Yin Yin, Limei Huang, Nuo Xu, Hua-Gang Ma, Chaoyan Yuan
{"title":"Comparative Analysis of the Efficacy of Four Different Surgical Modalities in the Treatment of Cesarean Scar Pregnancy: A Multicenter Retrospective Study.","authors":"Yin Yin, Limei Huang, Nuo Xu, Hua-Gang Ma, Chaoyan Yuan","doi":"10.1007/s12325-024-03097-0","DOIUrl":"https://doi.org/10.1007/s12325-024-03097-0","url":null,"abstract":"<p><strong>Introduction: </strong>This study explored the effects of four different surgical methods in the treatment of cesarean scar pregnancy (CSP).</p><p><strong>Methods: </strong>In this multicenter retrospective analysis of 359 patients, the surgical indices, the time taken for the serum human chorionic gonadotropin level to return to normal, the recovery time of menstruation, and the incidence of postoperative adverse reactions were comparatively analyzed. The clinical efficacies of various preoperative treatment methods to block the blood supply to CSP tissues and those of four different surgical methods to treat CSP, namely, curettage, hysteroscopic surgery, laparoscopic surgery, and vaginal surgery, were evaluated in this study.</p><p><strong>Results: </strong>Hysteroscopic pregnancy tissue removal in patients with type I CSP was found to be associated with low cost, rapid postoperative recovery, and a low incidence of postsurgical complications. Among patients with type II-III CSP, the operation success rate (96.97% for type II and 88.46% for type III) in those who underwent uterine artery embolization + curettage was lower than that in patients from the other groups (all 100%). Among patients with type III CSP who underwent transvaginal ligation of the descending uterine artery + hysteroscopic removal of the pregnancy tissues, three patients (12.5%) underwent hysteroscopic surgery under transumbilical single-port laparoscopic surveillance so as to avoid uterine perforation considering that the pregnancy tissue was only 1 mm away from the uterine plasma membrane layer.</p><p><strong>Conclusion: </strong>Hysteroscopic surgery without pretreatment can be adopted for patients with type I CSP. In contrast, patients with type II and III CSP should be initially pretreated with vascular ligation to prevent intraoperative bleeding, followed by laparoscopic or vaginal surgery.</p><p><strong>Trial registry: </strong>Clinical Trial Registry Number ChiCTR2000040357.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143031761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shingo Kato, Bruno Casaes Teixeira, Thomas Laurent, Yoshiyuki Yamada, Kiran Dave, Shweta Shah, Hyunchung Kim
{"title":"Treatment Patterns and Economic Burden of Ulcerative Colitis in Japan: A Retrospective Claims Analysis.","authors":"Shingo Kato, Bruno Casaes Teixeira, Thomas Laurent, Yoshiyuki Yamada, Kiran Dave, Shweta Shah, Hyunchung Kim","doi":"10.1007/s12325-024-03096-1","DOIUrl":"https://doi.org/10.1007/s12325-024-03096-1","url":null,"abstract":"<p><strong>Introduction: </strong>This retrospective claims analysis characterized contemporary ulcerative colitis (UC) treatment patterns and investigated the economic burden of UC in Japan.</p><p><strong>Methods: </strong>This study used anonymized claims data in the Medical Data Vision database. Patients were included if they had a confirmed UC diagnosis and ≥ 1 claim of systemic treatment for UC (index date) between June 2018 and December 2022, in addition to continuous enrollment for ≥ 6 months before and ≥ 12 months after the index date. Patients were excluded if they were aged < 18 years at index or if they had claimed systemic UC treatment during the pre-index period, had a confirmed diagnosis of Crohn's or Behçet's disease, or had a record of colectomy during the pre-index period. Outcomes of interest were treatment patterns, healthcare resource utilization (HCRU), and UC-related costs per person per month (PPPM). Further exploratory analyses were conducted to understand whether real-world treatment patterns with conventional therapy were optimally aligned with guideline recommendations. Two definitions of suboptimal treatment with conventional therapies were identified: prolonged treatment with corticosteroids (i.e., consecutive use for > 90 days) and corticosteroid cycling (i.e., three or more ≥ 30-day corticosteroid courses over 1 year, with a ≥ 60-day gap between courses).