Journal of Drug Assessment最新文献

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The National Association of Specialty Pharmacy Abstract Program 全国专业药学文摘项目协会
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658286
R. Brook, Sheila Arquette
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引用次数: 0
Implementation of an internal check of oral oncolytics: a single-center, specialty pharmacy safety initiative 口腔溶瘤药物内部检查的实施:一个单一的中心,专业药房安全倡议
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658303
M. Hughes, Richard Kriska, Gregory Strong, Jennifer Chung, Lily Nguyen, Daniel J. Rubin, M. Murphy, Joseph Favatella, D. Capozzi
{"title":"Implementation of an internal check of oral oncolytics: a single-center, specialty pharmacy safety initiative","authors":"M. Hughes, Richard Kriska, Gregory Strong, Jennifer Chung, Lily Nguyen, Daniel J. Rubin, M. Murphy, Joseph Favatella, D. Capozzi","doi":"10.1080/21556660.2019.1658303","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658303","url":null,"abstract":"Abstract Background: Oral oncolytic therapies (OOT) for patients with cancer continue to pose unique safety challenges. Unlike infusion therapies, there are few best practice recommendations for checking OOT. A multicenter review of four oncology clinics in the United States, estimated 8.1 errors in medications per 100 clinic visit identified. 1 The American Society of Health-System Pharmacists identify administration and ordering were the most common phases of the medication-use process where errors occur. 2 Despite the high-risk nature of OOT and high error-rate in these particular phases, with pharmacist surveillance, there continues to be little consensus for oral oncolytic safety to guide specialty pharmacists (SPs). Aims: The objectives of this single-center, quality improvement study was to review the quality metrics of the implementation of an oral oncolytic check process, in the specialty and ambulatory setting as a method to enhance medication safety and improve vigilance. Methods: The study was approved by the Institutional Review Board at the Hospital of the University of Pennsylvania. A standardized check process and documentation of capecitabine and temozolomide was implemented beginning in December 2016 for an adult oncology population. SPs have direct communication to pharmacy specialists and provider teams through the electronic medical record via Epic. Upon receipt of a new prescription, the SP reviews the prescription for: prescriber, chemotherapy regimen, indication, body surface area, dose verification, appropriate day supply/refills, laboratory values, allergy evaluation, drug interactions, and pre-medications. The SP documents this review as an intervention in Epic for every capecitabine and temozolomide prescriptions before processing. Intervention data between December 2016 and September 2018 was queried and quantified. Results: Over 22 months, a total of 1,619 intervention documents were reviewed with 551 intervention documents requiring intervention (34%). A total of 639 actionable interventions were identified. The top three categories were missing pre-medications (54.1%), missing/abnormal laboratory results (19.6%), and drug-drug interactions (13.6%). Rare interventions included dose clarification requests (3.6%), dose change requests (1.4%), and quantity supply requests (2.7%). A SP referred to a pharmacy specialist or provider outside of Epic communication in 21.2% of cases and 3.7% of cases respectively. The average time by the SP per intervention was 12.1 minutes (Range: 10-45 minutes). Conclusions: OOT is exponentially growing with unique risks associated when prescribing, with the SP being the last line of defense. Implementing an internal checking tool of oral oncolytics creates a standardized safety check and promotes active communication with oncology care teams. Addition of all OOT to incorporate mandatory documentation is ongoing.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44399972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correlates and barriers to medication adherence in multiple sclerosis patients and their impact on clinical outcomes 多发性硬化症患者药物依从性的相关性和障碍及其对临床结果的影响
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658319
Jenna Lee, Danielle McPherson, Mark D'Ambrosi, Martha Stutsky
