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1. Blastomycosis

Author

Ameen, Mahreen, Berth-Jones, John, Series Editor, Goh, Chee Leok, Series Editor, Maibach, Howard I., Series Editor, Lipner, Shari R., Series Editor, and Robles, Wanda, editor

Published
2024
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3. Drugs in Leprosy

Author

Talhari, Sinésio, Ameen, Mahreen, Nunzi, Enrico, editor, Massone, Cesare, editor, and Portaels, Françoise, editor

Published
2022
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5. Combining treat‐to‐target principles and shared decision‐making: International expert consensus‐based recommendations with a novel concept for minimal disease activity criteria in atopic dermatitis.

Author

Silverberg, Jonathan I., Gooderham, Melinda, Katoh, Norito, Aoki, Valeria, Pink, Andrew E., Binamer, Yousef, Rademaker, Marius, Fomina, Daria, Gutermuth, Jan, Ahn, Jiyoung, Valenzuela, Fernando, Ameen, Mahreen, Steinhoff, Martin, Kirchhof, Mark G., Lio, Peter, and Wollenberg, Andreas

Subjects
PATIENTS' attitudes, ATOPIC dermatitis, DERMATOLOGISTS, VOTING, QUALITATIVE research
Abstract

Background: Current treat‐to‐target recommendations for atopic dermatitis (AD) may not include high enough treatment targets and do not fully consider patient needs. Objective: To develop recommendations for optimized AD management, including disease severity assessments, treatment goals and targets, and guidance for treatment escalation/modification. Methods: An international group of expert dermatologists drafted a series of recommendations for AD management using insights from a global patient study and 87 expert dermatologists from 44 countries. Experts voted on recommendations using a modified eDelphi voting process. Results: The Aiming High in Eczema/Atopic Dermatitis (AHEAD) recommendations establish a novel approach to AD management, incorporating shared decision‐making and a concept for minimal disease activity (MDA). Consensus (≥70% agreement) was reached for all recommendations in 1 round of voting; strong consensus (≥90% agreement) was reached for 30/34 recommendations. In the AHEAD approach, patients select their most troublesome AD feature(s); the clinician chooses a corresponding patient‐reported severity measure and objective severity measure. Treatment targets are chosen from a list of 'moderate' and 'optimal' targets, with achievement of 'optimal' targets defined as MDA. Conclusions: Patient and expert insights led to the development of AHEAD recommendations, which establish a novel approach to AD management. Patients were not involved in the eDelphi voting process used to generate consensus on each recommendation. However, patient perspectives were captured in a global, qualitative patient research study that was considered by the experts in their initial drafting of the recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Continuous Tralokinumab Treatment over 4 Years in Adults with Moderate-to-Severe Atopic Dermatitis Provides Long-Term Disease Control

Author

Blauvelt, Andrew, primary, Langley, Richard G., additional, Peris, Ketty, additional, Silvestre, Juan Francisco, additional, Katoh, Norito, additional, Tauber, Marie, additional, Pinter, Andreas, additional, Ameen, Mahreen, additional, Gooderham, Melinda, additional, Øland, Christian Bjerregård, additional, Tindberg, Ann-Marie, additional, Gjerum, Le, additional, and Reich, Kristian, additional

Published
2024
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9. 551 - Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control

Author

Blauvelt, Andrew, primary, Langley, Richard G, additional, Peris, Ketty, additional, Silvestre, Juan Francisco, additional, Katoh, Norito, additional, Tauber, Marie, additional, Pinter, Andreas, additional, Ameen, Mahreen, additional, Gooderham, Melinda, additional, Øland, Christian Bjerregård, additional, Tindberg, Ann-Marie, additional, Gjerum, Le, additional, and Reich, Kristian, additional

Published
2024
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19. List of Contributors

