Drug Safety最新文献

{"title":"Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative.","authors":"Eric B Cohen, Meenal Patwardhan, Ritu Raheja, David H Alpers, Raul J Andrade, Mark I Avigan, James H Lewis, Don C Rockey, Francis Chui, Alexandru M Iacob, Camila C Linardi, Arie Regev, Jesse Shick, M Isabel Lucena","doi":"10.1007/s40264-024-01407-7","DOIUrl":"10.1007/s40264-024-01407-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11018680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139897973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS).","authors":"Pedro L Moro, Carol Ennulat, Hannah Brown, Gina Woody, Bicheng Zhang, Paige Marquez, Emily Jane Woo, John R Su","doi":"10.1007/s40264-024-01406-8","DOIUrl":"10.1007/s40264-024-01406-8","url":null,"abstract":"<p><strong>Introduction: </strong>Bivalent mRNA coronavirus disease 2019 (COVID-19) vaccines may be simultaneously administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines.</p><p><strong>Objective: </strong>The aim was to describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines.</p><p><strong>Methods: </strong>We searched the VAERS database for reports of adverse events (AEs) following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines during the period of September 1, 2022-March 31, 2023. We assessed the characteristics of these reports and described the most frequently reported AEs. Clinicians reviewed available medical records for reports of serious AEs and adverse events of special interest (AESI).</p><p><strong>Results: </strong>During the period of 1 September 2022 through 31 March 2023, VAERS received 3689 reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. The median age of vaccinees was 59 years (interquartile range 39, 70 years); 342 reports (9.3%) were classified as serious. The most common AEs among non-serious reports were severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2) infection (785, 23.5%), cough (592, 17.7%), and fatigue (568, 17.0%). The most common AEs among serious reports were Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection (88, 25.7%), dyspnea (81, 23.7%), and condition aggravated (55, 16.1%).</p><p><strong>Discussion: </strong>Reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19) was expected due to Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reporting requirements. CDC and FDA will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making.","authors":"Didrik Wessel, Nicolai Pogrebnyakov","doi":"10.1007/s40264-024-01409-5","DOIUrl":"10.1007/s40264-024-01409-5","url":null,"abstract":"<p><strong>Introduction: </strong>While pharmaceutical companies aim to leverage real-world data (RWD) to bridge the gap between clinical drug development and real-world patient outcomes, extant research has mainly focused on the use of social media in a post-approval safety-surveillance setting. Recent regulatory and technological developments indicate that social media may serve as a rich source to expand the evidence base to pre-approval and drug development activities. However, use cases related to drug development have been largely omitted, thereby missing some of the benefits of RWD. In addition, an applied end-to-end understanding of RWD rooted in both industry and regulations is lacking.</p><p><strong>Objective: </strong>We aimed to investigate how social media can be used as a source of RWD to support regulatory decision making and drug development in the pharmaceutical industry. We aimed to specifically explore the data pipeline and examine how social-media derived RWD can align with regulatory guidance from the US Food and Drug Administration and industry needs.</p><p><strong>Methods: </strong>A machine learning pipeline was developed to extract patient insights related to anticoagulants from X (Twitter) data. These findings were then analysed from an industry perspective, and complemented by interviews with professionals from a pharmaceutical company.</p><p><strong>Results: </strong>The analysis reveals several use cases where RWD derived from social media can be beneficial, particularly in generating hypotheses around patient and therapeutic area needs. We also note certain limitations of social media data, particularly around inferring causality.</p><p><strong>Conclusions: </strong>Social media display considerable potential as a source of RWD for guiding efforts in pharmaceutical drug development and pre-approval settings. Although further regulatory guidance on the use of social media for RWD is needed to encourage its use, regulatory and technological developments are suggested to warrant at least exploratory uses for drug development.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11018692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140038908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study.","authors":"Jingping Hu, Chaojin Chen, Xiaoyue Li, Xiangyang Zang, Jie Ke, Shaoli Zhou, Haiyan Mai, Chulian Gong","doi":"10.1007/s40264-024-01402-y","DOIUrl":"10.1007/s40264-024-01402-y","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic inflammatory response syndrome (SIRS) is one of the most serious complications in patients undergoing percutaneous nephrolithotomy (PCNL). Although glucocorticoids are increasingly used during PCNL, few studies have been concerned about the association between glucocorticoids and postoperative SIRS. The study aims to explore whether preoperative use of glucocorticoids is associated with SIRS after PCNL.