- |||||||||| [VIRTUAL] What's New in the Medicine Chest? () - Nov 26, 2020 - Abstract #FCPANP2020FCPANP_60;
Dr. Del Rosso concluded by noting that there are exciting agents coming down the pipeline—more JAK inhibitors, new biologics—but emphasized the continued need to be vigilant with these agents as they become available.
- |||||||||| tralokinumab (CAT 354) / LEO Pharma, AstraZeneca
Journal: Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma. (Pubmed Central) - Nov 2, 2020 Overall, reporting of adverse events (AEs) and serious AEs were similar for the tralokinumab and placebo groups. Although a greater proportion of tralokinumab-treated patients reported upper respiratory tract infections (35.7% versus 14.3%), there were no reported cases of pneumonia.Overall, tralokinumab did not demonstrate an OCS-sparing effect in patients with severe asthma.
- |||||||||| tralokinumab (CAT 354) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron
Biomarker, Review, Journal: Understanding the Immune Landscape in Atopic Dermatitis: The Era of Biologics and Emerging Therapeutic Approaches. (Pubmed Central) - Nov 2, 2020 The anti-IL-13 monoclonal antibodies lebrikizumab and tralokinumab, which bind different IL-13 epitopes with potentially different effects, are currently in advanced-stage trials. Here, we briefly review the underlying pathobiology of AD, the scientific basis for current AD targets, and summarize current clinical studies of these agents, including new research to develop both predictive and response biomarkers to further advance AD therapy in the era of precision medicine.
- |||||||||| Stelara (ustekinumab) / J&J
Retrospective data, Review, Journal: Systemic treatments for eczema: a network meta-analysis. (Pubmed Central) - Oct 23, 2020 Most studies were placebo-controlled and assessed only short-term efficacy of immunosuppressive agents. Further adequately powered head-to-head RCTs should evaluate comparative long-term efficacy and safety of available treatments for moderate to severe eczema.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Patient Clinical Characteristics and Biomarkers Associated with Underlying Exacerbation Risk in Asthma (PENNSYLVANIA CONVENTION CENTER, Room 113 B-C (100 Level)) - Mar 15, 2020 - Abstract #ATS2020ATS_3651; Evaluating pooled placebo patient populations will allow strategic insights into biomarker and patient clinical characteristics/response relationships for patients with asthma. Baseline blood eosinophil counts and FeNO are relevant predictors of exacerbation risk and uncontrolled asthma.
- |||||||||| Trial completion date, Trial primary completion date: Molecular Signatures in Inflammatory Skin Disease (clinicaltrials.gov) - Mar 9, 2020
P=N/A, N=200, Recruiting, Baseline blood eosinophil counts and FeNO are relevant predictors of exacerbation risk and uncontrolled asthma. Trial completion date: Dec 2019 --> Dec 2025 | Trial primary completion date: Dec 2018 --> Dec 2024
- |||||||||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca, Dupixent (dupilumab) / Sanofi, Regeneron
Journal: The IL-13/ OVOL1/FLG axis in atopic dermatitis. (Pubmed Central) - Feb 20, 2020 Genome-wide association studies also point to the crucial involvement of the IL-13, OVOL1 and FLG genes in the pathogenesis of AD. Biologics targeting IL-13, such as the anti-IL-4Rα antibody dupilumab and the anti-IL-13 antibody tralokinumab, successfully improve AD lesions and further highlight the importance of IL-13 in the pathogenesis of AD.
- |||||||||| Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 (clinicaltrials.gov) - Feb 13, 2020 P3, N=333, Active, not recruiting, Biologics targeting IL-13, such as the anti-IL-4Rα antibody dupilumab and the anti-IL-13 antibody tralokinumab, successfully improve AD lesions and further highlight the importance of IL-13 in the pathogenesis of AD. Trial completion date: May 2020 --> Oct 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
- |||||||||| Retrospective data, Review, Journal: Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis. (Pubmed Central) - Feb 7, 2020
Tralokinumab improved lung function compared to placebo...However, no statistically significant superiority was observed of one biologic over the other in the network meta-analysis. More studies with direct head to head comparisons and better defined endotypes are required.
- |||||||||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca
Clinical, P3 data, Journal: Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. (Pubmed Central) - Jan 19, 2020 P3 In STRATOS 1 and 2, ADA incidence was low, no differences were found between tralokinumab-treated and placebo groups in reporting of hypersensitivity reactions, and there were no Sampson criteria-evaluated anaphylaxis events with tralokinumab treatment. Together, the results suggest that tralokinumab treatment would not increase the risk for severe hypersensitivity or anaphylactic reactions.
- |||||||||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca, lebrikizumab (MILR1444A) / Dermira, Roche, Almirall, Dupixent (dupilumab) / Sanofi, Regeneron
Review, Journal: The Intriguing Role of Interleukin 13 in the Pathophysiology of Asthma. (Pubmed Central) - Dec 25, 2019 These results suggest that IL-4 and IL-13 share some, but not all functional activities in airway inflammation. Tralokinumab might show efficacy in a highly selected cohort of asthmatics characterized by overexpression of IL-13.
- |||||||||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca
Biomarker, Journal: Treatment of Atopic Dermatitis with Tralokinumab, an Anti-IL-13 Monoclonal Antibody. (Pubmed Central) - Nov 14, 2019 P2b Recruiting --> Active, not recruiting Tralokinumab treatment was associated with early and sustained improvements in AD symptoms, and an acceptable safety and tolerability profile, thereby providing evidence for targeting IL-13 in AD.
- |||||||||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca, lebrikizumab (MILR1444A) / Dermira, Roche, Almirall
Biomarker, Retrospective data, Journal: A meta-analysis of anti-interleukin-13 monoclonal antibodies for uncontrolled asthma. (Pubmed Central) - Nov 14, 2019 Periostin may be a good biomarker to detect the specific subgroup who could get better response to anti-IL-13 treatments. In view of blocking IL-13 alone is possibly not enough to achieve asthma control because of the overlapping pathophysiological roles of IL-13/IL-4 in inflammatory pathways, combined blocking of IL-13 and IL-4 with monoclonal antibodies may be more encouraging.
- |||||||||| Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca
Trial completion, Monotherapy: Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) (clinicaltrials.gov) - Nov 11, 2019 P3, N=802, Completed, In view of blocking IL-13 alone is possibly not enough to achieve asthma control because of the overlapping pathophysiological roles of IL-13/IL-4 in inflammatory pathways, combined blocking of IL-13 and IL-4 with monoclonal antibodies may be more encouraging. Active, not recruiting --> Completed
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