Navigating the Biosimilars from Bench to Bedside in Juvenile Idiopathic Arthritis.

The use of biosimilars is constantly growing, prompting healthcare payers to encourage the switch to these drugs which are less expensive than the reference bio-originator. While switching from a bio-originator to a biosimilar is supported by increasing evidence, data on the switch between different biosimilars of the same reference product are scant. Our study aimed to evaluate the effectiveness of the non-medical switch both between adalimumab (ADA) bio-originator and SB5 biosimilar and between two different ADA biosimilars in patients with inflammatory chronic arthritis. We observed adult patients with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) treated with ADA bio-originator or ABP501 ADA biosimilar (Amgevita) who switched to SB5 ADA biosimilar (Imraldi) for administrative/economic reasons. Patients were followed up for 4 months. One hundred and ten patients [33 RA, 40 PsA, 37 axSpA; F:M= 49:61; median age 56 years (25th-75th percentile 48-66)] switched from ADA bio-originator to SB5. After 4 months (T4), we observed a significant reduction of patients in remission/low disease activity (baseline 92.7% vs. T4 80.9%; p=0.009), with a risk of moderate-high disease activity significantly higher after the switch [RR 2.6 (95% IC 1.2 to 5.7), p=0.01]. However, no differences were found in DAS28-CRP, DAPSA, ASDAS-CRP, and BASDAI, while patients with RA and PsA experienced a worsening in the patient global assessment-VAS (p=0.04 and p=0.02, respectively), and in patients with PsA a worsening in HAQ was also observed (p=0.03). Forty patients switched from ABP501 biosimilar to SB5 [12 with RA, 25 with PsA, and 3 with axSpA; F:M=24:16; median age 56 years (25th-75th percentile 44-66)]. After 4 months, no differences in DAS28-CRP and DAPSA nor in the percentage of patients in remission/low disease activity were found compared to baseline. Likewise, no differences were found in patient-reported outcomes (PROs). Our results provide a reassuring profile of effectiveness when switching from ADA originator to one of its biosimilars and between two different biosimilars. However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients.

BackgroundAlthough biosimilars are routinely used in adults with musculoskeletal diseases, there are limited data regarding the use of biosimilars in patients with juvenile idiopathic arthritis(JIA).ObjectivesTo describe the characteristics of patients...

Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment. Nowadays, while biologic drugs comprise various vital therapeutic options for patients, they can be associated to significant costs to healthcare systems. The most crucial benefit of biosimilars is that they bring more significant cost reduction and increase access to advanced therapies. They also allow the treatment of newly diagnosed patients and dose optimization for those who need it. There is an inverse relationship between price and demand for treatment with biologics. For a more significant reduction in cost to be possible, greater use of biosimilars is necessary. For this to occur, it is imperative not only to use biosimilars in naïve patients but also to switch to biosimilars in those patients who have started therapy with reference biologics. At present, randomized and observational studies have demonstrated effectiveness and safety results in recommending a single switch between a reference product and a biosimilar, and vice versa. The purpose of this manuscript is to review the literature and discuss whether scientific evidence is enough to support multiple switches of biologics and biosimilars in IBD patients.

BackgroundBiosimilars are highly similar to reference products and can help in reducing the financial burden and medication underutilization while still being comparable to reference products in treating rheumatic diseases[1].ObjectivesThe objective...

Selected Developments in Biotechnology Law and the Biotechnology Industry

Prescription drug shortages have become increasingly common and more severe over the past decade. In addition, reported shortages are longer in duration and have had a greater effect on patient care. Some of the causes of current drug shortages are multifactorial, including the consolidation of drug manufacturers, quality problems at production plants that restrict the supply of drugs, and a lack of financial incentives for manufacturers to produce certain products, particularly generic medications. Generic injectable medications are most commonly affected by shortages because the production process is complex and costly for these drugs, and profit margins are often smaller than for branded medications. Many commonly used emergency department (ED) generic injectables have been affected by shortages, including multiple resuscitation and critical care drugs. Several reports have shown that shortages can potentially have major effects on the quality of medical care, including medication errors, treatment delays, adverse outcomes, and increased health care costs. Currently, no published data exist outside of case reports that directly link ED-based drug shortages to overall patient safety events; however, there are several examples in the ED where first-line therapies for life-saving medications have been in short supply, and alternatives have higher rates of adverse events, narrower therapeutic indexes, or both. Aside from increasing notification about shortages, the U.S. Food and Drug Administration has little power to coerce manufacturers to produce medications during a shortage. Therefore, ED providers must learn to mitigate the effects of shortages locally, through active communication with pharmacy staff to identify safe and effective alternatives for commonly used medications when possible. Particularly given the effect on critical care medications, therapeutic alternatives should be clearly communicated to all staff so that providers have easy access to this information during resuscitations. This review focuses on the etiology of drug shortages, their effect on the ED, and potential solutions and mitigation strategies.