Author

Abdullah, Anthony, primary, Abrouk, Michael, additional, Ahad, Tashmeeta, additional, Ahmed, Imtiaz, additional, Al Hammadi, Anwar, additional, Allen, Caroline, additional, Almohssen, Amer Ali, additional, Alwan, Wisam, additional, Ameen, Mahreen, additional, Amini, Sadegh, additional, Anderson, Bryan E., additional, Anhalt, Grant J., additional, Baker, Donald J., additional, Bala, Harini Rajgopal, additional, Baltz, Julia, additional, Banach, David, additional, Banfield, Cedric C., additional, Baran, Robert, additional, Bardhan, Ajoy, additional, Barkham, Melissa C., additional, Bello, Ysabel M., additional, Benton, Emma, additional, Bergfeld, Wilma F., additional, Berkowitz, Eric, additional, Berman, Brian, additional, Bernhard, Jeffrey D., additional, Bernstein, Daniel, additional, Berth-Jones, John, additional, Bhate, Chinmoy, additional, Bhatia, Bhavnit K., additional, Blume, Jonathan E., additional, Bordet, Nevianna, additional, Borysiewicz, Catherine, additional, Brauner, Gary J., additional, Brodell, Robert T., additional, Brown, Marc D., additional, Burd, Robert M., additional, Burdick, Anne E., additional, Butala, Niraj, additional, Callen, Jeffrey P., additional, Camacho, Ivan D., additional, Camasmie, Helena, additional, Caplivski, Daniel, additional, Cappell, Mitchell S., additional, Casey, Genevieve A., additional, Chan, Lawrence S., additional, Chan, Loi-Yuen, additional, Chen, Jennifer K., additional, Chen, Chen “Mary”, additional, Chiang, Nicole Yi Zhen, additional, Chiaravalloti, Anthony J., additional, Child, Fiona J., additional, Chu, Anthony C., additional, Clayton, Timothy H., additional, Cohen, Steven R., additional, Cooper, Elizabeth A., additional, Cooper, Susan M., additional, Collier, Nick, additional, Correnti, Christina M., additional, Coulson, Ian H., additional, Council, M. Laurin, additional, Cowper, Shawn E., additional, Craven, Nicholas M., additional, Creamer, Daniel, additional, Cruz, Ponciano D., additional, Cusack, Carrie Ann R., additional, Daunton, Adam, additional, Davis, Mark D.P., additional, Dawe, Robert S., additional, D’Cruz, David P., additional, de Berker, David, additional, DeHoratius, Danielle M., additional, Deng, Min, additional, Desai, Seemal R., additional, Devlin, Georgina, additional, DiGiovanna, John J., additional, Doctoroff, Alexander, additional, Dodiuk-Gad, Roni P., additional, Eichenfield, Dawn Z., additional, Eichenfield, Lawrence F., additional, Eisen, Drore, additional, Eke, Ure, additional, Elston, Dirk M., additional, Emanuel, Patrick O.M., additional, Enos, Clinton W., additional, Ensanyat, Shaheen H., additional, Falabella, Anna F., additional, Farberg, Aaron S., additional, Feigenbaum, Lawrence S., additional, Fernandez, Kristen Heins, additional, Fett, Nicole, additional, Finlay, Andrew Y., additional, Firoz, Bahar F., additional, Firoz, Elnaz F., additional, Fitzpatrick, James E., additional, Flischel, Amy E., additional, Foley, Kelly A., additional, Freedman, Derek, additional, Fremlin, Georgina A., additional, Fried, Richard, additional, Friedlander, Philip, additional, Friedman, Adam, additional, Forrestel, Amy K., additional, Fuchs, Brian S., additional, Gach, Joanna E., additional, Galan, Anjela, additional, Ganesh, Jaya, additional, Garg, Amit, additional, Geller, Lauren, additional, Gelmetti, Carlo M., additional, Ghazi, Elizabeth, additional, Ghunawat, Sneha, additional, Goldberg, Leonard H., additional, Goodfield, Mark J.D., additional, Gordon, Marsha L., additional, Gowda, Asha, additional, Grabell, Daniel A., additional, Grant, Matthew, additional, Grattan, Clive E.H., additional, Greaves, Malcolm W., additional, Green, Justin J., additional, Griffiths, Christopher E.M., additional, Gropper, Charles A., additional, Grossberg, Anna L., additional, Gupta, Aditya K., additional, Hadi, Ali S., additional, Hadi, Suhail M., additional, Hagans, Iris A., additional, Hairston, Bethany R., additional, Halpern, Analisa