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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 401 - 253 of 253 Journals sorted by number of followers
Pharmazeutische Zeitung     Full-text available via subscription   (Followers: 11)
Pharmazeutische Industrie     Full-text available via subscription   (Followers: 9)
Pharmaceutical Journal     Free   (Followers: 8)
Advanced Herbal Medicine     Open Access   (Followers: 8)
Pharmaceutical Fronts     Open Access   (Followers: 7)
Molekul     Open Access   (Followers: 7)
Advances in Pharmacology and Pharmacy     Open Access   (Followers: 6)
Drug Metabolism and Pharmacokinetics     Hybrid Journal   (Followers: 6)
AAPS Open     Open Access   (Followers: 5)
Journal of Drug Research in Ayurvedic Sciences     Open Access   (Followers: 4)
ACS Pharmacology & Translational Science     Hybrid Journal   (Followers: 4)
Advances in Traditional Medicine     Hybrid Journal   (Followers: 3)
Canadian Journal of Pain     Open Access   (Followers: 3)
PharmaNutrition     Hybrid Journal   (Followers: 3)
Journal of Drug Delivery Science and Technology     Hybrid Journal   (Followers: 3)
Journal of Herbal Science     Full-text available via subscription   (Followers: 3)
Journal of Pharmacological Sciences     Open Access   (Followers: 3)
Indian Journal of Drugs in Dermatology     Open Access   (Followers: 2)
British Journal of Pharmacy (BJPharm)     Open Access   (Followers: 2)
Current Research in Drug Discovery     Open Access   (Followers: 2)
Journal of Herbal Medicine     Hybrid Journal   (Followers: 2)
Asian Journal of Pharmaceutical Research and Health Care     Open Access   (Followers: 2)
Pharmacological Research - Modern Chinese Medicine     Open Access   (Followers: 2)
Archives of Pharmacy and Pharmaceutical Sciences     Open Access   (Followers: 2)
Current Issues in Pharmacy and Medical Sciences     Open Access   (Followers: 2)
International Journal of Immunopathology and Pharmacology     Open Access   (Followers: 2)
Advances in Pharmacoepidemiology & Drug Safety     Open Access   (Followers: 2)
European Journal of Medicinal Plants     Open Access   (Followers: 2)
Journal of Pharmaceutical Sciences and Pharmacology     Full-text available via subscription   (Followers: 2)
Journal of Education and Science     Open Access   (Followers: 2)
Drug Safety - Case Reports     Open Access   (Followers: 2)
Current Research in Pharmacology and Drug Discovery     Open Access   (Followers: 1)
Advances in Medical, Pharmaceutical and Dental Research     Open Access   (Followers: 1)
Pediatric Pharmacology     Open Access   (Followers: 1)
Journal of Metabolomics & Systems Biology     Open Access   (Followers: 1)
Regulatory Mechanisms in Biosystems     Open Access   (Followers: 1)
Integrative Medicine International     Open Access   (Followers: 1)
Journal of Applied Pharmaceutical Research     Open Access   (Followers: 1)
Herbal Medicines Journal     Open Access   (Followers: 1)
Farmakoèkonomika : Modern Pharmacoeconomic and Pharmacoepidemiology     Open Access   (Followers: 1)
Separation Science plus (SSC plus)     Hybrid Journal   (Followers: 1)
Advanced Therapeutics     Hybrid Journal   (Followers: 1)
Journal of Biopharmaceutics Sciences     Open Access   (Followers: 1)
Expert Review of Precision Medicine and Drug Development     Hybrid Journal   (Followers: 1)
Psychiatry and Clinical Psychopharmacology     Open Access   (Followers: 1)
Farmasains : Jurnal Ilmiah Ilmu Kefarmasian     Open Access   (Followers: 1)
Emerging Trends in Drugs, Addictions, and Health     Open Access   (Followers: 1)
Journal of Medicinal Plants for Economic Development     Open Access   (Followers: 1)
OpenNano     Open Access   (Followers: 1)
Safety and Risk of Pharmacotherapy     Open Access   (Followers: 1)
Journal of Pharmaceutical Technology, Research and Management     Open Access   (Followers: 1)
Journal of the American College of Clinical Pharmacy : JACCP     Hybrid Journal   (Followers: 1)
Open Pharmacoeconomics & Health Economics Journal     Open Access   (Followers: 1)
Pharmactuel     Open Access   (Followers: 1)
Al-Azhar Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Chinese Herbal Medicines     Full-text available via subscription   (Followers: 1)
Drugs : Real World Outcomes     Hybrid Journal   (Followers: 1)
Pharmakon : Arzneimittel in Wissenschaft und Praxis     Full-text available via subscription   (Followers: 1)
Sustainable Chemistry and Pharmacy     Full-text available via subscription   (Followers: 1)
Medicines     Open Access   (Followers: 1)
Antiviral Chemistry and Chemotherapy     Open Access   (Followers: 1)
Future Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Journal of Pharmaceutical Health Care and Sciences     Open Access   (Followers: 1)
East and Central African Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Ethiopian Pharmaceutical Journal     Full-text available via subscription   (Followers: 1)
Pharmacy & Pharmacology     Open Access   (Followers: 1)
Clinical Complementary Medicine and Pharmacology     Open Access  
Exploratory Research in Clinical and Social Pharmacy     Open Access  
Indonesian Journal of Pharmaceutical Education     Open Access  
Future Drug Discovery     Open Access  
IUPHAR/BPS Guide to Pharmacology CITE     Open Access  
Journal of Applied Pharmaceutical Sciences and Research     Open Access  
Cephalalgia Reports     Open Access  
Pharmacon : Jurnal Farmasi Indonesia     Open Access  
Pharmacia     Open Access  
Research Results in Pharmacology     Open Access  
Journal of Toxins     Open Access  
Journal of Pharmaceutics & Pharmacology     Open Access  
Natural Product Communications     Open Access  
PharmaTutor     Open Access  
International Journal of Pharmaceutical Sciences and Developmental Research     Open Access  
Toxicological Research     Hybrid Journal  
Current Medical Science     Hybrid Journal  
EUREKA : Health Sciences     Open Access  
Iraqi Journal of Pharmacy     Open Access  
Revista Colombiana de Ciencias Químico-Farmacéuticas     Open Access  
Medicine in Drug Discovery     Open Access  
Frontiers in Medical Technology     Open Access  
International Journal of Medical and Pharmaceutical Case Reports     Open Access  
Asian Journal of Research in Medical and Pharmaceutical Sciences     Open Access  
Journal of Pharmaceutical Health Services Research     Hybrid Journal  
AboutOpen     Open Access  
Current Protocols in Pharmacology     Hybrid Journal  
Medical Cannabis and Cannabinoids     Open Access  
Ukrainian Biopharmaceutical Journal     Open Access  
Pharmaceutical Journal of Sri Lanka     Open Access  
Isan Journal of Pharmaceutical Sciences (IJPS)     Open Access  
Ciencia e Investigación     Open Access  
Jurnal Farmasi Sains dan Komunitas (Journal of Pharmaceutical Sciences and Community)     Open Access  
Toxicon : X     Open Access  
International Journal of Pharmaceutics: X     Open Access  
Jurnal Farmasi dan Ilmu Kefarmasian Indonesia     Open Access  
Open Pharmacology Journal     Open Access  
ExRNA     Open Access  
International Journal of Pharmaceutics & Pharmacology     Open Access  
Antibody Therapeutics     Open Access  
Journal of Faculty of Pharmacy of Ankara University     Open Access  
Iraqi Journal of Pharmaceutical Sciences     Open Access  
Journal of Medicinal Botany     Open Access  
Journal of Medicinal Herbs and Ethnomedicine     Open Access  
International Journal of Pharmacokinetics     Hybrid Journal  
Neuropsychopharmacology Reports     Open Access  
Reviews on Clinical Pharmacology and Drug Therapy     Full-text available via subscription  
SynOpen     Open Access  
Matrix Science Pharma     Open Access  
Contract Pharma     Full-text available via subscription  
Journal of Cellular Neuroscience and Oxidative Stress     Open Access  
Istanbul Journal of Pharmacy     Open Access  
Acta Pharmaceutica Indonesia     Open Access  
Indonesian Journal of Pharmacy     Open Access  
EMC - Cosmetologia Medica e Medicina degli Inestetismi Cutanei     Full-text available via subscription  
High-Throughput     Open Access  
Scientia Pharmaceutica     Open Access  
Trends in Peptide and Protein Sciences     Open Access  
Acta Physiologica Hungarica     Full-text available via subscription  
Jurnal Farmasi Sains dan Praktis     Open Access  
Jurnal Kefarmasian Indonesia     Open Access  
Pharmaceutical Historian     Open Access  
Planta Medica International Open     Open Access  
Archives of Razi Institute     Open Access  
Journal of Pharmaceutical Research     Open Access  
EJNMMI Radiopharmacy and Chemistry     Open Access  
FarmaJournal     Open Access  
Journal of Negative and No Positive Results     Open Access  
Pharmaciana     Open Access  
Folia Medica Indonesiana     Open Access  
Актуальні питання фармацевтичної та медичної науки та практики     Open Access  
International Journal of Pharmacology, Phytochemistry and Ethnomedicine     Open Access  
Фармацевтичний часопис     Open Access  
Ciência Equatorial     Open Access  
Iranian Journal of Pharmaceutical Research     Open Access  
Research & Reviews : A Journal of Drug Design & Discovery     Full-text available via subscription  
Asian Journal of Medical and Pharmaceutical Researches     Open Access  
Research & Reviews : A Journal of Pharmacognosy     Full-text available via subscription  
Ars Pharmaceutica     Open Access  
Pharmacognosy Communications     Partially Free  
Egyptian Pharmaceutical Journal     Open Access  
Pharmacological Reports     Hybrid Journal  
PZ Prisma : Materialien zur Fort- und Weiterbildung     Full-text available via subscription  
Chinese Journal of Pharmaceutical Analysis     Full-text available via subscription  
Journal of Nanopharmaceutics and Drug Delivery     Full-text available via subscription  
Journal of Hydrogels     Full-text available via subscription  
Manufacturing Chemist     Full-text available via subscription  
Pharmaceutica Analytica Acta     Open Access  
Journal of Pharmacovigilance     Open Access  
Current Pharmacology Reports     Hybrid Journal  
Nigerian Journal of Natural Products and Medicine     Full-text available via subscription  
International Journal of Herbs and Pharmacological Research     Open Access  
Bangladesh Journal of Physiology and Pharmacology     Open Access  
Research Journal of Pharmacognosy     Open Access  

