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4. Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2)

Author

Simpson, Eric L., Prajapati, Vimal H., Leshem, Yael A., Chovatiya, Raj, de Bruin-Weller, Marjolein S., Ständer, Sonja, Pink, Andrew E., Calimlim, Brian M., Lee, Wan-Ju, Teixeira, Henrique, Ladizinski, Barry, Hu, Xiaofei, Yang, Yang, Liu, Yingyi, Liu, Meng, Grada, Ayman, Platt, Andrew M., and Silverberg, Jonathan I.

Published
2024
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7. A genome-wide meta-analysis of palmoplantar pustulosis implicates TH2 responses and cigarette smoking in disease pathogenesis

Author

Abraham, Thamir, Ali, Muhmad, August, Suzannah, Baudry, David, Becher, Gabrielle, Bewley, Anthony, Brown, Victoria, Cornelius, Victoria, Ghaffar, Sharizan, Ingram, John, Kavakleiva, Svetlana, Kelly, Susan, Khorshid, Mohsen, Lachmann, Helen, Ladoyanni, Effie, McAteer, Helen, McKenna, John, Meynell, Freya, Patel, Prakash, Pink, Andrew, Powell, Kingsley, Pushparajah, Angela, Sinclair, Catriona, Wachsmuth, Rachel, Hernandez-Cordero, Ariana, Thomas, Laurent, Smail, Alice, Lim, Zhao Qin, Saklatvala, Jake R., Chung, Raymond, Curtis, Charles J., Baum, Patrick, Visvanathan, Sudha, Burden, A. David, Cooper, Hywel L., Dunnill, Giles, Griffiths, Christopher E.M., Levell, Nick J., Parslew, Richard, Reynolds, Nick J., Wahie, Shyamal, Warren, Richard B., Wright, Andrew, Simpson, Michael, Hveem, Kristian, Barker, Jonathan N., Dand, Nick, Løset, Mari, Smith, Catherine H., and Capon, Francesca

Published
2024
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8. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials

Author

Silverberg, Jonathan I, Wollenberg, Andreas, Reich, Adam, Thaçi, Diamant, Legat, Franz J, Papp, Kim A, Stein Gold, Linda, Bouaziz, Jean-David, Pink, Andrew E, Carrascosa, José Manuel, Rewerska, Barbara, Szepietowski, Jacek C, Krasowska, Dorota, Havlíčková, Blanka, Kalowska, Monika, Magnolo, Nina, Pauser, Sylvia, Nami, Navid, Sauder, Maxwell B, Jain, Vipul, Padlewska, Kamila, Cheong, Soo Yeon, Fleuranceau Morel, Patricia, Ulianov, Liliana, and Piketty, Christophe

Published
2024
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16. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial

Author

Blauvelt, Andrew, Langley, Richard G., Lacour, Jean-Philippe, Toth, Darryl, Laquer, Vivian, Beissert, Stefan, Wollenberg, Andreas, Herranz, Pedro, Pink, Andrew E., Peris, Ketty, Fangel, Stine, Gjerum, Le, Corriveau, Joshua, Saeki, Hidehisa, Warren, Richard B., Simpson, Eric, and Reich, Kristian

Published
2022
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17. Single-cell analysis implicates TH17-to-TH2 cell plasticity in the pathogenesis of palmoplantar pustulosis

Author

McCluskey, Daniel, Benzian-Olsson, Natashia, Mahil, Satveer K., Hassi, Niina Karoliina, Wohnhaas, Christian T., Burden, A. David, Griffiths, Christopher E.M., Ingram, John R., Levell, Nick J., Parslew, Richard, Pink, Andrew E., Reynolds, Nick J., Warren, Richard B., Visvanathan, Sudha, Baum, Patrick, Barker, Jonathan N., Smith, Catherine H., and Capon, Francesca

Published
2022
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19. An expert consensus on managing dupilumab-related ocular surface disorders in people with atopic dermatitis 2024.