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of North American (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists in North America. It is important to realize that guidelines cannot always account for individual variation among patients. They are assessments of current scientific and clinical information provided as an educational service; are not continually updated and may not reflect the most recent evidence (new evidence may emerge between the time information is developed and when it is published or read); should not be considered inclusive of all proper treatments methods of care, or as a statement of the standard of care; do not mandate any particular course of medical care; and are not intended to supplant physician judgment with respect to particular patients or special clinical situations. Whether and the extent to which to follow guidelines is voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances. Although IDSA, AAN, and ACR make every effort to present accurate, complete, and reliable information, these guidelines are presented “as is” without any warranty, either express or implied. IDSA, AAN, and ACR (and their officers, directors, members, employees, and agents) assume no responsibility for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with these guidelines or reliance on the information presented. The guidelines represent the proprietary and copyrighted property of IDSA, AAN, and ACR. Copyright 2020 Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology. All rights reserved. No part of these guidelines may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of IDSA, AAN, or ACR. Permission is granted to physicians and healthcare providers solely to copy and use the guidelines in their professional practices and clinical decision-making. No license or permission is granted to any person or entity, and prior written authorization by IDSA, AAN, or ACR is required, to sell, distribute, or modify the guidelines, or to make derivative works of or incorporate the guidelines into any product, including but not limited to clinical decision support software or any other software product. Except for the permission granted above, any person or entity desiring to use the guidelines in any way must contact IDSA, AAN, or ACR for approval in accordance with the terms and conditions of third party use, in particular any use of the guidelines in any software product. Summarized below are the 2020 recommendations for the prevention, diagnosis, and treatment of Lyme disease. The panel followed a systematic process used in the development of other Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) clinical practice guidelines, which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation) (see Figure 1). A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text (http://onlinelibrary.wiley.com/doi/10.1002/acr.24495/abstract). A. Personal protective measures B. Repellents to prevent tick bites C. Removal of attached ticks A. Diagnostic tick testing B. Diagnostic testing of asymptomatic patients following tick bites Supplementary data. Supplementary materials (in addition to the full guideline) are available on the Arthritis Care & Research website at http://onlinelibrary.wiley.com/doi/10.1002/acr.24495/abstract. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Conflict of interest statement. See the Methodology section in the full guideline (on the Arthritis Care & Research website at http://online​library.wiley.com/doi/10.1002/acr.24495/abstract) for approach to conflict of interest (COI) by the IDSA/AAN/ACR COI review group. The following list is a reflection of what has been reported to the IDSA/AAN/ACR COI review group. To provide thorough transparency, the IDSA/AAN/ACR requires full disclosure of all relationships, regardless of relevancy to the guideline topic. The assessment of disclosed relationships for possible COI is based on the relative weight of the financial relationship (i.e., monetary amount) and the relevance of the relationship (i.e., the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). The reader of these guidelines should be mindful of this when the list of disclosures is reviewed. Dr. Lantos has received research funding from the National Cytomegalovirus Foundation and from the NIH and educational funding from Duke University; and has served as a consultant and reviewed trial protocol for Frederick O’Connor Medical Consultants, LLC. Dr. Bockenstedt has received research funding from the NIH and the Gordon and Llura Gund Foundation; has received remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research; and was awarded an endowed professorship as the Harold W. Jockers Professor of Medicine at Yale University. Dr. Falck-Ytter serves as director of the Evidence Foundation and the GRADE Network; conducts GRADE workshops with the Evidence Foundation; has served as the chair of the Guidelines Committee for the American Gastroenterological Association; and has received research funding from the Cleveland VA Medical Research and Education Foundation. Dr. Aguero-Rosenfeld serves as a council member for the New York City chapter of the American Society of Microbiology (ASM) and as a Board member of the American Lyme Disease Foundation; has provided legal testimony and consultation regarding Lyme disease and tick-borne diseases; and has received research grants from the NIH, BioFire, New York State Department of Health, and ViraMed. Dr. Auwaerter receives research funding from the