Risks and safety of biologics: A practical guide for allergists

Sitek, Andrea; Li, James T.; Pongdee, Thanai

doi:10.1016/j.waojou.2022.100737

Cited by 23 publications

(27 citation statements)

References 73 publications

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“…Despite this relatively broad approval status, there are still very few data on pregnancy. The few pregnancies mentioned in the literature were not associated with a higher risk for abortion or birth defects [13]. Like in other antibodies active transportation across the placenta takes place earliest after the 18th week of pregnancy.…”

Section: Reviewmentioning

confidence: 87%

Pregnancies in women with antineutrophil cytoplasmatic antibody associated vasculitis

Pecher,

Henes,

Henes

2023

Current Opinion in Rheumatology

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Purpose of review Antineutrophil cytoplasmatic antibody associated vasculitis (AAV) usually manifests after age fifty, thus making it very rare during reproductive age. Although rare, AAV, particularly eosinophilic granulomatosis with polyangiitis, can manifest at a younger age. AAV can also appear for the first time during pregnancy. Recent findings Data from pregnant patients with AAV mostly derive from case reports or retrospective studies, with an absolute number of <100 published cases. Therefore, numbers of results of pregnancy outcome vary widely. Summary As with other chronic autoimmune diseases, patients and infants seem to be at a higher risk for preterm delivery, intrauterine growth retardation and preeclampsia. Possible treatment for AAV in pregnancy depends upon gestational age and include glucocorticosteroids, azathioprine, intravenous immunoglobulins, and in severe cases rituximab and even cyclophosphamide. Plasma exchange might be an option in selected patients. Aside from cyclophosphamide these medications can also be used during breastfeeding. Acetylsalicylic-acid 100–150 mg/day reduces the risk of preeclampsia, also in this population. Patients should be counseled prior to conception and medication that is suitable for pregnancy should be established early on. During pregnancy, we recommend close monitoring of disease activity, blood pressure and ideally to co-consult with a gynecologist in an interdisciplinary approach.

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Section: Reviewmentioning

confidence: 87%

Pregnancies in women with antineutrophil cytoplasmatic antibody associated vasculitis

Pecher,

Henes,

Henes

2023

Current Opinion in Rheumatology

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“…For this reason, the herpes zoster immunization is primarily suggested for asthmatic adults aged 50 years or more [ 78 , 80 ]. Nevertheless, a recent review focusing on the risks of asthma biologic therapy underlined that a small percentage of patients receiving dupilumab, mepolizumab and benralizumab developed a herpes zoster infection and this risk is already labelled for mepolizumab [ 81 ].…”

Section: Discussionmentioning

confidence: 99%

Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

Cutroneo,

Arzenton,

Furci

et al. 2024

BioDrugs

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Background The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to August 2022, five biologics have been approved for the type 2 asthma phenotype: anti-IgE (omalizumab), anti-IL5 (mepolizumab, reslizumab, benralizumab), and anti-IL4 (dupilumab) monoclonal antibodies. These drugs are usually well tolerated, although long-term safety information is limited, and some adverse events have not yet been fully characterized. Spontaneous reporting systems represent the cornerstone for the detection of potential signals and evaluation of the real-world safety of all marketed drugs. Objective The aim of this study was to provide an overview of safety data of biologics for severe asthma using VigiBase, the World Health Organization global pharmacovigilance database. Methods We selected all de-duplicated individual case safety reports (ICSRs) attributed to five approved biologics for severe asthma in VigiBase, up to 31st August 2022 (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab). Descriptive frequency analyses of ICSRs were carried out both as a whole class and as individual products. Reporting odds ratios (ROR) with 95% confidence intervals (CIs) were used as the measure of disproportionality for suspected adverse drug reactions (ADRs) associated with the study drugs compared with either all other suspected drugs (Reference Group 1, RG1) or inhaled corticosteroids plus long-acting β-agonists (ICSs/LABAs) (Reference Group 2, RG2) or with oral corticosteroids (OCSs) (Reference Group 3, RG3). Results Overall, 31,724,381 ICSRs were identified in VigiBase and 167,282 (0.5%) were related to study drugs; the remaining reports were considered as RG1. Stratifying all biologic-related ICSRs by therapeutic indication, around 29.4% ( n = 48,440) concerned asthma use; omalizumab was mainly indicated as the suspected drug ( n = 20,501), followed by dupilumab, mepolizumab, benralizumab and reslizumab. Most asthma ICSRs concerned adults (57%) and women (64.1%). Asthma biologics showed a higher frequency of serious suspected ADR reporting than RG1 (41.3% vs 32.3%). The most reported suspected ADRs included asthma, dyspnea, product use issue, drug ineffective, cough, headache, fatigue and wheezing. Asthma biologics were disproportionally associated with several unknown or less documented adverse events, such as malignancies, pulmonary embolism and deep vein thrombosis with omalizumab; alopecia and lichen planus with dupilumab; alopecia and herpes infections with mepolizumab; alopecia, herpes zoster and eosinophilic granulomatosis with polyangiitis related to benralizumab; and alopecia with reslizumab. Conclusions The most frequently reported suspected ADRs of asthma biologics in VigiBase confirmed the presence of well-known adverse effects such as general disorders, injection-sit...

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“…Furthermore, we suspected urticaria to be an adverse event at high risk for treatment with omalizumab, although the data failed to reach statistical significance. Systemic hypersensitivity reactions was found to be associated with multiple biological treatments such as omalizumab, dupilumab, and benralizumab [38,39]. In spite of some evidence showing that hypersensitivity reactions including urticaria, skin rush, and anaphylaxis had a low incidence rate and no significant difference between omalizumab and placebo-treated patients [40], anaphylaxis has been proved to be related to omalizumab since its initial FDA approval for allergic asthma in 2003 and the product label even includes a black box warning [41,42].…”

Section: Discussionmentioning

confidence: 99%

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Lin

Wang

Zhu

et al. 2023

JCM

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(1) Background: Allergic rhinitis (AR) is a common disease in otolaryngology and novel biological therapies are required for clinical needs. To assess the tolerability of monoclonal antibodies, justifying their clinical applications, we presented a comprehensive safety profile of biologics in AR; (2) Methods: A systematic literature search was conducted following PRISMA guidelines for randomized clinical trials comparing monoclonal antibodies and placebo in AR. PubMed, Web of Science, Medline, and Cochrane were searched up until 9 January 2023. Among 3590 records in total, 12 studies with more than 2600 patients were included. Quality was assessed for all studies using Cochrane risk-of-bias tool for randomized trials, and subgrouped meta-analysis was performed; (3) Results: We accomplished an up-to-date literature overview and analysis on adverse events of monoclonal antibodies in AR. Total, common, severe, discontinuation-causing, and serious adverse events failed to reach statistical significance. Country was an essential factor for heterogeneity, and urticaria was the adverse event at highest risk (RR 2.81, 95% CI 0.79–9.95); (4) Conclusions: Monoclonal antibodies are considered well tolerated and relatively safe in patients with AR. The regions of patients and hypersensitive adverse reactions such as urticaria require a special caution in biological treatments in AR.

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Risks and safety of biologics: A practical guide for allergists

Cited by 23 publications

References 73 publications

Pregnancies in women with antineutrophil cytoplasmatic antibody associated vasculitis

Pregnancies in women with antineutrophil cytoplasmatic antibody associated vasculitis

Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

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