Author

Ardern-Jones, Michael R, Brown, Sara J, Flohr, Carsten, Hossain, Parwez, Irvine, Alan D, Johnston, Graham A, Lane, Mark, Langan, Sinéad M, Laws, Philip, O'Driscoll, Daniel, O'Kane, Donal, Payne, Alice, Petrof, Gabriela, Pink, Andrew E, Rauz, Saaeha, Robbie, Scott, Gore, Sri K, Shah, Mili, Woolf, Richard T, and Wang, Chenxi

Subjects
CORNEAL transplantation, ATOPIC dermatitis, DUPILUMAB, MEDICAL personnel, DERMATOLOGISTS
Abstract

Atopic dermatitis (AD) is the most common inflammatory skin condition and affects people of all ages. New therapies, including the monoclonal antibody therapy dupilumab, offer excellent efficacy. However, in clinical trials, and emphasized in real-world observations, an unexpected increased frequency of ocular adverse effects has become apparent. The effectiveness of dupilumab and the unpredictability of ocular adverse effects mean that clinicians need guidance on counselling patients prior to treatment and on managing them if adverse effects arise. The British Association of Dermatologists (BAD) and Royal College of Ophthalmologists collaborated on this consensus guidance on managing dupilumab-related ocular surface disorders (DROSD). A multidisciplinary group was formed of adult and paediatric dermatologists and ophthalmologists with expertise in DROSD, patient representatives and the BAD Clinical Standards Unit. A literature search was conducted and the results reviewed. All recommendations were reviewed, discussed and voted on. The recommendations pertain to dermatology and ophthalmology management, and apply to people of all ages, unless otherwise stated. Importantly, initiation of dupilumab for AD should not be delayed for most eye disorders except acute new problems (e.g. infections) or potentially severe conditions (e.g. a history of corneal transplant; ophthalmology advice should be sought first). There is insufficient evidence to recommend lubricant drops prophylactically. Dermatologists should assess eye complaints to diagnose DROSD; a severity grading system is provided. DROSD management differs slightly in those aged < 7 years, as ocular complications may affect neuro-ocular development. Therefore, irrespectively of DROSD severity, this population should be referred for ophthalmology advice. In those aged ≥ 7 years, dermatologists should feel confident to trial treatment and reserve ophthalmology advice for severe or nonresponding cases. Discussion about dupilumab withdrawal should be prompted by a significant impact on quality of life, threat to sight, or other complications. Although dupilumab is a highly effective agent for treating AD, the risk of ocular adverse effects should not inhibit clinicians or patients from using it, but clinicians should be aware of them. If a patient develops DROSD, there are clear pathways to assess severity and offer initial management. Where this is ineffective, dermatologists should assess the urgency and seek advice from or initiate referral to ophthalmology. While the evidence reviewed for these guidelines reflects the extensive literature on dupilumab, we believe our advice has relevance for ocular surface disorders in patients with AD treated with tralokinumab and lebrikizumab. [ABSTRACT FROM AUTHOR]

Published
2024
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20. 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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22. Factors associated with adverse COVID-19 outcomes in patients with psoriasis—insights from a global registry–based study