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Drugs : Real World Outcomes
Number of Followers: 1  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 2199-1154 - ISSN (Online) 2198-9788
Published by Springer-Verlag Homepage  [2467 journals]
  • Evidence of Accidental Dosing Errors with Immediate-Release Sodium
           Oxybate: Data from the US Food and Drug Administration Adverse Event
           Reporting System

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      Abstract: Introduction Sodium oxybate has been approved by the US Food and Drug Administration (FDA) to treat narcolepsy for 20 years; however, the only available products have been immediate-release (IR) formulations given twice nightly—once at bedtime and a second dose 2.5–4 h later—creating inherent risks with dosing administration errors. Objectives Evidence and risks associated with accidental ingestion of the second IR oxybate dose < 2.5 h after the first dose were examined. Methods The FDA Adverse Event Reporting System database was searched for “inappropriate schedule of product administration” with IR sodium oxybate or calcium/magnesium/potassium/sodium oxybates; reports classified as serious and with IR oxybate as the suspect product were further analyzed. Results Of 541 reports meeting the search criteria, 178 were classified as serious: accidental early administration of the second dose resulting in adverse events (AEs; n = 41); “near miss” (no harm reported following early dosing; n = 9); intentionally taking second dose early (n = 25); other inappropriate use (late dosing/not taking daily; n = 102); and one duplicate report. Of the 41 reports of taking the second dose too early resulting in AEs, 22% (9/41) used emergency services and 27% (11/41) resulted in hospitalizations. AEs reported with accidentally taking the second dose too early included CNS depression, bradycardia, respiratory depression, dizziness, seizure, confusion, delirium, difficulty awakening, drowsiness, falls, nausea, vomiting, and enuresis. Conclusions Patients, caregivers, clinicians, and Poison Control Centers should be aware of the risk of accidentally dosing twice-nightly IR oxybates earlier than 2.5 h after the first dose and the subsequent harm that may occur with early dosing.
      PubDate: 2023-01-20
       