Vincent, additional, Halverstam, Caroline, additional, Harper, Natasha, additional, Harries, Matthew J., additional, Harris, John, additional, Harrison, Shannon, additional, Hatch, Michael M., additional, Heagerty, Adrian H.M., additional, Hebert, Adelaide A., additional, Helms, Stephen E., additional, Hexsel, Camile L., additional, Hexsel, Doris M., additional, Heymann, Warren R., additional, Higgins, Elisabeth M., additional, Higgins, Claire L., additional, High, Whitney A., additional, Hönigsmann, Herbert, additional, Horenstein, Marcelo G., additional, Hruza, George J., additional, Hui, Andrea, additional, Huo, Ran, additional, Ibbotson, Sally H., additional, Ibrahim, Sherrif F., additional, Ilchyshyn, Andrew, additional, Ismail, Dina, additional, Jablonska, Stefania, additional, Jacobe, Heidi T., additional, James, William D., additional, Javed, Aysha, additional, Jemec, Gregor B.E., additional, Johnston, Graham A., additional, Jones, Stephen K., additional, Junkins-Hopkins, Jacqueline M., additional, Kaffenberger, Jessica, additional, Kane, Kelly R., additional, Kanelleas, Antonios, additional, Karadağ, Ayşe Serap, additional, Karas, Laura, additional, Katugampola, Ruwani P., additional, Katz, Bruce E., additional, Kellen, Roselyn, additional, Khan, Murtaza, additional, Khorasani, Hooman, additional, Kim, Ellen J., additional, Kim, Hee J., additional, Kirby, Brian, additional, Kirby, Joslyn S., additional, Klein, Rachel S., additional, Kleydman, Kate, additional, Koch, Dimitra, additional, Kohorst, John J., additional, Koo, John Y.M., additional, Kopp, Sandra A., additional, Korman, Neil J., additional, Kovarik, Carrie, additional, Kraemer, Kenneth H., additional, Krafchik, Bernice R., additional, Krishnamurthy, Karthik, additional, Kvernebo, Knut, additional, Lam, Charlene, additional, Lambert, Peter C., additional, Langtry, James A.A., additional, Larian, Amir A., additional, Larocca, Cecilia A., additional, Lawlor, E. Frances, additional, Lawrence, Clifford M., additional, Lebwohl, Mark G., additional, Lebwohl, Oscar, additional, Lehman, Julia S., additional, Leslie, Tabi A., additional, Lessin, Stuart R., additional, Levitt, Jacob O., additional, Lewis, Fiona M., additional, Liaqat, Maryam, additional, Liu, Kristina J., additional, Loosemore, Michael P., additional, Luger, Thomas A., additional, Lupi, Omar, additional, Lushniak, Boris D., additional, Lyon, Calum C., additional, Maderal, Andrea D., additional, Mahmoud, Bassel H., additional, Majewski, Slawomir, additional, Mallett, Richard B., additional, Manders, Steven M., additional, Mann, Ranon, additional, Mansouri, Yasaman, additional, Margolis, David J., additional, Markowitz, Orit, additional, Marsland, Alexander, additional, Martin-Clavijo, Agustin, additional, Martinez, Daniela, additional, Matiz, Catalina, additional, Maurer, Marcus, additional, McKerrow, Kevin, additional, Meah, Nekma, additional, Micali, Giuseppe, additional, Micheletti, Robert G., additional, Millard, Leslie G., additional, Miller, James E., additional, Wong Millsop, Jillian W., additional, Mimouni, Daniel, additional, Mirowski, Ginat W., additional, Mirza, Sultan A., additional, Molin, Sonja, additional, Morales-Burgos, Adisbeth, additional, Morison, Warwick L., additional, Mørk, Cato, additional, Morton, Colin A., additional, Motley, Richard J., additional, Mowbray, Megan, additional, Muldoon, Eavan G., additional, Muncaster, Anna E., additional, Murakawa, George J., additional, Murase, Jenny E., additional, Murdoch, Michele E., additional, Nabatian, Adam S., additional, Nakamura, Mio, additional, Nalluri, Rajani, additional, Nawas, Zeena Y., additional, Needham, Glen R., additional, Newell, Glenn C., additional, Newton-Bishop, Julia, additional, Nguyen, Adam V., additional, Nixon, Rosemary L., additional, O’Brien, Jack C., additional, Ogden, Stephanie, additional, Olbricht, Suzanne M., additional, O’Shea, Sally Jane, additional, Owen, Cindy E., additional, Pan, Michael, additional, Pappas-Taffer, Lisa, additional, Parish, Jennifer