Injection site reactions with the use of biological agents

Thomaidou, Elena; Ramot, Yuval

doi:10.1111/dth.12817

Cited by 61 publications

(55 citation statements)

References 8 publications

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“…ISRs have been noted with all US Food and Drug Administration-approved self-injectable biological agents [31]. None of the ISRs with ixekizumab were considered to be serious and all were mild or moderate in severity in this study.…”

Section: Discussionmentioning

confidence: 74%

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

et al. 2020

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Purpose Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors. Methods In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24–156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. Results Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population ( n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections). Conclusion In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports. Trial registration ClinicalTrials.gov identifier: NCT02349295. Electronic supplementary material The online version of this article (10.1007/s40744-020-00261-0) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 74%

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

et al. 2020

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“…2,3 Injection site reactions are among the most common adverse effects reported. 4,5 We herein report the first case of acquired hypersensitivity to Dupixent â confirmed by cutaneous allergy testing necessitating treatment cessation. A 39-year-old Caucasian female presented with a history of atopic dermatitis since infancy.…”

Section: Dear Editormentioning

confidence: 78%

Acquired hypersensitivity to dupilumab: first case report

Ludriksone

Elsner

Schliemann

2019

Acad Dermatol Venereol

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“…Injection site reactions (ISRs) are a local phenomenon and are one of the most commonly occurring AEs following administration of a drug or vaccine via injection [ 41 ]. ISRs can include swelling, erythema, pruritus and pain at the injection site [ 41 ]. In most cases, ISRs are mild to moderate and resolve after a few days.…”

Section: Risk Vs Benefit Considerationsmentioning

confidence: 99%

The changing landscape for the management of patients with neovascular AMD: brolucizumab in clinical practice

Pearce

Amoaku

Bailey

et al. 2022

Eye

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Untreated neovascular age-related macular degeneration (nAMD) can lead to severe and permanent visual impairment. The chronic nature of the disease can have a significant impact on patients’ quality of life and an economic and time burden on medical retina (MR) services, with the care need outweighing the growth of resources that clinical services can access. The introduction of a new treatment into clinical services can be challenging, especially for services that are already under capacity constraints. Guidance for practical implementation is therefore helpful. Roundtable meetings, facilitated by Novartis UK, between a working group of MR experts with experience of leading and managing NHS retinal services in the intravitreal era were conducted between 2020 and 2021. These meetings explored various aspects and challenges of introducing a new anti-vascular endothelial growth factor (VEGF) therapy to the UK medical retina services. Provision of clear expert recommendations and practical guidance nationally, that can be adapted locally as required to support clinicians and healthcare professionals (HCPs), is valuable in supporting the introduction of a new anti-VEGF therapy within the NHS environment. The experts provide ophthalmologic HCPs with a collation of insights and recommendations to support the introduction and delivery of brolucizumab in their local service in the face of current and projected growth in demand for retina care.

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Injection site reactions with the use of biological agents

Cited by 61 publications

References 8 publications

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Acquired hypersensitivity to dupilumab: first case report

The changing landscape for the management of patients with neovascular AMD: brolucizumab in clinical practice

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