scholarly journals Management of Patients under Treatment with Monoclonal Antibodies and New Biological Therapies

2021 ◽  
Vol 11 (11) ◽  
pp. 4865
Author(s):  
Marta Amigo-Basilio ◽  
Covadonga Álvarez-González ◽  
Carlos Cobo-Vázquez ◽  
Isabel Leco-Berrocal ◽  
Luis Miguel Sáez-Alcaide ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Conservative Treatment ◽  
Adverse Effects ◽  
Adverse Events ◽  
Oral Cavity ◽  
Study Design ◽  
Biological Therapy ◽  
Design Analysis ◽  
Biological Therapies ◽  
Analysis Of Cases

Objective: The aim of this study is to know the biological therapy drugs that are related to adverse events, what dental treatments are associated with the appearance of these events, their severity, and how they are resolved. Study design: Analysis of cases described in the literature on patients undergoing treatment with biological therapies who have developed adverse effects associated with these drugs. Results: Of the 62 articles reviewed, 49 describe 68 cases of MRONJ, most of which appeared in the jaw and received surgical and/or conservative treatment. Conclusions: Biological therapies can potentially develop adverse effects in the oral cavity, so strict monitoring by the dentist is necessary.

Biological therapy

2007 ◽  
pp. 249-260
Keyword(s):  
Immune Response ◽  
Monoclonal Antibodies ◽  
Immune System ◽  
Tumour Growth ◽  
Biological Therapy ◽  
Biological Therapies ◽  
Natural Substances ◽  
Anti Tumour Effect

Principles 250 Immunotherapy 252 Monoclonal antibodies 254 Other biological therapies 258 Biological therapies aim to produce an anti-tumour effect, either by activating the patient's immune system, or by administering natural substances present in the immune system as treatments. These treatments cause an immune response in the patient that eliminates or delays tumour growth....

Calcitonin Gene-Related Peptide Antagonists for the Prevention of Migraine: Highlights From Pivotal Studies and the Clinical Relevance of This New Drug Class

2020 ◽  
Vol 54 (8) ◽  
pp. 795-803
Author(s):  
Karissa Arca ◽  
Jenna Reynolds ◽  
Kara A. Sands ◽  
Harn J. Shiue
Keyword(s):  
Monoclonal Antibodies ◽  
Adverse Effects ◽  
Adverse Events ◽  
Clinical Relevance ◽  
Drug Class ◽  
Calcitonin Gene Related Peptide ◽  
Migraine Prophylaxis ◽  
Related Peptide ◽  
New Drug ◽  
Calcitonin Gene

Objective: To review the new drug class of calcitonin gene-related peptide antagonists (monoclonal antibodies) and their clinical relevance in migraine prophylaxis. Data Sources: A literature search was performed in PubMed (January 2009 to November 2019) using the terms migraine, calcitonin gene-related peptide (CGRP), erenumab, fremanezumab, and galcanezumab for clinical trials and studies. Study Selection and Data Extraction: Reports from human studies in English were evaluated for clinical evidence supporting pharmacology, efficacy, and adverse events. Initial pharmacokinetic and preclinical studies were excluded. Data Synthesis: In chronic and episodic migraine, prophylaxis with injections of monoclonal antibodies antagonizing CGRP reduced monthly migraine days with minimal clinically significant adverse events. In addition, there is evidence supporting efficacy in refractory migraine despite optimal prophylaxis. Relevance to Patient Care and Clinical Practice: This is the first target-specific migraine prophylaxis treatment to show efficacy with minimal adverse effects. A higher drug cost is a barrier but is balanced by improved quality of life. Current therapies have limited efficacy and tolerability because of poor side effect profiles. CGRP antagonists represent a shift to more precise migraine treatments. Conclusions: Monoclonal antibodies inhibiting CGRP are effective in migraine prophylaxis with minimal adverse effects. Targeting CGRP is a novel clinical strategy in managing migraine.

Design and implementation of a mobile app for the pharmacotherapeutic follow-up of patients diagnosed with immune-mediated inflammatory diseases: eMidCare (Preprint)

2022 ◽  
Author(s):  
Rosa Romero-Jimenez ◽  
Vicente Escudero-Vilaplana ◽  
Esther Chamorro-de-Vega ◽  
Arantza Ais-Larisgoitia ◽  
Maria Elena Lobato Matilla ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare Professionals ◽  
Biological Therapy ◽  
Inflammatory Diseases ◽  
Injection Site Reaction ◽  
Mobile App ◽  
Biological Therapies ◽  
Patient Profile ◽  
Immune Mediated

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.

Development of Bullous Pemphigoid While Receiving PD-1 Checkpoint Inhibitor Nivolumab

2018 ◽  
Vol 2 (3) ◽  
pp. 175-180
Author(s):  
Zachary P Nahmias ◽  
Eric D Merrill ◽  
Cristopher C Briscoe ◽  
Charles E Mount ◽  
Sabra Abner ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Monoclonal Antibodies ◽  
Conservative Treatment ◽  
Adverse Events ◽  
Bullous Pemphigoid ◽  
Treatment Approach ◽  
Checkpoint Inhibitor ◽  
Cutaneous Reactions ◽  
Bona Fide ◽  
Initiation Of Therapy