L., additional, Parish, Lawrence Charles, additional, Payette, Michael, additional, Peck, Gary L., additional, Pena, Sandra, additional, Peranteau, Jarad, additional, Pereira, Frederick A., additional, Perkins, William, additional, Perlis, Clifford S., additional, Phelps, Robert G., additional, Phillips, Tania J., additional, Poh-Fitzpatrick, Maureen B., additional, Pomeranz, Miriam Keltz, additional, Pop, Samantha R., additional, Porcu, Pierluigi, additional, Powell, James B., additional, Prok, Lori D., additional, Pyle, Tia M., additional, Qazaz, Surod, additional, Rajkomar, Vikram, additional, Rashid, Rabia S., additional, Rashighi, Mehdi, additional, Ratnavel, Ravi, additional, Regula, Christie G., additional, Renzi, Michael, additional, Revuz, Jean, additional, Reynolds, Rachel V., additional, Richard, Elisabeth, additional, Richard, Gabriele, additional, Rigel, Darrell S., additional, Robles, Wanda Sonia, additional, Rogge, Megan, additional, Rook, Alain H., additional, Manning, Jamie R., additional, Rosen, Ted, additional, Rosenbach, Misha, additional, Rosenfeld, David, additional, Rowland Payne, Christopher, additional, Rubin, Adam I., additional, Rubin, Courtney, additional, Rustin, Malcolm H.A., additional, Ruzicka, Thomas, additional, Samimi, Sara, additional, Schachner, Lawrence A., additional, Scheinfeld, Noah, additional, Schlosser, Bethanee J., additional, Schnur, Rhonda E., additional, Schwartz, Robert A., additional, Scorer, Matthew J., additional, Selkin, Bryan A., additional, Seymour, Jamie, additional, Shaver, Christine M., additional, Shea, Christopher R., additional, Shear, Neil H., additional, Shim, Tang Ngee, additional, Shimizu, Hiroshi, additional, Siegel, Julia, additional, Singer, Elisha, additional, Skelsey, Maral Kibarian, additional, Sladden, Chris, additional, Sladden, Michael, additional, Smith, Janellen, additional, Smucker, Joanne E., additional, Somani, Najwa, additional, Sommer, Lacy L., additional, Sommerlad, Mary, additional, Soon, Christine, additional, Sopkovich, Jennifer A., additional, Soter, Nicholas A., additional, Spencer, James M., additional, Staughton, Richard C.D., additional, Sterling, Jane C., additional, Sunderkötter, Cord, additional, Taibjee, Saleem M., additional, Tamura, Deborah, additional, Tan, Eunice, additional, Tang, William Y-M., additional, Taylor, Lynsey, additional, Thiers, Bruce H., additional, Thomas, Lucy J., additional, Thornton, Cody R., additional, Tobin, Anne-Marie, additional, Torgerson, Rochelle R., additional, Tosti, Antonella, additional, Tsatsou, Fragkiski, additional, Tsuji-Abe, Yukiko, additional, Tucker, William F.G., additional, Tyring, Stephen K., additional, Udkoff, Jeremy, additional, Unger, Robin H., additional, Unger, Walter P., additional, Utz, Sarah, additional, Valbuena, Martha C., additional, van de Kerkhof, Peter, additional, Van Voorhees, Abby S., additional, Vangipuram, Ramya, additional, Veitch, David, additional, Venning, Vanessa, additional, Versteeg, Sarah G., additional, Viera, Martha, additional, Vittorio, Carmela C., additional, Vleugels, Ruth Ann, additional, Wali, Gorav N., additional, Wallengren, Joanna, additional, Wan, Joy, additional, Wanat, Karolyn A., additional, Weichert, Gabriele, additional, Weidmann, Anja K., additional, Weinberg, Jeffrey M., additional, Werth, Victoria P., additional, White, Lucile E., additional, Wiener, Adam H., additional, Wilkin, Jonathan K., additional, Wilkin, Nathaniel K., additional, Williams, Jason, additional, Wilson, Niall, additional, Wiss, Karen, additional, Witkowski, Joseph A., additional, Wiznia, Lauren E., additional, Wong, Henry K., additional, Wong, Junie Li Chun, additional, Wright, Andrew L., additional, Wriston, Cooper C., additional, Wu, Benedict C., additional, Wulkan, Adam, additional, Zaenglein, Andrea L., additional, Zaki, Irshad, additional, Zeichner, Joshua A., additional, Zhu, Tian Hao, additional, Zone, John J., additional, Zouboulis, Christos C., additional, and Zuberbeir, Torstein, additional