Author

Shah, Aadarsh, Barea, Alberto, Romero-Maté, Alberto, Singapore, Alekya, Paolino, Alexandra, Mwale, Alice, Morales Callaghan, Ana Maria, Martinez, Ana, DeCrescenzo, Andrew, Pink, Andrew E., Jones, Ann, Sergeant, Ann, Essex, Annette, Bewley, Anthony, Makrygeorgou, Areti, van Huizen, Astrid, Pérez-Suárez, Beatriz, Farida, Benhadou, Claréus, Birgitta Wilson, Prims, Carla Tubau, Davis, Carrie, Quinlan, Catherine, Maybury, Catriona, Cesar, Gonzalez A., Barclay, Charlotte, Greco, Claudio, Brassard, Danielle, Cummings, Deanna, Kolli, Deepti, Descamps, Vincent, Genao, Diana Ruiz, Carras, Efrossini, Hawryluk, Elena, Martínez-García, Eliseo, Klujszo, Elzbieta, Dwyer, Emily, Toni, Emmanuel, Sonkoly, Enikö, Loayza, Enrique, Daudén, Esteban, Valenzuela, Fernando, Popov, Georgi, King, Georgie, Celine, Girard, Aparicio, Gloria, Johnston, Graham A., Cardozo, Gustavo Anibal, Pearson, Ian, Yanguas, Ignacio, Weisman, Jamie, Carolan, Jennifer E., Hughes, Jenny, Ortiz-Salvador, Jose-Maria, Carrascosa, Jose-Manuel, Schwartz, Joseph J., Jackson, Karina, Kerisit, Kathryn G., Wu, Keith, Asfour, Leila, de Graaf, Leontien, Lesort, Cécile, Meuleman, Lieve, Eidsmo, Liv, Skov, Lone, Gribben, Lorraine, Rustin, Malcolm, Velasco, Manel, Panchal, Manisha, Lakhan, Manpreet, Franco, Manuel D., Svensson, Marie-Louise, Vandaele, Mark, Marovt, Maruska, Zargari, Omid, De Caso, Pablo, Varela, Paulo, Jenkin, Peter, Phan, Céline, Hampton, Philip, Goldsmith, Portia, Bak, Rachel, Speeckaert, Reinhart, Romiti, Ricardo, Woolf, Richard, Mercado-Seda, Rogelio, Khatun, Rohima, Ceovic, Romana, Taberner, Rosa, Cohen, Russell W., Stefanescu, Simina, Kirk, Sarah, Reeken, Saskia, Ayob, Shanti, Pérez-Barrio, Silvia, Piaserico, Stefano, Hoey, Susannah, Torres, Tiago, Talme, Toomas, Desai, Trupti V., van Geest, Adrienne J., King, Victoria, Di Lernia, Vito, Koreja, Zahira, Hasab, Vito Zeeshaan, Mahil, Satveer K., Dand, Nick, Mason, Kayleigh J., Yiu, Zenas Z.N., Tsakok, Teresa, Meynell, Freya, Coker, Bola, McAteer, Helen, Moorhead, Lucy, Mackenzie, Teena, Rossi, Maria Teresa, Rivera, Raquel, Mahe, Emmanuel, Carugno, Andrea, Magnano, Michela, Rech, Giulia, Balogh, Esther A., Feldman, Steven R., De La Cruz, Claudia, Choon, Siew Eng, Naldi, Luigi, Lambert, Jo, Spuls, Phyllis, Jullien, Denis, Bachelez, Hervé, McMahon, Devon E., Freeman, Esther E., Gisondi, Paolo, Puig, Luis, Warren, Richard B., Di Meglio, Paola, Langan, Sinéad M., Capon, Francesca, Griffiths, Christopher E.M., Barker, Jonathan N., and Smith, Catherine H.

Published
2021
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23. Safety of Tralokinumab for the Treatment of Atopic Dermatitis in Patients with Up to 4.5 Years of Treatment: An Updated Integrated Analysis of Eight Clinical Trials

Author

Reich, Kristian, primary, Langley, Richard G., additional, Silvestre, Juan Francisco, additional, Staumont-Salle, Delphine, additional, Costanzo, Antonio, additional, Pink, Andrew, additional, Paller, Amy, additional, Katoh, Norito, additional, Wollenberg, Andreas, additional, Warren, Richard B., additional, Øland, Christian Bjerregård, additional, Tindberg, Ann-Marie, additional, Gjerum, Le, additional, and Simpson, Eric, additional

Published
2024
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26. 555 - Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials

Author

Reich, Kristian, primary, Langley, Richard G, additional, Silvestre, Juan Francisco, additional, Staumont-Salle, Delphine, additional, Costanzo, Antonio, additional, Pink, Andrew, additional, Paller, Amy, additional, Katoh, Norito, additional, Wollenberg, Andreas, additional, Warren, Richard B, additional, Øland, Christian Bjerregård, additional, Tindberg, Ann-Marie, additional, Gjerum, Le, additional, and Simpson, Eric, additional

