EADV

WILLOW is a phase II, double-blind study investigating enpatoran for the treatment of systemic and/or cutaneous lupus erythematosus (NCT05162586). touchIMMUNOLOGY were delighted to speak with Dr. David R Pearson (University of Minnesota, Minneapolis, MN, USA) about the findings from preclinical studies evaluating the glucocorticoid-sparing effect of enpatoran, and about the aims, eligibility criteria and primary and secondary outcome measures of the WILLOW study. The abstract 'Enpatoran: Preclinical Evidence Supporting Glucocorticoid Dose Reduction and Phase II Study Design in Patients with SLE and/or CLE (WILLOW).' (Abstract number: 1230) was presented at EADV 2022, 7-10 September, 2022. Questions Could you tell us a little about the preclinical studies evaluating the glucocorticoid-sparing effect of enpatoran? (0:20) What were the findings of these studies? (1:23) What are the aims, design and eligibility criteria of the WILLOW study? (3:13) What are the primary and secondary outcome measures of the study? (3:44) Disclosures: David R Pearson discloses consulting for Biogen, Inc and receiving grant/ research support from Corbus, EMD Serono, Emerald Health, Kadmon, Pfizer, and Priovant. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

Enpatoran is a selective dual inhibitor of TLR7 and TLR8 currently under phase 2 investigation for the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). touchIMMUNOLOGY were delighted to speak with Dr. David R Pearson (University of Minnesota, Minneapolis, MN, USA) around the unmet needs in the treatment of SLE and CLE and the rationale for investigating enpatoran in these indications. The abstract 'Enpatoran: Preclinical Evidence Supporting Glucocorticoid Dose Reduction and Phase II Study Design in Patients with SLE and/or CLE (WILLOW).' (Abstract number: 1230) was presented at EADV 2022, 7-10 September, 2022. Questions What are the unmet needs in the treatment of systemic lupus erythematosus (SLE) and/or cutaneous lupus erythematosus (CLE)? (0:20) What is enpatoran and what is the rationale for its use in the treatment of SLE and/or CLE? (1:09) Disclosures: David R Pearson discloses consulting for Biogen, Inc and receiving grant/ research support from Corbus, EMD Serono, Emerald Health, Kadmon, Pfizer, and Priovant. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

Apremilast is an oral small-molecule inhibitor of PDE4 currently approved in adult patients with plaque psoriasis. touchIMMUNOLOGY were delighted to talk with Dr. Loretta Fiorillo (University of Alberta, Edmonton, Canada) to discuss the the aims, design and eligibility criteria of the study investigating apremilast in paediatric patients with moderate to severe plaque psoriasis and how well the primary and secondary outcome measures were achieved. The abstract ‘Efficacy and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: 16-Week Results From a Phase 3, Randomized, Double Blind, Placebo-Controlled Study.’ ( Presentation ID D1T01.3E) was presented at EADV 2022, 7-10 September, 2022. Questions What were the aims, design and eligibility criteria of the study you are presenting? (0:26) What were the primary and secondary outcome measures and how well were they achieved at 16 weeks? (2:13) What are the clinical implications of these findings? (3:25) Disclosures: Loretta Fiorillo discloses receiving grant/ research support from Amgen, Pfizer, Galderma, Leo, and Timber; and serving on advisory boards for Amgen, Pfizer, Galderma, Leo, and Timber. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

Apremilast is an oral small-molecule inhibitor of PDE4 currently approved in adult patients with plaque psoriasis. It was a pleasure to talk with Dr. Loretta Fiorillo (University of Alberta, Edmonton, Canada) around the unmet needs in the treatment of plaque psoriasis in paediatric patients and the clinical evidence supporting apremilast in this indication. The abstract 'Efficacy and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: 16-Week Results From a Phase 3, Randomized, Double Blind, Placebo-Controlled Study.' ( Presentation ID D1T01.3E) was presented at EADV 2022, 7-10 September, 2022. Questions: What are the unmet needs in the treatment of plaque psoriasis in paediatric patients? (0:26) What is apremilast, and what clinical evidence supports its use in the treatment of plaque psoriasis? (2:16) Disclosures: Loretta Fiorillo discloses receiving grant/ research support from Amgen, Pfizer, Galderma, Leo, and Timber; and serving on advisory boards for Amgen, Pfizer, Galderma, Leo, and Timber. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress.

TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) were randomized, double-blind, vehicle-controlled phase 3 studies investigating ruxolitinib cream in adults and adolescents with vitiligo. touchIMMUNOLOGY were delighted to speak with Prof. Thierry Passeron (University Hospital of Nice, Nice, France) to discuss the rationale and findings from his pooled analysis looking at the effect of ruxolitinib cream on achievement of VASI50 by body region. The abstract 'Effect of Ruxolitinib Cream on Achievement of VASI50 by Body Region: Week 52 Pooled Analysis of the TRuE-V Phase 3 Studies.' (Abstract number: 3640) was presented at EADV 2022, 7-10 September, 2022. Questions Could you give us a brief overview of the clinical development of ruxolitinib cream which has led to its approval for the treatment of vitiligo? (0:11) What have been the efficacy and safety findings of the TRuE-V studies, and how clinically meaningful are these findings? (0:52) What was the rationale for the pooled analysis you are presenting? (1:45) What were the findings of this analysis and what are the implications of these findings? (2:38) What has been the clinical impact of ruxolitinib cream in this indication since its approval? (3:27) Disclosures: Thierry Passeron discloses consulting for Almirall, Abbvie, Amgen, Astellas, BMS, Celgene, Galderma, GSK, Incyte, Isocell, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Sanofi-Genzyme, SUN pharma, and UCB pharma; receiving grant/ research support from Abbvie, Almirall, BMS, Celgene, Incyte, Isocell, LEO Pharma, and Lilly; and receiving honoraria from Almirall, Abbvie, Amgen, Astellas, BMS, Celgene, Galderma, GSK, Incyte, Isocell, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Sanofi-Genzyme, SUN pharma, and UCB pharma. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