Fisher Center for Environmental Infectious Diseases and the NIH; serves on the Board of Directors of the American Lyme Disease Foundation and as the Vice Chair of the Infectious Diseases Society of America (IDSA) Foundation; serves as a scientific advisor for DiaSorin, Adaptive Technologies, and Shionogi; provides legal expert opinion testimony regarding Lyme disease; had stock in Johnson & Johnson; has served as an editor for Johns Hopkins POC-IT ABX Guide, an advisor for the Food and Drug Administration (FDA), Genentech, Dynavax, Aradigm, Cempra, BioMérieux, Cerexa, and Medscape; has received research funding from Cerexa; has served on the FDA Advisory Board, the Medscape Advisory Board, and the IDSA Board of Directors; and his spouse has equity interest in venture capital–funded Capricor. Dr. Belani reviews non-continuing medical education (CME) lectures for and received honoraria and travel reimbursement from Horizon Therapeutics; and has received research funding from the NIH and the Children’s Hospitals and Clinics of Minnesota. Dr. Bowie has provided expert testimony to the Canadian Senate Subcommittee on Bill C-442: An Act Respecting a National Lyme Disease Strategy on behalf of the Association of Medical Microbiology and Infectious Disease Canada; and has received research funding from GlaxoSmithKline, Pfizer Canada, the Canadian Institutes of Health Research, and Vancouver Coastal Health Research Institute. Dr. Branda receives research funding from the Lyme Disease Biobank Foundation and Zeus Scientific; serves as a scientific advisor and consultant to DiaSorin, Inc.; has served as a scientific advisor and consultant for T2 Biosystems; has served on the scientific advisory board of Roche Diagnostics and AdvanDx; has received research funding from Karius, Inc., Alere, Inc., T2 Biosystems, BioMérieux, TBS Technologies, Immunetics, Inc., DiaSorin, Inc., Kephera Diagnostics, Inc., and the Bay Area Lyme Foundation; has participated in unfunded research collaborations with Karius Inc. and Kephera Diagnostics; was a member of the editorial board of the Journal of Clinical Microbiology; was a co-inventor on an application for a patent to protect intellectual property; and his spouse is an employee of Informed DNA. Dr. Clifford receives research funding from the NIH and the Alzheimer’s Association; serves as scientific consultant to Inhibikase and Excision BioTherapeutics; serves on Data and Safety Monitoring Boards (DSMB) for Biogen, Genzyme/Sanofi, Genentech, EMD Serono, Shire, Wave Life Sciences, Pfizer, Atara, Mitsubishi Tanabe, and IQVIA (formerly Quintiles); serves on Progressive Multifocal Leukoencephalopathy (PML) adjudication committees for Amgen, GlaxoSmithKline, EMD Serono, Bristol Myers Squibb, Roche, and the Takeda Oncology (formerly Millennium) Adjudication Committee–FDA, as well as Dr. Reddy’s Laboratories; has previously received research funding from the NIH; and his spouse formerly held stock in Johnson & Johnson. Dr. DiMario has received research funding from Novartis. Dr. Halperin serves as an Editorial Board Member of Neurology, and Vice Chair of the American Academy of Neurology (AAN) Guideline Subcommittee; has stock in Abbott Labs, AbbVie, Merck, and Johnson & Johnson; provides and has previously provided legal expert testimony defending physicians in medical malpractice cases on various neurologic issues, including Lyme disease; has received research funding from NIH, the Centers for Disease Control and Prevention (CDC); and has served as a section editor of neuroinfectious diseases in Neurology & Neuroscience Reports. Dr. Krause receives research funding from the Yale Emerging Infections Program; receives remuneration from Gold Standard Diagnostics for a collaborative research project; has stock in Gilead Sciences and First Trust NASDAQ Pharmaceuticals ETF; has received research funding from the NIH, the Centers for Disease Control and Prevention (CDC), the Gordon and Llura Gund Foundation, and L2 Diagnostics for NIH-sponsored research; has served as a scientific consultant and provided medical education and training for Oxford Immunotec, Inc.; has a patent pending (Enhanced Chemiluminescent enzyme-linked immunosorbent assay for detection of antibodies against Babesia microti), for which US Provisional Patent Application No. 62/580,588, was filed on November 2, 2017; serves on the Board of Directors for the American Lyme Disease Foundation and the Editorial Boards of Pathogens and Plos Neglected Tropical Diseases and the Editorial Advisory Board of Clinical Infectious Diseases; was on the Editorial Board of Journal of Clinical Microbiology, and will be on the Editorial Board of Clinical Microbiology Reviews starting January 2021. Dr. Liang has stock in Johnson & Johnson; received research funding from the Veterans Health Administration, the Arthritis Foundation, and the NIH; has served on the FDA Advisory Panel, Institute of Medicine panels; served as a scientific reviewer for the Research Grant Council of Hong Kong and the NIH; served on the Board of the Lupus Clinical Trials Consortium, Beacon Hill Villages, and Rx Foundation and advised the Institute for Clinical and Economic Review and the China Medical Board; previously had stock in Sequenom; and his spouse has stock in Johnson & Johnson. Dr. Meissner is a current member of the CDC Workgroups and serves as a volunteer consultant on the American Academy of Pediatrics Committee on Infectious Diseases and the NIH DSMB. Dr. Nigrovic receives research funding from