The Portuguese Society of Rheumatology position paper on the use of biosimilars

Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.info:eu-repo/semantics/publishedVersio

Para o estudo da evolução do ensino e da formação em administração educacional em Portugal

Estudos sobre a evolução do ensino de disciplinas, na formação de professores em Portugal, são recentes. O controle burocrático centralizado reteve as dimensões do controle político-administrativo. De certo modo, protegeu a esfera educativa das influências modernizantes, do capitalismo industrial e das lógicas mercantis e gerencialistas. Defendeu a educação do domínio político, da intervenção de movimentos sociais, das propagandas de ideais democráticos e da cidadania. A utilização da designação "Administração educacional" ilustra as dificuldades sentidas, ao longo dos últimos anos, em termos da construção acadêmica de uma área, seja pela falta de tradição, seja pelos antecedentes históricos.In Portugal, studies about the evolution of disciplines teaching in the teachers formation are recent. The centralized bureaucratic control has held back the dimensions of politic administrative control. In a certain way, it has protected the education against the new-fashioned influences, manufacturing capitalism, and mercantile and managerial logics. This centralized bureaucratic control has also profected the education against the politic dominion, the intervention of social movements, the advertising of democratic ideals, and against the citizenship. The use of the term "Educational administration" shows the difficulties met by the searchers along the latest years, since there is no tradiction nor historic antecedence

Multimodal diagnostics for keratoconus and ectatic corneal diseases: a paradigm shift

Abstract Different diagnostic approaches for ectatic corneal diseases (ECD) include screening, diagnosis confirmation, classification of the ECD type, severity staging, prognostic evaluation, and clinical follow-up. The comprehensive assessment must start with a directed clinical history. However, multimodal imaging tools, including Placido-disk topography, Scheimpflug three-dimensional (3D) tomography, corneal biomechanical evaluations, and layered (or segmental) tomography with epithelial thickness by optical coherence tomography (OCT), or digital very high-frequency ultrasound (dVHF-US) serve as fundamental complementary exams for measuring different characteristics of the cornea. Also, ocular wavefront analysis, axial length measurements, corneal specular or confocal microscopy, and genetic or molecular biology tests are relevant for clinical decisions. Artificial intelligence enhances interpretation and enables combining such a plethora of data, boosting accuracy and facilitating clinical decisions. The applications of diagnostic information for individualized treatments became relevant concerning the therapeutic refractive procedures that emerged as alternatives to keratoplasty. The first paradigm shift concerns the surgical management of patients with ECD with different techniques, such as crosslinking and intrastromal corneal ring segments. A second paradigm shift involved the quest for identifying patients at higher risk of progressive iatrogenic ectasia after elective refractive corrections on the cornea. Beyond augmenting the sensitivity to detect very mild (subclinical or fruste) forms of ECD, ectasia risk assessment evolved to characterize the inherent susceptibility for ectasia development and progression. Furthermore, ectasia risk is also related to environmental factors, including eye rubbing and the relational impact of the surgical procedure on the cornea

Optimized Artificial Intelligence for Enhanced Ectasia Detection Using Scheimpflug-Based Corneal Tomography and Biomechanical Data

Purpose: To optimize artificial intelligence (AI) algorithms to integrate Scheimpflug-based corneal tomography and biomechanics to enhance ectasia detection. Design: Multicenter cross-sectional case-control retrospective study. Methods: A total of 3886 unoperated eyes from 3412 patients had Pentacam and Corvis ST (Oculus Optikgeräte GmbH) examinations. The database included 1 eye randomly selected from 1680 normal patients (N) and from 1181 “bilateral” keratoconus (KC) patients, along with 551 normal topography eyes from patients with very asymmetric ectasia (VAE-NT), and their 474 unoperated ectatic (VAE-E) eyes. The current TBIv1 (tomographic-biomechanical index) was tested, and an optimized AI algorithm was developed for augmenting accuracy. Results: The area under the receiver operating characteristic curve (AUC) of the TBIv1 for discriminating clinical ectasia (KC and VAE-E) was 0.999 (98.5% sensitivity; 98.6% specificity [cutoff: 0.5]), and for VAE-NT, 0.899 (76% sensitivity; 89.1% specificity [cutoff: 0.29]). A novel random forest algorithm (TBIv2), developed with 18 features in 156 trees using 10-fold cross-validation, had a significantly higher AUC (0.945; DeLong, P <.0001) for detecting VAE-NT (84.4% sensitivity and 90.1% specificity; cutoff: 0.43; DeLong, P <.0001) and a similar AUC for clinical ectasia (0.999; DeLong, P =.818; 98.7% sensitivity; 99.2% specificity [cutoff: 0.8]). Considering all cases, the TBIv2 had a higher AUC (0.985) than TBIv1 (0.974; DeLong, P <.0001). Conclusions: AI optimization to integrate Scheimpflug-based corneal tomography and biomechanical assessments augments accuracy for ectasia detection, characterizing ectasia susceptibility in the diverse VAE-NT group. Some patients with VAE may have true unilateral ectasia. Machine learning considering additional data, including epithelial thickness or other parameters from multimodal refractive imaging, will continuously enhance accuracy. NOTE: Publication of this article is sponsored by the American Ophthalmological Society. © 2022Open access articleThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Portuguese recommendations for the prevention, diagnosis and management of primary osteoporosis - 2018 update

