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Article ; Online: Sex stratification of adverse events should be included in studies about skin disease.

Spuls, P I

Journal of the European Academy of Dermatology and Venereology : JEADV

2024 Volume 38, Issue 4, Page(s) 635–636

MeSH term(s)	Humans ; Skin Diseases/etiology ; Male ; Female
Language	English
Publishing date	2024-03-24
Publishing country	England
Document type	Journal Article
ZDB-ID	1128828-0
ISSN	1468-3083 ; 0926-9959
ISSN (online)	1468-3083
ISSN	0926-9959
DOI	10.1111/jdv.19879
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Article ; Online: Immunogenicity of biologic therapies in psoriasis: Myths, facts and a suggested approach.

Tsakok, T / Rispens, T / Spuls, P / Nast, A / Smith, C / Reich, K

Journal of the European Academy of Dermatology and Venereology : JEADV

2021 Volume 35, Issue 2, Page(s) 329–337

Abstract: With biologic drugs dominating the therapeutic space for severe immune-mediated inflammatory disease, it is critical for clinicians to be familiar with the concept of drug immunogenicity, with the potential for our patients to develop antidrug antibodies ...

Abstract	With biologic drugs dominating the therapeutic space for severe immune-mediated inflammatory disease, it is critical for clinicians to be familiar with the concept of drug immunogenicity, with the potential for our patients to develop antidrug antibodies (ADA) of clinical relevance. Whilst there are clear differences between different therapeutic biologics in terms of reported ADA rates, there is no accepted dermatology guideline or grouping of drugs by risk of clinically relevant ADA, nor a consensus on approach to ADA management. This is partly because making valid comparisons of immunogenicity across drugs is fundamentally flawed: the differing types of ADA assay, trial design and included patient population - as well as the molecular structure of the biologic molecules themselves - are all highly influential on reported ADA prevalence and impact on clinical response. Therefore, the first part of this article aims to give an overview of ADA that also clarifies common misconceptions on the subject, whilst the second part of this article outlines Phase III immunogenicity data on commonly used biologics for psoriasis, the most common dermatological indication. Based on this, and acknowledging current limitations in available evidence, we propose a working categorization of biologics together with a broad approach to management: Group 1 - biologics with higher risk of clinically relevant ADA; Group 2 - biologics with lower risk of clinically relevant ADA; and Group 3 - biologics with no established risk of clinically relevant ADA. However, these groupings represent a working concept only; more research is required, using comparable ADA assays and consistent reporting of related outcomes. Finally, there is an urgent need for better characterization of individuals at particular risk of developing ADA to inform future clinical decision-making.
MeSH term(s)	Antibodies ; Biological Products/therapeutic use ; Biological Therapy ; Humans ; Psoriasis/drug therapy
Chemical Substances	Antibodies ; Biological Products
Language	English
Publishing date	2021-01-01
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1128828-0
ISSN	1468-3083 ; 0926-9959
ISSN (online)	1468-3083
ISSN	0926-9959
DOI	10.1111/jdv.16980
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Article ; Online: Paternal and maternal use of dupilumab in patients with atopic dermatitis: a case series.

Bosma, A L / Gerbens, L A A / Middelkamp-Hup, M A / Spuls, P I

Clinical and experimental dermatology

2021 Volume 46, Issue 6, Page(s) 1089–1092

Abstract: Dupilumab is a relatively new treatment option for patients with moderate to severe atopic dermatitis. There is a lack of knowledge about the effects of treatment with dupilumab during conception for both men and women, as well as during pregnancy and ... ...

Abstract	Dupilumab is a relatively new treatment option for patients with moderate to severe atopic dermatitis. There is a lack of knowledge about the effects of treatment with dupilumab during conception for both men and women, as well as during pregnancy and lactation in women. We report four patients (two men, two women) who expressed a wish to conceive during treatment with dupilumab in daily practice. Both men conceived during dupilumab treatment, while the two women discontinued dupilumab because of anticipated pregnancy. Apart from disease flares in both of the patients who discontinued treatment, no complications were reported concerning the ability to conceive, the course of the pregnancy or the fetal outcome. We present an overview of the current available literature on dupilumab during conception, pregnancy and lactation, which can guide considerations for patients on dupilumab wishing to conceive a child. Until more data are available, preference should be given to treatment with topical corticosteroids, phototherapy, systemic corticosteroids and ciclosporin.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Humanized/therapeutic use ; Dermatitis, Atopic/drug therapy ; Dermatologic Agents/therapeutic use ; Female ; Fertilization ; Humans ; Lactation ; Male ; Pregnancy ; Pregnancy Outcome ; Withholding Treatment
Chemical Substances	Antibodies, Monoclonal, Humanized ; Dermatologic Agents ; dupilumab (420K487FSG)
Language	English
Publishing date	2021-06-04
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	195504-4
ISSN	1365-2230 ; 0307-6938
ISSN (online)	1365-2230
ISSN	0307-6938
DOI	10.1111/ced.14725
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Zs.A 1278: Show issues

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Article ; Online: By using a core outcome set we measure what matters to patients.