  • Validation of Algorithms to Identify Bone Metastases Using Administrative
           Claims Data in a Japanese Hospital

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      Abstract: Background Validated coding algorithms are essential to generate high-quality, real-world evidence from claims data studies. Objective We aimed to evaluate the validity of the algorithms to identify patients with bone metastases using claims data from a Japanese hospital. Patients and Methods This study used administrative claims data and electronic medical records at Juntendo University Hospital from April 2017 to March 2019. We developed two candidate claims-based algorithms to detect bone metastases, one based on diagnosis codes alone (Algorithm 1) and the other based on the combination of diagnosis and imaging test codes (Algorithm 2). Of the patients identified by Algorithm 1, 100 patients were randomly sampled. Among these 100 patients, 88 patients met the conditions of Algorithm 2; further, 12 additional patients were randomly sampled from those identified by Algorithm 2, thus obtaining a total of 100 patients for Algorithm 2. They were evaluated for their true diagnosis using the patient chart review as the gold standard. The positive predictive value (PPV) was calculated to assess the accuracy of each algorithm. Results For Algorithm 1, 82 patients were analyzed after excluding 18 patients without diagnostic imaging reports. Of these, 69 patients were true positive by chart review, resulting in a PPV of 84.1% (95% confidence interval (CI) 74.5–90.6). For Algorithm 2, 92 patients were analyzed after excluding eight patients whose diagnoses were not judged by chart review. Of these, 76 patients were confirmed positive by chart review, yielding a PPV of 82.6% (95% CI 73.4–89.1). Conclusion Both claims-based algorithms yielded high PPVs of approximately 85%, with no improvement in PPV by adding imaging test conditions. The diagnosis code-based algorithm is sufficient and valid for identifying bone metastases in this Japanese hospital.
      PubDate: 2023-01-18
       
  • Olaparib First-Line Maintenance Monotherapy in BRCA-Mutated Epithelial
           Ovarian Cancer: Descriptive Analysis of the First French Real-World Data
           Study

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      Abstract: Background Olaparib, a poly(ADP-ribose) polymerase inhibitor, was approved by the European Commission in June 2019, following the results of the SOLO-1/GOG 3004 trial as maintenance monotherapy in adult patients with BRCA-mutated epithelial ovarian cancer. Objective This study aimed to provide a descriptive analysis of the first real-world data from patients with BRCA-mutated ovarian cancer who received olaparib as first-line maintenance monotherapy in the French cohort Temporary Authorisation for Use (Autorisation Temporaire d’Utilisation de cohorte, ATUc) programme from 11 March, 2019 to 16 January, 2020. Methods Eligible patients were aged 18 years and over with confirmed epithelial ovarian, primary peritoneal or Fallopian tube cancer and a deleterious or suspected deleterious germline or somatic BRCA 1/2 mutation. Patients were in complete or partial clinical response at the end of first-line platinum-based chemotherapy. Olaparib maintenance therapy was initiated within 8 weeks of the patients’ last dose of chemotherapy. Real-world data were collected through treatment access request forms completed by physicians. Clinical and safety data were collected monthly until the end of the ATUc programme. Results A total of 107 centres in metropolitan France and the French Overseas Departments and Territories requested the inclusion for 238 patients, of whom 194 received maintenance olaparib. In total, 87.6% of the primary tumour locations were ovary, the most common histology was high-grade serous (93.0%) and the most common International Federation of Gynaecology and Obstetrics (Fédération Internationale de Gynécologie et d’Obstétrique) stage was IIIC (56.8%). BRCA testing was performed in routine practice, prior to inclusion into the ATUc programme. All patients had a BRCA mutation: 52.5% had a somatic mutation, 38.4% had a germinal mutation and 9.1% had germinal and somatic mutations. Twenty-four (12%) patients experienced serious adverse drug reactions at the last safety follow-up (17 February, 2020). The most common were anaemia (12 [6%] patients), neutropenia (3 [2%] patients) and thrombocytopenia (3 [2%] patients). Conclusions The rapid enrolment into the ATUc programme highlighted the strong unmet need for patients with ovarian cancer and a BRCA mutation in first-line maintenance treatment. Olaparib was well tolerated and no new safety signals were observed in this real-world patient population.
      PubDate: 2023-01-11
       
  • Safety and Effectiveness of Lenvatinib in Patients with Unresectable
           Hepatocellular Carcinoma in Real-World Clinical Practice: An Observational
           Post-Marketing Study in Japan

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      Abstract: Background Lenvatinib was approved for use in unresectable hepatocellular carcinoma (uHCC) in Japan in 2018. Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clinical settings. Objective This study aimed to evaluate the real-world safety and effectiveness of lenvatinib for uHCC in clinical practice in Japan. Patients and Methods Between July 2018 and January 2019, patients with uHCC who were administered lenvatinib for the first time were enrolled in this prospective, multicenter, observational post-marketing study (NCT03663114). Patients were orally administered lenvatinib and followed up for 12 months. For safety, adverse drug reactions (ADRs) were evaluated. For effectiveness, the objective response rate (ORR) was calculated to evaluate tumor response. Overall survival (OS) was estimated using the Kaplan–Meier method. Results Data of 703 patients (median age, 73 years; 80.2% males) were analyzed. The median (range) treatment duration was 25.3 (0.3–68.9) weeks. The mean ± standard deviation initial dose was 7.37 ± 1.65 mg in patients with body weight < 60 kg and 10.43 ± 2.49 mg in those with body weight ≥ 60 kg. ADRs (any grade) were reported in 84.9% of the patients, with Grade ≥ 3 ADRs reported in 42.5% of the patients. The most common ADRs (> 10%) were decreased appetite, fatigue, hypertension, proteinuria, palmar-plantar erythrodysesthesia, hypothyroidism, and diarrhea. The median OS of the 703 patients was 498.0 days. In 494 patients assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR was 39.5% (95% confidence interval: 35.1–43.9%). Patients with better liver or renal function at baseline achieved significantly higher ORR than those with worse liver or renal function. Conclusions In patients with uHCC in real-world clinical practice in Japan, treatment with lenvatinib was generally well tolerated, and no new safety concerns were identified. The ORR and median OS were similar to or better than the results of the Japanese subset of the global Phase III REFLECT trial. Our results demonstrated that clinically meaningful treatment responses were achieved with lenvatinib in real-world clinical practice.
      PubDate: 2023-01-05
       
