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1.
Medicine (Baltimore) ; 99(30): e21151, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791688

RESUMO

BACKGROUND: The introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) into clinical practice has dramatically improve the clinical outcomes of individuals with rheumatoid arthritis (RA). However, bDMARDs are associated with high costs, which has resulted in restricted treatment access and a burden on medical insurance finances. Although biosimilars offer cost-saving, their effectiveness and safety must be established in Post-Marketing Surveillance (PMS). Infliximab (IFX), a chimeric monoclonal antibody to TNF-alpha, is the first bDMARD; its biosimilar, CT-P13, is the first biosimilar DMARD approved for RA treatment in Japan. We will evaluate whether switching from originator IFX to CT-P13 is not inferior for maintaining non-clinical relapse to continued treatment with originator IFX in RA patients achieving clinical remission. METHODS/DESIGN: This study is an interventional, multicenter, open-label, single-arm against historical control and noninferiority clinical trial with a 24-week follow-up. Eighty RA patients who are treated by originator IFX for ≥24 weeks and are achieving clinical remission will be included. Patients will be switched to CT-P13 with the unchanged dosing regimen. We will evaluate disease activity by measuring clinical disease activity indices and by using musculoskeletal ultrasound (MSUS). The primary endpoint is the ratio of patients who experience a nonclinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of many biomarkers such as cytokines and chemokines. DISCUSSION: The study results are expected to show the noninferiority of switching to CT-P13 over the continuation of originator IFX. The strength of this study is its prospective evaluation of therapeutic efficacy using not only clinical disease activity indices but also MSUS to accurately and objectively evaluate disease activity at the joint level among patients drawn from multiple centers with a standardized evaluation by MSUS. We will explore whether parameters at baseline can predict a nonclinical relapse after switching from originator IFX to CT-P13 by integrating multilateral assessments, i.e., clinical disease activity indices, MSUS findings, and serum biomarkers. TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on October 11, 2019 as jRCTs071190030.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Quimiocinas/sangue , Infliximab/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/sangue , Artrite Reumatoide/diagnóstico por imagem , Biomarcadores/sangue , Substituição de Medicamentos , Estudos de Equivalência como Asunto , Humanos , Japão , Quimioterapia de Manutenção , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Índice de Gravidade de Doença , Ultrassonografia , Adulto Jovem
2.
Yonsei Med J ; 61(8): 712-719, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32734735

RESUMO

PURPOSE: There has been no extensive study to compare the efficacy between rituximab originator (Mabthera®) and its biosimilar (Truxima®) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). Here, we investigated the clinical effects of rituximab on poor outcomes of MPA and GPA in Korean patients, and compared those between Mabthera® and Truxima®. MATERIALS AND METHODS: We retrospectively reviewed the medical records of a total of 139 patients, including 97 MPA patients and 42 GPA patients. At diagnosis, antineutrophil cytoplasmic antibody positivity and comorbidities were assessed. During follow-up, all-cause mortality, relapse, end-stage renal disease, cerebrovascular accident and acute coronary syndrome were evaluated as poor outcomes. In this study, rituximab was used as either Mabthera® or Truxima®. RESULTS: The median age at diagnosis was 60.1 years and 46 patients were men (97 MPA and 42 GPA patients). Among poor outcomes, patients receiving rituximab exhibited a significantly lower cumulative relapse-free survival rate compared to those not receiving rituximab (p=0.002). Nevertheless, rituximab use did not make any difference in other poor outcomes of MPA and GPA except for relapse, which might be a rebuttal to the fact that rituximab use after relapse eventually led to better prognosis. There were no significant differences in variables at diagnosis and during follow-up between patients receiving Mabthera® and those receiving Truxima®. Patients receiving Truxima® exhibited a similar pattern of the cumulative survival rates of each poor outcome to those receiving Mabthera®. CONCLUSION: Truxima® prevents poor outcomes of MPA and GPA as effectively as does Mabthera®.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Granulomatose com Poliangiite/tratamento farmacológico , Poliangiite Microscópica/tratamento farmacológico , Rituximab/uso terapêutico , Feminino , Granulomatose com Poliangiite/mortalidade , Humanos , Masculino , Poliangiite Microscópica/mortalidade , Pessoa de Meia-Idade , Prognóstico , Recidiva , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
3.
Farm. hosp ; 44(3): 100-108, mayo-jun. 2020. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-192340