Prinsen, C A C / Spuls, P I / Terwee, C B

The British journal of dermatology

2018 Volume 178, Issue 3, Page(s) 579–580

MeSH term(s)	Delphi Technique ; Humans ; Treatment Outcome ; Vascular Malformations
Language	English
Publishing date	2018-03-29
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.16273
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Article ; Online: Measurement instruments for the core outcome set of congenital melanocytic naevi and an assessment of the measurement properties according to COSMIN: a systematic review.

Fledderus, A C / Boom, T / Legemate, C M / van der Horst, C M A M / Spuls, P I

JPRAS open

2022 Volume 35, Page(s) 58–75

Abstract: Background: Congenital melanocytic naevi (CMN) can impact on patients' lives due to their appearance and the risk they carry of neurological complications or melanoma development. The development of a core outcome set (COS) will allow standardised ... ...

Abstract	Background: Congenital melanocytic naevi (CMN) can impact on patients' lives due to their appearance and the risk they carry of neurological complications or melanoma development. The development of a core outcome set (COS) will allow standardised reporting and enable comparison of outcomes. This will help to improve guidelines. In previous research, relevant stakeholders reached a consensus over which core outcomes should be measured in any future care or research. The next step of the COS development is to select the appropriate measurement instruments. Aim: Step 1: to update a systematic review identifying all core outcomes and measurement instruments available for CMN. Step 2: to evaluate the measurement properties of the instruments for the core outcomes. Methods: This study was registered in PROSPERO and performed according to the PRISMA checklist. Step 1 includes a literature search in EMBASE (Ovid), PubMed and the Cochrane Library to identify core outcomes and instruments previously used in research of CMN. Step 2 yields a systematic search for studies on the measurement properties of instruments that were either developed or validated for CMN, including a methodological quality assessment following the COSMIN methodology. Results: Step 1 included twenty-nine studies. Step 2 yielded two studies, investigating two quality of life measurement instruments. Conclusion: Step 1 provided an overview of outcomes and instruments used for CMN. Step 2 showed that additional research on measurement properties is needed to evaluate which instruments can be used for the COS of CMN. This study informs the instrument selection and/or development of new instruments.
Language	English
Publishing date	2022-11-23
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2834721-3
ISSN	2352-5878 ; 2352-5878
ISSN (online)	2352-5878
ISSN	2352-5878
DOI	10.1016/j.jpra.2022.11.003
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Article ; Online: Can serum biomarkers predict the outcome of systemic immunosuppressive therapy in adult atopic dermatitis patients?

Hurault, G / Roekevisch, E / Schram, M E / Szegedi, K / Kezic, S / Middelkamp-Hup, M A / Spuls, P I / Tanaka, R J

Skin health and disease

2022 Volume 2, Issue 1, Page(s) e77

Abstract: Background: Atopic dermatitis (AD or eczema) is a most common chronic skin disease. Designing personalised treatment strategies for AD based on patient stratification is of high clinical relevance, given a considerable variation in the clinical ... ...

Abstract	Background: Atopic dermatitis (AD or eczema) is a most common chronic skin disease. Designing personalised treatment strategies for AD based on patient stratification is of high clinical relevance, given a considerable variation in the clinical phenotype and responses to treatments among patients. It has been hypothesised that the measurement of biomarkers could help predict therapeutic responses for individual patients. Objective: We aim to assess whether serum biomarkers can predict the outcome of systemic immunosuppressive therapy in adult AD patients. Methods: We developed a statistical machine learning model using the data of an already published longitudinal study of 42 patients who received azathioprine or methotrexate for over 24 weeks. The data contained 26 serum cytokines and chemokines measured before the therapy. The model described the dynamic evolution of the latent disease severity and measurement errors to predict AD severity scores (Eczema Area and Severity Index, (o)SCORing of AD and Patient Oriented Eczema Measure) two-weeks ahead. We conducted feature selection to identify the most important biomarkers for the prediction of AD severity scores. Results: We validated our model in a forward chaining setting and confirmed that it outperformed standard time-series forecasting models. Adding biomarkers did not improve predictive performance. Conclusions: In this study, biomarkers had a negligible and non-significant effect for predicting the future AD severity scores and the outcome of the systemic therapy.
Language	English
Publishing date	2022-01-07
Publishing country	England
Document type	Journal Article
ISSN	2690-442X
ISSN (online)	2690-442X
DOI	10.1002/ski2.77
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Article ; Online: Shifting focus from "what we do" to the "impact of what we do": Application of outcome measures to routine clinical care in dermatology.