Published
2024
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27. Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2)

Author

MS Dermatologie/Allergologie, Infection & Immunity, Simpson, Eric L., Prajapati, Vimal H., Leshem, Yael A., Chovatiya, Raj, de Bruin-Weller, Marjolein S., Ständer, Sonja, Pink, Andrew E., Calimlim, Brian M., Lee, Wan Ju, Teixeira, Henrique, Ladizinski, Barry, Hu, Xiaofei, Yang, Yang, Liu, Yingyi, Liu, Meng, Grada, Ayman, Platt, Andrew M., Silverberg, Jonathan I., MS Dermatologie/Allergologie, Infection & Immunity, Simpson, Eric L., Prajapati, Vimal H., Leshem, Yael A., Chovatiya, Raj, de Bruin-Weller, Marjolein S., Ständer, Sonja, Pink, Andrew E., Calimlim, Brian M., Lee, Wan Ju, Teixeira, Henrique, Ladizinski, Barry, Hu, Xiaofei, Yang, Yang, Liu, Yingyi, Liu, Meng, Grada, Ayman, Platt, Andrew M., and Silverberg, Jonathan I.

Published
2024

29. Molecular genetic analysis of hidradenitis suppurativa (acne inversa)

Author

Pink, Andrew Edward, Barker, Jonathan Nicholas William Noel, and Trembath, Richard Charles

Subjects
616.5
Abstract

Hidradenitis suppurativa (HS) is a chronic inflammatory dermatosis that presents with painful nodules, abscesses and sinus tracts in apocrine gland-bearing regions. Disease pathogenesis is poorly understood and there is a consequent paucity of effective treatment options. HS has been associated with smoking and obesity and can be inherited in an autosomal dominant (AD) manner. Heterozygous mutations in the gamma-secretase genes NCSTN, PSEN1 and PSENEN have recently been reported in some Chinese multiplex kindreds with HS. The overall aim of this programme of research was to understand the genetic architecture of HS, the ultimate goal being to clarify the molecular mechanisms involved in disease pathogenesis. The principle objectives were four-fold: 1/ Explore the involvement of mutations in NCSTN, PSEN1 and PSENEN in British familial cases of HS. 2/ Functionally characterise any identified mutations. 3/ Determine the contribution of mutations in NCSTN, PSEN1 and PSENEN in the general disease population. 4/ Analyse the clinical phenotype of individuals harbouring gamma-secretase gene mutations. Heterozygous gamma-secretase gene mutations were detected in affected individuals from two of seven British multiplex kindreds demonstrating AD inheritance. Mutations were detected in NCSTN (c.1125+1 G>A) and PSENEN (c.66_67insG) which resulted in aberrant splicing (p.Glu333_Gln367del) and a frameshift (p.Phe23ValfsX98) respectively. Both mutant transcripts appeared unstable and subject to decay in primary human fibroblasts. A corresponding reduction in respective protein expression in mutant versus wild type fibroblasts implied that haploinsufficiency of the gamma-secretase components may underlie the development of HS in those cases. This apparent haploinsufficiency did not however affect gamma-secretase endopeptidase or carboxypeptidase activity in vitro. Forty eight individuals were sequentially recruited from a tertiary referral HS clinic and screened for variation in NCSTN, PSENEN and PSEN1. Three individuals harboured novel variants in NCSTN but no novel or rare (<1% population frequency) variation was detected in PSEN1 or PSENEN. All three NCSTN variants were of uncertain pathogenicity. Mutations in the gamma-secretase genes NCSTN, PSENEN and PSEN1 would therefore appear to underlie up to 7% of British cases of HS. Phenotypic analysis of individuals with likely pathogenic gamma-secretase mutations revealed early onset, severe, widespread and treatment resistant disease often associated with atypical flexural pigmentation and prominent cystic changes in atypical areas. Given that gamma-secretase gene mutations only appear to underlie a small proportion of HS cases it was hypothesised that there is further genetic heterogeneity underlying HS. Unexplained familial cases and unrelated but carefully phenotyped and sub-grouped individuals were therefore assessed using a combination of traditional and next generation gene mapping techniques. No pathogenic mutations in additional genes were identified. The identification of gamma-secretase gene mutations in HS informs disease pathogenesis, potentially implicates the gamma-secretase-Notch signalling axis in disease development, provides a platform for ongoing functional studies and will hopefully facilitate the identification of new therapeutic targets in this debilitating disease. Ongoing genetic and functional investigation is now required to confirm the presence of further genetic heterogeneity and to establish the relevance of gamma-secretase-Notch signalling in the wider patient cohort.

