- |||||||||| Journal: Treatment options for moderate to severe atopic dermatitis. (Pubmed Central) - Nov 13, 2022
Biologics and Jakinibs should be considered before the traditional systemic anti-inflammatory agents. Clinicians should consider a modified step management for AD as they await the development of national and international guideline recommendations for how best to position the biologics and Jakinibs into the AD treatment algorithm.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
P3 data, Journal: Patient-oriented measures for phase 3 studies of tralokinumab for treatment of atopic dermatitis (ECZTRA 1, 2 and 3). (Pubmed Central) - Nov 9, 2022
Clinicians should consider a modified step management for AD as they await the development of national and international guideline recommendations for how best to position the biologics and Jakinibs into the AD treatment algorithm. Tralokinumab with or without TCS exhibited early and clinically meaningful improvements vs placebo in several PROs, which may be beneficial to patients because atopic dermatitis symptom relief is a key treatment concern for patients.
- |||||||||| Adbry (tralokinumab-ldrm) / LEO Pharma, AstraZeneca
Trial completion date: TraSki: Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function (clinicaltrials.gov) - Nov 2, 2022
P2, N=16, Active, not recruiting,
Tralokinumab with or without TCS exhibited early and clinically meaningful improvements vs placebo in several PROs, which may be beneficial to patients because atopic dermatitis symptom relief is a key treatment concern for patients. Trial completion date: Dec 2022 --> Mar 2023
- |||||||||| Living network meta-analysis of systemic treatments for atopic dermatitis (Le Centre Sheraton Montréal) - Oct 30, 2022 - Abstract #ISAD2022ISAD_114;
Change in signs with abrocitinib 100 mg and upadacitinib 15 mg were similar to dupilumab. Higher doses of abrocitinib and upadacitinib may be somewhat more efficacious than dupilumab whereas baricitinib and tralokinumab may be less efficacious.
- |||||||||| Therapeutic agents for atopic dermatitis in 2022 and beyond (Le Centre Sheraton Montréal) - Oct 30, 2022 - Abstract #ISAD2022ISAD_105;
Some other systemic drugs with various proposed modes of action are in earlier stages of development. Choosing the right form of treatment for atopic dermatitis is a challenge and a complex issue.
- |||||||||| The future in pediatrics (Le Centre Sheraton Montréal) - Oct 30, 2022 - Abstract #ISAD2022ISAD_27;
Tralokinumab and lebrikizumab will be the next biologics available for children, but others are in trial that may modify disease course, the next frontier...On the horizon and already in use are new tools for collection of patient-reported outcomes and quantitative data, such as wearable sensor devices that can capture a range of quantitative data, including in young babies, related to itch, scratch, skin inflammation and barrier function. Through these new monitoring and therapeutic tools, early and effective intervention can be achieved, ideally reducing disease duration and the risk of development of the many comorbidities associated with AD in children and adolescents
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Meaningful Responses In Tralokinumab-Treated Adolescents With Atopic Dermatitis Not Achieving IGA 0/1 at Week-16 (Exhibit Hall (Upper Concourse); Monitor 17) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_777;
P3
A greater proportion of tralokinumab 300mg patients vs. placebo (35.2% vs. 15.0%) achieved ≥6-point improvement in CDLQI. Conclusion Many tralokinumab-treated adolescents who did not achieve IGA 0/1 at Week 16 and/or used rescue therapy still achieved clinically meaningful improvements in AD signs, symptoms, and/or QoL.
- |||||||||| Journal: Impact of a decade of research into atopic dermatitis. (Pubmed Central) - Sep 29, 2022
Skin microbiome, epidermal metabolites/structural components, and local inflammatory biomarkers are now commonly assessed using genomic and proteomic analysis of tape strips rather than more invasive biopsy to identify factors such as CCL17 which correlate with disease severity and response to therapy. Overall, the last decade has ushered in a new and exciting era in our understanding, diagnosis and treatment of this common allergic skin disease.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
P3 data, Journal: Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. (Pubmed Central) - Sep 25, 2022
P3
Overall, the last decade has ushered in a new and exciting era in our understanding, diagnosis and treatment of this common allergic skin disease. Tralokinumab, with or without TCS, displayed similar efficacy and safety in patients with moderate-to-severe AD across the North American population, and was comparable to the non-North American population.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
The tralokinumab long-term safety (Amber 1+2) - Sep 13, 2022 - Abstract #EADV2022EADV_3639;
Not yet recruiting --> Recruiting Sponsored by LEO Pharma A/S
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Clinical, P2 data, P3 data, Retrospective data, Journal: Safety of Tralokinumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis: Pooled Analysis of Five Randomized, Double-blind, Placebo-controlled Phase 2 and Phase 3 Trials. (Pubmed Central) - Sep 13, 2022
Across the AD population pool from five clinical trials, tralokinumab was well tolerated, with consistent safety findings during treatment of moderate-to-severe AD patients. The safety profile during prolonged tralokinumab treatment was consistent with the initial treatment period; frequency of events did not increase over time.
