scholarly journals Expert opinion on the use of cladribine tablets in clinical practice

2020 ◽  
Vol 13 ◽  
pp. 175628642093501 ◽  
Author(s):  
Per Soelberg Sørensen ◽  
Diego Centonze ◽  
Gavin Giovannoni ◽  
Xavier Montalban ◽  
Daniel Selchen ◽  
...  

Background: Gaps in current product labels and a lack of detailed clinical guidelines leaves clinicians’ questions on the practical management of patients receiving cladribine tablets for the treatment of relapsing multiple sclerosis (MS) unanswered. We describe a consensus-based programme led by international MS experts with the aim of providing recommendations to support the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of nine international MS experts led the programme and developed 11 clinical questions concerning the practical use of cladribine tablets. Statements to address each question were drafted using available evidence, expert experiences and perspectives from the SC and an extended faculty of 33 MS experts, representing 19 countries. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7–9, on a 9-point scale. Results: Consensus was achieved on 46 out of 47 recommendations. Expert-agreed practical recommendations are provided on topics including: the definition of highly active disease; patterns of treatment response and suboptimal response with cladribine tablets; management of pregnancy planning and malignancy risk, infection risk and immune function, and switching to and from cladribine tablets. Conclusion: These expert recommendations provide up-to-date relevant guidance on the use of cladribine tablets in clinical practice.

2021 ◽  
Author(s):  
Peter Rieckmann ◽  
Diego Centonze ◽  
Gavin Giovannoni ◽  
Le H Hua ◽  
Celia Oreja-Guevara ◽  
...  

Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID 19 pandemic, in particular relating to COVID 19 vaccination. Objective: We describe a consensus-based programme led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID 19 vaccination and the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID 19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinical recommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the SC members, voted on the recommendations. Consensus on recommendations was achieved when more than or equal to 75% of respondents expressed an agreement score of 7 to 9, on a 9 point scale. Results: Consensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID 19, and whether they should be prioritized; the timing of vaccination around dosing of cladribine tablets (i.e., before and after a treatment course); and the safety of COVID 19 vaccination for these patients. Conclusions: These expert recommendations provide timely guidance on COVID 19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinical practice.


2021 ◽  
Vol 14 ◽  
pp. 175628642110582
Author(s):  
Peter Rieckmann ◽  
Diego Centonze ◽  
Gavin Giovannoni ◽  
Le H. Hua ◽  
Celia Oreja-Guevara ◽  
...  

Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID-19 pandemic, in particular relating to COVID-19 vaccination. Objective: We describe a consensus-based program led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID-19 vaccination and the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID-19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinical recommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the 10 SC members, voted on the recommendations. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7–9, on a 9-point scale. Results: Consensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID-19, and whether they should be prioritized; the timing of vaccination around dosing of cladribine tablets (i.e. before and after a treatment course); and the safety of COVID-19 vaccination for these patients. Conclusion: These expert recommendations provide timely guidance on COVID-19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinical practice.


2015 ◽  
Vol 44 (4) ◽  
pp. 199-214 ◽  
Author(s):  
Tomas Kalincik

Relapses (episodic exacerbations of neurological signs or symptoms) are a defining feature of relapsing-remitting multiple sclerosis (MS), the most prevalent MS phenotype. While their diagnostic value relates predominantly to the definition of clinically definite MS, their prognostic value is determined by their relatively high associated risk of incomplete remission resulting in residual disability. The mechanisms governing a relapse incidence are unknown, but numerous modifiers of relapse risk have been described, including demographic and clinical characteristics, many of which represent opportunities for improved disease management. Also relapse phenotypes have been associated with patient and disease characteristics and an individual predisposition to certain phenotypic presentations may imply individual neuroanatomical disease patterns. While immunomodulatory therapies and corticosteroids represent the mainstay of relapse prevention and acute management, respectively, their effect has only been partial and further search for more efficient relapse therapies is warranted. Other areas of research include pathophysiology and determinants of relapse incidence, recurrence and phenotypes, including the characteristics of the relapsing and non-relapsing multiple sclerosis variants and their responsiveness to therapies.


2016 ◽  
Vol 33 (S1) ◽  
pp. S528-S529
Author(s):  
A. D’Agostino ◽  
S. Covanti ◽  
M. Rossi Monti ◽  
V. Starcevic

IntroductionOver the past decade, emotion dysregulation has become a very popular term in the psychiatric and clinical psychology literature and it has been described as a key component in a range of mental disorders. For this reason, it has been recently called the “hallmark of psychopathology” (Beauchaine et al., 2007). However, many issues make this concept controversial.ObjectivesTo explore emotion dysregulation, focusing on problems related to its definition, meanings and role in many psychiatric disorders.AimsTo clarify the psychopathological core of emotion dysregulation and to discuss potential implications for clinical practice.MethodsA literature review was carried out by examining articles published in English between January 2003 and June 2015. A search of the databases PubMed, PsycINFO, Science Direct, Medline, EMBASE and Google Scholar was performed to identify the relevant papers.ResultsAlthough, there is no agreement about the definition of emotion dysregulation, the following five overlapping, not mutually exclusive dimensions were identified: decreased emotional awareness, inadequate emotional reactivity, intense experience and expression of emotions, emotional rigidity and cognitive reappraisal difficulty. These dimensions characterise a number of psychiatric disorders in different proportions, with borderline personality disorder and eating disorders seemingly more affected than other conditions.ConclusionsThis review highlights a discrepancy between the widespread clinical use of emotion dysregulation and inadequate conceptual status of this construct. Better understanding of the various dimensions of emotion dysregulation has implications for treatment. Future research needs to address emotion dysregulation in all its multifaceted complexity.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2001 ◽  
Vol 29 (6) ◽  
pp. 842-849 ◽  
Author(s):  
Lisa A. Suzuki ◽  
Mary B. McRae ◽  
Ellen L. Short