</p><p><strong>Results: </strong>Overall, 15,429 patients were included. The most frequently observed class of first-line treatment was 5-aminosalicylic acid monotherapy (75.0%); treatment modification was observed in 39.7% of patients. Within 1 year of follow-up, patients had a mean (SD) of 9.8 (6.8) outpatient visits, and a hospital stay was reported in 23.9% of patients. Mean total cost PPPM was ¥76,374. Of patients with ≥ 1 course of corticosteroids, 39.8% received suboptimal treatment with conventional therapies. HCRU and total costs were higher for patients with versus without suboptimal treatment with conventional therapies.</p><p><strong>Conclusions: </strong>Japanese patients with UC would benefit from treatment options that can reduce costs, HCRU, and suboptimal treatment with conventional therapies.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143031763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Khashayar Azimpour, Patricia Dorling, Irene Koulinska, Swati Kunduri, Zhiyi Lan, Julia Poritz, Gabriel Tremblay, Angie Raad-Faherty
{"title":"Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials.","authors":"Khashayar Azimpour, Patricia Dorling, Irene Koulinska, Swati Kunduri, Zhiyi Lan, Julia Poritz, Gabriel Tremblay, Angie Raad-Faherty","doi":"10.1007/s12325-024-03095-2","DOIUrl":"https://doi.org/10.1007/s12325-024-03095-2","url":null,"abstract":"<p><strong>Introduction: </strong>Fabry disease (FD) is a rare lysosomal storage disorder that is associated with pain and progressive damage to the renal, cardiac, and cerebrovascular systems. Enzyme replacement therapy (ERT) is one of the treatment options for FD and the most recently approved ERT agent, pegunigalsidase alfa, has shown clinical efficacy in three phase 3 clinical trials of adults with FD: BALANCE, BRIDGE, and BRIGHT. Recent published guidelines support the mapping of health utility state data to the EuroQol-5 Dimension-3 Level (EQ-5D-3L) index to align with the preferred methodology used by the National Institute for Health and Care Excellence (NICE). Therefore, the primary objective of this study was to estimate EQ-5D-3L values in clinical trials of pegunigalsidase alfa for FD for future cost-utility analyses.</p><p><strong>Methods: </strong>A mixed effects model was developed to predict values derived from EQ-5D-3L for the following health states used in cost-utility analyses: no Fabry clinical event (FCE)/no pain-related adverse event (AE), pain-related AE, cardiac FCE, cerebrovascular FCE, and renal FCE.</p><p><strong>Results: </strong>The baseline EQ-5D-3L utility value had a statistically significant (p < 0.0001) impact on utility values, whereas study, age, sex, disease type, treatment arm, kidney function, and serious AE were not statistically significant. Health state utility values with 95% confidence intervals (CI) for the final model were as follows: no FCE/no pain-related AE, 0.8005 (0.7675, 0.8334); pain-related AE, 0.7737 (0.7262, 0.8211); cardiac FCE, 0.7189 (0.6274, 0.8103); cerebrovascular FCE, 0.7923 (0.6633, 0.9212); and renal FCE, 0.6881 (0.3887, 0.9874).</p><p><strong>Conclusions: </strong>The utility values generated by the present study are generally in line with EQ-5D values in the FD literature and can be used to inform both economic evaluations and our understanding of the impact that FD has on quality of life.