the NIH, Department of Defense, and the NIH Center for Research Resources and for Advancing Translational Sciences (NCATS), Global Lyme Alliance, and Peabody Foundation; serves on the Editorial Board for Annals of Emergency Medicine; has served as scientific consultant for Adaptive Technologies; has received research funding from the NIH, Provider and Payer Quality Initiative (PPQI) Research Foundation, Harvard Catalyst, Hood Foundation, Bay Area Lyme Foundation, CDC, Emergency Medical Services for Children (EMSC), the National Patient-Centered Clinical Research Network (PCORNet), Milton Foundation, and Boston Children’s Hospital. Dr. Nocton receives research funding from Bristol Myers Squibb; serves as a member of the Subboard of Pediatric Rheumatology of the American Board of Pediatrics; and has received research funding from AbbVie, NIH, and the Arthritis Foundation. Dr. Pruitt has received research funding from Teva Pharmaceuticals and has served on the AAN Editorial Board of Neurology Clinical Practice. Ms Rips has received research funding from the Center for AIDS Research, Biogen Idec, Hoffmann-LaRoche, Sun Pharmaceutical Industries Ltd., Genzyme, the Alzheimer’s Association, and the American College of Radiology; and has served as a speaker for Teva Pharmaceuticals. Dr. Rosenfeld serves as a Council Member of the American College of Cardiology; has stock in Abbott, Proctor & Gamble, and General Electric; has received Fellowship Support from Boston Scientific, Medtronic, and Abbott Laboratories (formerly St. Jude Medical); has received research funding from Boehringer Ingelheim Pharmaceuticals, Inc.; and has served on the Program Committee and the Patient and Caregivers Committee of the Heart Rhythm Society. Dr. Savoy serves on the American Academy of Family Physicians (AAFP) Board of Directors, as an ex-officio Board member of Delaware Academy of Family Physicians (DAFP), as the Chair of the Centers for Medicare and Medicaid Services (CMS) Advisory Panel on Outreach and Education, and as Secretary of the Board of Directors of the Association of Departments of Family Medicine; receives honoraria from AAFP, DAFP, CMS, and Merck; has served on an Advisory Council for Highmark Health and as an advisor to the AAFP Adolescent Immunization Project; has received honoraria from AAFP; has served as the President of DAFP, as Editor of DelFamDoc, and as a member of AAFP Commissions. Dr. Sood has received research funding from the NIH; and has provided expert testimony for Danaher Lagnese, PC. Dr. Steere receives research funding from the NIH and the Mathers Foundation; has received research funding from the NIH, the American College of Rheumatology, the Mathers Foundation, the English-Bonter-Mitchell Foundation, Immunetics, Inc., Zeus Diagnostics, and the Ounsworth-Fitzgerald Foundation; and has served as a scientific advisor for Baxter Bioscience Institute of Systems Biology, Immunetics, Inc., Roche Diagnostics, and Viramed. Dr. Strle receives research funding from the Slovenian Research Agency; serves as the Head of Health Counsel of the Ministry of Health of the Republic of Slovenia and as a member of the Steering Committee for the European Society of Clinical Microbiology and Infectious Diseases Study Group for Lyme Borreliosis; serves on the Roche Diagnostics Advisory Board on Lyme Disease Diagnostics; and has received honoraria from Roche Diagnostics. Dr. Sundel receives research funding from the NIH and AbbVie, Inc.; serves as a content author and editor for UpToDate; provides expert testimony to Chin-Caplan, PC; has provided expert testimony for Conway Homer, PC; has served as an advisor for Paul Hastings, LLC; has served as a content editor for SimulConsult and as a Medical Education Resources lecturer for CME-granting educational courses; has received remuneration from SimulConsult as a co-investigator for an NIH-sponsored grant; and has received research funding from the NIH. Dr. Tsao receives research funding from the National Science Foundation, NIH, CDC, the Michigan Lyme Disease Association, and the Michigan Department of Health and Human Services; serves as a Scientific Council Advisor Member for the Canadian Lyme Disease Research Network and as a scientific advisor for the American Lyme Disease Association; has received research funding from Michigan State University; has served as an Associate Editor for Ticks and Tick-Borne Diseases and on the Tick Vectors, Surveillance, and Prevention Subcommittee of the US Department of Health and Human Services Tick-Borne Disease Working Group; and has received remuneration for providing educational seminars for Boehringer Ingelheim (formerly Merial). Dr. Wormser receives research funding from Immunetics, Inc., Rarecyte, Inc., Institute for Systems Biology, and Quidel Corporation; serves on the Board of the American Lyme Disease Foundation; provides and has previously provided expert testimony in malpractice cases; has stock in AbbVie, Inc. and Abbott Laboratories; has received research funding from the CDC, NIH, BioMérieux, Bio-Rad Laboratories, and DiaSorin, Inc; has served as a scientific research advisor for Baxter International and as a Lyme disease advisor and expert for the Missouri Board of Registration for the Healing Arts; has a patent approved (US patent no. 10,669,567 B2) for High Sensitivity Method for Early Lyme Disease Detection; filed 2 patent applications related to early Lyme disease detection (application no: 62/277,252) and Lyme arthritis and post-treatment Lyme disease syndrome (application no: 62/725,745); and has served on the Editorial Boards for Clinical Infectious Diseases, Vector-Borne and Zoonotic Diseases, and Ticks and Tick-Borne Diseases. Dr. Zemel has served as an advisor for Novartis Promotional Speakers Bureau. No other disclosures relevant to this article were reported. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. The expert panel expresses its gratitude for thoughtful reviews of an earlier version to the external reviewers. The panel thanks the IDSA, AAN, and ACR for supporting the guideline development process. All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Dr. Lantos had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rips, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rips, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of North American (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists in North America. It is important to realize that guidelines cannot always account for individual variation among patients. They are assessments of current scientific and clinical information provided as an educational service; are not continually updated and may not reflect the most recent evidence (new evidence may emerge between the time information is developed and when it is published or read); should not be considered inclusive of all proper treatments methods of care, or as a statement of the standard of care; do not mandate any particular course of medical care; and are not intended to supplant physician judgment with respect to particular patients or special clinical situations. Whether and the extent to which to follow guidelines is voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances. Although IDSA, AAN, and ACR make every effort to present accurate, complete, and reliable information, these guidelines are presented “as is” without any warranty, either express or implied. IDSA, AAN, and ACR (and their officers, directors, members, employees, and agents) assume no responsibility for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with these guidelines or reliance on the information presented. The guidelines represent the proprietary and copyrighted property of IDSA, AAN, and ACR. Copyright 2020 Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology. All rights reserved. No part of these guidelines may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of IDSA, AAN, or ACR. Permission is granted to physicians and healthcare providers solely to copy and use the guidelines in their professional practices and clinical decision-making. No license or permission is granted to any person or entity, and prior written authorization by IDSA, AAN, or ACR is required, to sell, distribute, or modify the guidelines, or to make derivative works of or incorporate the guidelines into any product, including but not limited to clinical decision support software or any other software product. Except for the permission granted above, any person or entity desiring to use the guidelines in any way must contact IDSA, AAN, or ACR for approval in accordance with the terms and conditions of third party use, in particular any use of the guidelines in any software product. Summarized below are the 2020 recommendations for the prevention, diagnosis, and treatment of Lyme disease. The panel followed a systematic process used in the development of other Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) clinical practice guidelines, which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation) (see Figure 1). A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text (http://onlinelibrary.wiley.com/doi/10.1002/acr.24495/abstract). A. Personal protective measures B. Repellents to prevent tick bites C. Removal of attached ticks A. Diagnostic tick testing B. Diagnostic testing of asymptomatic patients following tick bites Supplementary data. Supplementary materials (in addition to the full guideline) are available on the Arthritis Care & Research website at http://onlinelibrary.wiley.com/doi/10.1002/acr.24495/abstract. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Conflict of interest statement. See the Methodology section in the full guideline (on the Arthritis Care & Research website at http://online​library.wiley.com/doi/10.1002/acr.24495/abstract) for approach to conflict of interest (COI) by the IDSA/AAN/ACR COI review group. The following list is a reflection of what has been reported to the IDSA/AAN/ACR COI review group. To provide thorough transparency, the IDSA/AAN/ACR requires full disclosure of all relationships, regardless of relevancy to the guideline topic. The assessment of disclosed relationships for possible COI is based on the relative weight of the financial relationship (i.e., monetary amount) and the relevance of the relationship (i.e., the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). The reader of these guidelines should be mindful of this when the list of disclosures is reviewed. Dr. Lantos has received research funding from the National Cytomegalovirus Foundation and from the NIH and educational funding from Duke University; and has served as a consultant and reviewed trial protocol for Frederick O’Connor Medical Consultants, LLC. Dr. Bockenstedt has received research funding from the NIH and the Gordon and Llura Gund Foundation; has received remuneration from L2 Diagnostics for investigator-initiated NIH-sponsored research; and was awarded an endowed professorship as the Harold W. Jockers Professor of Medicine at Yale