- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Predictors of Sustained Response to Tralokinumab Dosing Every Four Weeks in Adults with Modernate to Severe Atopic Dermatitis () - Jun 23, 2022 - Abstract #FOBI2022FOBI_139; Regardless of Dosing Interval, The Two Most Important Predictors of Sustained Response At Week 52 with Tralokinumab Monotherapy Were Iga Score and Maximum Daily Pruritic NRS <3 At Week 16. Stable Achievement Of Clear Skin and Mild Or No Pruritic Sympoms at Consecutive Time Points with Tralokinumab Q2W for 4 Consecutive Weeks was identified as a positive predictor of sustained long-term response with the Q4W dosing regiment.
- |||||||||| Journal: Atopic dermatitis : the therapeutic revolution is underway (Pubmed Central) - Jun 8, 2022
Since that time, other agents such as tralokinumab arrived on the market, but also the small molecules called «JAK inhibitors» (upadacitinib, baricitinib, etc.). This article provides an inventory of the existing or imminent therapeutic options for atopic dermatitis.
- |||||||||| Clinical, Retrospective data, Review, Journal: Systemic Immunomodulatory Treatments for Atopic Dermatitis: Update of a Living Systematic Review and Network Meta-analysis. (Pubmed Central) - May 22, 2022
In this systematic review and meta-analysis, abrocitinib, 200 mg; and upadacitinib, 30 mg daily, were associated with slightly better scores than dupilumab, and upadacitinib, 15 mg daily, was associated with similar scores to dupilumab. Abrocitinib, 100 mg daily, baricitinib, 4 mg and 2 mg daily, and tralokinumab, 300 mg, every 2 weeks were associated with slightly worse scores.
- |||||||||| Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca
Trial completion date, Trial primary completion date: TraSki: Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function (clinicaltrials.gov) - May 17, 2022 P2, N=16, Active, not recruiting, Abrocitinib, 100 mg daily, baricitinib, 4 mg and 2 mg daily, and tralokinumab, 300 mg, every 2 weeks were associated with slightly worse scores. Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Jul 2022
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, Dupixent (dupilumab) / Sanofi, Regeneron, Mitchga (nemolizumab) / Roche, Maruho, Galderma
Journal: Biological medication in atopic dermatitis. (Pubmed Central) - Apr 28, 2022 Dupilumab, is approved for the treatment of moderate to severe atopic dermatitis. Tralokinumab and nemolizumab have shown promising results in patients with atopic dermatitis.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, eblasakimab (ASLAN004) / ASLAN Pharma
Journal: Biological agents targeting interleukin-13 for atopic dermatitis. (Pubmed Central) - Apr 28, 2022 The aim of this review article is to describe preclinical and clinical data for selective IL-13 inhibitors against AD, including lebrikizumab and tralokinumab, which are in a more advanced phase of development. The up-to-date overview of the strengths and limitations of different agents used to treat AD discussed in this article might be useful in driving treatment decision.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Journal: New Drug for Atopic Dermatitis. (Pubmed Central) - Apr 28, 2022 The up-to-date overview of the strengths and limitations of different agents used to treat AD discussed in this article might be useful in driving treatment decision. Tralokinumab-ldrm (Adbry) is now approved for the treatment of moderate to severe atopic dermatitis in adults whose disease has not been controlled by topical therapies.Nurses and NPs should teach patients how to administer the drug subcutaneously and that more than one injection is needed to fulfill the prescribed dose.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Clinical, Journal: Conjunctivitis in adult patients with moderate-to-severe atopic dermatitis: results from five tralokinumab clinical trials. (Pubmed Central) - Apr 22, 2022 Tralokinumab-ldrm (Adbry) is now approved for the treatment of moderate to severe atopic dermatitis in adults whose disease has not been controlled by topical therapies.Nurses and NPs should teach patients how to administer the drug subcutaneously and that more than one injection is needed to fulfill the prescribed dose. Treatment with tralokinumab was associated with increased incidence of conjunctivitis compared to placebo, but these cases were mostly mild and transient.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Clinical, Journal: Mechanistic modeling of a human IgG monoclonal antibody (tralokinumab) Fab-arm exchange with endogenous IgG in healthy volunteers. (Pubmed Central) - Apr 19, 2022 Half molecules of tralokinumab randomly associate with those of endogenous IgG to form monovalent hybrid molecules, which became the dominant form of tralokinumab within 1 day postdose in healthy volunteers. As the potency of monovalent tralokinumab is comparable with that of bivalent tralokinumab, the IgG Fab-arm exchange with endogenous IgG is not expected to affect the potency of neutralization of interleukin-13 in vivo.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Clinical, Journal: A rare case of vernal keratoconjunctivitis in a patient with atopic dermatitis treated with tralokinumab. (Pubmed Central) - Apr 15, 2022 The patient was taking tralokinumab for three years for severe atopic dermatitis (AD), low dose isotretinoin for acne vulgaris and had asthma and allergic rhinitis. The patient trialled over-the-counter ophthalmic lubricants, including preservative-free hypromellose, carmellose, hyaluronate, and autologous serum eye drops in addition to olopatidine but developed topical intolerance.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Review, Journal: Tralokinumab in Atopic Dermatitis: A Profile of Its Use. (Pubmed Central) - Apr 12, 2022 The majority of adverse events with tralokinumab, including injection-site reactions and conjunctivitis, were of mild to moderate severity. The tolerability profile of tralokinumab longer term was consistent with that in the phase III trials.