{"title":"Correlates and barriers to medication adherence in multiple sclerosis patients and their impact on clinical outcomes","authors":"Jenna Lee, Danielle McPherson, Mark D'Ambrosi, Martha Stutsky","doi":"10.1080/21556660.2019.1658319","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658319","url":null,"abstract":"Abstract Background: Multiple sclerosis (MS), a debilitating, chronic disease of the central nervous system, is the most common cause of neurological defects in young adults. There are currently over a dozen disease-modifying therapies (DMTs) that reduce relapse rates and slow disease progression. Despite positive efficacy studies, there are many barriers to medication adherence, which may impact patient outcomes. Aims: The purpose of this study is to evaluate the correlation between medication adherence and clinical outcomes and to identify barriers to adherence in the MS patients filling DMT prescriptions at Yale New Haven Health Outpatient Pharmacy Services (OPS). Methods: This retrospective study was conducted with 138 adult patients filling MS medications at OPS between 1 January 2018 and 31 July 2018. Subjective adherence and outcomes data were obtained through semi-annual MS patient assessments. The following data were evaluated for correlation with medication adherence: age, gender, ethnicity, language, smoking status, alcohol dependency, PMH of depression, Charlson comorbidity index, medication frequency and route, insurance provider, and medication co-pay. Retrospective medication possession ratio (MPR) data were collected from the pharmacy dispensing system, and hospital admissions obtained through the electronic health record (EHR). Results: Adherence data demonstrated that 3.6% of patients had an MPR <80% and 15.2% had an MPR <90%. A statistically significant correlation (p < .05) was identified between patients with a diagnosis of depression and patients with an MPR <80%, suggesting a correlation between worsening adherence and increasing depressive symptoms. A statistically significant correlation (p < .05) was identified between patients with hospital admissions or ED visits due to MS symptoms and patients with an MPR <80% as well as the cumulative MPR results, suggesting a correlation between worsening adherence and increasing hospital admission or ED visits due to MS. Conclusions: Patients with lower adherence to DMTs were associated with a higher rate of hospital admissions or ED visits due to MS symptoms documented in the EHR indicating the importance of medication adherence for this patient population. The importance of mental health for patients should be emphasized in this population as increasing depression symptoms were correlated with decreasing medication adherence.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658319","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47416834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medication adherence and graft survival among kidney transplant recipients 肾移植受者的药物依从性和移植物存活率
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658328
Safia Boghani, H. Kirkham, E. Witt, N. Hira, W. Cherikh, A. Wilk, J. Maghirang, Glen Pietradoni
{"title":"Medication adherence and graft survival among kidney transplant recipients","authors":"Safia Boghani, H. Kirkham, E. Witt, N. Hira, W. Cherikh, A. Wilk, J. Maghirang, Glen Pietradoni","doi":"10.1080/21556660.2019.1658328","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658328","url":null,"abstract":"Abstract Background: Though medication adherence is essential for graft survival, non-adherence to immunosuppressants post kidney transplant is common (30–35%), potentially leading to poor quality of life and increased healthcare costs. Aims: The objective of this study was to examine the association between graft survival and adherence in kidney transplant recipients. Methods: This retrospective, observational cohort study used claims data from a single, large national pharmacy chain and post-transplant follow-up data from the OPTN Network database. The sample included adult deceased donor kidney transplant recipients (most recent transplant if more than one) who had: >2 pharmacy claims for any immunosuppressant >150 days apart in the 12 months after their first fill in the study period (2013–2016). Proportion of days covered (PDC) by any immunosuppressant for 12 months after first fill was calculated as a measure of adherence (defined as PDC >80%). Graft survival was defined as having a surviving graft at the end of the study period. Logistic regression was used to estimate the association between adherence and graft survival controlling for covariates (age at transplant, time since transplant, gender, race/ethnicity, copay, number of prescriptions for chronic conditions, pharmacy insurance plan, brand medication usage, digital fills, filling at a transplant specialized pharmacy, receiving financial assistance, the interaction between brand medication usage and receiving financial assistance, and the interaction between age and adherence). Results: Of the 14,703 kidney transplant recipients eligible for the study, 73% were adherent and 85% had a surviving graft (1 to 9780 post-transplant). After adjusting for covariates, the odds of having a surviving graft were higher for adherent patients than for non-adherent patients (OR = 2.75, [1.95, 3.87]; p < .001). Other notable factors associated with graft survival included having no post-index prescriptions for chronic conditions (OR = 3.48, [2.95, 4.11]; p < .001) and commercial insurance (vs. Medicare Part B) (OR = 1.35, [1.16, 1.56]; p < .001). Conclusions: This analysis suggests adherent patients were more likely to have a surviving graft than those who were not adherent to immunosuppressants. As medication adherence behaviors may vary across patient populations, future studies should aim to show which patient behaviors contribute to medication adherence.