RESUMO

El proceso de aprobación de los biosimilares de anticuerpos monoclonales en la Unión Europea está dirigido a descartar la presencia de diferencias significativas con el biológico original en los atributos de calidad, eficacia, inmunogenicidad y seguridad. Proporciona además la justificación para extrapolar la evidencia obtenida con un biosimilar en al menos una indicación al resto de indicaciones aprobadas para su biológico original, simplificando el programa de desarrollo de los biosimilares. Los biosimilares de anticuerpos monoclonales disponibles en la Unión Europea para el tratamiento de enfermedades inflamatorias y del cáncer han cumplido todos los requerimientos establecidos para la aprobación, y en muchos casos disponen de evidencia adicional. Además, los datos de uso en la vida real están confirmando la seguridad y eficacia de estos fármacos en las distintas patologías en las que se están utilizando. En España, varias sociedades médicas avalan el proceso regulatorio de los biosimilares y reconocen su papel en la eficiencia del sistema sanitario. No obstante, todavía existen algunas barreras que limitan su uso. La aplicación de diferentes medidas a nivel de paciente, prescriptor, institucional y nacional podría aumentar la penetración de los biosimilares, liberando recursos que podrían invertirse en otras terapias y, potencialmente, favorecer la innovación


The approval pathway for biosimilars of monoclonal antibodies in the European Union is aimed at ruling out the presence of significant differences with the original biological in quality attributes, efficacy, immunogenicity and safety. It also provides the rationale for extrapolating the evidence obtained with a biosimilar in at least one indication to the rest of the approved indications of its original biological, thus simplifying the deve-lopment programme of biosimilars. Biosimilars of monoclonal antibodies available in the European Union for the treatment of inflammatory diseases and cancer have fulfilled all the requirements for approval, and many of them have additional evidence available. Moreover, real world data confirms the safety and efficacy of these drugs in the indications they are being used for. In Spain, many scientific societies endorse the regulatory pathway of biosimilars and acknowledge their role in the efficiency of the healthcare system. Even so, some barriers remain that limit their use. The implementation of different measures at the patient, prescriber, institutional, and national levels might increase the penetration of biosimilars, freeing up resources that may be invested in other therapies and, potentially, boost innovation


Assuntos
Humanos , Anticorpos Monoclonais/uso terapêutico , Inflamação/tratamento farmacológico , Neoplasias/tratamento farmacológico , Medicamentos Biossimilares/normas , Produtos Biológicos/normas , Medicamentos Biossimilares/uso terapêutico , União Europeia , Aprovação de Drogas/legislação & jurisprudência
4.
Gan To Kagaku Ryoho ; 47(3): 397-401, 2020 Mar.
Artigo em Japonês | MEDLINE | ID: mdl-32381902

RESUMO

Several biosimilars have appeared in cancer treatment. They should contribute to the reduction of medical cost. However, in Japan, a suspicion of medical staffs and patients to biosimilars and an obstruction of High-Cost Medical Expense Benefit to the burden reduction of patients suppress the use of biosimilars. Recently, several guidelines declare to promote the use of biosimilars. High-quality biosimilars are also going to be developed by next generation biotechnologies. The positive selection of biosimilars hopefully contribute to patients and national medical economy. In this review, we mention about the current subjects and future prospects of biosimilars.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Neoplasias/tratamento farmacológico , Humanos
5.
Clin Drug Investig ; 40(6): 541-553, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32328979

