tralokinumab
Regulatory sources consulted
Approved indications
- Moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older who are candidates for systemic therapy.
Contraindications
Absolute
- Hypersensitivity to tralokinumab or excipients.
Clinical warnings
- Major warning · Stop immediately for systemic hypersensitivity. Refer for ophthalmologic examination if conjunctivitis does not resolve with standard treatment. — CIMA/AEMPS, ficha técnica 1211554002
- Major warning · Treat helminth infections before starting; if they occur and do not respond, stop until resolved. Complete live vaccines before treatment and do not administer them during therapy. — CIMA/AEMPS, ficha técnica 1211554002
Drug interactions
- HighLive or live-attenuated vaccines
Mechanism: Their safety or efficacy during tralokinumab has not been established.
Recommendation: Do not administer concomitantly; complete before starting.
CIMA/AEMPS, ficha técnica 1211554002https://cima.aemps.es/cima/dochtml/ft/1211554002/FT_1211554002.html
Adverse events
Common (≥1%)
Upper respiratory tract infections · Injection-site reactions · Conjunctivitis · Allergic conjunctivitis · Eosinophilia
Pregnancy and lactation
Preferably avoid during pregnancy. During breastfeeding, decide whether to stop breastfeeding or treatment according to benefit for the child and mother.
Recent literature (PubMed)
Atopic dermatitis (AD) is an inflammatory skin condition with multiple systemic treatments and uncertainty regarding their comparative impact on AD outcomes. We sought to systematically synthesize the benefits and harms of AD systemic treatments. For the 2023 American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters AD guidelines, we searched MEDLINE, EMBASE, CENTRAL, Web of Science, and GREAT databases from inception to November 29, 2022, for randomized trials addressing systemic treatments and phototherapy for AD. Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random-effects network meta-analyses addressed AD severity, itch, sleep, AD-related quality of life, flares, and harms. The Grading of Recommendations Assessment, Development and Evaluation approach informed certainty of evidence ratings. This review is registered in the Open Science Framework (https://osf.io/e5sna). The 149 included trials (28,686 patients with moderate-to-severe AD) evaluated 75 interventions. With high-certainty evidence, high-dose upadacitinib was among the most effective for 5 of 6 patient-important outcomes; high-dose abrocitinib and low-dose upadacitinib were among the most effective for 2 outcomes. These Janus kinase inhibitors were among the most harmful in increasing adverse events. With high-certainty evidence, dupilumab, lebrikizumab, and tralokinumab were of intermediate effectiveness and among the safest, modestly increasing conjunctivitis. Low-dose baricitinib was among the least effective. Efficacy and safety of azathioprine, oral corticosteroids, cyclosporine, methotrexate, mycophenolate, phototherapy, and many novel agents are less certain. Among individuals with moderate-to-severe AD, high-certainty evidence demonstrates that high-dose upadacitinib is among the most effective in addressing multiple patient-important outcomes, but also is among
Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a complex pathophysiology that underlies a wide spectrum of clinical phenotypes. AD remains challenging to treat owing to the limited response to available therapies. However, recent advances in understanding of disease mechanisms have led to the discovery of novel potential therapeutic targets and drug candidates. In addition to regulatory approval for the IL-4Ra inhibitor dupilumab, the anti-IL-13 inhibitor tralokinumab and the JAK1/2 inhibitor baricitinib in Europe, there are now more than 70 new compounds in development. This Review assesses the various strategies and novel agents currently being investigated for AD and highlights the potential for a precision medicine approach to enable prevention and more effective long-term control of this complex disease.
Atopic dermatitis is a common, chronically recurring inflammatory skin disease. It gives rise to a high disease burden and is of major importance in social medicine. This review is based on pertinent publications retrieved by a selective search in PubMed, including the current German and European guidelines. Basic therapy with drug-free topical agents markedly improves the barrier function of the skin. Adults should apply at least 250 g per week. Patient-specific trigger factors such as allergens, stress, microbial pathogens, or skin irritants should be eliminated or avoided. In mild and moderately severe forms, external treatment with topical glucocorticosteroids and topical calcineurin inhibitors usually suffices; proactive therapy is given to patients with frequent recurrences or a long course of disease. Systemic anti-inflammatory treatment with biological agents such as dupilumab and tralokinumab, Janus kinase inhibitors such as baricitinib, upadacitinib, and abrocitinib, or conventional immunosuppressant drugs is indicated particularly in severe cases. The patient should be actively involved in the choice and planning of treatment; the patient's age and the cutaneous findings should be taken into account. Interdisciplinary patient education yields a sustained benefit. A combination of baseline therapy, reactive and proactive anti-inflammatory therapy, and systemic therapy as needed is the foundation of successful interdisciplinary treatment for atopic dermatitis.
Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is characterised by dry, inflamed skin accompanied by intense itchiness (pruritus). To appraise the clinical and cost effectiveness of abrocitinib, tralokinumab and upadacitinib within their marketing authorisations as alternative therapies for treating moderate-to-severe atopic dermatitis compared to systemic immunosuppressants (first-line ciclosporin A or second-line dupilumab and baricitinib). Studies were identified from an existing systematic review (search date 2019) and update searches of electronic databases (MEDLINE, EMBASE, CENTRAL) to November 2021, from bibliographies of retrieved studies, clinical trial registers and evidence provided by the sponsoring companies of the treatments under review. A systematic review of the clinical effectiveness literature was carried out and a network meta-analysis undertaken for adults and adolescents at different steps of the treatment pathway. The primary outcome of interest was a combined response of Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4; where this was consistently unavailable for a step in the pathway, an analysis of Eczema Area and Severity Index 75 was conducted. A de novo economic model was developed to assess cost effectiveness from the perspective of the National Health Service in England. The model structure was informed through systematic review of the economic literature and by consulting clinical experts. Effectiveness data were obtained from the network meta-analysis. Costs and utilities were obtained from the evidence provided by sponsoring companies and standard UK sources. Network meta-analyses indicate that abrocitinib 200 mg and upadacitinib 30 mg may be more effective, and tralokinumab may be less effective than dupilumab and baricitinib
The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This first part of the guideline includes general information on its scope and purpose, the health questions covered, target users and a methods section. It also provides guidance on which patients should be treated with systemic therapies, as well as recommendations and detailed information on each systemic drug. The systemic treatment options discussed in the guideline comprise conventional immunosuppressive drugs (azathioprine, ciclosporin, glucocorticosteroids, methotrexate and mycophenolate mofetil), biologics (dupilumab, lebrikizumab, nemolizumab, omalizumab and tralokinumab) and janus kinase inhibitors (abrocitinib, baricitinib and upadacitinib). Part two of the guideline will address avoidance of provocation factors, dietary interventions, immunotherapy, complementary medicine, educational interventions, occupational and psychodermatological aspects, patient perspective and considerations for paediatric, adolescent, pregnant and breastfeeding patients.