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658328","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42791832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Impact of specialty pharmacy taking ownership of the prior authorization process of multiple sclerosis specialty medications to increase access to infusible disease-modifying therapy (DMT) 专科药房拥有多发性硬化症专科药物的事先授权程序以增加可输注的疾病改良疗法(DMT)的影响
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658304
Miranda Whetstone, J. Reichard, Shelley Sigmon
{"title":"Impact of specialty pharmacy taking ownership of the prior authorization process of multiple sclerosis specialty medications to increase access to infusible disease-modifying therapy (DMT)","authors":"Miranda Whetstone, J. Reichard, Shelley Sigmon","doi":"10.1080/21556660.2019.1658304","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658304","url":null,"abstract":"Abstract Background: Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS) that is a leading cause of disability. Many disease-modifying therapies (DMT) with different routes of administration have been approved and introduced to the market to treat MS. These DMT are often costly and require Prior Authorizations (PA) which can lead to barriers in accessing DMT. This project was a response to the need for timely PA approval for patients needing infusible DMT. A previous project reviewed the impact of the specialty pharmacy taking ownership of all DMTs in regards to approved authorizations and timeliness of the approval. After this project highlighting the need and cost savings to the institution, an additional staff member was added to focus on infusible DMT PA. Aims: To increase the number of approved authorizations of infusible DMT and increase the timeliness of authorizations in order for patients to receive appropriate and timely DMT. Methods: The program was developed by a specialty pharmacy team and neurology team. The target audience were patients being initiated on a DMT for MS from September 2018–April 2019. A note was sent in the electronic medical record (EMR) to the pharmacy team to initiate the PA process when the neurologist prescribed a new DMT. Communication was made to the neurology team regarding the status of the DMT PA before scheduling a patient for their infusion. Results: A total of 92 patients had a new PA completed. Eighty-three (90%) authorizations were approved and three (3%) were denied. Of the three denials, additional appeals were done either by completing appeal letters or scheduling peer-to-peers. Two of the three patients then qualified to receive free medication through the manufacturer due to having two denials in place. One has applied for free medication and is currently pending. A total of 10 appeal letters were written, and seven peer-to-peers were set up for the attending physician. Five PAs were cancelled. Three of these required authorization through pharmacy benefits vs medical benefits, one received free medication through the manufacturer, thus the PA was cancelled, and one did not have a referral from the Veteran’s Association (VA) to be seen outside of the VA. One authorization was not covered due to the plan only covering preventative care. Overall, 89 (96.7%) patients received their DMT infusion. Conclusions: This program provides a new service to increase the number of approved infusible DMT to improve access and outcomes for MS patients.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658304","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47377446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Clinical impact of pharmacist interventions on improving outcomes in patients receiving immune globulin therapy in a home setting 药师干预对改善患者在家庭环境中接受免疫球蛋白治疗结果的临床影响
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658294
J. DiStefano, L. Vaughan
