TY - JOUR
T1 - Patient-oriented measures for phase 3 studies of tralokinumab for the treatment of atopic dermatitis (ECZTRA 1, 2, and 3)
AU - Simpson, Eric L.
AU - Wollenberg, Andreas
AU - Soong, Weily
AU - Steffensen, Louise Abildgaard
AU - Kurbasic, Azra
AU - Schneider, Shannon
AU - Zoidis, John
AU - Silverberg, Jonathan I.
N1 - Funding Information:
Medical writing and editorial assistance were provided by Aimee Bias, PhD and Lauren Smith, BA (Hons), from Complete HealthVizion, funded by LEO Pharma Inc. Supplementary data related to this article can be found at https://doi.org/10.1016/j.anai.2022.07.007 Disclosures: Dr Simpson reports receiving grants from Celgene, Galderma, Merck, Novartis, and Tioga; personal fees from Boehringer Ingelheim, Dermavant, Dermira, Fortè Bio, Incyte, Menlo, Ortho Dermatologics, Pierre Fabre, Sanofi, and Valeant; and grants and personal fees from AbbVie, Kyowa Hakko Kirin, LEO Pharma, Lilly, MedImmune, Pfizer, and Regeneron outside the submitted work. Dr Wollenberg reports receiving honoraria for the conduct of the ECZTRA trials in the Ludwig Maximilian University of Munich from LEO Pharma A/S during the conduct of the study; personal fees from AbbVie, Aileens, Chugai, Galderma, GlaxoSmithKline, LEO Pharma, Lilly, MedImmune, Merck, Novartis, Pfizer, Regeneron, and Sanofi-Aventis; and grants from LEO Pharma outside the submitted work. Dr Soong reports receiving grants and personal fees from AbbVie, AstraZeneca, Amgen, Genentech, GlaxoSmithKline, LEO, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and Teva; and grants from Aimmune, Allakos, Galderma, and Incyte. Dr Steffensen, Dr Kurbasic, Dr Schneider, and Dr Zoidis are current or former employees of LEO Pharma. Dr Zoidis died on March 28 during the final preparation of this manuscript. Dr Silverberg reports receiving personal fees from AbbVie, AnaptysBio, Arena, Asana, Bluefin, Boehringer Ingelheim, Celgene, Dermavant, Dermira, DS Biopharma Kiniksa, LEO Pharma, Lilly, Luna, Menlo, Novartis, Pfizer, Realm, Regeneron, and Sanofi-Genzyme; and grants and personal fees from Galderma and GlaxoSmithKline outside the submitted work. Funding: The tralokinumab ECZTRA 1, 2, and 3 trials were sponsored by LEO Pharma A/S (Ballerup, Denmark).
Funding Information:
Medical writing and editorial assistance were provided by Aimee Bias, PhD and Lauren Smith, BA (Hons), from Complete HealthVizion, funded by LEO Pharma Inc.
Publisher Copyright:
© 2022 The Authors
PY - 2022/11
Y1 - 2022/11
N2 - Background: Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has exhibited marked efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated. Objective: To evaluate early changes in patient-reported outcomes (PROs) across the ECZTRA 1, 2, and 3 tralokinumab trials. Methods: Monotherapy data (ECZTRA 1 + 2) was pooled; ECZTRA 3 evaluated tralokinumab plus optional TCS. The PROs were assessed through the trials. Results: A total of 1596 and 380 patients were randomized in ECZTRA 1 and 2 and ECZTRA 3, respectively. Baseline demographics and clinical characteristics were similar between groups. Early separation from placebo was observed in percentage improvement in worst average daily pruritus numerical rating score (NRS) (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3) and from day 2 in ECZTRA 1 and 2 daily data. More tralokinumab-treated patients achieved clinically meaningful improvements (≥ 4 points) in NRS by week 2 (ECZTRA 1 + 2) or week 3 (ECZTRA 3) vs placebo. Improvements in eczema-related sleep NRS were seen within 2 weeks (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3), supported by similar improvements in other sleep measures. Meaningful changes in Dermatology Life Quality Index were observed from week 2 (ECZTRA 1 + 2). Results were supported by numerical differences from placebo in Patient-Oriented Eczema Measure total score (week 2, both data sets). Conclusion: 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.
AB - Background: Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has exhibited marked efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated. Objective: To evaluate early changes in patient-reported outcomes (PROs) across the ECZTRA 1, 2, and 3 tralokinumab trials. Methods: Monotherapy data (ECZTRA 1 + 2) was pooled; ECZTRA 3 evaluated tralokinumab plus optional TCS. The PROs were assessed through the trials. Results: A total of 1596 and 380 patients were randomized in ECZTRA 1 and 2 and ECZTRA 3, respectively. Baseline demographics and clinical characteristics were similar between groups. Early separation from placebo was observed in percentage improvement in worst average daily pruritus numerical rating score (NRS) (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3) and from day 2 in ECZTRA 1 and 2 daily data. More tralokinumab-treated patients achieved clinically meaningful improvements (≥ 4 points) in NRS by week 2 (ECZTRA 1 + 2) or week 3 (ECZTRA 3) vs placebo. Improvements in eczema-related sleep NRS were seen within 2 weeks (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3), supported by similar improvements in other sleep measures. Meaningful changes in Dermatology Life Quality Index were observed from week 2 (ECZTRA 1 + 2). Results were supported by numerical differences from placebo in Patient-Oriented Eczema Measure total score (week 2, both data sets). Conclusion: 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.
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U2 - 10.1016/j.anai.2022.07.007
DO - 10.1016/j.anai.2022.07.007
M3 - Article
C2 - 35843520
AN - SCOPUS:85136666246
SN - 1081-1206
VL - 129
SP - 592-604.e5
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 5
ER -