</p><p><strong>Methods: </strong>A total of 1259 patients who underwent PCNL between January 2015 and April 2021 were enrolled in the retrospective cohort study. Risk factors for post-PCNL SIRS were identified by univariate and multivariate regression analysis. To further explore the association between preoperative administration of glucocorticoids and SIRS, 113 pairs of patients were matched for the confounding factors using propensity score matching (PSM) analysis. The odds ratios (OR) and 95 % confidence intervals (CI) for the above variables were analyzed.</p><p><strong>Results: </strong>The incidence of SIRS after PCNL was 9.6 % (121/1259) and the patients who suffered from postoperative SIRS had longer hospital stays and higher hospital costs (all p < 0.05). Multivariate logistic regression analysis indicated that female, preoperative leukocyte count, insertion of central vein catheter, serum albumin, preoperative high-sensitive C-reactive protein/albumin ratio, preoperative transfusion, preoperative administration of glucocorticoids were independent risk factors for SIRS (all p < 0.05). After minimization, the effects of confounding factors by PSM, preoperative administration of glucocorticoids was significantly correlated with SIRS in patients after PCNL (OR=2.44, 95 %CI: 1.31-4.55, p = 0.005).</p><p><strong>Conclusion: </strong>Preoperative administration of glucocorticoids is an independent risk factor for SIRS in patients undergoing PCNL.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally.","authors":"Irina Caplanusi, Agnieszka Szmigiel, Menno van der Elst, Marie Louise Schougaard Christiansen, Steffen Thirstrup, Cosimo Zaccaria, Bénédicte Cappelli, Georgy Genov, Sabine Straus","doi":"10.1007/s40264-024-01405-9","DOIUrl":"10.1007/s40264-024-01405-9","url":null,"abstract":"<p><p>The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the pandemic. An unprecedented number of case reports of suspected adverse reactions after vaccination called for huge efforts for the assessment of this safety information, to ensure that any possible risks were detected and managed as early as possible, while ruling out coincidental but temporally related adverse health outcomes. We describe the role of the European Medicines Agency alongside the EU regulatory network in the safety monitoring of the COVID-19 vaccines, and provide an insight into challenges, particularities and outcomes of the scientific assessment and regulatory decisions in the complex, dynamic international environment of the pandemic. We discuss the flexible procedural tools that were used to ensure an expedited scientific assessment of safety issues, and subsequent updates of the product information (i.e., labelling) when available evidence (e.g., spontaneous reports, findings from observational studies and/or scientific literature) suggested that causal association is at least a reasonable possibility. The safety monitoring was accompanied by enhanced transparency measures, proactive communication, and easy access to information, which played a key role in public reassurance. The pandemic has been a powerful booster for worldwide collaboration, exchange of information and work-sharing. The safety monitoring of COVID-19 vaccines continues, and the lessons learned will be applied in future safety reviews, as well as future health emergencies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11018685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139939829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review.","authors":"Daniele Sartori, Jeffrey K Aronson, Nils Erlanson, G Niklas Norén, Igho J Onakpoya","doi":"10.1007/s40264-024-01403-x","DOIUrl":"10.1007/s40264-024-01403-x","url":null,"abstract":"<p><strong>Introduction and objective: </strong>The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serious and are prioritized for signal detection, irrespective of statistical criteria. We have analysed the results of our previously published scoping review to determine whether DME signals differ from those of other adverse events in terms of time to communication and characteristics of supporting reports of suspected adverse drug reactions.</p><p><strong>Methods: </strong>For all signals, we obtained the launch year of medicinal products from textbooks or regulatory agencies, extracted the year of the first report in VigiBase and calculated the interval between the first report and communication (time to communication, TTC). We further retrieved the average completeness (via vigiGrade) of the reports in each case series in the years before the communication. We categorised as DME signals those concerning an event in the EMA's list. We described the two groups of signals using medians and interquartile ranges (IQR) and compared them using the Brunner-Munzel test, calculating 95% confidence intervals (95% CI) and P values.