Sue’s proposed model is based on a critique of the Eurocentric assumptions underlying current clinical practice and reflects his innovative thinking and unique synthesis of past research. The specific areas addressed in this article focus on an examination of the multidimensional model of cultural competence (MDCC) and issues related to the definition of competence and its measurement. Areas of needed elaboration in the model include complexities related to power hierarchies (i.e., authority, authorization, and leadership) and implications for training and practice. Particular emphasis is placed on the complexities of cultural competence and the important contributions of Sue’s MDCC as an important step in making cultural competence a reality in the practice of counseling psychology.


2014 ◽  
Vol 9 ◽  
Author(s):  
Roberto Tramarin ◽  
Mario Polverino ◽  
Maurizio Volterrani ◽  
Bruna Girardi ◽  
Claudio Chimini ◽  
...  

Background: Cardiovascular and respiratory diseases are leading causes of morbidity and their co-occurrence has important implications in mortality and other outcomes. Even the most recent guidelines do not reliably address clinical, prognostic, and therapeutic concerns due to the overlap of respiratory and cardiac diseases. Study objectives and design: In order to evaluate in the reality of clinical practice the epidemiology and the reciprocal impact of cardio-pulmonary comorbidity on the clinical management, diagnostic workup and treatment, 1,500 cardiac and 1,500 respiratory inpatients, admitted in acute and rehabilitation units, will be enrolled in a multicenter, nationwide, prospective observational study. For this purpose, each center will enroll at least 50 consecutive patients. At discharge, data analysis will be aimed at the definition of cardiac and pulmonary inpatient comorbidity prevalence, demographic characteristics, length of hospital stay, and risk factors, taking into account also procedures, pharmacological and non-pharmacological treatment, and follow up in patients with cardio-respiratory comorbidity. Conclusions: The purely observational design of the study aims to give new relevant information on the assessment and management of overlapping patients in real life clinical practice, and new insight for improvement and implementation of current guidelines on the management of individual diseases.


2016 ◽  
Vol 38 (2) ◽  
pp. 103-115 ◽  
Author(s):  
Raissa Miller

Understanding and integrating neuroscience research into clinical practice represents a rapidly growing area in mental health. An expanding body of neuroscience literature increasingly informs clinical practice by validating theory, guiding clinical assessment and conceptualization, directing effective interventions, and facilitating cross-disciplinary communication. Little attention, however, has been given to the use of neuroeducation with clients. In this article, the author provides mental health counselors with a definition of neuroeducation and a rationale for incorporating neuroeducation into clinical practice. The author identifies common neuroeducation topics and offers activity suggestions to illustrate their use in counseling. Finally, the author offers best practices for implementing neuroeducation, including attention to counselor competence, client readiness, and neuroscience of learning principles. Implications for research are also discussed.


2021 ◽  
Vol 11 ◽  
Author(s):  
Angel P. Sempere ◽  
Leticia Berenguer-Ruiz ◽  
Ines Borrego-Soriano ◽  
Amparo Burgos-San Jose ◽  
Luis Concepcion-Aramendia ◽  
...  

Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded.Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4–6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.


2012 ◽  
Vol 56 (4) ◽  
pp. 1990-1996 ◽  
Author(s):  
Alix Pantel ◽  
Stéphanie Petrella ◽  
Nicolas Veziris ◽  
Florence Brossier ◽  
Sylvaine Bastian ◽  
...  

ABSTRACTFluoroquinolone (FQ) resistance is emerging inMycobacterium tuberculosis. The main mechanism of FQ resistance is amino acid substitution within the quinolone resistance-determining region (QRDR) of the GyrA subunit of DNA gyrase, the sole FQ target inM. tuberculosis. However, substitutions in GyrB whose implication in FQ resistance is unknown are increasingly being reported. The present study clarified the role of four GyrB substitutions identified inM. tuberculosisclinical strains, two located in the QRDR (D500A and N538T) and two outside the QRDR (T539P and E540V), in FQ resistance. We measured FQ MICs and also DNA gyrase inhibition by FQs in order to unequivocally clarify the role of these mutations in FQ resistance. Wild-type GyrA, wild-type GyrB, and mutant GyrB subunits produced from engineeredgyrBalleles by mutagenesis were overexpressed inEscherichia coli, purified to homogeneity, and used to reconstitute highly active gyrase complexes. MICs and DNA gyrase inhibition were determined for moxifloxacin, gatifloxacin, ofloxacin, levofloxacin, and enoxacin. All these substitutions are clearly implicated in FQ resistance, underlining the presence of a hot spot region housing most of the GyrB substitutions implicated in FQ resistance (residues NTE, 538 to 540). These findings help us to refine the definition of GyrB QRDR, which is extended to positions 500 to 540.


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