Background: Advances in osteoporosis (OP)case definition, treatment options, optimal therapy duration and pharmacoeconomic evidence in the national context motivated the Portuguese Society of Rheumatology (SPR) to update the Portuguese recommendations for the diagnosis and management of osteoporosis published in 2007. Methods: SPR bone diseases’ working group organized meetings involving 55 participants (rheumatologists, rheumatology fellows and one OP specialist nurse) to debate and develop the document. First, the working group selected 11 pertinent clinical questions for the diagnosis and management of osteoporosis in standard clinical practice. Then, each question was investigated through literature review and draft recommendations were built through consensus. When insufficient evidence was available, recommendations were based on experts’ opinion and on good clinical practice. At two national meetings, the recommendations were discussed and updated. A draft of the recommendations full text was submitted to critical review among the working group and suggestions were incorporated. A final version was circulated among all Portuguese rheumatologists before publication and the level of agreement was anonymously assessed using an online survey. Results: The 2018 SPR recommendations provide comprehensive guidance on osteoporosis prevention, diagnosis, fracture risk assessment, pharmacological treatment initiation, therapy options and duration of treatment, based on the best available evidence. They attained desirable agreement among Portuguese rheumatologists. As more evidence becomes available, periodic revisions will be performed. Target audience and patient population: The target audience for these guidelines includes all clinicians. The target patient population includes adult Portuguese people. Intended use: These recommendations provide general guidance for typical cases. They may not be appropriate in all situations - clinicians are encouraged to consider this information together with updated evidence and their best clinical judgment in individual cases

Pteridófitas de um remanescente de Floresta Atlântica em São Vicente Férrer, Pernambuco, Brasil: Pteridaceae Pteridophytes of a remainder of Atlantic Forest in São Vicente Férrer, Pernambuco, Brazil: Pteridaceae

Foi realizado um levantamento florístico da pteridoflora da Mata do Estado, localizada no município de São Vicente Férrer, Zona da Mata Norte do Estado de Pernambuco. O estudo foi desenvolvido nesta área, devido a sua grande extensão, ca. 600ha, e também pela existência de uma grande diversidade de pteridófitas, resultado de um gradiente de umidade onde os fatores ambientais e físicos como os níveis de altitude, as precipitações pluviométricas, bem como a distribuição dessas precipitações têm importância fundamental para a vegetação da área. Foram empregados métodos tradicionais para o levantamento florístico, no período de um ano. Para a análise e identificação taxonômica dos exemplares coletados, foram utilizadas técnicas usuais e literaturas especializadas. São apresentadas ilustrações e distribuição geográfica das espécies, bem como, descrição da espécie nova referência e comentários da família, gêneros e espécies. O trabalho contribui para um maior conhecimento florístico e ecológico da pteridoflora de Reservas de Floresta Atlântica Serrana no Nordeste do Brasil. A família Pteridaceae está representada na área estudada por 20 espécies, distribuídas em sete gêneros (Pityrogramma Link, Adiantopsis Fée, Hemionitis L. e Acrostichum L. uma espécie cada; Doryopteris J. Sm. quatro espécies; Adiantum L. nove espécies e Pteris L. três espécies e uma variedade). Foi registrada uma nova referência para o estado de Pernambuco: Adiantum humile Kunze.<br>A floristic survey of the pteridoflora at the Mata do Estado, located in the Municipality of São Vicente Férrer, Mata Norte (Atlantic Forest) Zone in the state of Pernambuco, Brazil, was performed. The study was developed in this area, due to its great extension of ca. 600ha, and also because of a great of diversity pteridophytes , result of a humidity gradient where the environmental and physical factors such as the altitude levels and the,, precipitation, as well as the distribution of those precipitations has fundamental importance for the vegetation of the area. Traditional methods were used to carry out the floristic survey. The usual methods and specialized literature were utilized for the analysis and identification of the collected specimens. Illustrations and geographic distribution of the species are presented, and also a description of new reference species and comments on families, genera and species. The work aims to contribute to a better floristic and ecological understanding of the pteridoflora of the Atlantic Forest Reserves located in the mountainous region of the Northeastern Brazil. The family Pteridaceae is represented in the studied area with by twenty especies distributed in seven genera (Pityrogramma Link, Adiantopsis Fee, Hemionitis L. with and Acrostichum L. with one specie each; Doryopteris J. Sm. with four species; Adiantum L. with nine species and Pteris L. a tree species and one variety). Adiantum humile Kunze is a new reference for the state of Pernambuco

ANKH and susceptibility to and severity of ankylosing spondylitis

Objective. Unconfirmed reports describe association of ankylosing spondylitis (AS) with several candidate genes including ANKH. Cellular export of inorganic pyrophosphate is regulated by the ANK protein, and mutant mice (ank/ank), which have a premature stop codon in the 3′ end of the ank gene, develop severe ankylosis. We tested the association between single-nucleotide polymorphisms (SNP) in these genes and susceptibility to AS in a population of patients with AS. We investigated the role of these genes in terms of functional (BASFI) and metrological (BASMI) measures, and the association with radiological severity (mSASSS). Methods. Our study was conducted on 355 patients with AS and 95 ethnically matched healthy controls. AS was defined according to the modified New York criteria. Four SNP in ANKH (rs27356, rs26307, rs25957, and rs28006) were genotyped. Association analysis was performed using Cochrane-Armitage and linear regression tests for dichotomous and quantitative variables. Analyses of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASFI, and mSASSS were controlled for sex and disease duration. Results. None of the 4 markers showed significant single-locus disease associations (p > 0.05), suggesting that ANKH was not a major determinant of AS susceptibility in our population. No association was observed between these SNP and age at symptom onset, BASDAI, BASFI, BASMI, or mSASSS. Conclusion. These results confirm data in white Europeans that ANKH is probably not a major determinant of susceptibility to AS. ANKH polymorphisms do not markedly influence AS disease severity, as measured by BASMI and mSASSS. The Journal of Rheumatology Copyrigh