scholarly journals Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?

2019 ◽  
Vol 10 ◽  
Author(s):  
Daniel C. Baumgart ◽  
Laurent Misery ◽  
Sue Naeyaert ◽  
Peter C. Taylor
2021 ◽  
pp. 1-5
Author(s):  
Jean-Pierre Zellweger ◽  
◽  
Delia Goletti ◽  

After contact with a case of transmissible tuberculosis (TB), some of the exposed individuals may be infected and develop an immune reaction against Mycobacterium tuberculosis (Mtb), the causative agent of the disease. The replication of mycobacteria is usually stopped within cellular structures called granulomas, whose integrity relies on a complex interplay between cells and cytokines, the most prominent of them being TNF. In case of deficiency or inhibition of the activity of TNF, the granulomas may disrupt and release the surviving mycobacteria which may multiply, disseminate and lead to active TB disease. Several immune-mediated inflammatory diseases, among which rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis and psoriasis can be treated by biological therapies acting by the inhibition of TNF or cytokines like IL-17 and IL-23. If these therapies, in particular TNF-inhibitors, are administered to people infected by Mtb, there is a risk of decreasing the integrity of granulomas and increasing the probability of mutiplication of mycobacteria and TB reactivation. Therefore, in persons with rheumatological, gastro-enterological and dermatological diseases candidate to biological therapies there is a general recommendation of screening for TB infection (TBI) at baseline. The screening should include also a search for history of prior TB or contact with TB, a test for the presence of TBI, and if scored positive, a chest X-Ray


2022 ◽  
Author(s):  
Rosa Romero-Jimenez ◽  
Vicente Escudero-Vilaplana ◽  
Esther Chamorro-de-Vega ◽  
Arantza Ais-Larisgoitia ◽  
Maria Elena Lobato Matilla ◽  
...  

BACKGROUND Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. OBJECTIVE Our objective was to design and implement an app for remote monitoring and communication with IMID patients. We also assessed the usability of and satisfaction with the app. METHODS A multidisciplinary group comprising pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, cross-sectional, descriptive study of all available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we started offering the app to all IMID patients who initiated a new biological therapy. We performed an observational, longitudinal study of patients followed using the app to assess the tool's impact on safety, communication, satisfaction, and usability. The inclusion period was from December 2020 to August 2021. The inclusion criteria were age ≥ 18 years, diagnosis of an IMID, and ownership of a Smartphone. Patients with language barriers were excluded. RESULTS We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 86 patients were installed with the app (the median age was 48.3 [18.1-79.4] years and 62.4 were female). The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. The app sections that patients browsed for the longest time were Messages (21.9%), Start screen (20.9%), My questionnaires (20.4%), My medication (8.8%), and Adverse events (7.1%). CONCLUSIONS We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals. Patient satisfaction and retention were very high.


2020 ◽  
pp. 100-107
Author(s):  
John D. Isaacs ◽  
Nishanthi Thalayasingam

Therapeutic monoclonal antibodies and related molecules are increasingly used to treat immune-mediated and inflammatory diseases. They interact very precisely with a soluble or cell-bound ligand to have three predominant effects: neutralization of proinflammatory cytokines or growth factors; modulation of intercellular interactions; or depletion of pathogenic cells. They deliver significantly enhanced specificity in comparison to traditional synthetic drugs and have delivered substantial improvements in clinical outcomes in many immune, inflammatory, and allergic diseases. However, there are no biomarkers to help decide which biological class to try first in a particular patient, hence one of the main challenges for the future is the identification of ‘stratifiers’ to guide therapy.


Lupus ◽  
2020 ◽  
Vol 29 (6) ◽  
pp. 525-532
Author(s):  
Christopher J Edwards ◽  
Salvatore Bellinvia

Biological therapies have widened the therapeutic armamentarium for immune-mediated inflammatory diseases, providing in many cases a broad range of treatment options with different mechanisms of action. The widespread use of biological agents in systemic lupus erythematosus is currently limited to belimumab and rituximab, although results of promising larger Phase III clinical trials are awaited or have been recently circulated, especially for anti-cytokine therapies. The loss of exclusivity over the last years for several originator biologics has started the successful introduction of biosimilar products into clinical practice. There is an abbreviated pathway to biosimilar approval, but this is underpinned by the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Nevertheless, there are unique reasons why development of biosimilars may be particularly challenging in lupus.


Author(s):  
A Melgarejo-Ortuño ◽  
RM Romero Jiménez ◽  
E Chamorro De Vega ◽  
A Ais Larisgoitia ◽  
ME Lobato Matilla ◽  
...  

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 871.2-871
Author(s):  
F. Araujo ◽  
N. Gonçalves ◽  
A. F. Mourão

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.


2021 ◽  
Vol 22 (14) ◽  
pp. 7506
Author(s):  
Charles Gwellem Anchang ◽  
Cong Xu ◽  
Maria Gabriella Raimondo ◽  
Raja Atreya ◽  
Andreas Maier ◽  
...  

Immune-mediated inflammatory diseases (IMIDs), such as inflammatory bowel diseases and inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis), are marked by increasing worldwide incidence rates. Apart from irreversible damage of the affected tissue, the systemic nature of these diseases heightens the incidence of cardiovascular insults and colitis-associated neoplasia. Only 40–60% of patients respond to currently used standard-of-care immunotherapies. In addition to this limited long-term effectiveness, all current therapies have to be given on a lifelong basis as they are unable to specifically reprogram the inflammatory process and thus achieve a true cure of the disease. On the other hand, the development of various OMICs technologies is considered as “the great hope” for improving the treatment of IMIDs. This review sheds light on the progressive development and the numerous approaches from basic science that gradually lead to the transfer from “bench to bedside” and the implementation into general patient care procedures.


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