scholarly journals How to Manage COVID-19 Vaccination in Immune-Mediated Inflammatory Diseases: An Expert Opinion by IMIDs Study Group

2021 ◽  
Vol 12 ◽  
Author(s):  
Francesca Ferretti ◽  
Rosanna Cannatelli ◽  
Maurizio Benucci ◽  
Stefania Carmagnola ◽  
Emilio Clementi ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Risk Groups ◽  
Position Paper ◽  
Point Of View ◽  
Daily Routine ◽  
Efficacy And Safety ◽  
Specific Data ◽  
Immune Mediated ◽  
Chronic Therapy ◽  
Vectored Vaccine

Since March 2020, the outbreak of Sars-CoV-2 pandemic has changed medical practice and daily routine around the world. Huge efforts from pharmacological industries have led to the development of COVID-19 vaccines. In particular two mRNA vaccines, namely the BNT162b2 (Pfizer-BioNTech) and the mRNA-1273 (Moderna), and a viral-vectored vaccine, i.e. ChAdOx1 nCoV-19 (AstraZeneca), have recently been approved in Europe. Clinical trials on these vaccines have been published on the general population showing a high efficacy with minor adverse events. However, specific data about the efficacy and safety of these vaccines in patients with immune-mediated inflammatory diseases (IMIDs) are still lacking. Moreover, the limited availability of these vaccines requires prioritizing some vulnerable categories of patients compared to others. In this position paper, we propose the point of view about the management of COVID-19 vaccination from Italian experts on IMIDs and the identification of high-risk groups according to the different diseases and their chronic therapy.

scholarly journals Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001374
Author(s):  
Andreas Kerschbaumer ◽  
Josef S Smolen ◽  
Peter Nash ◽  
Thomas Doerner ◽  
Maxime Dougados ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Task Force ◽  
Inflammatory Diseases ◽  
Janus Kinase ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Literature Research ◽  
Immune Mediated ◽  
Venous Thromboembolic Events

ObjectivesReview of efficacy and safety of Janus kinase (JAK) inhibition in immune-mediated inflammatory diseases (IMIDs).MethodsA systematic literature research (SLR) of all publications on JAK inhibitors (JAKi) treatment published until March 2019 using MEDLINE, EMBASE and the Cochrane Library. Efficacy and safety were assessed in randomised controlled trials (RCTs), integrating long-term extension periods additionally for safety evaluation.Results3454 abstracts were screened with 85 included in the final analysis (efficacy and RCT safety: n=72; safety only: n=13). Efficacy of RCTs investigating tofacitinib (TOFA, n=27), baricitinib (BARI, n=9), upadacitinib (UPA, n=14), filgotinib (FILGO, n=7), decernotinib (DEC, n=3) and peficitinib (PEF, n=7) was evaluated. Six head-to-head trials comparing JAKi with tumour necrosis factor inhibitors (TNFi) were included. Efficacy of JAKi was shown in rheumatoid arthritis (RA) for all agents, psoriatic arthritis (TOFA, FILGO), ankylosing spondylitis (TOFA, FILGO), systemic lupus erythematosus (BARI), chronic plaque psoriasis (TOFA, BARI, PEF), ulcerative colitis (TOFA, UPA), Crohn’s disease (UPA, FILGO) and atopic dermatitis (TOFA, BARI, UPA). Safety analysis of 72 RCTs, one cohort study and 12 articles on long-term extension studies showed increased risks for infections, especially herpes zoster, serious infections and numerically higher rates of venous thromboembolic events. No increased malignancy rates or major adverse cardiac events were observed.ConclusionJAKi provide good efficacy compared to placebo (and to TNFi in RA and Pso) across various IMIDs with an acceptable safety profile. This SLR informed the task force on points to consider for the treatment of IMIDs with JAKi with the available evidence.

scholarly journals Point of view on the vaccination against COVID-19 in patients with autoimmune inflammatory rheumatic diseases

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001594
Author(s):  
Victoria Furer ◽  
Christien Rondaan ◽  
Nancy Agmon-Levin ◽  
Sander van Assen ◽  
Marc Bijl ◽  
...  
Keyword(s):  
Expert Opinion ◽  
Rheumatic Diseases ◽  
Current Data ◽  
Position Paper ◽  
Point Of View ◽  
Inflammatory Rheumatic Diseases ◽  
Efficacy And Safety

In view of the COVID-19 pandemic, there is an unmet clinical need for the guidelines on vaccination of patients with autoimmune inflammatory rheumatic diseases (AIIRD). This position paper summarises the current data on COVID-19 infection in patients with AIIRD and development of vaccines against COVID-19, discusses the aspects of efficacy and safety of vaccination, and proposes preliminary considerations on vaccination against COVID-19 in patients with AIIRD, mainly based on the expert opinion and knowledge on the use of other vaccines in this population of patients.

scholarly journals Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement

2020 ◽  
Vol 80 (1) ◽  
pp. 71-87 ◽  
Author(s):  
Peter Nash ◽  
Andreas Kerschbaumer ◽  
Thomas Dörner ◽  
Maxime Dougados ◽  
Roy M Fleischmann ◽  
...  
Keyword(s):  
Kinase Inhibitors ◽  
Consensus Statement ◽  
Task Force ◽  
Inflammatory Diseases ◽  
Steering Committee ◽  
Janus Kinase ◽  
Expert Committee ◽  
Efficacy And Safety ◽  
Janus Kinase Inhibitors ◽  
Immune Mediated