</p><p><strong>Trial registration: </strong>NCT03018730, NCT02795676, NCT03180840.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143021864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Improving Therapeutic Adherence and Reducing Therapeutic Inertia in the Management of People with Cardiometabolic Diseases: A Call-to-Action from the Middle East.","authors":"Wael Almahmeed, Zainab Alabadla, Fatheya Al Awadi, Dalal Alrohmaihi, Mostafa AlShamiri, Hussein Elbadawi, Hassan El-Tamimi, Abdel-Nasser Elzouki, Mohamed Farghaly, Khadija Hafidh, Mohamed Hassanein, Adel Khalifa Hamad, Kamlesh Khunti, Hani Sabbour, Aletta E Schutte","doi":"10.1007/s12325-024-03103-5","DOIUrl":"https://doi.org/10.1007/s12325-024-03103-5","url":null,"abstract":"<p><p>Hypertension, dyslipidemia, and type 2 diabetes are highly prevalent and poorly controlled cardiometabolic diseases in the Middle East. Therapeutic non-adherence and therapeutic inertia are major contributors to this suboptimal disease control. Regardless of the cardiometabolic disease, evidence-based solutions may be used to improve therapeutic non-adherence and overcome inertia, and thereby help to alleviate the heavy burden of cardiovascular disease in the Middle East. Such solutions include the routine and early use of single-pill combinations, educational initiatives for patients, and multidisciplinary team-based care. This article highlights these and other potential solutions for therapeutic non-adherence and inertia, as discussed at the 2024 Evidence in the Cardiometabolic Environment (EVIDENT) Summit. There is now a 'call-to-action' from healthcare providers and other stakeholder groups to ensure that the solutions discussed at this meeting are implemented within health systems in the Middle East to significantly improve cardiovascular outcomes.Infographic available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
María Dolores Ballesteros-Pomar, Ened Rodríguez-Urgellés, Miquel Sastre-Belío, Alberto Martín-Lorenzo, Volker Schnecke, Lluís Segú, Max Brosa, Nuria Vilarrasa
{"title":"Assessment of the Potential Clinical and Economic Impact of Weight Loss in the Adult Population with Obesity and Associated Comorbidities in Spain.","authors":"María Dolores Ballesteros-Pomar, Ened Rodríguez-Urgellés, Miquel Sastre-Belío, Alberto Martín-Lorenzo, Volker Schnecke, Lluís Segú, Max Brosa, Nuria Vilarrasa","doi":"10.1007/s12325-024-03094-3","DOIUrl":"https://doi.org/10.1007/s12325-024-03094-3","url":null,"abstract":"<p><strong>Introduction: </strong>Obesity and its complications are associated with high morbidity/mortality and a significant healthcare cost burden in Spain. It is therefore essential to know the potential clinical and economic benefits of reducing obesity. The objective of this study is to predict the decrease in rates of onset of potential complications associated with obesity and the cost savings after a weight loss of 15% over 10 years in Spain.</p><p><strong>Methods: </strong>Data were combined in an adapted version of a weight loss benefit simulation model. Sources with demographic information on the Spanish population and the distribution of obesity and type 2 diabetes mellitus (T2DM) were used to obtain the data for the model. In addition, use was made of prevalence data on obesity-associated complications from a cohort of patients with obesity in the United Kingdom (UK). These data were combined by age and sex to create a Spanish synthetic cohort.</p><p><strong>Results: </strong>The simulation showed that, for a cohort of 100,000 individuals with a body mass index (BMI) of 30-50 kg/m<sup>2</sup>, a weight loss of 15% is estimated to lead to relevant relative risk reductions in obstructive sleep apnoea (OSA) (- 56.4%), T2DM (- 39.2%), asthma (- 20.2%) and arterial hypertension (- 18.7%). The estimated overall savings were €105 million for a cohort of 100,000 individuals, mainly resulting from the decrease in T2DM and arterial hypertension (23% and 22% of the total savings at year 10, respectively), as well as osteoarthritis and chronic kidney disease (CKD) (16% and 13%, respectively).