{"title":"Clinical impact of pharmacist interventions on improving outcomes in patients receiving immune globulin therapy in a home setting","authors":"J. DiStefano, L. Vaughan","doi":"10.1080/21556660.2019.1658294","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658294","url":null,"abstract":"Abstract Background: Immune globulin (IG) therapy is considered a safe and frequently used treatment in a wide range of disease states but has well known associated adverse drug reactions (ADRs) that may be problematic. Patients that receive IG in the home setting may be at higher risk for undertreated ADRs due to the limited number of immediate interventions in the home. Published literature indicate minor reactions are reported in up to 20% of IG infusions and serious ADRs in 2–6%. A pro-active approach to the prevention or reduction of known IG ADRs is critical for these patients. Pharmacists can have the greatest impact on ADRs due to their on-going and regular communication with the patients. Aims: To determine the frequency, type, and severity of ADRs associated with IG infusions and the impact of pharmacist intervention on reducing or eliminating the ADRs. Methods: An ADR Assessment tool was developed to track ADRs reported by patients during or after IG infusions, the severity of the ADR, interventions made by the pharmacist, acceptance of those interventions by the IG prescriber and the outcome of those interventions on reducing or preventing recurrence of the same ADRs. Results: ADRs tracked over a 2-year period show 98% of reported ADRs were mild or moderate in severity having limited impact on the patient’s normal activities. These were all able to be managed at home with simple and readily available therapeutic treatments. After the occurrence of an ADR, pharmacist interventions made to the IG prescriber on future IG infusions had an acceptance of 93%. Pharmacists suggested ADR interventions had a 90% success rate in the total or partial prevention of the same ADR during the next infusion cycle. During this same 2-year period, of the ADRs reported, 0.35% were categorized as serious. Review of these patients and reported serious ADRs showed events that were consistent with the FDA box warnings required on all IG products but did not result in discontinuation of IG therapy in half of these patients. Conclusions: Pharmacists can have a significant impact on preventing or reducing ADRs associated with IG therapy. In addition, the interventions suggested by the pharmacist have a high acceptance rate by prescribers and a positive effect on preventing recurrence of ADRs.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658294","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44925223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of specialty pharmacist integration on time to medication access for pimavanserin 专科药师整合对匹马西林用药可及性的影响
IF 2.4
Journal of Drug Assessment Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658307
Sabrina Livezey, R. McCormick, Nisha B. Shah, Leena Choi, Joshua DeClercq, A. Zuckerman
{"title":"Impact of specialty pharmacist integration on time to medication access for pimavanserin","authors":"Sabrina Livezey, R. McCormick, Nisha B. Shah, Leena Choi, Joshua DeClercq, A. Zuckerman","doi":"10.1080/21556660.2019.1658307","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658307","url":null,"abstract":"Abstract Background: Patient access to pimavanserin treatment, an antipsychotic agent used to treat Parkinson’s disease-related psychosis, is limited by insurance approval and navigating a limited distribution network. Once initiated, safety and efficacy monitoring is needed to ensure adherence and clinical benefit. Aims: To determine the impact of specialty pharmacist integration on time to pimavanserin access. A secondary objective is to describe pharmacist interventions related to pimavanserin. Methods: This was a single-center, retrospective cohort study with a pre–post design. Patients prescribed pimavanserin through the center’s neurology clinic during May 2016 through July 2018 were included. An electronic chart review was performed to collect data for patient demographics (age, race, gender), insurance information (type, prior authorization process), and pharmacist interventions. The primary outcome was defined as time to medication access (in days) between the initial intent to treat and insurance approval. Univariate analysis and multiple logistic regression were performed to assess the associations between medication access time and pharmacist integration. Results: Ninety-four patients met inclusion criteria. Patients were mostly male (80%) and Caucasian (96%). Median age was 74 years. Baseline demographics between the pre- and post-integration cohorts were similar. Pre-integration, 33 patients were prescribed pimavanserin, with 82% attaining insurance approval and 79% starting therapy. Post-integration, 61 patients were prescribed pimavanserin, with 95% attaining insurance approval and 93% starting therapy. Median time to access decreased following integration (3 days compared to 24.5 days). Patients prescribed pimavanserin pre-integration had a 23-fold increase in odds of experiencing a longer time to access compared to post-integration (OR = 23; 95% CI = 8–69; p < 0.001). In addition, patients with non-commercial insurance were more likely to have a shorter medication access time compared to patients with commercial insurance. The pharmacist performed at least one intervention for 85% of patients, including medication counseling (n = 58) and interventions to improve clinical care (n = 120) and medication access (n = 135). Conclusions: Integration of a specialty pharmacist decreased time to pimavanserin access and facilitated pharmacy interventions to ensure safety and efficacy of use. Additional research is needed to evaluate the impact of faster medication access on clinical outcomes.