University. Dr. Falck-Ytter serves as director of the Evidence Foundation and the GRADE Network; conducts GRADE workshops with the Evidence Foundation; has served as the chair of the Guidelines Committee for the American Gastroenterological Association; and has received research funding from the Cleveland VA Medical Research and Education Foundation. Dr. Aguero-Rosenfeld serves as a council member for the New York City chapter of the American Society of Microbiology (ASM) and as a Board member of the American Lyme Disease Foundation; has provided legal testimony and consultation regarding Lyme disease and tick-borne diseases; and has received research grants from the NIH, BioFire, New York State Department of Health, and ViraMed. Dr. Auwaerter receives research funding from the Fisher Center for Environmental Infectious Diseases and the NIH; serves on the Board of Directors of the American Lyme Disease Foundation and as the Vice Chair of the Infectious Diseases Society of America (IDSA) Foundation; serves as a scientific advisor for DiaSorin, Adaptive Technologies, and Shionogi; provides legal expert opinion testimony regarding Lyme disease; had stock in Johnson & Johnson; has served as an editor for Johns Hopkins POC-IT ABX Guide, an advisor for the Food and Drug Administration (FDA), Genentech, Dynavax, Aradigm, Cempra, BioMérieux, Cerexa, and Medscape; has received research funding from Cerexa; has served on the FDA Advisory Board, the Medscape Advisory Board, and the IDSA Board of Directors; and his spouse has equity interest in venture capital–funded Capricor. Dr. Belani reviews non-continuing medical education (CME) lectures for and received honoraria and travel reimbursement from Horizon Therapeutics; and has received research funding from the NIH and the Children’s Hospitals and Clinics of Minnesota. Dr. Bowie has provided expert testimony to the Canadian Senate Subcommittee on Bill C-442: An Act Respecting a National Lyme Disease Strategy on behalf of the Association of Medical Microbiology and Infectious Disease Canada; and has received research funding from GlaxoSmithKline, Pfizer Canada, the Canadian Institutes of Health Research, and Vancouver Coastal Health Research Institute. Dr. Branda receives research funding from the Lyme Disease Biobank Foundation and Zeus Scientific; serves as a scientific advisor and consultant to DiaSorin, Inc.; has served as a scientific advisor and consultant for T2 Biosystems; has served on the scientific advisory board of Roche Diagnostics and AdvanDx; has received research funding from Karius, Inc., Alere, Inc., T2 Biosystems, BioMérieux, TBS Technologies, Immunetics, Inc., DiaSorin, Inc., Kephera Diagnostics, Inc., and the Bay Area Lyme Foundation; has participated in unfunded research collaborations with Karius Inc. and Kephera Diagnostics; was a member of the editorial board of the Journal of Clinical Microbiology; was a co-inventor on an application for a patent to protect intellectual property; and his spouse is an employee of Informed DNA. Dr. Clifford receives research funding from the NIH and the Alzheimer’s Association; serves as scientific consultant to Inhibikase and Excision BioTherapeutics; serves on Data and Safety Monitoring Boards (DSMB) for Biogen, Genzyme/Sanofi, Genentech, EMD Serono, Shire, Wave Life Sciences, Pfizer, Atara, Mitsubishi Tanabe, and IQVIA (formerly Quintiles); serves on Progressive Multifocal Leukoencephalopathy (PML) adjudication committees for Amgen, GlaxoSmithKline, EMD Serono, Bristol Myers Squibb, Roche, and the Takeda Oncology (formerly Millennium) Adjudication Committee–FDA, as well as Dr. Reddy’s Laboratories; has previously received research funding from the NIH; and his spouse formerly held stock in Johnson & Johnson. Dr. DiMario has received research funding from Novartis. Dr. Halperin serves as an Editorial Board Member of Neurology, and Vice Chair of the American Academy of Neurology (AAN) Guideline Subcommittee; has stock in Abbott Labs, AbbVie, Merck, and Johnson & Johnson; provides and has previously provided legal expert testimony defending physicians in medical malpractice cases on various neurologic issues, including Lyme disease; has received research funding from NIH, the Centers for Disease Control and Prevention (CDC); and has served as a section editor of neuroinfectious diseases in Neurology & Neuroscience Reports. Dr. Krause receives research funding from the Yale Emerging Infections Program; receives remuneration from Gold Standard Diagnostics for a collaborative research project; has stock in Gilead Sciences and First Trust NASDAQ Pharmaceuticals ETF; has received research funding from the NIH, the Centers for Disease Control and Prevention (CDC), the Gordon and Llura Gund Foundation, and L2 Diagnostics for NIH-sponsored research; has served as a scientific consultant and provided medical education and training for Oxford Immunotec, Inc.; has a patent pending (Enhanced Chemiluminescent enzyme-linked immunosorbent assay for detection of antibodies against Babesia microti), for which US Provisional Patent Application No. 62/580,588, was filed on November 2, 2017; serves on the Board of Directors for the American Lyme Disease Foundation and the Editorial Boards of Pathogens and Plos Neglected Tropical Diseases and the Editorial Advisory Board of Clinical Infectious Diseases; was on the Editorial Board of Journal of Clinical Microbiology, and will be on the Editorial Board of Clinical Microbiology Reviews starting January 2021. Dr. Liang has