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron
Journal: A mathematical model to identify optimal combinations of drug targets for dupilumab poor responders in atopic dermatitis. (Pubmed Central) - Apr 9, 2022 Our model identified IL-13 as a potential predictive biomarker to stratify dupilumab good responders, and simultaneous inhibition of IL-13 and IL-22 as a promising drug therapy for dupilumab poor responders. This model will serve as a computational platform for model-informed drug development for precision medicine, as it allows evaluation of the effects of new potential drug targets and the mechanisms behind patient variability in drug response.
- |||||||||| Clinical, P2 data, P3 data, Review, Journal: Review and analysis of biologic therapies currently in phase II and phase III clinical trials for atopic dermatitis. (Pubmed Central) - Apr 8, 2022
Further assessment of tezepelumab and etokimab are needed to assess their safety and efficacy in patients with moderate-to-severe AD. Tralokinumab, lebrikizumab, fezakinumab, nemolizumab, and GBR 830 are effective treatment options for adults with moderate-to-severe AD, but further large-scale studies are needed to confirm their efficacy as monotherapy in children with moderate-to-severe AD.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Journal: Therapeutic potential of biologics in prurigo nodularis. (Pubmed Central) - Apr 7, 2022 The off-label advent of dupilumab offered advanced insight into the pathogenesis of CNPG and showed an impressive relief of pruritus in the vast majority of patients. New therapies including biologics (e.g., nemolizumab, tralokinumab, lebrikizumab), small molecules (e.g., neurokinin-1 receptor antagonists, janus kinase inhibitors) as well as mu-opioid receptor antagonists and nalbuphine, a μ-antagonist/κ-agonist, are in the pipeline and offer new hope for an improved future patient care.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Journal: Tralokinumab-ldrm. (Pubmed Central) - Apr 6, 2022 New therapies including biologics (e.g., nemolizumab, tralokinumab, lebrikizumab), small molecules (e.g., neurokinin-1 receptor antagonists, janus kinase inhibitors) as well as mu-opioid receptor antagonists and nalbuphine, a μ-antagonist/κ-agonist, are in the pipeline and offer new hope for an improved future patient care. No abstract available
- |||||||||| Trial completion date, Trial primary completion date: Molecular Signatures in Inflammatory Skin Disease (clinicaltrials.gov) - Apr 1, 2022
P=N/A, N=300, Recruiting, Trial completion date: Jan 2023 --> May 2023 Trial completion date: Dec 2025 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Mar 2028
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Review, Journal: The use of biologics in food allergy. (Pubmed Central) - Mar 1, 2022 The ever better knowledge of the mechanisms of food allergy allowing these developments will improve not only the perspective of patients with the most serious immediate food allergies such as anaphylaxis, but also those of patients with related diseases such as atopic dermatitis, eosinophilic esophagitis, and EGIDs. Biologics are also intended to complement OIT strategies that have developed over the years.
- |||||||||| Eucrisa (crisaborole) / Pfizer, Xolair (omalizumab) / Roche, Novartis
Journal: An update to the 2013-2014 American Academy of Dermatology (AAD) guidelines for the pharmacological management of atopic dermatitis. (Pubmed Central) - Feb 26, 2022 The AAD guidelines must be updated in the future to include several new treatment modalities that have revolutionized the pharmacologic management of patients with AD, including dupilumab and crisaborole. The future of AD treatment is also extremely bright, as JAK inhibitors and Il-13/31 antibodies have shown convincing results in the improvement of AD patients' lives in various trials and studies that have been examined in this paper.