</p><p><strong>Conclusions: </strong>Sustained weight loss could significantly reduce the burden derived from future complications associated to obesity in Spain, as well as the excess economic cost associated with its treatment.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Real-World Effectiveness of Long-Acting Injectable and Oral Antipsychotic Agents in US Medicare Patients with Schizophrenia.","authors":"Pengxiang Li, Zhi Geng, Carmela Benson, Charmi Patel, Jalpa A Doshi","doi":"10.1007/s12325-024-03075-6","DOIUrl":"https://doi.org/10.1007/s12325-024-03075-6","url":null,"abstract":"<p><strong>Introduction: </strong>Daily oral antipsychotics (OAPs) are the mainstay of schizophrenia treatment; however, long-acting injectable antipsychotics (LAIs) are associated with better treatment adherence and improved outcomes.</p><p><strong>Methods: </strong>This study assessed the real-world comparative effectiveness of LAIs and daily OAPs using claims data from a nationally representative sample of fee-for-service Medicare beneficiaries with schizophrenia. Antipsychotic discontinuation, psychiatric hospitalization, and treatment failure were compared relative to different reference groups using within-individual Cox regression models.</p><p><strong>Results: </strong>The study included 152,835 patients (mean age, 53.5 years; 54.0% male and 61.5% white). LAIs when grouped by dosing intervals were associated with significantly lower risk of antipsychotic discontinuation (hazard ratios [HRs] 0.27-0.69), psychiatric hospitalization (HRs 0.76-0.88), and treatment failure (HRs 0.55-0.74) compared with OAPs. When LAIs of different dosing intervals and OAPs were broken out by type of agent and compared with oral risperidone, second-generation LAIs, specifically LAI paliperidone (every 3 months [Q3M] and monthly [Q1M]), LAI aripiprazole (Q1M), and LAI risperidone (primarily every 2 weeks), had a significantly lower risk of antipsychotic discontinuation (HRs 0.19-0.67), psychiatric hospitalization (HRs 0.76-0.91), and treatment failure (HRs 0.53-0.85). Second-generation LAI paliperidone (Q3M) had the lowest risk for negative outcomes relative to OAPs; this effect was maintained when the reference group was changed to oral risperidone, LAI risperidone, LAI aripiprazole (Q1M), and LAI haloperidol (Q1M) (33-47% lower risk).</p><p><strong>Conclusion: </strong>Efforts are needed to enhance identification of appropriate candidates for LAIs and increase their uptake, especially longer dosing interval LAIs, in the Medicare population.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Dreher, Hanna-Teresa Heier, Andrea Kienle-Gogolok, Kristina Röschmann-Doose, Jörg Simon, Ravi Singhal, Heidrun Täschner, Jörn Thomsen, Joachim Weimer, Thomas Wittig, Otto Wonhas, Manuela Thinesse-Mallwitz
{"title":"Randomised, Placebo-Controlled, Double-Blind Trial to Assess Efficacy and Safety of ELOM-080 in Outpatients with COVID-19.","authors":"Michael Dreher, Hanna-Teresa Heier, Andrea Kienle-Gogolok, Kristina Röschmann-Doose, Jörg Simon, Ravi Singhal, Heidrun Täschner, Jörn Thomsen, Joachim Weimer, Thomas Wittig, Otto Wonhas, Manuela Thinesse-Mallwitz","doi":"10.1007/s12325-024-03093-4","DOIUrl":"https://doi.org/10.1007/s12325-024-03093-4","url":null,"abstract":"<p><strong>Introduction: </strong>Incidences of infections with Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2) are still high and treatment guidelines lack specific recommendations for outpatients with Coronavirus-induced disease 2019 (COVID-19). Phytomedicine ELOM-080, an enhancer of mucociliary clearance (MCC), showed benefits as add-on therapy in hospitalised COVID-19 patients.