  • Retrospective Observational Study of Outcomes in HER2-Positive Metastatic
           Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine
           (T-DM1) and Subsequent Treatments After T-DM1 in the United States

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      Abstract: Background Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies. Objective This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States. Patients and methods Adult patients with HER2-positive (HER2+) metastatic breast cancer (mBC) initiating treatment with T-DM1 between 1/1/2013 and 9/30/2018 were included and followed through 12/31/2018. Data were obtained from the iKnowMed electronic health record. Demographic, clinical, and pre- and post-T-DM1 treatment characteristics were described. The Kaplan-Meier method was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). Results Of 318 patients treated with T-DM1, 184 (57.9%) had prior treatment with pertuzumab. The median age was 58 years. Most patients had visceral disease (93.4%), and 62.3% had two or more prior treatments for mBC before T-DM1 (range 0–9). The most common subsequent regimens were trastuzumab + vinorelbine (22.5%), HER2-targeted monotherapy (22.5%), and trastuzumab + other chemotherapy (19.6%). Median TTD with T-DM1 was 5.9 months (95% confidence interval [CI] 4.6–6.9); median OS from the start of T-DM1 therapy was 19.2 months (95% CI 16.8–24.5). Conclusions Patients treated with T-DM1 in this study appeared to have more advanced disease than patients in clinical trials and were treated in later lines of therapy. Variability was observed across subsequent therapy selections. Treatment patterns and outcomes appeared comparable for patients who received prior pertuzumab. The short treatment durations and survival with T-DM1 therapy in the real-world setting underscore the need for effective post-trastuzumab therapies.
      PubDate: 2022-12-20
       
  • Systematic Literature Review of Real-World Effectiveness Results Data for
           First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic
           Lymphoma

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      Abstract: Background and Objective Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of ibrutinib in the first-line treatment of chronic lymphocytic leukemia in real-world clinical settings. Methods MEDLINE, EMBASE, and relevant conference websites were searched for articles published in the USA from 1 January, 2014 to 30 June, 2020. Overall survival, progression-free survival, overall response rate, and time to next treatment were summarized. Results This analysis included a total of 12 publications representing data from 112 to 2033 patients from community and academic centers, and the multicenter informCLL registry. Patients were predominantly male (60–99%) with a median age range from 62 to 77 years, and included those with high-risk genomic features (del[17p]: 21–33%; del[11q]: 33%; and unmutated immunoglobulin heavy chain variable gene: 59%). Real-world effectiveness with ibrutinib complemented the efficacy demonstrated in randomized clinical trials. Across various studies, the 12-month overall survival rates ranged from 95% to 96%; 18-month overall survival rates were similarly high (91%). Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies. In the studies that reported time to next treatment, 91% and 87% of patients treated with first-line ibrutinib did not initiate new treatment at 12 months and 24 months, respectively. Conclusions This systematic literature review confirms the benefit of ibrutinib as a first-line treatment in patients with chronic lymphocytic leukemia in real-world clinical settings and is consistent with results from randomized clinical trials, including in patients with high-risk genomic features.
      PubDate: 2022-12-19
       
  • Multikinase Inhibitor Treatment Patterns for Advanced Thyroid Cancer in
           Japan: An Administrative Claims Database Study

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      Abstract: Background The multikinase inhibitors (MKIs) sorafenib, lenvatinib, and vandetanib are approved for advanced thyroid cancer (TC) in Japan. How sequential treatment with MKIs is conducted in Japanese clinical practice is unknown. Methods This retrospective observational cohort study used a Japanese administrative claims database (April 2008–September 2021). Patients with a confirmed TC subtype diagnosis of papillary (PTC), follicular (FTC), medullary (MTC), or anaplastic (ATC), who received MKI treatment after TC diagnosis within the index period (June 2014–August 2021), were included. Overall MKI treatment duration was estimated by Kaplan–Meier analysis. Results The analysis population included 795 patients (PTC, N = 447; FTC, N = 86; MTC, N = 32; ATC, N = 230). Median age was ≥ 64 years; most patients (> 60%) were female except for the MTC subgroup (43.8%). First-line (1L) MKI treatment was mainly lenvatinib for PTC (81.7%), FTC (83.7%), and ATC (97.8%), and vandetanib for MTC (62.5%). Among patients discontinuing 1L MKI treatment and evaluable for subsequent therapy [PTC: 57.9% (259/447); FTC: 48.8% (42/86); MTC: 62.5% (20/32); ATC: 70.4% (162/230)], 26.3% (68/259), 21.4% (9/42), 50.0% (10/20), and 4.9% (8/162) of PTC, FTC, MTC, and ATC patients, respectively, received second-line (2L) treatment. Median (95% CI) overall MKI treatment duration was 21.2 (17.9–27.5), 43.9 (30.9–not assessable), 39.0 (17.7–not assessable), and 4.0 (3.0–4.8) months for PTC, FTC, MTC, and ATC, respectively. Conclusion Advanced TC treatment options are limited. In this study, most patients received only 1L MKI treatment; of those who discontinued 1L, ≤ 50% progressed to 2L.
      PubDate: 2022-12-17
       
  • CYP2D6 Substrate Dispensing Among Patients Dispensed Mirabegron: An
           Administrative Claims Analysis