RESUMO

BACKGROUND: The infliximab biosimilar CT-P13 has widely received regulatory approval in all indications of reference infliximab, including rheumatoid arthritis (RA) and ankylosing spondylitis (AS). OBJECTIVE: This retrospective analysis investigated drug survival and long-term safety and effectiveness of CT-P13 in patients with RA or AS in the Republic of Korea. METHODS: This non-interventional, retrospective, multicenter analysis collected medical record data for adult patients with RA or AS who received CT-P13 treatment at five Korean referral hospitals (2012-2017). Drug survival and long-term safety were primary outcomes. The secondary outcome was long-term effectiveness, assessed by disease activity measures. RESULTS: Overall, 491 patients were treated with CT-P13 (154 patients with RA [135 infliximab-naïve; 19 switched from reference infliximab]; 337 patients with AS [219 infliximab-naïve; 118 switched from reference infliximab]). Drug survival was similar in naïve and switched patients. Treatment-emergent adverse events (TEAEs) occurred in 31.8% and 29.4% of patients with RA and AS, respectively; incidence was similar in naïve and switched groups. Upper respiratory tract infection, influenza-like illness, and urticaria were the most common TEAEs. Overall, nine (1.8%) patients experienced serious adverse events (SAEs) deemed potentially drug-related; SAEs led to permanent CT-P13 discontinuation in five (1.0%) patients, including three with tuberculosis. Disease activity decreased over time. CONCLUSION: Up to 5 years of CT-P13 treatment was safe and effective in patients with RA and AS, based on drug survival, incidence of TEAEs, and disease activity. Drug survival and safety were similar in naïve patients and switched groups, supporting switching from reference infliximab to CT-P13.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Adulto , Anticorpos Monoclonais/efeitos adversos , Antirreumáticos/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Substituição de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , República da Coreia , Estudos Retrospectivos , Resultado do Tratamento
6.
J Oncol Pharm Pract ; 26(3_suppl): 22-32, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32268828

RESUMO

Background: The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilars Task Force was charged to develop educational activities and resources to assist members when implementing biosimilar medicines into their local practice. To facilitate the process, the task force conducted a survey in order to understand biosimilar implementation practice by ISOPP members across the world and the challenges that oncology pharmacists face when adopting biosimilars into their clinical practice. Methods: A cross-sectional survey was conducted between 20 April 2019 and 27 May 2019. Members of ISOPP and a number of national oncology pharmacy groups were invited to complete the survey. The survey contained 29 items and consisted of three sections: respondents' demographics, respondents' institutional practice relating to biosimilar implementation and post implementation practice at the respondents' institutions. Descriptive statistics were utilized to analyze the survey results. Results: A total of 265 ISOPP members were surveyed, with 50 members providing a response (response rate = 19%). In addition, 40 nonmembers participated in the survey, bringing the total to 90 respondents. The most common factors that influence the decision to implement use of a biosimilar as reported by respondents are medication costs/pricing (92%), available clinical data (73%), and product availability (63%). Respondents also commented on the barriers to biosimilar implementation at their institutions, which included a reluctance of prescribers to use biosimilars (due to the lack of familiarity or perceived inferiority), a reluctance to switch established patients from an originator to a biosimilar and the preferences of insurance companies or funding bodies. Conclusion: The results of this survey reinforce the need for greater education and training for health care professionals in the use of biosimilars, the importance of sharing good practice, and a need for standardization.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Neoplasias/tratamento farmacológico , Farmacêuticos/estatística & dados numéricos , Estudos Transversais , Humanos , Assistência Farmacêutica/estatística & dados numéricos , Inquéritos e Questionários
7.
J Oncol Pharm Pract ; 26(3_suppl): 11-21, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32268832

RESUMO

Background: The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilar Task Force was charged to develop educational resources to address the learning needs related to biosimilars use of oncology pharmacy practitioners. To facilitate the process, the task force conducted a survey in order to identify unmet education needs as well as barriers for obtaining biosimilar education among oncology pharmacy practitioners. Methods: A cross sectional survey was conducted between 10 December 2018 and 18 February 2019. Members of International Society of Oncology Pharmacy Practitioners and national oncology pharmacy groups were invited to complete the survey. The survey contained 22 items and consisted of four sections. Descriptive statistics were utilized to analyze the survey results. Results: A total of 363 International Society of Oncology Pharmacy Practitioners members were surveyed, with 75 members providing a response (response rate = 21%). In addition, 11 non-International Society of Oncology Pharmacy Practitioners members also participated in the survey, bringing the total to 86 respondents. The top three areas in which respondents reported learning needs included evaluating comparative efficacy of a biosimilar to an originator's product (74.4%), managing the switchover to a biosimilar from the original product (74.4%), and understanding medication safety issues in relation to biosimilars use (73.3%). The most common challenges faced in obtaining education on biosimilars included limited financial support for education on biosimilar products (38.4%), heavy workload (31.4%), and inadequate educational resources (27.9%). Conclusion: This survey has identified numerous biosimilar learning needs as well as challenges faced in obtaining biosimilars education among oncology pharmacy practitioners. Educational activities should be created to address these learning needs, and innovative strategies should be considered to overcome practitioner's barriers in obtaining biosimilars education.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Educação em Farmácia/métodos , Assistência Farmacêutica/organização & administração , Estudos Transversais , Humanos , Neoplasias/tratamento farmacológico , Inquéritos e Questionários
8.
J Oncol Pharm Pract ; 26(3_suppl): 3-10, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32268831