Published
2014

30. 649 - Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials.

Author

Reich, Kristian, Langley, Richard G, Silvestre, Juan Francisco, Staumont-Salle, Delphine, Costanzo, Antonio, Pink, Andrew, Paller, Amy, Katoh, Norito, Wollenberg, Andreas, Warren, Richard B, Øland, Christian Bjerregård, Tindberg, Ann-Marie, Gjerum, Le, and Simpson, Eric

Subjects
RESPIRATORY infections, ATOPIC dermatitis, CLINICAL trials, TERMINATION of treatment, SKIN infections
Abstract

Introduction/Background Clinical trials of up to 52 weeks showed that tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, was efficacious and well-tolerated as monotherapy and combination with TCS. Objectives Here, we evaluate the long-term safety of tralokinumab in an integrated analysis of seven phase 3 parent trials (PTs) (NCT03131648, NCT03160885, NCT03363854, NCT03562377, NCT03526861, NCT03761537, NCT04587453), and the ongoing, up to 5-year extension study (ECZTEND; NCT03587805). Methods Two datasets were analyzed: placebo-controlled (initial 16-week period of the PTs), and all-tralokinumab combining PTs with ECZTEND including patients from first dose until end of tralokinumab exposure or data cut-off (April 30th, 2022). In the all-tralokinumab dataset, periods on placebo were disregarded. Treatment-emergent adverse events (AEs) were recorded. AEs of special interest (AESIs) were predefined. Proportions of patients with events and incidence rates (IR) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as time until first event or exposure end, whichever came first, and incidence was defined as first event. Results 2693 patients (≥12 years) received tralokinumab for up to 238.5 weeks (≈4.5 years) with a median exposure time of 76.5 weeks in the all-tralokinumab dataset. Median age at baseline was 33.0 years (min-max; 12-92). 10.4% of patients were 12-17 years. 2307 patients experienced an AE (IR=202.0), most (97.3%) of which were mild-to-moderate. Serious AEs (SAEs) were reported in 226 patients (IR=4.5); SAEs were considered possibly or probably related by the investigator in 50 patients (IR=0.9). No preferred term level SAEs were reported with an IR≥0.1. Discontinuation of treatment due to AEs was low (IR=2.8). AEs leading to drug withdrawal with an IR>0.1 were dermatitis atopic (IR=0.5) and injection site reaction (ISR) (IR=0.2). Frequently reported AEs in the all-tralokinumab dataset were consistent with the placebo-controlled dataset, including nasopharyngitis (IR=18.4), upper respiratory tract infection (IR=6.9), conjunctivitis (IR=5.0), ISR (IR=3.6), conjunctivitis allergic (IR=2.7), and injection site pain (IR=1.5). AESIs, including eye disorders, skin infections requiring systemic treatment, eczema herpeticum, and malignancies, were observed in the all-tralokinumab dataset at rates similar to or lower than the placebo-controlled dataset. Conclusion Long-term use of tralokinumab, for up to 4.5 years, was well-tolerated, and the pattern of AEs was consistent with the initial placebo-controlled treatment period with no new safety signals identified. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Dupilumab in chronic actinic dermatitis: a retrospective case series.