</p><p><strong>Results: </strong>Of 4520 signals, 919 concerned DMEs and 3601 concerned non-DMEs. Signals of DMEs were supported by a median of 15 reports (IQR 6-38 reports) with a completeness score of 0.52 (IQR 0.43-0.62) and signals of non-DMEs by 20 reports (IQR 6-84 reports) with a completeness score of 0.46 (IQR 0.38-0.56). The probability that a random DME signal was supported by fewer reports than non-DME signals was 0.56 (95% CI 0.54-0.58, P < 0.001) and that of one having lower average completeness was 0.39 (95% CI 0.36-0.41, P < 0.001). The median TTCs of DME and non-DME signals did not differ (10 years), but the TTC was as low as 2 years when signals (irrespective of classification) were supported by reports whose average completeness was > 0.80.</p><p><strong>Conclusions: </strong>Signals of designated medical events were supported by fewer reports and higher completeness scores than signals of other adverse events. Although statistically significant, the differences in effect sizes between the two groups were small. This suggests that listing certain adverse events as DMEs is not having the expected effect of encouraging a focus on reports of the types of suspected adverse reactions that deserve special attention. Further enhancing the completeness of the reports of suspected adverse drug reactions supporting signals of designated medical events might shorten their time to communication and reduce the number of reports required to support them.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11018663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139943991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review.","authors":"Paige Verona, Jocelyn Edwards, Kassidy Hubert, Federica Avorio, Vincenzina Lo Re, Roberta Di Stefano, Anna Carollo, Heather Johnson, Alessio Provenzani","doi":"10.1007/s40264-024-01398-5","DOIUrl":"10.1007/s40264-024-01398-5","url":null,"abstract":"<p><p>Tacrolimus, a calcineurin inhibitor, is an immunosuppressant used globally to prevent rejection after organ transplantation. Although it significantly improves outcomes for solid organ transplant patients, it is associated with various side effects such as nephrotoxicity and neurotoxicity. Tacrolimus-induced neurotoxicity is frequently encountered in clinical practice and can present with a variety of symptoms that may occur even at therapeutic levels. Although tacrolimus-induced neurotoxicity is well documented, there is limited literature available on pharmacologic management. Twenty-eight case reports of tacrolimus-induced neurotoxicity were identified and analyzed in addition to other literature including reviews, retrospective studies, and animal model studies. The severity of cases of tacrolimus-induced neurotoxicity reported ranged from mild symptoms that could be managed with symptomatic treatment to conditions such as posterior reversible encephalopathy syndrome and chronic inflammatory demyelinating polyradiculoneuropathy that may require more immediate intervention. This information was utilized in addition to clinical experience to compile potential management options for prevention and treatment of neurotoxic adverse events. This review is limited by the utilization of primarily retrospective studies and case reports. The available literature on the subject is largely narrative and there are no guidelines on treatment of tacrolimus-induced neurotoxicity at the time of this research. This comprehensive review may guide further studies to investigate the pathophysiology of tacrolimus-induced neurotoxicity and to define patient-specific strategies for mitigation or minimization of neurotoxicity. This is especially important given that management of tacrolimus-induced neurotoxicity can include changes to immunosuppression that can result in an increased risk of rejection.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139729308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure","authors":"Vera Battini, Marianna Cocco, Maria Antonietta Barbieri, Greg Powell, Carla Carnovale, Emilio Clementi, Andrew Bate, Maurizio Sessa","doi":"10.1007/s40264-024-01430-8","DOIUrl":"https://doi.org/10.1007/s40264-024-01430-8","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Current drug–drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to false-positive disproportionality signals in spontaneous reporting system (SRS) databases.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>This study aims to develop a method for detecting and prioritizing temporally plausible disproportionality signals of DDIs in SRS databases by incorporating co-exposure time in disproportionality analysis.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The method was tested in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). The CRESCENDDI dataset of positive controls served as the primary source of true-positive DDIs. Disproportionality analysis was performed considering the time of co-exposure. Temporal plausibility was assessed using the flex point of cumulative reporting of disproportionality signals. Potential confounders were identified using a machine learning method (i.e. Lasso regression).