RESUMO

With the development of innovative cancer treatments over recent decades, the cost of cancer care has risen exponentially, limiting patient access to patented originator biotherapeutics in many countries. The introduction of biosimilars to the market has created new opportunities as well the need for changes in practice within healthcare institutions. A 'biosimilar' is a biotherapeutic product which is highly similar in terms of quality, safety and efficacy to an already licensed originator product. Although biosimilars lack clinically meaningful differences in therapeutic activity as compared to the originator product, these complex biological molecules are not considered identical chemical copies, unlike generics, and minor differences in molecular structure and inactive compounds may exist. A thorough understanding of these differences and their clinical implications is necessary for optimising medicines-use practices involving biosimilars. This position statement, developed by the International Society of Oncology Pharmacy Practitioners Biosimilars Taskforce, aims to provide the global oncology pharmacy community with guidance to support decisions around biosimilar use. The 11 statements cover the regulation and evaluation of biosimilars, practical issues around local implementation, the education of healthcare staff and patients, and the requirement for ongoing pharmacovigilance and outcome monitoring.


Assuntos
Antineoplásicos/administração & dosagem , Medicamentos Biossimilares/uso terapêutico , Neoplasias/tratamento farmacológico , Humanos , Assistência Farmacêutica/organização & administração , Farmacovigilância
9.
Asia Pac J Clin Oncol ; 16(4): 211-221, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32285612

RESUMO

Despite their availability for over a decade, the exact nature of biosimilar medicines is still poorly understood with paucity of clear treatment guidelines for their use in clinical practice in Australia. Although hematologists have had experience with biosimilars in the setting of supportive care, with the approval of the first biosimilar rituximab in hematological malignancies, it is important to revisit this topic. To inform the use of biosimilar medicines in clinical practice, we have developed a consensus statement from an Expert Panel of Australian hematologists, oncologists, and cancer pharmacists. These recommendations address the approach to use of biosimilar products in place of the corresponding reference medicine in a number of different clinical contexts. Our recommendations are based on the premise that biosimilar medicines can be considered therapeutically equivalent to their reference brand and used in a similar way to the reference product in any approved indication. We advocate for local approaches to the provision of patient information, dispensing of the intended brand and pharmacovigilance, to be developed in consultation with local hematologists and aim to improve confidence in the appropriate use of biosimilar medicines and their expected outcomes among hematologists.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Hematologia/métodos , Austrália , Medicamentos Biossimilares/farmacologia , Humanos
10.
Arthritis Rheumatol ; 72(7): 1067-1071, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32253823

RESUMO

OBJECTIVE: To compare uptake in the ordering of biosimilars at a Veterans Affairs Medical Center (VAMC) to that at an academic medical center, where institutional incentives for infused medications differ. METHODS: We performed a cross-sectional study of medical record data and estimated institutional financial incentives at 2 medical centers in Philadelphia: 1) the University of Pennsylvania Health System (UPHS), and 2) the local VAMC. All ordering events for filgrastim or infliximab products were quantified over time and stratified according to product (biosimilar versus reference product) and center. Financial incentives to the institutions over time were determined based on actual drug costs for the VAMC and average sales prices (ASPs) and Medicare Part B reimbursement rates for UPHS. RESULTS: There were 15,761 infusions of infliximab at UPHS, of which 99% were for the reference product. There was a sharper decline in the use of reference products at the VAMC; 62% of the 446 infliximab infusions ordered at the VAMC were for the reference product. ASPs were consistently lower for biosimilar infliximab products, but the estimated institutional financial incentives remained similar over time for biosimilar and reference infliximab at UPHS. At the VAMC, the costs for 100-mg vials of reference infliximab and infliximab-abda were $623.48 and $115.58, respectively: a $507.90 (81%) savings per vial. CONCLUSION: The uptake of infliximab biosimilars has been slow at an academic medical center compared to a nearby VAMC, where financial savings are realized by the institution from its use. Slow adoption of biosimilar medications may impact the rates of decline in costs.