Author

O'Reilly, Marese, Paolino, Alexandra, Pathmarajah, Pirunthan, Ferguson, John, Smith, Catherine H, Sarkany, Robert, Dawe, Robert S, Salam, Amr, Pink, Andrew E, Fassihi, Hiva, and Ibbotson, Sally

Subjects
DUPILUMAB, SKIN inflammation, ECZEMA, LITERATURE reviews
Abstract

This article discusses the use of dupilumab in the treatment of chronic actinic dermatitis (CAD), a rare skin condition characterized by photosensitivity. The study found that while dupilumab was effective in improving dermatitis symptoms in patients with CAD and concomitant atopic dermatitis (AD), it was less effective in improving photosensitivity. The study suggests that further research is needed to evaluate the efficacy of dupilumab in CAD. [Extracted from the article]

Published
2024
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32. The musical culture of freemasonry in early eighteenth-century London

Author

Pink, Andrew George and McVeigh, S.

Subjects
780
Abstract

The musical associations of freemasonry with late eighteenth-century music are well known from the long-held musicological interest in the masonic character of such works as Haydn's Creation, Mozart's Magic Flute, and Rameau's Zoroastre. However, the evolution of a distinct and varied masonic musical culture in London during the first fifty years of the century, following freemasonry's founding there in 1716, have been entirely overlooked by studies of this period. Eighteenth-century English freemasonry not only benefited from the riches of London's musical life, but also made its own contribution to it. Freemasonry's wide-ranging network of fraternal relationships connected musicians, actors, artists, playwrights, and poets directly with patrons and audiences drawn from all levels of society, from royalty and aristocrats and politicians down to the 'ordinary man in the street'. Apparently, English freemasonry was at first a peculiarly London phenomenon, but quickly spread nationally and internationally. From the outset it acquired its own distinctive repertoire of songs and a highly stylised performance tradition within the lodge. But eighteenth-century English freemasonry was a more public form of sociability than it is today, and its music was known widely outside the lodge. Freemasons regularly patronised the London theatre, their songs an integral part of the programme, and they annually rode and marched through the London streets in their hundreds, accompanied by a marching band, perhaps the first known examples of such an ensemble in the West. The figure of King Solomon looms large in masonic traditions. The cluster of three Solomon oratorios by Boyce, Broadway and Handel, all written in London in the 1740s, are here linked together not only by their masonic rhetoric but also by their associations with the political struggle between George II and Frederick, Prince of Wales, himself a freemason. The thesis proposes a masonic author for the hitherto anonymous librettist of Handel's Solomon.

Published
2007

34. International Consensus Definition and Diagnostic Criteria for Generalized Pustular Psoriasis From the International Psoriasis Council

Author

Choon, Siew Eng, van de Kerkhof, Peter, Gudjonsson, Johann E., de la Cruz, Claudia, Barker, Jonathan, Morita, Akimichi, Romiti, Ricardo, Affandi, Azura Mohd, Asawanonda, Pravit, Burden, Arthur David, Gonzalez, César, Marrakchi, Slaheddine, Mowla, Mohammad Rafiqul, Okubo, Yukari, Oon, Hazel H., Terui, Tadashi, Tsai, Tsen-Fang, Callis-Duffin, Kristina, Fujita, Hideki, Jo, Seong Jin, Merola, Joseph, Mrowietz, Ulrich, Puig, Lluïs, Thaçi, Diamant, Velásquez, Margarita, Augustin, Matthias, El Sayed, Mahira, Navarini, Alexander A., Pink, Andrew, Prinz, Jörg, Turki, Hamida, Magalhães, Renata, Capon, Francesca, and Bachelez, Hervé