</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Disproportionality analysis was conducted on 122 triplets with more than three cases, resulting in the prioritization of 61 disproportionality signals (50.0%) involving 13 adverse events, with 61.5% of these included in the European Medicine Agency’s (EMA’s) Important Medical Event (IME) list. A total of 27 signals (44.3%) had at least ten cases reporting the triplet of interest, and most of them (<i>n</i> = 19; 70.4%) were temporally plausible. The retrieved confounders were mainly other concomitant drugs.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Our method was able to prioritize disproportionality signals with temporal plausibility. This finding suggests a potential for our method in pinpointing signals that are more likely to be furtherly validated.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140828963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics","authors":"Robin E. Ferner, Jeffrey K. Aronson","doi":"10.1007/s40264-024-01428-2","DOIUrl":"https://doi.org/10.1007/s40264-024-01428-2","url":null,"abstract":"<p>For any therapeutic intervention in an individual, there is a balance between the potential benefits and the possible harms. The extent to which the benefits are desirable in a given condition depends on the efficacy of the intervention, the chance of obtaining it and the seriousness and intensity of the condition. The extent to which the harms are undesirable depends on the nature of the hazard that can lead to harm, the chance that the harm will occur and its seriousness and intensity. Rational therapeutic decisions require clinicians to consider competing courses of action, with potential benefits of different desirability and potential harms of different undesirability. They also have a duty to explain to the patient, for the contemplated interventions, both the possible benefits and the potential harms that the patient may consider significant. In an individual patient, it is necessary to consider (a) the probabilities of benefit from both intervention and non-intervention and (b) the probabilities of harm from both intervention and non-intervention. However, there are several potential problems. Here, we consider how failure to distinguish maximum benefits from probable benefits, or hazards (potential harms) from probable harms, and failure to consider all the competing probabilities may lead to imperfect therapeutic decisions. We also briefly discuss methods to assess the benefit to harm balance.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140828964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study","authors":"Ying Li, Lin Dang, Chengzhi Lv, Bingjiang Lin, Juan Tao, Nan Yu, Ya Deng, Huiping Wang, Xiaojing Kang, Hui Qin, Rong Chen, Jinnan Li, Yunsheng Liang, Yanhua Liang, Yuling Shi","doi":"10.1007/s40264-024-01427-3","DOIUrl":"https://doi.org/10.1007/s40264-024-01427-3","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Ixekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis. However, there are limited data on the real-world safety of ixekizumab in Chinese patient populations. We performed an observational study of ixekizumab for the treatment of moderate-to-severe plaque psoriasis in routine clinical practice in China. Here we present a further safety analysis of this study.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>In this prospective, observational, single-arm, multicenter, post-marketing safety study, adults (≥18 years) with moderate-to-severe plaque psoriasis receiving ixekizumab were enroled at dermatology departments in hospitals across China and prospectively followed for 12 weeks or until their last dose of ixekizumab. In this analysis, we evaluated adverse events (AEs) of special interest (AESIs) identified using MedDRA^® search strategies. We also analyzed AEs and AESIs occurring in greater than ten patients in subgroups by age (&lt; 65/≥ 65 years), sex, body weight (&lt; 60/60 kg to &lt; 80/≥ 80 kg), renal impairment, hepatic impairment, history of tuberculosis, history of HBV infection, recent or active infection, history of allergic reaction/hypersensitivity, and number (0–1/2–4/5–7) of ixekizumab 80 mg injections after baseline until day 105.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>This analysis included 663/666 patients enrolled in the primary study. At least one AESI was reported in 224 (33.8%) patients and considered related to ixekizumab in 181 (27.3%); the most common were injection site reactions (<i>n</i> = 131, 19.8%), infections (<i>n</i> = 80, 12.1%), and allergic reactions/hypersensitivity events (<i>n</i> = 59, 8.9%). The proportion of patients with ≥ 1 AE was higher for females versus males (99/186, 53.2% versus 184/477, 38.6%, <i>p</i> = 0.0006). The proportion of patients with ≥ 1 AE increased with the number of ixekizumab injections after baseline [61/188 (32.4%) for zero to one injection, 151/338 (44.7%) for two to four injections, and 61/106 (57.5%) for five to seven injections; <i>p</i> = 0.0001].</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>In this real-world study, ixekizumab was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis, with no difference in safety across most patient subgroups.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140829047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}