Published
2018
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21. Perception and Experience of Biologic Therapy in Atopic Dermatitis: A Qualitative Focus Group Study of Physicians and Patients in Europe and Canada

Author

Ameen, Mahreen, Meller, Stephan, Pinter, Andreas, Shear, Neil H., Soria, Angele, Royal Free London NHS Foundation Trust, Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Frankfurt University Hospital, University of Toronto, Service de dermatologie et allergologie [CHU Tenon], CHU Tenon [AP-HP], and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
medicine.medical_specialty, Patients, Experiences, education, Dermatology, Disease, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Physicians, Medicine, 030212 general & internal medicine, Adverse effect, Intensive care medicine, Original Research, Atopic dermatitis, business.industry, medicine.disease, Dupilumab, Focus group, 3. Good health, Tolerability, Qualitative study, business, Psychosocial, [SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology, Biologic therapy
Abstract

Introduction The Biologics in Atopic Dermatitis: Experiences & Learnings (BADEL) project aims to improve real-life understanding of how, where, and when biologics can play a role in the treatment of atopic dermatitis (AD) from the perspective of healthcare professionals (HCPs) and patients. Methods Individual experiences of 24 patients with moderate-to-severe AD and who had been treated with biologic therapy (dupilumab) for ≥ 3-6 months, and 20 HCPs with a sub-specialty interest in AD were collected by means of focus groups held in Canada, Germany, France, Italy and the United Kingdom. Dupilumab was the only biologic therapy available at the time of the study. Results Most patients had suffered from AD for many years, particularly from itch and psychosocial issues, with AD negatively impacting all aspects of their life. They had experienced a long treatment journey and seen many dermatologists, enduring treatment delays and failures. They had been prescribed various therapies without long-term success. Biologics provided symptom improvement, offering many patients a near-normal quality of life. Side effects, especially conjunctivitis, were the greatest drawback, and there were a few issues with incomplete or unreliable efficacy. HCPs agreed that biologic therapy for AD in the majority of patients demonstrated rapid onset, good efficacy and tolerability, and are a viable option in patients who had exhausted all other treatment options. However, those patients who failed to sufficiently respond or developed intolerable adverse effects, particularly ocular symptoms, require alternative therapeutic options. Conclusion Biologics can provide a near-normal quality of life for many patients with AD. Patients with AD who have failed conventional therapies should be offered all such novel therapies. Education and good patient-HCP communication will enable patients to manage their disease and treatment expectations. Patients and HCPs alike eagerly await alternative targeted therapies, which will offer greater choice and flexibility.