Abstract

IMPORTANCE: Generalized pustular psoriasis (GPP) lacks internationally accepted definitions and diagnostic criteria, impeding timely diagnosis and treatment and hindering cross-regional clinical and epidemiological study comparisons. OBJECTIVE: To develop an international consensus definition and diagnostic criteria for GPP using the modified Delphi method. EVIDENCE REVIEW: The rarity of GPP presents a challenge in acquiring comprehensive published clinical data necessary for developing standardized definition and criteria. Instead of relying on a literature search, 43 statements that comprehensively addressed the fundamental aspects of the definitions and diagnostic criteria for GPP were formulated based on expert reviews of 64 challenging GPP cases. These statements were presented to a panel of 33 global GPP experts for voting, discussion, and refinements in 2 virtual consensus meetings. Consensus during voting was defined as at least 80% agreement; the definition and diagnostic criteria were accepted by all panelists after voting and in-depth discussion. FINDINGS: In the first and second modified Delphi round, 30 (91%) and 25 (76%) experts participated. In the initial Delphi round, consensus was achieved for 53% of the statements, leading to the approval of 23 statements that were utilized to develop the proposed definitions and diagnostic criteria for GPP. During the second Delphi round, the final definition established was, “Generalized Pustular Psoriasis is a systemic inflammatory disease characterized by cutaneous erythema and macroscopically visible sterile pustules.” It can occur with or without systemic symptoms, other psoriasis types, and laboratory abnormalities. GPP may manifest as an acute form with widespread pustules or a subacute variant with an annular phenotype. The identified essential criterion was, “Macroscopically visible sterile pustules on erythematous base and not restricted to the acral region or within psoriatic plaques.” CONCLUSIONS AND RELEVANCE: The achievement of international consensus on the definition and diagnostic criteria for GPP underscores the importance of collaboration, innovative methodology, and expert engagement to address rare diseases. Although further validation is needed, these criteria can serve as a reference point for clinicians, researchers, and patients, which may contribute to more accurate diagnosis and improved management of GPP.

Published
2024
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36. Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials

Author

Simpson, Eric L, Pink, Andrew E, Blauvelt, Andrew, Gooderham, Melinda, Armstrong, April W, Worm, Margitta, Katoh, Norito, Peris, Ketty, Puig, Lui, Barbarot, Sébastien, Mark, Thoma, Steffensen, Louise Abildgaard, Tindberg, Ann-Marie, Wollenberg, Andreas, Peris, Ketty (ORCID:0000-0002-5237-0463), Simpson, Eric L, Pink, Andrew E, Blauvelt, Andrew, Gooderham, Melinda, Armstrong, April W, Worm, Margitta, Katoh, Norito, Peris, Ketty, Puig, Lui, Barbarot, Sébastien, Mark, Thoma, Steffensen, Louise Abildgaard, Tindberg, Ann-Marie, Wollenberg, Andreas, and Peris, Ketty (ORCID:0000-0002-5237-0463)

Abstract

Background: Two phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe atopic dermatitis (AD). To further explore the long-term efficacy of tralokinumab for AD, a pooled analysis of these trials was conducted. Methods: ECZTRA 1 and 2 patients (n = 1596 total) were randomized to tralokinumab 300 mg or placebo every 2 weeks (q2w) over 16 weeks. Patients achieving Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) and/or 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 16, were re-randomized to tralokinumab q2w, every 4 weeks (q4w), or placebo (tralokinumab withdrawal) for another 36 weeks. Patients not achieving the response criteria at Week 16 received open-label tralokinumab q2w plus optional topical corticosteroids (TCS). A pooled, prespecified analysis assessed the proportions of Week 16 responders that maintained IGA 0/1 and/or EASI-75 at Week 52. Pooled data from all patients initiated with tralokinumab, regardless of the response at Week 16 or dosing regimen received thereafter, were analyzed post hoc. Results: In patients who achieved the primary endpoints at Week 16, IGA 0/1 responses were maintained at Week 52 without rescue treatment (including TCS) by 55.9%, 42.4%, and 34.0% of patients re-randomized to tralokinumab q2w, q4w, or placebo (tralokinumab withdrawal), respectively, while EASI-75 responses were maintained by 57.3%, 50.4%, and 26.4%, respectively (prespecified analysis). In a post hoc analysis of all patients initiated with tralokinumab, response rates improved over time with continued tralokinumab treatment beyond Week 16 to Week 52 for EASI-50 (63.1-82.7%), EASI-75 (37.6-61.8%), EASI-90 (20.4-37.3%), and IGA 0/1 (23.0-36.2%). Conclusions: Tralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with moderate-to-severe AD. Clinical tr