LIBERTY-PN PRIME (NCT04183335) was a randomised, double-blind, placebo-controlled phase 3 trial, investigating dupilumab for the treatment of prurigo nodularis. touchIMMUNOLOGY caught up with Prof. Gil Yosipovitch (Miller School of Medicine, University of Miami, Miami, FL, USA) to discuss the aims, design and eligibility criteria of the phase 3 study and the findings in terms of itch response and skin lesions. The abstract 'Dupilumab Significantly Improves Itch and Skin Lesions in Patients with Prurigo Nodularis: Results from a 2nd Phase 3 Trial (LIBERTY-PN PRIME)' was presented at EADV 2022, 7-10 September, 2022. Questions Could you tell us a little about prurigo nodularis and the unmet needs in its treatment? (0:22) What are the current clinical applications of dupilumab, and what is the rationale for its use in this treatment setting? (1:07) What were the aims, design and eligibility criteria of the LIBERTY-PN-PRIME study? (1:58) What were the findings in terms of itch response and skin lesions? (3:16) What was the safety profile of dupilumab in this indication? (4:16) Disclosures: Gil Yosipovitch discloses consulting for Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient and Pfizer; receiving grant/ research support from Sanofi Regenron, Eli Lilly, Novartis, Pfizer, Escient; serving on advisory boards for Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient and Pfizer; receiving honoraria from Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient, Pfizer and Novartis. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967) are phase 3, randomised, double-blind, placebo-controlled trials, investigating lebrikizumab monotherapy in moderate to severe atopic dermatitis. touchIMMUNOLOGY caught up with Prof. Gil Yosipovitch (Miller School of Medicine, University of Miami, Miami, FL, USA) around the ADvocate 1 and ADvocate 2 phase 3 studies and the findings from his analysis of these studies presented at EADV, focusing on improvement in itch severity. The abstract 'Lebrikizumab monotherapy improved itch in adults and adolescents with moderate to severe atopic dermatitis in two phase 3 trials.' (Abstract number: 765) was presented at EADV 2022, 7-10 September, 2022. Questions What is the impact of itch on quality of life in atopic dermatitis? (0:21) Could you give us a brief overview of the ADvocate 1 and ADvocate 2 studies and their primary findings? (0:38) What were the findings in terms of itch severity, and how clinically meaningful was this change? (1:26) What will be the clinical impact of these findings? (2:51) Disclosures: Gil Yosipovitch discloses consulting for Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient and Pfizer; receiving grant/ research support from Sanofi Regenron, Eli Lilly, Novartis, Pfizer, Escient; serving on advisory boards for Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient and Pfizer; receiving honoraria from Sanofi Regeneron, Eli Lilly, Galderma, Sanofi, Kiniksa, Trevi, Escient, Pfizer and Novartis. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) were two phase 3 trials investigating tapinarof cream, a novel, steroid-free, AhR modulating agent for the treatment of plaque psoriasis. It was a pleasure to speak with Dr Linda Stein Gold (Henry Ford Health System, Detroit, MI, USA) around the aims, design, endpoints and quality of life and clinical efficacy findings from the two pivotal phase 3 trials. The abstract 'Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Improvements in Quality of Life and Clinical Efficacy in Two Pivotal Phase 3 Trials.' (Abstract number: 1175) was presented at EADV 2022, 7-10 September, 2022. Questions What were the aims and design of the PSOARING 1 and PSOARING 2 studies? (0:18) How well were the endpoints of the studies achieved? (1:16) What were the findings that you presented at EADV? (2:17) Disclosures: Linda Stein Gold discloses consulting for Dermavant, Arcutis, Leo and Ortho Derm; receiving grant/ research support from Dermavant, Arcutis, Leo and Ortho Derm; serving on advisory boards for Dermavant, Arcutis, Leo and Ortho Derm; receiving honoraria from Dermavant, Arcutis, Leo and Ortho Derm and participating in speaker’s bureaus for Dermavant, Arcutis, Leo and Ortho Derm. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress. 

Tapinarof cream 1% once daily, a topical aryl hydrocarbon receptor (AhR)-modulating agent was recently approved by the FDA for the treatment of plaque psoriasis. touchIMMUNOLOGY were delighted to speak with Dr Linda Stein Gold (Henry Ford Health System, Detroit, MI, USA) to learn more about the unmet needs in the treatment of plaque psoriasis, the rationale for the use of tapinarof cream 1% in this indication and how the recent FDA approval will impact the treatment paradigm. The abstract 'Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Improvements in Quality of Life and Clinical Efficacy in Two Pivotal Phase 3 Trials.' (Abstract number: 1175) was presented at EADV 2022, 7-10 September, 2022. Questions What are the unmet needs in the treatment of plaque psoriasis? (0:17) What is the mechanism of action of Tapinarof cream 1% and the rationale for its use in plaque psoriasis? (0:51) Following FDA approval, where does Tapinarof cream 1% fit in the treatment paradigm for plaque psoriasis? (1:28) Disclosures: Linda Stein Gold discloses consulting for Dermavant, Arcutis, Leo and Ortho Derm; receiving grant/ research support from Dermavant, Arcutis, Leo and Ortho Derm; serving on advisory boards for Dermavant, Arcutis, Leo and Ortho Derm; receiving honoraria from Dermavant, Arcutis, Leo and Ortho Derm and participating in speaker's bureaus for Dermavant, Arcutis, Leo and Ortho Derm. Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones. This content was developed by Touch Medical Media and is not affiliated with the  European Academy of Dermatology & Venereology  (EADV) or the congress.