stock in Johnson & Johnson; received research funding from the Veterans Health Administration, the Arthritis Foundation, and the NIH; has served on the FDA Advisory Panel, Institute of Medicine panels; served as a scientific reviewer for the Research Grant Council of Hong Kong and the NIH; served on the Board of the Lupus Clinical Trials Consortium, Beacon Hill Villages, and Rx Foundation and advised the Institute for Clinical and Economic Review and the China Medical Board; previously had stock in Sequenom; and his spouse has stock in Johnson & Johnson. Dr. Meissner is a current member of the CDC Workgroups and serves as a volunteer consultant on the American Academy of Pediatrics Committee on Infectious Diseases and the NIH DSMB. Dr. Nigrovic receives research funding from the NIH, Department of Defense, and the NIH Center for Research Resources and for Advancing Translational Sciences (NCATS), Global Lyme Alliance, and Peabody Foundation; serves on the Editorial Board for Annals of Emergency Medicine; has served as scientific consultant for Adaptive Technologies; has received research funding from the NIH, Provider and Payer Quality Initiative (PPQI) Research Foundation, Harvard Catalyst, Hood Foundation, Bay Area Lyme Foundation, CDC, Emergency Medical Services for Children (EMSC), the National Patient-Centered Clinical Research Network (PCORNet), Milton Foundation, and Boston Children’s Hospital. Dr. Nocton receives research funding from Bristol Myers Squibb; serves as a member of the Subboard of Pediatric Rheumatology of the American Board of Pediatrics; and has received research funding from AbbVie, NIH, and the Arthritis Foundation. Dr. Pruitt has received research funding from Teva Pharmaceuticals and has served on the AAN Editorial Board of Neurology Clinical Practice. Ms Rips has received research funding from the Center for AIDS Research, Biogen Idec, Hoffmann-LaRoche, Sun Pharmaceutical Industries Ltd., Genzyme, the Alzheimer’s Association, and the American College of Radiology; and has served as a speaker for Teva Pharmaceuticals. Dr. Rosenfeld serves as a Council Member of the American College of Cardiology; has stock in Abbott, Proctor & Gamble, and General Electric; has received Fellowship Support from Boston Scientific, Medtronic, and Abbott Laboratories (formerly St. Jude Medical); has received research funding from Boehringer Ingelheim Pharmaceuticals, Inc.; and has served on the Program Committee and the Patient and Caregivers Committee of the Heart Rhythm Society. Dr. Savoy serves on the American Academy of Family Physicians (AAFP) Board of Directors, as an ex-officio Board member of Delaware Academy of Family Physicians (DAFP), as the Chair of the Centers for Medicare and Medicaid Services (CMS) Advisory Panel on Outreach and Education, and as Secretary of the Board of Directors of the Association of Departments of Family Medicine; receives honoraria from AAFP, DAFP, CMS, and Merck; has served on an Advisory Council for Highmark Health and as an advisor to the AAFP Adolescent Immunization Project; has received honoraria from AAFP; has served as the President of DAFP, as Editor of DelFamDoc, and as a member of AAFP Commissions. Dr. Sood has received research funding from the NIH; and has provided expert testimony for Danaher Lagnese, PC. Dr. Steere receives research funding from the NIH and the Mathers Foundation; has received research funding from the NIH, the American College of Rheumatology, the Mathers Foundation, the English-Bonter-Mitchell Foundation, Immunetics, Inc., Zeus Diagnostics, and the Ounsworth-Fitzgerald Foundation; and has served as a scientific advisor for Baxter Bioscience Institute of Systems Biology, Immunetics, Inc., Roche Diagnostics, and Viramed. Dr. Strle receives research funding from the Slovenian Research Agency; serves as the Head of Health Counsel of the Ministry of Health of the Republic of Slovenia and as a member of the Steering Committee for the European Society of Clinical Microbiology and Infectious Diseases Study Group for Lyme Borreliosis; serves on the Roche Diagnostics Advisory Board on Lyme Disease Diagnostics; and has received honoraria from Roche Diagnostics. Dr. Sundel receives research funding from the NIH and AbbVie, Inc.; serves as a content author and editor for UpToDate; provides expert testimony to Chin-Caplan, PC; has provided expert testimony for Conway Homer, PC; has served as an advisor for Paul Hastings, LLC; has served as a content editor for SimulConsult and as a Medical Education Resources lecturer for CME-granting educational courses; has received remuneration from SimulConsult as a co-investigator for an NIH-sponsored grant; and has received research funding from the NIH. Dr. Tsao receives research funding from the National Science Foundation, NIH, CDC, the Michigan Lyme Disease Association, and the Michigan Department of Health and Human Services; serves as a Scientific Council Advisor Member for the Canadian Lyme Disease Research Network and as a scientific advisor for the American Lyme Disease Association; has received research funding from Michigan State University; has served as an Associate Editor for Ticks and Tick-Borne Diseases and on the Tick Vectors, Surveillance, and Prevention Subcommittee of the US Department of Health and Human Services Tick-Borne Disease Working Group; and has received remuneration for providing educational seminars for Boehringer Ingelheim (formerly Merial). Dr. Wormser receives research funding from Immunetics, Inc., Rarecyte, Inc., Institute