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      Abstract: Background Overactive bladder (OAB) is characterized by the presence of bothersome urinary symptoms. Pharmacologic treatment options for OAB include anticholinergics and β3-adrenergic agonists. Use of β3-adrenergic agonists may result in similar treatment efficacy with a decreased side effect profile compared with anticholinergics because high anticholinergic burden is associated with cardiovascular and neurologic side effects. However, the β3-adrenergic agonist mirabegron, one of two approved drugs within this class, is a moderate cytochrome P450 (CYP) 2D6 inhibitor, and coadministration of drugs that are CYP2D6 substrates with mirabegron may lead to adverse drug effects. Objective The aim of this study was to quantify how often CYP2D6 substrates were dispensed in patients receiving mirabegron among adults of any age and among those ≥ 65 years of age. Methods In this retrospective descriptive analysis, a deidentified administrative claims database in the United States, IQVIA PharMetrics® Plus, was used to identify dispensing claims for CYP2D6 substrates and mirabegron from November 2012 to September 2019. Prevalence of CYP2D6 substrate dispensing was assessed in patients dispensed mirabegron among all adults ≥ 18 years old and additionally among a cohort of those ≥ 65 years old. Patient baseline profiles at the time of mirabegron and CYP2D6 substrate codispensing and at the time of mirabegron dispensing were compared. CYP2D6 substrates were categorized as those with the potential for increased risk of QT prolongation, with anticholinergic properties, with narrow therapeutic index (NTI), contraindicated or having a black box warning when used with CYP2D6 inhibitors, or used for depression or other psychiatric disease. Dispensing data and patient profiles were summarized descriptively. Results Overall, 68.5% of adults ≥ 18 years old dispensed mirabegron had overlapping dispensings for one or more CYP2D6 substrate; 60.6% and 53.6% had overlapping dispensings for CYP2D6 substrates with anticholinergic properties or risk of QT prolongation, respectively. CYP2D6 substrates with NTI, contraindicated with CYP2D6 inhibitors, or for psychiatric use were codispensed in 17.7%, 16.6%, and 38.0% of adult mirabegron users, respectively. Mirabegron users receiving one or more concurrent CYP2D6 substrate were more likely to be older, have more comorbidities and baseline polypharmacy, and have increased healthcare resource utilization compared with those without concurrent CYP2D6 substrates. Commonly codispensed CYP2D6 substrates included hydrocodone, oxycodone, tramadol, metoprolol, and tamsulosin. Findings were similar for patients in the older cohort (≥ 65 years old), with 72.1% receiving overlapping CYP2D6 substrates. Conclusions Codispensing of CYP2D6 substrates, especially those with anticholinergic properties or risk of QT prolongation, was common among adults and older adults receiving mirabegron. Results highlight the need for improved awareness of CYP2D6 substrate prescribing among patients receiving pharmacologic treatment for OAB that inhibits the CYP2D6 pathway.
      PubDate: 2022-12-02
       
  • Treatment Patterns, Clinical Outcomes and Health Care Resource Utilisation
           in Patients with EGFR-mutated Metastatic Non-Small Cell Lung Cancer: A
           Real-World Study in South Korea

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      Abstract: Background Despite the dynamic treatment landscape for EGFR mutant-positive metastatic non-small cell lung cancer (EGFRm+ mNSCLC), most of the earlier studies have focused on US or Western populations. Objective The objective of this study was to explore real-world treatment patterns and outcomes of South Korean patients with EGFRm+ mNSCLC. Methods Retrospective chart review of adult patients with EGFRm+ mNSCLC who received systemic treatment between January-2019 and June-2019. Results A total of 162 patients were included from 21 hospitals, with a median follow-up of 15.6 months. Median age was 65.0 years, 22% had central nervous system metastasis, and 57% and 38% had exon 19 deletion and exon 21 L858R, respectively. Among 144 patients (89%) who received first-line EGFR-tyrosine kinase inhibitor, afatinib was most the common (44%), followed by gefitinib (28%) and erlotinib (13%). First-line chemotherapy was more common when an EGFR-mutation was detected after versus before first-line treatment initiation (31% vs 5%). Discontinuation of first-line treatment was mostly due to disease-progression (81%) and toxicity (7%). Among 58 (78%) patients who received second-line treatment, osimertinib was the most common (40%). Most (60%) patients reported ≥1 Grade ≥3 adverse event during first-line treatment. Following initiation of first-line treatment, physician visits and chest X-rays were the most frequent healthcare utilisation events. Rates of emergency-room visits and hospitalization were 12% and 16%, respectively, with a mean length-of-stay of 10.4 days. At 12 months, overall survival rate was 95%, and numerically worse for patients with exon 21 versus 19 mutations. Conclusions Characteristics and clinical outcomes of Korean patients with EGFRm+ mNSCLC in real-world practice were comparable to those observed in clinical trials. As osimertinib was not reimbursed for first-line treatment before study completion, further investigation is warranted to explore evolving treatment practice.
      PubDate: 2022-12-02
       
  • Treatment Pathways and Health Outcomes of German Patients with Chronic
           Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell
           Transplantation: A Retrospective Health Claims Data Analysis

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      Abstract: Background Although chronic graft-versus-host-disease (cGvHD) is an important long-term complication after allogenic hematopoietic cell transplantation (allo-HCT) and is associated with increased healthcare resource utilization, real-world evidence is scarce. Objectives The aim of the study was to evaluate survival of patients with cGvHD in Germany and to analyze hospitalization and treatment patterns. Patients and Methods Based on a German claims database with 4.9 million enrollees, a retrospective longitudinal analysis covering a 6-year period between 2013 and 2018 was conducted. Patients with allo-HCT in 2014 or 2015 (index date) and no record of transplantation or documentation of GvHD 365 days prior to index were included. Patients who subsequently developed a cGVHD were compared with those who did not develop a cGVHD within 3 years after index date. cGVHD cases were identified based on documented International Classification of Diseases, Tenth Revision (ICD-10) diagnosis and treatment algorithms. Since the onset of cGvHD is defined at 100 days after allo-HCT, only those alive beyond day 100 were considered in the survival analysis. Patients who did not survive the first 100 days after allo-HCT were censored to prevent a selection bias due to early mortality within patients without GvHD. Survival rates were plotted using the Kaplan–Meier estimator. The number of hospitalizations and average lengths of stay as well as treatment patterns were descriptively examined. Results Overall, 165 cGvHD patients were identified and compared with 43 patients without cGVHD. Short-term survival rates were better for patients with cGvHD; the 6-month survival probability was 95.8% for patients with cGVHD and 83.7% for patients without cGVHD. However, long-term survival was better in patients without GvHD; The 30-month survival probability was 65.5% for patients with cGVHD and 76.7% for patients without cGVHD. While overall 90% of cGvHD patients were hospitalized at least once, the share was only half for patients without GvHD (44%). 78.2% of patients with cGVHD received corticosteroids in combination with other predefined immunosuppressants. Conclusion Findings from this study reveal a high disease burden associated with cGvHD. This underlines the high medical need for new interventional strategies to improve survival and morbidity after allo-HCT.
      PubDate: 2022-12-01
       
