous (IV) belimumab administered in patients with SLE in South Korea.</p><p><strong>Methods: </strong>This observational study (GSK Study 216984) enrolled patients with active SLE and patients with lupus nephritis across 18 South Korean institutions (July 2021-February 2023). Patients received on-label IV belimumab plus standard therapy (antimalarials, glucocorticoids and immunosuppressants). Data were collected for a minimum of 48 weeks as part of routine clinical practice (July 2021-March 2024). Safety was assessed by monitoring the incidence of adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs)/ADRs and AEs of special interest (including psychiatric events) and summarised descriptively. Changes in SELENA-SLEDAI scores, laboratory biomarkers and glucocorticoid dosage from baseline to week 24 or 48 were tested using the Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Of 126 enrolled patients, 105 were eligible for the ≥ 48-week safety evaluation (completed ≥ 24 weeks of belimumab treatment). Patients were mostly female (91.4%, n = 96/105), with mean (SD) SLE duration of 9.9 (8.1) years; 45.7% (n = 48/105) of patients had lupus nephritis. AEs and SAEs were experienced by 66.7% (n = 70/105) and 18.1% (n = 19/105) of patients; most events were mild or moderate in severity and unlikely to be related to belimumab. ADRs were reported for 3.8% (n = 4/105) of patients, and psychiatric events for 2.9% (n = 3/105). SELENA-SLEDAI and laboratory biomarkers significantly improved, and glucocorticoid dosage significantly reduced, between baseline and weeks 24 and 48.</p><p><strong>Conclusions: </strong>This real-world study identified no new safety concerns and demonstrated effectiveness of belimumab, supporting its use in Korean patients.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"265-278"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu in Asian Patients with Allergic Rhinitis.","authors":"Pongsakorn Tantilipikorn, Yau Kay Chung Julian, Te-Huei Yeh, Yap Yoke Yeow, George Chow, Hans Christian Kuhl, Duc Tung Nguyen, Rajesh Kumar Ramalingam","doi":"10.1007/s40801-026-00546-w","DOIUrl":"10.1007/s40801-026-00546-w","url":null,"abstract":"<p><strong>Background: </strong>Allergic rhinitis (AR) is highly prevalent in Asia, but limited data exist on the real-world effectiveness of MP-AzeFlu (azelastine/fluticasone combination nasal spray) in Asian populations.</p><p><strong>Objective: </strong>To evaluate the real-world effectiveness of MP-AzeFlu in Asian patients with moderate-to-severe AR.</p><p><strong>Methods: </strong>This prospective, multicenter, noninterventional study enrolled patients with moderate-to-severe AR in Thailand, Taiwan, Malaysia, and Hong Kong. The patients received MP-AzeFlu and completed visual analog scale (VAS) assessments for AR symptoms over 28 days. The primary outcome was the proportion of responders (VAS score < 50 mm at least once during follow-up).</p><p><strong>Results: </strong>Of the 916 patients included in the safety population, 329 (35.92%) were males and 587 (64.08%) were females. Significant improvements were observed in the overall AR and nasal and ocular symptoms from day 1 through day 28 (p < 0.0001 for all). Asthma symptoms improved significantly in patients with comorbid asthma (11.7%), and 60% reduced use of asthma reliever medication was reported. Quality of life measures, including sleep quality and daily activities, also improved significantly. MP-AzeFlu was well-tolerated, with only six patients reporting mild adverse events.</p><p><strong>Conclusions: </strong>In this real-world study, MP-AzeFlu provided rapid and sustained improvement in AR symptoms and quality of life in Asian patients with moderate-to-severe AR. MP-AzeFlu has also shown beneficial effects in patients with comorbid asthma. These results support the effectiveness of MP-AzeFlu in AR management in Asian populations.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"171-182"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147716341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effectiveness of the Safety Communication for Concurrent Benzodiazepine-Opioid Therapy: A Retrospective Real-World Analysis.","authors":"Raseel Alroba, Ohoud Almadani, Dalal Alqahtani, Maha Aldoughaim, Adel Alrwisan","doi":"10.1007/s40801-025-00532-8","DOIUrl":"10.1007/s40801-025-00532-8","url":null,"abstract":"<p><strong>Background: </strong>In 2018, Saudi Food and Drug Authority (SFDA) issued a safety communication concerning the potential risk of respiratory depression related to concurrent use of benzodiazepines and opioids. This study aims to evaluate the impact of this safety communication on clinical practice by examining trends in prescribing both medications concurrently pre- and post-safety communication date.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study utilizing data from the Real-world Evidence Research Network comprised adult (≥ 18 years old) users of benzodiazepines and opioids from 2016 throughout 2020. This study employed an interrupted time series analysis using an Autoregressive Integrated Moving Average (ARIMA) model to examine changes in concurrent benzodiazepine and opioid use in Saudi Arabia (SA) before and after the safety communication date. Sensitivity analyses were conducted to assess the reliability of the findings.</p><p><strong>Results: </strong>A total of 43,906 episodes of concurrent use of benzodiazepines and opioids were identified for 32,035 patients. Comparing concurrent use of benzodiazepines and opioids pre- and post-safety communication, we observed a slight decrease, from 22.5% (22,846 of 101,538 episodes) to 20.4% (21,096 of 103,409 episodes). The result from our selected model, ARIMA, revealed that the estimated step change was 9.3 in prescriptions (95% CI - 154.5 to 173.2) while the estimated change in slope was - 1.7 prescriptions per month (95% CI - 29.4 to 26.1).</p><p><strong>Conclusions: </strong>In this study, we observed no significant changes in frequencies and trends in concurrent prescriptions of benzodiazepines and opioids before and after the safety communication. This highlights the need for continuous assessment of risk minimization strategies in achieving the targeted outcome.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"193-200"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147467339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}