Assuntos
Centros Médicos Acadêmicos , Antirreumáticos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Filgrastim/uso terapêutico , Fármacos Hematológicos/uso terapêutico , Infliximab/uso terapêutico , United States Department of Veterans Affairs , Antirreumáticos/economia , Medicamentos Biossimilares/economia , Redução de Custos , Custos de Medicamentos , Filgrastim/economia , Gastroenterologia , Fármacos Hematológicos/economia , Humanos , Infliximab/economia , Infusões Intravenosas , Medicare Part B , Motivação , Philadelphia , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Mecanismo de Reembolso , Reumatologia , Estados Unidos
11.
Internist (Berl) ; 61(5): 522-529, 2020 May.
Artigo em Alemão | MEDLINE | ID: mdl-32333085

RESUMO

BACKGROUND: Biologic therapies are a key component of modern medicine, especially in the treatment of chronic conditions and in particular immune-mediated diseases. Biosimilars are molecularly highly similar variants of biologic therapies approved after patent expiration of the original product. OBJECTIVES: To provide an overview of the emerging role of biosimilars and present data with respect to efficacy and safety. CURRENT DATA: Since the approval of human insulin as the first biologic therapy, over 150 biologic therapeutics have been approved in the European Union (EU). Due to the high cost of development and production, biologic therapies place a heavy burden on healthcare systems and, at costs totaling 13.8 billion Euros annually, comprise one third of the annual drug expenditure in Germany. Biosimilars are highly similar versions of already approved biologic therapies that do not have clinically relevant differences with respect to efficacy, safety and immunogenicity, as far as can currently be ascertained. Through competition with the original product, biosimilars have been able to drive down prices and relieve the healthcare system without changing overall efficacy. The potential savings through biosimilars are estimated to be 500 million Euros in Germany alone. Currently, over 50 biosimilars of 16 different biologic therapies are approved in the EU. CONCLUSIONS: Biosimilars are safe and economical alternatives to biooriginal drugs that can boost access to modern, high-cost therapies and relieve healthcare systems.


Assuntos
Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Custos de Medicamentos , Produtos Biológicos/economia , Medicamentos Biossimilares/economia , Alemanha , Humanos
14.
Z Rheumatol ; 79(3): 241-254, 2020 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-32219519

RESUMO

BACKGROUND: Cytokines and associated intracellular signal cascades play a major role in the pathogenesis of autoimmune diseases. Janus kinases (JAK) are part of these intracellular signal transduction processes. A relatively new drug group of targeted synthetic disease-modifying antirheumatic drugs (tsDMARD) are JAK inhibitors (JAKi) and are a promising treatment approach for autoimmune diseases. EFFICACY: Hitherto, three JAKis, Tofacitinib, Baricitinib and Upadacitinib, have been approved for treatment of Rheumatoid Arthritis (RA) in the USA, Switzerland and the EU. Filgotinib, another JAKi, also showed promising results in the treatment of RA. Furthermore, tofacitinib received approval for the treatment of ulcerative colitis and psoriatic arthritis. In addition to the JAKis already mentioned, several other JAKis, e.g. filgotinib and peficitinib, are being and were investigated in various studies on indications, such as atopic dermatitis, ankylosing spondylitis and systemic lupus erythematosus. SAFETY: Being immunosuppressants, JAKis show an elevated incidence of severe infections, comparable to biologics. The increased reactivation of varicella zoster virus is especially noteworthy. Under JAKi treatment cytopenia is also more frequent. Lymphopenia under JAKi treatment is of particular clinical relevance because of its association with an increase in the number of severe infections. Furthermore, an elevated risk of thromboembolic events, particularly pulmonary embolism has been noted. The risks concerning metabolic alterations and the occurrence of malignant neoplasms are comparable to those under treatment with biologics.