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658307","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45124144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Hepatitis C virus genotype analysis in patients with chronic hepatitis in North Eastern Bulgaria. 保加利亚东北部慢性肝炎患者丙型肝炎病毒基因型分析
IF 2.4
Journal of Drug Assessment Pub Date : 2019-08-08 eCollection Date: 2019-01-01 DOI: 10.1080/21556660.2019.1654484
Zarina Brady, Zhivka Stoykova
{"title":"Hepatitis C virus genotype analysis in patients with chronic hepatitis in North Eastern Bulgaria.","authors":"Zarina Brady, Zhivka Stoykova","doi":"10.1080/21556660.2019.1654484","DOIUrl":"10.1080/21556660.2019.1654484","url":null,"abstract":"<p><p><b>Background:</b> The main objective of this study was to analyse the spread of hepatitis C virus (HCV) genotype in patients with chronic liver disease; commenting on the molecular characterization of HCV and gender and age in Varna, Bulgaria. Across Europe and the world, HCV is a significant economic concern and public health crisis. Defined by genotype variations, HCV is the leading cause of chronic liver disease, liver related morbidity, and mortality worldwide. Active examination for asymptomatic patients is essential, initiating early treatment aimed at the specific HCV genotype, effective outcomes, and reducing transmission and mortality in Bulgaria. <b>Methods and materials:</b> Nucleic acid extraction and amplification were performed with commercially available test kits on 115 patients blood samples collected from March 2018 to October 2018. Male (<i>n</i> = 58) (50.43%, 95% CI = 41.29%-59.57%) and female (<i>n</i> = 57) (49.57%, 95% CI = 41.29%-59.57%) samples were equally distributed (mean age = 51.4 years; SD = ±16.5 years; range = 17-87 years old). <b>Results:</b> Genotype 1b predominated (73%, 95% CI = 64.89%-81.11%), followed by high prevalence of 1a (13.9%, 95% CI = 7.58%-20.22%) and 3 genotypes (11.3%, 95% CI = 5.51%-17.09%). Genotypes 2 and 4 were equally the least prevalent (0.9%, 95% CI = -0.83%-2.63%). In genotype 1b, 60.7% were women and 39.3% were men; in genotype 1a, 25% were women and 75% were men; and in genotype 3, only 7.7% were women and 92.3% were men. Males were most prevalent in genotypes 1a (75%) and 3 (92.3%), while women were most prevalent in genotype 1b (60.7%). <b>Conclusions:</b> HCV genotype lb is the predominant variant within the epidemiological pattern of HCV genotypes in patients with chronic liver diseases in North Eastern Bulgaria.</p>","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746290/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47244244","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}
引用次数: 0
Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn's disease or ulcerative colitis. 生物仿制药英夫利昔单抗(CT-P13)在克罗恩病或溃疡性结肠炎患者中的有效性和安全性
IF 2.4
Journal of Drug Assessment Pub Date : 2019-06-18 eCollection Date: 2019-01-01 DOI: 10.1080/21556660.2019.1626735
Cristian Gheorghe, Pavel Svoboda, Bogdan Mateescu
{"title":"Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn's disease or ulcerative colitis.","authors":"Cristian Gheorghe,&nbsp;Pavel Svoboda,&nbsp;Bogdan Mateescu","doi":"10.1080/21556660.2019.1626735","DOIUrl":"https://doi.org/10.1080/21556660.2019.1626735","url":null,"abstract":"<p><p><b>Objective:</b> To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's disease (CD) or ulcerative colitis (UC). <b>Methods:</b> This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. <b>Results:</b> Altogether, 85 patients with CD (<i>n</i> = 38) or UC (<i>n</i> = 47) received biosimilar infliximab for up to 30 weeks. Most patients (<i>n</i> = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant (<i>p</i> < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved (<i>p</i> < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. <b>Conclusion:</b> Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.</p>","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1626735","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37381857","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}
引用次数: 6
Epidemiology of atopic dermatitis in Europe. 欧洲特应性皮炎的流行病学。
IF 2.4
Journal of Drug Assessment Pub Date : 2019-06-12 eCollection Date: 2019-01-01 DOI: 10.1080/21556660.2019.1619570
Elżbieta Kowalska-Olędzka, Magdalena Czarnecka, Anna Baran
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引用次数: 91
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