  • Drug-Induced QT Prolongation and Torsade de Pointes in Spontaneous Adverse
           Event Reporting: A Retrospective Analysis Using the Japanese Adverse Drug
           Event Report Database (2004–2021)

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      Abstract: Background Drugs with new mechanisms of action are continually being developed, but it is difficult to capture whether a drug induces QT prolongation/torsade de pointes (TdP) in preclinical and preapproval clinical trials. Objective To evaluate drugs associated with drug-induced QT prolongation/TdP using a real-world database in Japan. Patients and methods A search was performed in the Japanese Adverse Drug Event Report (JADER) database for QT prolongation and TdP. The reporting odds ratio (ROR) was calculated to identify potential drug-induced QT prolongation/TdP association. Results Among the reported 4,326,484 data entries, 3410 patients exhibited QT prolongation/TdP (2707 with QT prolongation, 703 with TdP) with the suspected drugs. Of these patients, 53.9% were females. The highest occurrence was in the 70- to 79-year-old age group (24.7%). The most common types of drugs involved were cardiovascular drugs, central nervous system (CNS) drugs, anticancer drugs, and anti-infective drugs; the rate of overdose was reportedly very low at 1.6%. The highest adjusted RORs were observed for nifekalant (351.41, 95% confidence interval (CI) 235.85–523.59), followed by vandetanib (182.55, 95% CI 108.11–308.24), evocalcet (181.59, 95% CI 132.96–248.01), bepridil (160.37, 95% CI 138.17–186.13), diarsenic trioxide (79.43, 95% CI 63.98–98.62), and guanfacine (78.29, 95% CI 58.51–104.74). Among the drugs launched in Japan during the last decade, vandetanib had the highest adjusted RORs. Conclusions This study using the JADER database showed that antiarrhythmic drugs, calcium-sensing receptor agonists, small-molecule targeted anticancer drugs, and CNS drugs are associated with QT prolongation/TdP. Further pharmacoepidemiological studies, such as cohort studies using large databases, are needed to prove these causal relationships.
      PubDate: 2022-12-01
       
  • Adverse Drug Events Related to Common Asthma Medications in US
           Hospitalized Children, 2000–2016

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      Abstract: Background The reduction in adverse drug events is a priority in healthcare. Medications are frequently prescribed for asthmatic children, but epidemiological trends of adverse drug events related to anti-asthmatic medications have not been described in hospitalized children. Objective The objective of this study was to report incidence trends, risk factors, and healthcare utilization of adverse drug events related to anti-asthmatic medications by major drug classes in hospitalized children in the USA from 2000 to 2016. Methods A population-based temporal analysis included those aged 0–20 years who were hospitalized with asthma from the 2000 to 2016 Kids Inpatient Database. Age-stratified weighted temporal trends of the inpatient incidence of adverse drug events related to anti-asthmatic medications (i.e., corticosteroids and bronchodilators) were estimated. Stepwise multivariate logistic regression models generated risk factors for adverse drug events. Results From 2000 to 2016, 12,640 out of 698,501 pediatric asthma discharges (1.7%) were associated with adverse drug events from anti-asthmatic medications. 0.83% were adverse drug events from corticosteroids, resulting in a 1.14-fold increase in the length of stay (days) and a 1.42-fold increase in hospitalization charges (dollars). The overall incidence (per 1000 discharges) of anti-asthmatic medication adverse drug events increased from 5.3 (95% confidence interval [CI] 4.6–6.1) in 2000 to 21.6 (95% CI 18.7–24.6) in 2016 (p-trend = 0.024). Children aged 0–4 years had the most dramatic increase in the incidence of bronchodilator adverse drug events from 0.2 (95% CI 0.1–0.4) to 19.3 (95% CI 15.2–23.4) [p-trend ≤ 0.001]. In general, discharges among asthmatic children with some comorbidities were associated with an approximately two to five times higher odds of adverse drug events. Conclusions The incidence of adverse drug events from common anti-asthmatic medications quadrupled over the past decade, particularly among preschool-age children who used bronchodilators, resulting in substantial increased healthcare costs. Those asthmatic children with complex medical conditions may benefit the most from adverse drug event monitoring.
      PubDate: 2022-12-01
       
  • Prophylactic Antimicrobial Prescribing in Australian Residential Aged-Care
           Facilities: Improvement is Required

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      Abstract: Background and Objective Inappropriate antimicrobial use can lead to adverse consequences, including antimicrobial resistance. The objective of our study was to describe patterns of prophylactic antimicrobial prescribing in Australian residential aged-care facilities and thereby provide insight into antimicrobial stewardship strategies that might be required. Methods Annual point prevalence data submitted by participating residential aged-care facilities as part of the Aged Care National Antimicrobial Prescribing Survey between 2016 and 2020 were extracted. All antimicrobials except anti-virals were counted; methenamine hippurate was classified as an antibacterial agent. Results The overall prevalence of residents prescribed one or more prophylactic antimicrobial on the survey day was 3.7% (n = 4643, 95% confidence interval 3.6–3.8). Of all prescribed antimicrobials (n = 15,831), 27.1% (n = 4871) were for prophylactic use. Of these prophylactic antimicrobials, 87.8% were anti-bacterials and 11.4% antifungals; most frequently, cefalexin (28.7%), methenamine hippurate (20.1%) and clotrimazole (8.8%). When compared with prescribing of all antimicrobial agents, prophylactic antimicrobials were less commonly prescribed for pro re nata administration (7.0% vs 20.3%) and more commonly prescribed greater than 6 months (52.9% vs 34.1%). The indication and review or stop date was less frequently documented (67.5% vs 73.8% and 20.9% vs 40.7%, respectively). The most common body system for which a prophylactic antimicrobial was prescribed was the urinary tract (54.3%). Of all urinary tract indications (n = 2575), about two thirds (n = 1681, 65.3%) were for cystitis and 10.6% were for asymptomatic bacteriuria. Conclusions Our results clearly identified immediate antimicrobial stewardship strategies that aim to improve prophylactic antimicrobial prescribing in Australian residential-aged care facilities are required.
      PubDate: 2022-12-01
       