- |||||||||| Effect of Biologics on Allergic Response and Airway Hyperresponsiveness: A Systematic Literature Review (Area I, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_823;
Tezepelumab also consistently attenuated nonspecific AHR to methacholine or mannitol. These findings provide further insight into the mechanisms of AHR and the clinical benefits of asthma biologics and suggest that tezepelumab may broadly target mediators or cells involved in asthma inflammation.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, Olumiant (baricitinib) / Incyte, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Review, Journal: Atopic dermatitis: an expanding therapeutic pipeline for a complex disease. (Pubmed Central) - Feb 4, 2022 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.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Journal: IL-13 antagonists in the treatment of atopic dermatitis. (Pubmed Central) - Feb 3, 2022 Currently, the only monoclonal antibody (mAb) approved for AD treatment is dupilumab, an antagonist of the IL-4 receptor alpha (IL-4Rα) subunit common to IL-4 and IL-13 receptors, but clinical trials evaluating anti-IL-13 mAbs are providing promising results. The topics of this review will be mAbs targeting IL-13 for the treatment of AD such as dupilumab, tralokinumab and lebrikizumab, small molecules targeting the IL-13 pathway, and a brief explanation of therapies targeting IL-13 for the treatment of other skin diseases.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Review, Journal: Tralokinumab: First Approval. (Pubmed Central) - Jan 27, 2022 Based on results from the ECZTRA 1-3 trials, tralokinumab has recently been approved in the EU for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. This article summarizes the milestones in the development of tralokinumab leading to this first approval for atopic dermatitis.
- |||||||||| Journal: Antibodies to watch in 2022. (Pubmed Central) - Jan 27, 2022
Finally, our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline of antibody therapeutics grew by over 30% in the past year. Of those in late-stage development, marketing applications for at least 22 may occur by the end of 2022.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Review, Journal: Tralokinumab for the Treatment of Atopic Dermatitis. (Pubmed Central) - Jan 14, 2022 In addition, in association with topical corticosteroids, tralokinumab was well tolerated and effective and had a favorable risk-benefit profile. These data provide additional evidence that IL-13 is central to AD pathogenesis, suggesting that tralokinumab may be seen as an innovative option for the treatment of moderate-to-severe AD.
- |||||||||| Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca
Trial completion: A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects (clinicaltrials.gov) - Jan 5, 2022 P1, N=101, Completed, These data provide additional evidence that IL-13 is central to AD pathogenesis, suggesting that tralokinumab may be seen as an innovative option for the treatment of moderate-to-severe AD. Active, not recruiting --> Completed
- |||||||||| Review, Journal: Novel therapies in the treatment of atopic dermatitis (Pubmed Central) - Dec 28, 2021
Other monoclonal antibodies such as nemolizumab, tralokinumab, lebrikizumab and fezakinumab demonstrated statistically significant clinical improvements in phase 2 and 3 trials...JAK inhibitors such as abrocitinib, baricitinib and upadacitinib showed promising effects in improvement of skin lesions and itch reduction...Thus, during SARS-CoV-2 infection it might be safer to use JAK inhibitors in case of necessity of a rapid immune response. There is a need to differentiate subtypes of atopic dermatitis, based on clinical symptoms and inflammatory mediators to choose an optimal therapeutic option for each patient.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Clinical, Journal: Therapeutic targeting of the IL-13 pathway in skin inflammation. (Pubmed Central) - Dec 18, 2021 In addition, phase III randomized clinical trials (RCTs) evaluating specific blockade of IL-13 with tralokinumab for treatment of AD also demonstrated favorable results, and phase III RCT evaluating lebrikizumab are ongoing. The role of IL-13 in other skin diseases should be further investigated.
- |||||||||| Adtralza (tralokinumab) / LEO Pharma, AstraZeneca, Dupixent (dupilumab) / Sanofi, Regeneron
Journal: Biologics in atopic dermatitis. (Pubmed Central) - Dec 16, 2021 The role of IL-13 in other skin diseases should be further investigated. The recent breakthroughs in treatment represent an opportunity to resolve an unmet need; the management of atopic dermatitis which is unresponsive to topical therapy.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Clinical, Review, Journal: Anti-interleukin-13 and anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for people with asthma. (Pubmed Central) - Nov 29, 2021 Therefore, anti-interleukin-13 or anti-interleukin-4 agents may be appropriate for adults with moderate-to-severe uncontrolled asthma who have not responded to other treatments. These conclusions are generally supported by moderate or high-certainty evidence based on studies with an observation period of up to one year.
- |||||||||| Adtralza (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Journal: Inhibition of IL-13: A New Pathway for Atopic Dermatitis. (Pubmed Central) - Nov 24, 2021 Both lebrikizumab and tralokinumab demonstrated acceptable safety profiles in AD (and non-AD) trials with adverse events often being comparable between treatment and control groups. Thus, IL-13 inhibitors may provide a safe and effective treatment alternative for patients with moderate-to-severe AD.
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