</p><p><strong>Methods: </strong>This randomised, double-blind, placebo-controlled proof-of-concept study investigated whether outpatients with mild to moderate acute symptomatic COVID-19 would benefit from a 14-day treatment with ELOM-080 with regard to potential early treatment effects on cough and further typical COVID-19 symptoms. Outpatients with mild to moderate acute symptomatic COVID-19 documented symptom severity and count of coughs on a daily basis. Investigators documented safety and symptom severity during the visits.</p><p><strong>Results: </strong>This study missed its primary objective, which was reduction in coughing fits in comparison to placebo treatment. In primary analysis, no relevant differences were observed between treatment arms. Data for all randomised patients showed broad heterogeneity in, e.g., time courses of coughing fits, which affected both magnitude and timing of the changes from baseline. However, post hoc analyses with a population with suspected dysfunctional MCC revealed that patients significantly benefitted from treatment with ELOM-080 in terms of reduction in coughing fits (p = 0.0070), difficulty breathing on exertion (p = 0.0252), and earlier remission of symptoms by 1-3 days.</p><p><strong>Conclusion: </strong>We have shown that patients with dysfunctional MCC benefit from treatment with ELOM-080. These results might be of clinical importance, as up to now no therapy has obtained market approval for the treatment of outpatients with COVID-19.</p><p><strong>Trial registration: </strong>EudraCT number: 2022-003478-22.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ka-On Lam, Karen Hoi-Lam Li, Roland Ching-Yu Leung, Vikki Tang, Thomas Yau
{"title":"Trifluridine/Tipiracil (FTD/TPI) in Metastatic Colorectal Cancer in Hong Kong: A Territory-Wide Cohort Study.","authors":"Ka-On Lam, Karen Hoi-Lam Li, Roland Ching-Yu Leung, Vikki Tang, Thomas Yau","doi":"10.1007/s12325-024-03077-4","DOIUrl":"https://doi.org/10.1007/s12325-024-03077-4","url":null,"abstract":"<p><strong>Introduction: </strong>Randomized phase III trials showed that using trifluridine/tipiracil (FTD/TPI) in patients with pre-treated metastatic colorectal cancer (mCRC) conferred survival benefit versus placebo. Here, we investigated the effectiveness and safety of FTD/TPI and sought to identify prognostic factors among the mCRC population in Hong Kong.</p><p><strong>Methods: </strong>A non-interventional, retrospective, multicenter cohort study enrolled patients with mCRC who received FTD/TPI in seven public hospitals in Hong Kong between 2016 and 2020. Overall survival (OS) was the primary endpoint; treatment duration and occurrence of neutropenia were secondary endpoints. We also performed a post hoc analysis to identify factors influencing OS and treatment duration.</p><p><strong>Results: </strong>Overall, 456 patients were included (median age, 64.0 years; 57.5% men). Approximately half (225/456; 49.3%) had RAS wild-type tumors; the median treatment duration was 12.4 weeks (95% confidence interval [CI] 11.1-13.1). Median OS was 7.59 months (95% CI 7.00-8.21). Overall, 289 (63.4%) patients developed neutropenia of any grade and 159 (34.9%) developed grade ≥ 3 neutropenia. Neutropenia at 1 month occurred in 193 (43.1%) patients. The use of granulocyte colony-stimulating factor for neutropenia was reported for 42 (9.2%) patients. The development of neutropenia, absolute neutrophil count decrease of ≥ 2 grades in 1 month, absence of liver metastasis, and RAS wild-type status were associated with significantly longer OS and, except for RAS wild-type status (not analyzed), longer treatment duration (p < 0.05 for all comparisons).</p><p><strong>Conclusion: </strong>Our data show that treatment with FTD/TPI offers survival benefits in patients with refractory mCRC in Hong Kong consistent with randomized controlled trials and other real-world studies. Furthermore, the prognosis in patients receiving FTD/TPI appears to be significantly better in those who develop neutropenia, with RAS wild-type status, or those without liver metastases, despite a higher rate of dose reduction in the real-world setting.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patrick Eugeni, Megan E Rooney, Nicolas P Saikali, Zhongzheng Niu, Maurice T Driessen, Lynda J Krasenbaum, Karen Carr, Michael J Seminerio, Jennifer W McVige