Published
2023

37. The Treat-to-Target Project in Atopic Dermatitis:One Year On

Author

de Bruin-weller, Marjolein, Deleuran, Mette, Biedermann, Tilo, Bissonnette, Robert, Foley, Peter, Girolomoni, Giampiero, Hercogová, Jana, Hong, Chih Ho, Katoh, Norito, Pink, Andrew E., Richard, Marie Aleth, Shumack, Stephen, Silvestre, Juan F., Thyssen, Jacob P., Weidinger, Stephan, de Bruin-weller, Marjolein, Deleuran, Mette, Biedermann, Tilo, Bissonnette, Robert, Foley, Peter, Girolomoni, Giampiero, Hercogová, Jana, Hong, Chih Ho, Katoh, Norito, Pink, Andrew E., Richard, Marie Aleth, Shumack, Stephen, Silvestre, Juan F., Thyssen, Jacob P., and Weidinger, Stephan

Abstract

Atopic dermatitis is a chronic skin condition for which a range of systemic treatments have recently been approved. A treat-to-target strategy has been deve-loped previously alongside an algorithm to guide the management of patients with atopic dermatitis. Here, we review the strategy and algorithm in the context of the evolving therapeutic landscape, and identify areas for further refinement and development.

Published
2023

39. The Treat-to-Target Project in Atopic Dermatitis: One Year On

Author

De Bruin-Weller, Marjolein, primary, Deleuran, Mette, additional, Biedermann, Tilo, additional, Bissonnette, Robert, additional, Foley, Peter, additional, Girolomoni, Giampiero, additional, Hercogová, Jana, additional, Hong, Chih-Ho, additional, Katoh, Norito, additional, Pink, Andrew, additional, Richard, Marie-Aleth, additional, Shumack, Stephen, additional, Silvestre, Juan Francisco, additional, Thyssen, Jacob P., additional, and Weidinger, Stephan, additional

Published
2023
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42. Damaging Alleles Affecting Multiple CARD14 Domains Are Associated with Palmoplantar Pustulosis

Author

Niaouris, Athanasios, primary, Hernández-Cordero, Ariana, additional, Haddad, Salma, additional, Hassi, Niina Karoliina, additional, Benzian-Olsson, Natashia, additional, Bugarin Diz, Carmen, additional, Burden, A. David, additional, Cooper, Hywel L., additional, Griffiths, Christopher E.M., additional, Parslew, Richard, additional, Pink, Andrew E., additional, Reynolds, Nick J., additional, Wahie, Shyamal, additional, Warren, Richard B., additional, Wright, Andrew, additional, Simpson, Michael, additional, Baum, Patrick, additional, Visvanathan, Sudha, additional, Barker, Jonathan N., additional, Smith, Catherine H., additional, Capon, Francesca, additional, Abraham, Thamir, additional, Ali, Muhmad, additional, August, Suzannah, additional, Baudry, David, additional, Becher, Gabrielle, additional, Bewley, Anthony, additional, Cornelius, Victoria, additional, Dunnill, Giles, additional, Ferguson, Adam, additional, Ghaffar, Sharizan, additional, Ingram, John, additional, Kavakleiva, Svetlana, additional, Kelly, Susan, additional, Khorshid, Mohsen, additional, Lachmann, Helen, additional, Ladoyanni, Effie, additional, McAteer, Helen, additional, McKenna, John, additional, Meynell, Freya, additional, Levell, Nick, additional, Patel, Prakash, additional, Pushparajah, Angela, additional, Sinclair, Catriona, additional, Wachsmuth, Rachel, additional, and Wilson, Rosemary, additional

Published
2023
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49. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey

Author

Augustin, Matthias, primary, Costanzo, Antonio, additional, Pink, Andrew, additional, Seneschal, Julien, additional, Schuster, Christopher, additional, Mert, Can, additional, Guerreiro, Mariana, additional, Tietz, Nicole, additional, Grond, Susanne, additional, and De Bruin-Weller, Marjolein, additional

Published
2022
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