- |||||||||| Impact of Differential Baseline Utility Values: Atopic Dermatitis (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1632;
A limitation of the scenario analysis is that the absolute improvement observed in trials is lost. Standardising baseline utilities and applying relative changes derived from a meta-analysis would be the preferred option, subject to data availability.
- |||||||||| Journal: European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy. (Pubmed Central) - Aug 28, 2022
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.
- |||||||||| Journal: Safety of biologics for atopic diseases during pregnancy. (Pubmed Central) - Aug 24, 2022
Indeed, worsening of the underlying atopic disease during pregnancy appears to be more detrimental to the viability of the pregnancy. Given the small sample size and scarcity of studies, future research should include prospective studies with comparable control groups without exposure to biologics and multicenter registries for long-term follow-up.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca, lebrikizumab (LY3650150) / Roche, Almirall, Eli Lilly
Clinical, Retrospective data, Review: The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. (Pubmed Central) - Aug 17, 2022
Antagonizing IL-13 with lebrikizumab and tralokinumab have demonstrated encouraging clinical efficacy against moderate-to-severe AD with excellent safety profile, albeit they did come with a higher risk of conjunctivitis than placebo treatment. https://www.crd.york.ac.uk/prospero/, identifier ID=CRD42021254920.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
EASI p-EASI: predicting disease severity in atopic dermatitis patients treated with tralokinumab () - Aug 16, 2022 - Abstract #ESDR2022ESDR_523;
P3
The biomarker signature p-EASI correlated with disease severity in moderate-severe AD patients treated with tralokinumab in a clinical trial setting. The use of objective biomarkers such as p-EASI may be considered as a tool to objectively assess treatment effect of new drugs for AD.
- |||||||||| Review, Journal: Pruritus in atopic dermatitis-comparative evaluation of novel treatment approaches (Pubmed Central) - Aug 12, 2022
As to systemic therapies, several approved biologics (dupilumab, tralokinumab) and small molecules (baricitinib, upadacitinib, abrocitinib) lead to a rapid improvement of pruritus by interfering with the signal transduction of proinflammatory cytokines. While Janus kinase inhibitors initially lead to a faster relief of pruritus than biologics, the antipruritic efficacy of biologics and Janus kinase inhibitors seems to be similar in long-term use.
- |||||||||| Journal: Inappropriate systemic therapy in severe atopic dermatitis-severe long-term damage (Pubmed Central) - Aug 10, 2022
Nevertheless, there are cases in which modern treatment options are not taken into account, as shown by a 28-year-old patient with serious side effects from long-term treatment with systemic glucocorticoids. In addition to the extensive clarification of the consequential damage, guideline-based therapy with dupilumab was initiated as well as interdisciplinary cooperation with endocrinologists, ophthalmologists, osteologists and nutritionists.
- |||||||||| Review, Journal: Modern systemic therapies for atopic dermatitis : Which factors determine the choice of therapy? (Pubmed Central) - Aug 10, 2022
On the one hand, direct therapeutic effects on the severity of the disease are considered and, on the other hand, the spectrum of potential adverse drug reactions are discussed. In particular, short- and long-term effects, the safety profile and the patient's concomitant diseases represent key factors for shared decision-making with regard to select the optimum personalized therapy option.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
PK/PD data, Journal: Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. (Pubmed Central) - Aug 3, 2022
For body weight, the difference in exposure between the upper- and lower-weight quartiles in patients with AD was <2-fold, supporting the appropriateness of flat dosing (300 mg). Given the reduced exposure associated with higher body weight, coupled with the reduced exposure provided by dosing every 4 weeks, it is uncertain whether higher-weight patients will achieve sufficient exposure to maintain efficacy if dosed every 4 weeks instead of the standard every 2 weeks.
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Tralokinumab treatment modifies stratum corneum lipid composition in skin of adolescents with atopic dermatitis (Ponce Foyer) - Jun 26, 2022 - Abstract #EAC2022EAC_56;
P3
These shifts in the cutaneous biomarker profile highlight the role of IL-13 as a key driver of the AD molecular signature, and support the role of targeted biologic therapy for long-term AD management. Tralokinumab improved AD severity and shifted skin NMF and lipid parameters from a lesional to non-lesional skin profile, demonstrating the effectiveness of neutralizing IL-13 in improving the skin barrier, evidenced by shifts in lipids of importance for maintaining intact SC structure
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
Review, Journal: Review of Tralokinumab in the Treatment of Atopic Dermatitis. (Pubmed Central) - Jun 23, 2022
Tralokinumab improved AD severity and shifted skin NMF and lipid parameters from a lesional to non-lesional skin profile, demonstrating the effectiveness of neutralizing IL-13 in improving the skin barrier, evidenced by shifts in lipids of importance for maintaining intact SC structure Tralokinumab is an efficacious and safe systemic treatment for moderate-to-severe AD.
- |||||||||| 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_846;
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.
- |||||||||| 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_624;
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.
- |||||||||| 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_386;
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.
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