{"title":"US Real-World Effectiveness, Tolerability, and Healthcare Resource Utilization After Addition of Fremanezumab for Preventive Treatment in Patients Using Gepants for Acute Treatment of Migraine: Results From a Retrospective Chart Review.","authors":"Patrick Eugeni, Megan E Rooney, Nicolas P Saikali, Zhongzheng Niu, Maurice T Driessen, Lynda J Krasenbaum, Karen Carr, Michael J Seminerio, Jennifer W McVige","doi":"10.1007/s12325-024-03063-w","DOIUrl":"https://doi.org/10.1007/s12325-024-03063-w","url":null,"abstract":"<p><strong>Introduction: </strong>Fremanezumab, a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway, and gepants, small molecule CGRP receptor antagonists, are both approved for the treatment of migraine or its symptoms. This study assessed effectiveness, tolerability, and migraine-related healthcare resource utilization (HCRU) after the addition of fremanezumab for preventive migraine treatment in patients using gepants for acute treatment.</p><p><strong>Methods: </strong>Data were extracted during a retrospective chart review from electronic medical records from the Dent Neurologic Institute. Eligible patients were ≥ 18 years old, using gepants (rimegepant or ubrogepant), who initiated fremanezumab between January 1, 2020, and May 1, 2021 (index date: date of fremanezumab initiation) and continued concomitant use of gepants and fremanezumab for ≥ 1 month (post-index; between 7-9 months of follow-up). Outcomes included monthly migraine days (MMD), adverse events (AEs), reasons for discontinuation, and migraine-related HCRU.</p><p><strong>Results: </strong>A total of 55 patients [female, 93%; mean (SD) age, 43.5 (13.5) years] met the inclusion criteria. All patients were diagnosed with chronic migraine. Patients had an average (SD) MMD of 15.8 (7.4) at the index date. Average (SE) change in MMD from index date to post-index was - 6.5 (1.0) days (p < 0.0001). Five patients (9.1%) experienced AEs post-index; no serious AEs (SAEs) were reported. The number of migraine-related medications used decreased from the index date to post-index by a mean of 0.6 for preventive medications (p = 0.070), and 0.8 for acute medications (p = 0.050). The number of outpatient office-based visits also decreased [mean (SD): 6 months pre-index, 5.8 (4.4) vs. 6 months post-index, 4.1 (4.0); p < 0.0001].</p><p><strong>Conclusion: </strong>The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and yielded no SAEs or AEs that were novel to these migraine medication classes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ataru Igarashi, Shiro Tanaka, Raf De Moor, Nan Li, Mariko Hirozane, David Bin-Chia Wu, Li Wen Hong, Dae Young Yu, Mahmoud Hashim, Brian Hutton, Krista Tantakoun, Christopher Olsen, Fatemeh Mirzayeh Fashami, Imtiaz A Samjoo, Chris Cameron
{"title":"Correction to: Indirect Treatment Comparisons in Healthcare Decision Making: A Targeted Review of Regulatory Approval, Reimbursement, and Pricing Recommendations Globally for Oncology Drugs in 2021-2023.","authors":"Ataru Igarashi, Shiro Tanaka, Raf De Moor, Nan Li, Mariko Hirozane, David Bin-Chia Wu, Li Wen Hong, Dae Young Yu, Mahmoud Hashim, Brian Hutton, Krista Tantakoun, Christopher Olsen, Fatemeh Mirzayeh Fashami, Imtiaz A Samjoo, Chris Cameron","doi":"10.1007/s12325-024-03087-2","DOIUrl":"10.1007/s12325-024-03087-2","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}