for Systems Biology, and Quidel Corporation; serves on the Board of the American Lyme Disease Foundation; provides and has previously provided expert testimony in malpractice cases; has stock in AbbVie, Inc. and Abbott Laboratories; has received research funding from the CDC, NIH, BioMérieux, Bio-Rad Laboratories, and DiaSorin, Inc; has served as a scientific research advisor for Baxter International and as a Lyme disease advisor and expert for the Missouri Board of Registration for the Healing Arts; has a patent approved (US patent no. 10,669,567 B2) for High Sensitivity Method for Early Lyme Disease Detection; filed 2 patent applications related to early Lyme disease detection (application no: 62/277,252) and Lyme arthritis and post-treatment Lyme disease syndrome (application no: 62/725,745); and has served on the Editorial Boards for Clinical Infectious Diseases, Vector-Borne and Zoonotic Diseases, and Ticks and Tick-Borne Diseases. Dr. Zemel has served as an advisor for Novartis Promotional Speakers Bureau. No other disclosures relevant to this article were reported. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. The expert panel expresses its gratitude for thoughtful reviews of an earlier version to the external reviewers. The panel thanks the IDSA, AAN, and ACR for supporting the guideline development process. All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Dr. Lantos had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rips, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Lantos, Rumbaugh, Bockenstedt, Falck-Ytter, Aguero-Rosenfeld, Auwaerter, Baldwin, Bannuru, Belani, Bowie, Branda, Clifford, DiMario, Halperin, Krause, Lavergne, Liang, Meissner, Nigrovic, Nocton, Osani, Pruitt, Rips, Rosenfeld, Savoy, Sood, Steere, Strle, Sundel, Tsao, Vaysbrot, Wormser, Zemel. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis Council

BackgroundThe appearance of biologics in the last decade of the 20th century has significantly changed life perspectives for patients with rheumatic diseases. Etanercept, a soluble anti-tumor necrosis factor alpha (TNF-α)...

ABSTRACTIntroduction: The patent expiration of some biologics used in chronic conditions such as inflammatory bowel disease (IBD) has led to the development of biosimilar monoclonal antibodies. The tailored regulatory approval route for biosimilar development ensures that approved biosimilars show similarity to their originators in terms of efficacy and safety, and avoids unnecessary repetition of clinical trials carried out with the originator product. However, some patients may still have concerns about using biosimilars and it is the responsibility of healthcare professionals (HCPs) to alleviate these concerns.Areas covered: This review highlights clinical and real-world evidence supporting efficacy and safety of biosimilars in patients with IBD. Moreover, based on international surveys, potential patient concerns are highlighted, along with possible actions HCPs can take to address these concerns.Expert commentary: The rising use of biosimilars in IBD is expected to have a positive impact on the availability of biologics and healthcare costs. Several biosimilars have been approved for use and more are likely to come to the market in the future; however, transitioning patients to biosimilars could pose an unexpected challenge without the help and support of HCPs.

Conducting clinical trials in paediatric rheumatology has been difficult in the past mainly because of the lack of funding for academic studies and the lack of interest by pharmaceutical companies for the small and non-rewarding paediatric market. The situation changed dramatically few years ago with the introduction of the Best Pharmaceuticals for Children Act in USA and of a specific legislation for paediatric medicines development (Paediatric Regulation) in the European Union (EU). The main reasons for success are: the availability of two large international non-for-profit networks working in close collaboration, such as the Pediatric Rheumatology Collaborative Study Group (PRCSG at http://www.prcsg.org), covering North America, and the Paediatric Rheumatology International Trials Organisation (PRINTO at http://www.printo.it), covering more than 50 countries worldwide; the availability of validated measures to evaluate response to therapy, now called JIA American College of Rheumatology (ACR) criteria, accepted by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA); last but not least the advent of the biologic therapies (anti TNF, Anti IL 1 and 6, anti CTL4Ig) which have revolutionized juvenile idiopathic arthritis (JIA) treatment. Some problems however remain still to be solved: There is a need to harmonise all the regulatory aspects related to drugs that are used in the treatment of paediatric rheumatic diseases and in particular in JIA; the issue of me too drugs; the issue of proper pK studies; the ethics of drugs provision and of trial implementation; the implementation of proper pharmacovigilance systems. This presentation will review the reasons for success and the problems that still remains to be solved for conducting trials in JIA.

FDA's role in anesthetic drug development.

BackgroundInfliximab (a human murine chimeric anti-tumour necrosis factor alpha monoclonal antibody) is known to decrease disease activity of juvenile idiopathic arthritis (JIA) but its effect on longitudinal growth in relation...

Pharmacists and health systems prepare to add biosimilars to formularies