ObjectivesJanus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety.MethodsExisting data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration.ResultsThe Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale.ConclusionThe consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management.

scholarly journals JAK-inhibitors: pharmacological properties and comparative clinical efficacy and safety

2021 ◽  
Vol 30 (1) ◽  
pp. 51-60
Author(s):  
P. Novikov ◽  
T. Shevtsova ◽  
E. Shchegoleva ◽  
S. Moiseev
Keyword(s):  
Clinical Trials ◽  
Inflammatory Diseases ◽  
Controlled Trials ◽  
Similar Response ◽  
Pharmacological Properties ◽  
Efficacy And Safety ◽  
Jak Inhibitors ◽  
Randomized Controlled ◽  
Immune Mediated ◽  
Direct Head

JAK-inhibitors interrupt the intracellular JAK-STAT signalling pathway that mediates action of various cytokines which are involved in the pathogenesis of rheumatoid arthritis (RA) and other immune-mediated inflammatory diseases. The objective of literature review was to compare the results of clinical trials of three JAK-inhibitors, that is, tofacitinib, baricitinib and upadacitinib, that differ in selectivity against JAK, in patients with RA. We have found no direct head-to-head clinical trials of JAK-inhibitoris. However, in the randomized controlled trials both non-selective (tofacitinib and baricitinib) and selective (upadacitinib) JAK-inhibitors were proved to be more effective than placebo and were associated with the similar response rates. Safety profiles of JAK-inhibitors were also comparable.

scholarly journals 4CPS-329 Do patients with immune mediated inflammatory diseases think they know their medication?

2021 ◽  
Author(s):  
A Melgarejo-Ortuño ◽  
RM Romero Jiménez ◽  
E Chamorro De Vega ◽  
A Ais Larisgoitia ◽  
ME Lobato Matilla ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Immune Mediated

scholarly journals POS1180 TREATMENT COMPLIANCE OF PATIENTS WITH RHEUMATOID ARTHRITIS DURING THE FIRST WAVE OF THE SARS-CoV-2/COVID-19 PANDEMIC IN PORTUGAL: RESULTS FROM THE COVID IN RA (COVIDRA) SURVEY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 871.2-871
Author(s):  
F. Araujo ◽  
N. Gonçalves ◽  
A. F. Mourão
Keyword(s):  
Rheumatoid Arthritis ◽  
Inflammatory Diseases ◽  
Immunosuppressive Treatment ◽  
Treatment Compliance ◽  
Web Based ◽  
Symptoms Of Depression ◽  
Immune Mediated ◽  
Attending Physician ◽  
The Impact ◽  
E Mail

Background:The outcomes of the infection by the SARS-CoV-2 in patients with immune-mediated inflammatory diseases were largely unknown during the early days of the COVID-19 pandemic. It was hypothesized that these patients were at higher risk of morbidity and mortality due to their inherent immune dysfunction and immunosuppressive therapy. Several rheumatology societies issued recommendations urging patients not to stop their anti-rheumatic treatments.Objectives:To assess treatment compliance of patients with rheumatoid arthritis (RA) during the first wave of the SARS-CoV-2/COVID-19 pandemic in Portugal.Methods:The web-based survey COVIDRA (COVID in RA) was developed to assess the impact of the first wave mandatory confinement in patients with RA focusing on 5 domains: RA symptoms, attitudes towards medication, employment status, physical exercise and mental health. The questionnaire was sent to RA patients through e-mail and social media of the Portuguese Society of Rheumatology and two patient associations; and it was filled locally at two rheumatology centers in Lisbon. Recruitment took place during June and July 2020. Descriptive statistics were generated by the survey software and were afterwards transported and evaluated using appropriate biostatistics software.Results:We obtained 441 valid questionnaires. Most respondents were female (88.4%), caucasian (93.6%), with a mean age of 58 (+/-13) years. The majority (57.6%) had longstanding disease (>10 years) and were treated with csDMARDs (63.2%) and/or bDMARDs/tsDMARDS (23,7%). Only 14% (N=61) discontinued or reduced the dosage or frequency of their RA treatment. Most of these changes were previously planned by the attending physician (27.9%). Only 11 patients (18%) discontinued their immunosuppressive medication out of fear of becoming infected with SARS-CoV-2 (corresponding to 2.5% of total responders). Another 11 patients did so because they had no prescription, couldn’t go to the community/hospital pharmacy or couldn’t afford the medication. Although these numbers preclude any statistical analysis, when compared to patients who persisted on their treatment, those discontinuing due to fear of contagion were younger (56.4 vs 58.5 years), all female (100 vs 86.8%), with long-lasting disease (≥ 11 years) (90.9% vs 57.5%), more frequently treated with bDMARDs (36.4 vs 23.1%) and presenting more symptoms of depression (54.5 vs 49.7%).Conclusion:Most RA patients complied with their treatment during the first wave of the SARS-CoV-2 pandemic in Portugal. Only a minority changed their immunosuppressive treatment due to fear of SARS-CoV-2 infection. Very similar rates of immunosuppressive discontinuation due to fear of contagion were reported by other authors (such as Schmeiser et al, Pineda-sic et al and Fragoulis et al).Disclosure of Interests:Filipe Araujo Speakers bureau: Pfizer, Biogen, Novartis, Menarini, Consultant of: MSD, Nuno Gonçalves: None declared, Ana Filipa Mourão: None declared.

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