Published
2021

22. 33298 Long-term safety and efficacy of tralokinumab in more than 1400 moderate-to-severe atopic dermatitis patients treated for up to 42 months: An interim analysis of ECZTEND

Author

Blauvelt, Andrew, primary, Langley, Richard, additional, Simpson, Eric, additional, Warren, Richard B., additional, Costanzo, Antonio, additional, Saeki, Hidehisa, additional, Toth, Darryl, additional, Tauber, Marie, additional, Pinter, Andreas, additional, Ameen, Mahreen, additional, and Reich, Kristian, additional

Published
2022
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24. Psoriasis

Author

Ameen, Mahreen, Barker, Jonathan N.W.N., Gordon, Kenneth B., editor, and Ruderman, Eric M., editor

Published
2005
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25. A Real-World Data Study on the Healthcare Resource Use for Uncontrolled Moderate-to-Severe Atopic Dermatitis in Secondary Care in the United Kingdom Prior to the Introduction of Biologic Treatment

Author

Hudson,Richard DA, Ameen,Mahreen, George,Susannah MC, Harwood,Catherine A, Weller,Richard B, Lear,John T, Rout,Rajesh, Surendranathan,Thishi, Petrovic,Milos, Bewley,Anthony P, Hudson,Richard DA, Ameen,Mahreen, George,Susannah MC, Harwood,Catherine A, Weller,Richard B, Lear,John T, Rout,Rajesh, Surendranathan,Thishi, Petrovic,Milos, and Bewley,Anthony P

Abstract

Richard DA Hudson,1 Mahreen Ameen,2 Susannah MC George,3 Catherine A Harwood,4,5 Richard B Weller,6,7 John T Lear,8,9 Rajesh Rout,1 Thishi Surendranathan,1 Milos Petrovic,1 Anthony P Bewley4 1Sanofi, Berkshire, UK; 2Royal Free NHS Foundation Trust, London, UK; 3University Hospitals Sussex NHS Foundation Trust, Brighton, UK; 4Barts Health NHS Trust, London, UK; 5QMUL, London, UK; 6NHS Lothian, Edinburgh, UK; 7University of Edinburgh, Edinburgh, UK; 8Salford Royal NHS Foundation Trust, Salford, UK; 9Manchester Academic Health Science Centre, Manchester University, Manchester, UKCorrespondence: Richard DA Hudson, Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK, Email richard.hudson@sanofi.comBackground: Whilst there is international evidence around the high healthcare resource utilization (HRU) associated with atopic dermatitis (AD), there is a lack of published data from the United Kingdom (UK).Methods: A retrospective, descriptive, observational study was conducted to evaluate the burden of moderate-to-severe AD on the National Health Service (NHS) in an adult UK population treated with traditional standard of care prior to the introduction of biologics. Patients (n=59) were recruited from 6 UK NHS Hospital Trusts and observed over three years.Results: 707 dermatology clinic visits were recorded over the observation period, amounting to 6.6 visits per patient-year, most commonly for routine check-ups most of which involved dermatology consultants (n=469, 66%). Physicians were the most consulted healthcare professional (n=652, 92%); emollients were the most common treatment (n=80 courses). 174 flares requiring additional medical advice were recorded in total (1.6 per patient-year).Discussion/Conclusions: Complex treatment pathways for adult patients in the UK with moderate-to-severe AD incur considerable HRU, particularly for those patients non-responsive to systemic therapies with broad immunosuppressant action. Recent advances in biologics-base