  • Retrospective Cohort Evaluating the Comparative Effectiveness of
           Ceftaroline and Daptomycin as First-Line Therapies for Inpatient Treatment
           of Diabetic Foot Infection in the United States Veterans Health Care
           System

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      Abstract: Background Both ceftaroline and daptomycin are possible therapeutic options for diabetic foot infection (DFI) and both are active against methicillin-resistant Staphylococcus aureus (MRSA) infection; however, no previous studies have evaluated their effectiveness head-to-head. Objective This study compared hospital readmission and mortality proportions among patients receiving ceftaroline fosamil or daptomycin for DFI. Patients and Methods This was a retrospective cohort, comparative effectiveness study of adults (aged ≥ 18 years) admitted to United States Veterans Health Care System hospitals with a diagnosis code for DFI between 1 October 2010 and 30 September 2014 with an electronic order for ceftaroline or daptomycin as first-line therapy within 14 days of admission. Baseline characteristics were compared using Chi-square, Fisher's exact, and Wilcoxon rank-sum tests. Hospital readmission and patient mortality proportions were compared through multivariable logistic regression models with Hispanic ethnicity, prior hospitalization, dyslipidemia, and Charlson comorbidity score as covariates. Results In total, 223 patients were included (ceftaroline, n = 71; daptomycin n = 152). At baseline, ceftaroline patients were more likely to be Hispanic (18 vs. 6%, p < 0.01) and have been hospitalized in the past 90 days (34 vs. 19%, p = 0.02). Unadjusted 90-day hospital readmission proportions for ceftaroline versus daptomycin were 34 vs. 49%, and unadjusted 90-day mortality proportions were 1% vs. 8%. In multivariable models, ceftaroline patients were less likely to experience 90-day hospital readmission (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.25–0.85) and 90-day mortality (OR 0.14, 95% CI 0.01–0.77). Conclusions In this population, ceftaroline was associated with lower 90-day hospital readmission and 90-day mortality compared with daptomycin when used as first-line therapy for DFI.
      PubDate: 2022-12-01
       
  • Factors Associated with Discontinuation of Statin Therapy in Patients with
           Lymphoma Aged 80 Years and Older: A Retrospective Single-Institute Study

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      Abstract: Background There is little evidence to support or negate the benefits of statin therapy for primary prevention of cardiovascular disease (CVD) in lymphoma patients aged 80 years or older. Objective We evaluated comprehensive geriatric assessment (CGA) scores and previously reported risk factors for failure of statin therapy discontinuation in lymphoma patients aged 80 years and older with the aim of identifying those in whom discontinuation of statins for primary CVD prevention is indicated. Patients and methods Our study cohort comprised 50 patients aged 80 years and older treated with chemotherapy for lymphoma at our institute from January 2011 to July 2020. We retrospectively analyzed the associations between CGA, including Geriatric 8, instrumental activities of daily living, and Charlson comorbidity index, and previously reported factors associated with failure of statin therapy discontinuation, defined as reintroduction of statins after their discontinuation, in this patient cohort. Results Twenty years or less of statin therapy was an independent predictor of failure of statin therapy discontinuation (hazard ratio 8.240, 95% confidence interval 1.380–49.10). There were significant differences in the rate of failure of statin discontinuation between patients receiving statins for ≥ 20 years versus < 20 years (p = 0.010). Multivariate analysis of CGA-related scores identified no significant risk factors for failure of statin discontinuation. Conclusions Discontinuation of statin therapy may be indicated in lymphoma patients aged 80 years and older who have used statins for 20 years or more.
      PubDate: 2022-12-01
       
  • Increased Risk of Stroke Due to Non-adherence and Non-persistence with
           Direct Oral Anticoagulants (DOACs): Real-World Analyses Using a Nested
           Case–Control Study from The Netherlands, Italy and Germany

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      Abstract: Background A high degree of adherence to direct oral anticoagulants is essential for reducing the risk of ischaemic stroke and systemic embolism in patients with atrial fibrillation, owing to the rapid decline in anticoagulation activity when doses are omitted (i.e. rebound effect). Objective We aimed to assess the relationship between non-adherence and non-persistence with direct oral anticoagulants and the incidence of ischaemic stroke in patients with atrial fibrillation. Methods A nested case–control study was conducted in the Netherlands, Italy and Germany among patients with atrial fibrillation starting direct oral anticoagulants between the drug approval date and the end of database availability. Patients with an ischaemic stroke during the follow-up were selected as cases and compared with matched controls (matched on age ± 5 years, sex, year of cohort entry date and CHA2DS2-VASc-score at cohort entry date). The cohort entry date was the first dispensing date. Study patients were those aged ≥ 45 years, with ≥ 1 year database history, ≥ 1 year follow-up and at least two direct oral anticoagulant dispensings after the cohort entry date. Adherence and persistence to direct oral anticoagulant treatment were defined as the proportion of days covered ≥ 80% or direct oral anticoagulant continuous use between the cohort entry date and the index date (i.e. date of ischaemic stroke), respectively. Results In The Netherlands, Italy and Germany, 105 cases and 395 controls, 1580 cases and 6248 controls, and 900 cases and 3570 controls were included, respectively. Odds ratios (ORs) for stroke among current users who were non-adherent compared to adherent users were 0.43 (95% confidence interval [CI] 0.09–1.96) in The Netherlands, 1.11 (95% CI 0.98–1.26) in Italy and 1.21 (95% CI 1.01–1.45) in Germany. The risk of stroke was significantly higher among non-persistent users compared with persistent users in all three databases [OR 1.56 (95% CI 1.00–2.44), OR 1.48 (1.32–1.65) and OR 1.91 (95% CI 1.64–2.22), respectively]. In The Netherlands and Germany, the risk of stroke was higher the longer a patient had stopped using direct oral anticoagulants. Conclusions Both non-adherence (in Germany) and non-persistence increased the risk of stroke, either using a once-daily or twice-daily regime.
      PubDate: 2022-12-01
       