Assuntos
Antirreumáticos , Artrite Psoriásica , Artrite Reumatoide , Inibidores de Janus Quinases , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Humanos , Janus Quinase 3/antagonistas & inibidores , Inibidores de Janus Quinases/efeitos adversos , Inibidores de Janus Quinases/uso terapêutico , Janus Quinases/antagonistas & inibidores
16.
Autoimmun Rev ; 19(5): 102509, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32173513

RESUMO

Up to 40% of patients treated with tumor necrosis factor alpha inhibitors (TNFi) do not respond to therapy. Testing drug bioavailability and/or anti-drug antibody (ADAb) levels may justify dosage adjustment or switch to different drugs, enabling a personalized medicine approach. We report a multicenter cross-sectional study on different methods [ELISA and a cell based functional assay (reporter gene assay - RGA)] for drug/ADAb detection, and on the relationship between drug bioavailability and ADAb. 163 patients with rheumatoid arthritis (RA) treated with infliximab (IFX; n = 67), adalimumab (ADL; n = 49) or etanercept (ETA; n = 47) were tested for drug and ADAb levels. Furthermore, we report prospective data from additional 70 patients (59 RA and 11 juvenile idiopathic arthritis - JIA) tested for drug and ADAb levels at baseline (T0) and after 3 (T3) and 6 months (T6) of treatment with ADL or ETA only. IFX-treated patients were not included because of the increasing use of IFX biosimilars. Stringent inclusion criteria were used in order to avoid unwanted variables in both studies; none of the patients used TNFi before the study, and TNFi was used only in combination with methotrexate. Clinical response was defined according to EULAR response criteria. The two assays performed comparably in the comparison study. Accordingly, ELISA was selected for the prospective study because of its feasibility in the clinical setting. The cross-sectional study found ADAb in IFX and ADL treated groups only, that were associated with a decrease in pharmacological drug availability in the blood. Comparable results were found for the ADL-treated group in the prospective study which also showed a relationship between drug/ADAb levels and the loss of clinical response. Altogether our findings support drug and anti-drug Ab monitoring in the real-world clinical setting thus enabling individualized treatment and reducing disability in chronic inflammatory arthritis.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/imunologia , Medicina de Precisão , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adalimumab/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Estudos Transversais , Etanercepte/uso terapêutico , Feminino , Humanos , Infliximab/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores
18.
Drugs ; 80(2): 99-113, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32002851

RESUMO

Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/imunologia , Medicamentos Biossimilares/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Doenças Inflamatórias Intestinais/imunologia , Medicamentos Biossimilares/efeitos adversos , Humanos
19.
Ann Rheum Dis ; 79(6): 744-759, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32033937

RESUMO

OBJECTIVES: To inform the 2019 update of the European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA). METHODS: A systematic literature research (SLR) to investigate the efficacy of any disease-modifying antirheumatic drug (DMARD) (conventional synthetic (cs)DMARD, biological (b) and biosimilar DMARD, targeted synthetic (ts)DMARD) or glucocorticoid (GC) therapy in patients with RA was done by searching MEDLINE, Embase and the Cochrane Library for articles published between 2016 and 8 March 2019. RESULTS: 234 abstracts were selected for detailed assessment, with 136 finally included. They comprised the efficacy of bDMARDs versus placebo or other bDMARDs, efficacy of Janus kinase (JAK) inhibitors (JAKi) across different patient populations and head-to-head of different bDMARDs versus JAKi or other bDMARDs. Switching of bDMARDs to other bDMARDs or tsDMARDs, strategic trials and tapering studies of bDMARDs, csDMARDs and JAKi were assessed. The drugs evaluated included abatacept, adalimumab, ABT-122, baricitinib, certolizumab pegol, SBI-087, CNTO6785, decernotinib, etanercept, filgotinib, golimumab, GCs, GS-9876, guselkumab, hydroxychloroquine, infliximab, leflunomide, mavrilimumab, methotrexate, olokizumab, otilimab, peficitinib, rituximab, sarilumab, salazopyrine, secukinumab, sirukumab, tacrolimus, tocilizumab, tofacitinib, tregalizumab, upadacitinib, ustekinumab and vobarilizumab. The efficacy of many bDMARDs and tsDMARDs was shown. Switching to another tumour necrosis factor inhibitor (TNFi) or non-TNFi bDMARDs after TNFi treatment failure is efficacious. Tapering of DMARDs is possible in patients achieving long-standing stringent clinical remission; in patients with residual disease activity (including patients in LDA) the risk of flares is increased during the tapering. Biosimilars are non-inferior to their reference products. CONCLUSION: This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Substituição de Medicamentos , Quimioterapia Combinada , Glucocorticoides/uso terapêutico , Humanos , Inibidores de Janus Quinases/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicamentos Sintéticos/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores
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