Published
2022

26. A Real-World Data Study on the Healthcare Resource Use for Uncontrolled Moderate-to-Severe Atopic Dermatitis in Secondary Care in the United Kingdom Prior to the Introduction of Biologic Treatment

Author

Hudson, Richard DA, primary, Ameen, Mahreen, additional, George, Susannah MC, additional, Harwood, Catherine A, additional, Weller, Richard B, additional, Lear, John T, additional, Rout, Rajesh, additional, Surendranathan, Thishi, additional, Petrovic, Milos, additional, and Bewley, Anthony P, additional

Published
2022
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34. 650 - Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis.

Author

Blauvelt, Andrew, Hong, H Chih-ho, Peris, Ketty, Katoh, Norito, Tauber, Marie, Ameen, Mahreen, Gooderham, Melinda, Øland, Christian Bjerregård, Tindberg, Ann-Marie, Gjerum, Le, and Reich, Kristian

Subjects
CLINICAL trials, ATOPIC dermatitis, DISEASE relapse, INTERLEUKIN-13, SYMPTOMS
Abstract

Introduction/Background To ensure minimal residual disease and to prevent relapses, recently published consensus reports have defined optimal long-term treatment targets for atopic dermatitis (AD).1,2 Tralokinumab, a monoclonal antibody specifically neutralizing interleukin-13, is approved for the treatment of moderate-to-severe AD. ECZTEND (NCT03587805) is an ongoing open-label, 5-year extension trial investigating the long-term safety and efficacy of tralokinumab 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS). Objectives To determine the proportion of patients treated for up to 4 years with tralokinumab in AD clinical trials who: 1) exhibit stable improvement, with no or minimal fluctuations, in lesion extent and severity long-term (ie, response in ≥80% of attended visits), and 2) exhibit a stable long-term composite response (ie, up to 4 years of tralokinumab treatment and response in ≥80% of attended trial visits) in signs and symptoms of AD, and quality of life based on recent treat-to-target recommendations (EASI ≤7 and either DLQI ≤5 or Itch NRS ≤4). Methods This post hoc analysis included 347 patients who were continuously treated with tralokinumab for 52 weeks in the identically designed phase 3 monotherapy trials ECZTRA 1&2 and subsequently for up to 152 weeks in ECZTEND as of the April 30, 2022 data cutoff. Stability of long-term response, with no or minimal fluctuations, was defined as meeting the target endpoints at ≥80% of attended visits between Weeks 16-152 in ECZTEND. Endpoints analyzed were EASI ≤7, EASI ≤2, and a composite long-term treatment target: EASI ≤7 and either DLQI ≤5 or worst weekly pruritus NRS ≤4. Results A stable EASI ≤7 response (at ≥80% of attended visits) was observed in 70.2% (233/332) of tralokinumab-treated patients over Weeks 16-152 of ECZTEND. A stable EASI ≤2 response was observed in 34.0% (113/332) of patients, and a long-term optimal composite target, EASI ≤7 and either DLQI ≤5 or Itch NRS ≤4, was observed in 60.5% (201/332) of patients. Conclusions High proportions of clinical trial patients maintained stable responses, with no or minimal fluctuations in efficacy, with continued tralokinumab 300 mg Q2W plus optional TCS for up to 4 years of treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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46. Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control.