  • Osteonecrosis of the Jaw Caused by Denosumab in Treatment-Naïve and
           Pre-Treatment with Zoledronic Acid Groups: A Time-to-Onset Study Using the
           Japanese Adverse Drug Event Report (JADER) Database

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      Abstract: Background Medication-related osteonecrosis of the jaw is a serious adverse event associated with bone-modifying agents, such as injectable bisphosphonate (zoledronic acid) and the anti-receptor activator of nuclear factor-κB ligand antibody (denosumab). Objective This study aims to evaluate and compare the time-to-onset profile for medication-related osteonecrosis of the jaw associated with denosumab between treatment-naïve (naïve group) and pre-treatment with zoledronic acid (post-zoledronic acid group) patients using the Japanese Adverse Drug Event Report database. Methods Medication-related osteonecrosis of the jaw was defined according to the Medical Dictionary for Regulatory Activities. The medication-related osteonecrosis of the jaw onset profiles were evaluated using the Weibull shape parameter and the log-rank test. Results The Japanese Adverse Drug Event Report database contains 632,409 reports published between April 2004 and March 2020. In the time-to-onset analysis, after extracting the combinations with complete information for the treatment start date and the medication-related osteonecrosis of the jaw onset date, 272 reports of the naïve group and 86 reports of the post-zoledronic acid group were analyzed. The median onset in the naïve and post-zoledronic acid groups was 487.0 (25–75%: 274.0–690.8) and 305.5 (25–75%: 158.3–508.5) days, respectively. Medication-related osteonecrosis of the jaw occurred earlier in the post-zoledronic acid group than in the naïve group, and the log-rank test demonstrated a significant difference in their time transitions (p < 0.0001). Conclusions The results indicated a risk of medication-related osteonecrosis of the jaw in naïve and post-zoledronic acid groups and a shorter onset time in the latter than in the former. Thus, healthcare professionals should take the early risk of medication-related osteonecrosis of the jaw into account when switching patients from zoledronic acid to denosumab treatment.
      PubDate: 2022-12-01
       
  • Acknowledgement to Referees

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      PubDate: 2022-11-23
       
  • Trends in the Use of Sedative-Hypnotics, Opioids, and Neuromuscular
           Blockers in Hospitalized Patients During the COVID-19 Pandemic:
           Observational Retrospective Study

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      Abstract: Background The coronavirus disease 2019 (COVID-19) pandemic has increased the use of drugs administered for mechanical ventilation, leading to shortages in some countries. Objective The aim was to identify trends in the consumption of sedatives, hypnotics, neuromuscular blockers, and opioids used for anesthetic induction and deep sedation in hospitals in Colombia. Method This was a descriptive, longitudinal, and retrospective study with monthly follow-up of sedative, hypnotic, opioid, and neuromuscular blocker dispensing in 20 clinics and hospitals from January to November 2020. The frequencies of use of each drug and variations in the institutions and intensive care units (ICUs) were identified. Results A total of 1,252,576 units of the analyzed drugs were delivered to 79,094 treated patients, 55.0% of whom were women (n = 43,521). The drugs with the greatest increase in consumption were rocuronium (1058% variation in March–November) and propofol (511%). The consumption of midazolam and vecuronium initially increased, but by the end of the study period, it decreased. Among drugs dispensed only in ICUs, 920,170 units were delivered (73.5% of the drugs dispensed during the study), and the most often dispensed drugs were fentanyl (n = 251,519; 27.3% of the drugs used in the ICU) and midazolam (5 mg/5 mL) solution (n = 188,568; 20.5%). Specifically in the ICU, the drugs with the greatest increase in use were rocuronium (19,709%), propofol (2622%), and ketamine (2591%). Conclusion Rapid changes in the use of drugs were evident, which demonstrates the need for closer cooperation among treating physicians, service providers, pharmaceutical managers, and state institutions to maintain a sufficient and timely supply of critical drugs in this type of contingency.
      PubDate: 2022-11-03
      DOI: 10.1007/s40801-022-00337-z
       
  • Clinical Characteristics of Registry Participants with Psoriatic Arthritis
           Initiating Guselkumab: An Analysis from the CorEvitas Psoriatic
           Arthritis/Spondyloarthritis Registry

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      Abstract: Background The monoclonal antibody guselkumab is the first selective inhibitor of the interleukin-23 p19 subunit approved to treat adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Given its recent approval for active PsA, data describing patients with PsA initiating guselkumab outside of clinical trials are limited. Objective This analysis describes characteristics of patients with rheumatologist-diagnosed PsA initiating guselkumab in the US-based, prospective, observational CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Methods Demographics, lifestyle/disease characteristics, comorbidities, prior treatment, and disease activity were summarized for patients with PsA initiating guselkumab from registry inception through 30 September, 2021. Results Of 113 patients initiating guselkumab, the majority were female (63%), obese (67%), had psoriasis (89%), and initiated guselkumab as monotherapy (81%). Common comorbidities were hypertension (32%), depression (30%), and diabetes mellitus (26%). Mean tender (6.8) and swollen (2.0) joint counts, clinical Disease Activity Index for PsA score (19.1), and 57% of participants with ≥ 3% body surface area affected by psoriasis indicated moderate disease activity. Axial involvement was identified in 49% of patients. Median patient-reported pain and fatigue visual analog scale scores (0–100) were 60 and 59, respectively. Prior to guselkumab, 76% of patients had received two or more biologic disease-modifying antirheumatic drugs; the last therapy prior to guselkumab was a biologic disease-modifying antirheumatic drug in 81% of patients. Conclusions Registry participants with PsA initiating guselkumab had active peripheral joint and skin disease, with substantial pain and fatigue; a considerable proportion had axial involvement. Future studies will evaluate the effectiveness of guselkumab in this population.
      PubDate: 2022-10-15
      DOI: 10.1007/s40801-022-00326-2
       
 
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