Monoclonal antibodies against PD-1 are becoming increasingly important agents in the oncologist's armamentarium against a variety of cancers, including melanoma and squamous cell carcinoma. Most reported cutaneous reactions to these agents are mild and resolve with a conservative treatment approach. We present two cases of patients treated with anti-PD-1 agents who developed bullous pemphigoid shortly after initiation of therapy. We then review the literature of anti-PD-1-associated bullous pemphigoid, which is likely a bona fide side effect of anti-PD-1 therapy. Finally, we discuss management of these cases, where the risks of bullous pemphigoid must be weighed against the benefits of anti-PD-1 treatment. As the number of indications for PD-1 monoclonal antibodies expands, dermatologists will need to recognize their cutaneous adverse events and assist oncologists in the management of such complications.

scholarly journals P287 Patient sex does not affect endoscopic outcomes of biologicals in patients with inflammatory bowel disease, but is possibly associated with adverse events: A systematic review

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S296-S296
Author(s):  
M R K L Lie ◽  
E Paulides ◽  
C J van der Woude
Keyword(s):  
Adverse Events ◽  
Biological Therapy ◽  
Meta Analysis ◽  
Certolizumab Pegol ◽  
Skin Lesions ◽  
Secondary Outcome ◽  
Cochrane Central Register ◽  
Biological Therapies ◽  
Central Register ◽  
Study Type

Abstract Background There are several known factors influencing the efficacy and tolerability of biological therapies. Whether patient sex affects this is currently unclear, yet this knowledge would be helpful for risk and benefit stratification. This study assesses the role of patient sex on the efficacy and tolerability of biological therapies used for the treatment of IBD. Methods A systematic literature search was performed on 08 April 2019 using Embase (including Medline), Medline OvidSP, Cochrane Central Register of Controlled Trials, Web of Science and Pubmed. The primary outcome was the influence of patient sex on endoscopic outcomes in IBD patients treated with biologicals. The secondary outcome was the influence of patient sex on adverse events during biological therapy. Studies examining either of the outcomes were included in the assessment, regardless of study type or setting. Results The search yielded 19461 citations. After review 55 studies were included in the study, involving 28465 patients treated with adalimumab, certolizumab pegol, infliximab or vedolizumab. Of the 41 studies that objectively examined patient sex and efficacy of biological therapy, none found a significant association. Of the 14 studies examining patient sex and adverse events, 7 found that adverse events such as infections or skin lesions occur more frequently in female than in male patients. No meta-analysis of the primary or secondary outcome could be performed due to lack of exact reporting of summary measures. Conclusion There is no evidence for a sex difference in endoscopically measured response to biological therapies in IBD patients. However, there is a possible influence of sex on the occurrence of adverse events with a higher incidence in females.

scholarly journals Therapeutic and Systemic Adverse Events of Immune Checkpoint Inhibitors Targeting the PD-1/PD-L1 axis for Clinical Management of NSCLC

2021 ◽  
Vol 30 ◽  
pp. 096368972110415
Author(s):  
Jing Chen ◽  
Yaser Alduais ◽  
Baoan Chen
Keyword(s):  
Monoclonal Antibodies ◽  
Adverse Effects ◽  
Adverse Events ◽  
Immune Evasion ◽  
Checkpoint Inhibitors ◽  
Small Cell ◽  
Critical Parameters ◽  
Small Cell Lung ◽  
Randomized Controlled ◽  
Google Search

Non-small-cell lung cancer takes up the majority of lung carcinoma-caused deaths. It is reported that targeting PD-1/PD-L1, a well-known immune evasion checkpoint, can eradicate tumor. Checkpoint inhibitors, such as monoclonal antibodies, are actively employed in cancer treatment. Thus, this review aimed to assess the therapeutic and toxic effects of PD-1/PD-L1 inhibitors in treatment of NSCLC. So far, 6 monoclonal antibodies blocking PD-1/PD-L1 interaction are identified and used in clinical trials and randomized controlled trials for NSCLC therapy. These antibody-based therapies for NSCLC were collected by using search engine PubMed, and articles about the assessment of adverse events were collected by using Google search. Route of administration and dosage are critical parameters for efficient immunotherapy. Although antibodies can improve overall survival and are expected to be target-specific, they can cause systemic adverse effects in the host. Targeting certain biomarkers can limit the toxicity of adverse effects of the antibody-mediated therapy. Clinical experts with knowledge of adverse effects (AEs) of checkpoint inhibitors can help manage and reduce mortalities associated with antibody-based therapy of NSCLC.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Biological therapy of allergic diseases during the COVID-19 pandemic

2020 ◽  
Vol 17 (3) ◽  
pp. 115-120
Author(s):  
Elena S. Fedenko ◽  
Olga G. Elisyutina ◽  
Natalia I. Il`ina
Keyword(s):  
Biological Therapy ◽  
Treatment Approach ◽  
Allergic Diseases ◽  
Scientific Data ◽  
Biological Therapies ◽  
Active Infection ◽  
The Past ◽  
Type 2 Immune Response ◽  
Antiviral Medications

The outbreak of the SARS-CoV-2-induced Coronavirus Disease 2019 (COVID-19) pandemic started in December 2019 in Wuhan, China, continued to spread across the globe and spanned 188 countries. Under the new circumstances treatment approach for T2 allergic diseases such as asthma, chronic hives, atopic dermatitis, and sinusitis with polyps has been changed. In the past years, new biological therapies monoclonal antibodies for these diseases have been developed targeting different aspects of the type 2 immune response. New knowledge on the COVID-19 disease course raises many issues around the safety of biologicals in patients with active infection, as well as their interactions with antiviral medications. In Russia new biological therapies entered clinical practice but its effectiveness and safety still are not known. This newsletter is based on Considerations on Biologicals for Patients with allergic disease in times of the COVID-19 pandemic: an EAACI Statement and the latest scientific data.

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