Author

Blauvelt, Andrew, Langley, Richard G., Peris, Ketty, Silvestre, Juan Francisco, Katoh, Norito, Tauber, Marie, Pinter, Andreas, Ameen, Mahreen, Gooderham, Melinda, Øland, Christian Bjerregård, Tindberg, Ann-Marie, Gjerum, Le, and Reich, Kristian

Subjects
ITCHING, ATOPIC dermatitis, PREVENTIVE medicine, CLINICAL trials, ADULTS, MISSING data (Statistics)
Abstract

Introduction/Background There is a need for additional long-term treatment options for patients with moderate-to-severe atopic dermatitis (AD) that provide sustained disease control with a favorable safety profile. Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is approved for the treatment of moderate-to-severe AD in multiple countries. Clinical trials of up to 52-wk duration showed that tralokinumab was effective and well tolerated as monotherapy and in combination with topical therapy. ECZTEND (NCT03587805) is an ongoing open-label, 5-yr extension trial investigating the long-term safety and efficacy of tralokinumab ± optional topical corticosteroids (TCS). Objectives: To assess the efficacy of long-term tralokinumab treatment, we conducted a post hoc interim subgroup analysis restricted to the largest, most homogenous patient population, with the longest treatment duration. Methods: Adult patients with moderate-to-severe AD who were continuously treated with tralokinumab ± optional TCS for 52 wks in the parent phase 3 trials ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885) and for up to 152 wks in ECZTEND as of data cutoff April 30, 2022, were included. Endpoints included proportion of patients achieving Investigator's Global Assessment (IGA) score of 0/1 (clear/almost clear skin), at least 75% or 90% improvement in Eczema Area and Severity Index (EASI) relative to parent trial baseline (EASI-75 or EASI-90), EASI =7, worst weekly pruritus Numeric Rating Scale (NRS) =4, and Dermatology Life Quality Index (DLQI) =5. Results are presented using observed data. Sensitivity analyses on patients who completed Wk 152 in ECZTEND (or who withdrew, but were enrolled in the study at least 152 wks prior to the study cutoff) were performed using modified non-responder imputation (mNRI) with discontinuations due to AEs or lack of efficacy imputed as non-responders and a 2-step multiple imputation (MI) for other missing data [Step 1: Missing data up to 1 year in ECZTEND were imputed using a standard regression-based MI method; Step 2: Missing data post 1 year imputed by carrying forward the within-subject area under the curve of days in-response]. Results: 347 adult patients with a mean age (SD) of 42.2 (14.5) yrs and a mean EASI (SD) of 30.8 (13.7) at parent trial baseline were included in this analysis. After 4 yrs of total tralokinumab treatment (at Wk 152 in ECZTEND), IGA 0/1 [% (n/N)] was observed in 52.6% (92/175) of patients. EASI-75 {% (n/N) [95% CI]} was achieved in 84.5% (147/174) [78.4, 89.1] of patients as observed, and in 73.4% (254.8/347) [68.6, 78.3] using mNRI. EASI-90 was achieved in 64.4% (112/174) [57.0, 71.1] of patients as observed, and in 53.4% (185.2/347) [47.8, 59.0] using mNRI. Additionally, EASI =7 (mild disease) was observed in 84.5% (147/174) of patients, worst weekly pruritus NRS =4 (no to mild itch) in 68.0% (119/175), and DLQI =5 (no to small effect of AD on quality of life) in 79.0% (128/162) of patients. The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use. Conclusions: Continuous use of tralokinumab ± optional TCS provided long-term disease control over 4 yrs in adult patients with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Genetic Analysis of PSORS1 Distinguishes Guttate Psoriasis and Palmoplantar Pustulosis

Author

Asumalahti, Kati, Ameen, Mahreen, Suomela, Sari, Hagforsen, Eva, Michaëlsson, Gerd, Evans, Julie, Munro, Margo, Veal, Colin, Allen, Michael, Leman, Joyce, David Burden, A., Kirby, Brian, Connolly, Maureen, Griffiths, Christopher E. M., Trembath, Richard C., Kere, Juha, Saarialho-Kere, Ulpu, and Barker, Jonathan N. W. N.

Published
2003

Catalog

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