Garg, Amit / Dirr, McKenzie A / Jemec, Gregor B E / Ingram, John R / Schmitt, Jochen / Spuls, Phyllis / Alam, Murad

Journal of the American Academy of Dermatology

2022 Volume 87, Issue 2, Page(s) e83–e84

MeSH term(s)	Dermatology ; Humans ; Outcome Assessment, Health Care ; Quality of Life
Language	English
Publishing date	2022-04-30
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	603641-7
ISSN	1097-6787 ; 0190-9622
ISSN (online)	1097-6787
ISSN	0190-9622
DOI	10.1016/j.jaad.2022.04.042
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Zs.A 1540: Show issues

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Article ; Online: Phototherapy for atopic dermatitis: A survey of European practice.

Steyn, M / Gerbens, L A A / Spuls, P I / Mashayekhi, S / Deleuran, M / Barbarot, S / Wollenberg, A / Ferguson, J / Ibbotson, S / Flohr, C

Journal of the European Academy of Dermatology and Venereology : JEADV

2023 Volume 38, Issue 3, Page(s) 521–529

Abstract: Background: Phototherapy is used to treat atopic dermatitis (AD). Evidence for its efficacy, impact on quality of life, cost-effectiveness and short- and long-term safety with real-life usage is weak.: Objectives: We established a taskforce to ... ...

Abstract	Background: Phototherapy is used to treat atopic dermatitis (AD). Evidence for its efficacy, impact on quality of life, cost-effectiveness and short- and long-term safety with real-life usage is weak. Objectives: We established a taskforce to examine how phototherapy is currently being used as a treatment for AD across the United Kingdom and Europe to inform our understanding and guide future research into management of patients with AD using UV-based phototherapies. Methods: An anonymous electronic multiple-response survey exploring phototherapy prescribing practices and experience of phototherapy modalities was developed by the study authors and sent to members of phototherapy networks from the United Kingdom and Europe. Responses were received between February and July 2021. Results: About 144 respondents from 27 European countries completed the survey. NBUVB was the most widely used [n = 138 (96%)]. Home-based NBUVB was available in 8/27 countries (25/144 respondents, 17%). Oral psoralen-UVA (PUVA) was more widely available than bath PUVA (n = 106, 74% vs. n = 60, 42%) and used mainly in adult patients. 49/144 (34%) of respondents had access to UVA1. Phototherapy would be considered instead of systemic treatment in 96% of adults and 82% of children for NBUVB, versus 40% of adults and 3% of children for PUVA. Starting doses, standard dosing increments, length of treatment courses, lifetime limits for treatments and thresholds for performing annual skin assessments varied between responders. Conclusions: NBUVB was the most widely used phototherapy for AD in adult and paediatric patients, while PUVA and UVA1 were less used. Prescribing practices varied considerably, highlighting the lack of consensus practice in many different aspects of phototherapy for the treatment of AD in children and adults. This indicates that further studies are required to determine optimal phototherapeutic regimens for AD and informs our understanding of parameters that should be included in future high-quality randomized controlled trials (RCT) of phototherapy.
MeSH term(s)	Adult ; Humans ; Child ; Dermatitis, Atopic/therapy ; Phototherapy ; Ultraviolet Therapy ; Europe ; United Kingdom
Language	English
Publishing date	2023-11-27
Publishing country	England
Document type	Journal Article
ZDB-ID	1128828-0
ISSN	1468-3083 ; 0926-9959
ISSN (online)	1468-3083
ISSN	0926-9959
DOI	10.1111/jdv.19638
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Article ; Online: Implementation of the HOME core outcome set for clinical trials of atopic eczema-barriers and opportunities: the HOME IX meeting report.

Jacobson, M E / Thomas, K S / Apfelbacher, C J / Leshem, Y A / Williams, H C / Gerbens, L A A / Spuls, P I / Schmitt, J / Howells, L / Katoh, N / Simpson, E L

Archives of dermatological research

2023 Volume 315, Issue 9, Page(s) 2617–2622

Abstract: The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs ( ... ...

Abstract	The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25-26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.
MeSH term(s)	Humans ; Dermatitis, Atopic/therapy ; Dermatitis, Atopic/diagnosis ; Eczema ; Outcome Assessment, Health Care ; Quality of Life ; Research Design ; Severity of Illness Index ; Treatment Outcome ; Clinical Trials as Topic
Language	English
Publishing date	2023-07-11
Publishing country	Germany
Document type	Congress
ZDB-ID	130131-7
ISSN	1432-069X ; 0340-3696
ISSN (online)	1432-069X
ISSN	0340-3696
DOI	10.1007/s00403-023-02647-w
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Article ; Online: Expanding the molecular and clinical spectrum of autosomal recessive congenital ichthyosis caused by pathogenic variants in NIPAL4 and PNPLA1 and evaluation of novel therapeutic interventions.

Rossel, S V J / Clabbers, J M K / Steijlen, P M / van den Akker, P C / Spuls, P I / Middelkamp Hup, M A / van Maarle, M C / Vreeburg, M / Bolling, M C / van Geel, M / Gostyński, A

Journal of the European Academy of Dermatology and Venereology : JEADV

2023 Volume 37, Issue 12, Page(s) e1405–e1409

MeSH term(s)	Humans ; Acyltransferases ; Genes, Recessive ; Ichthyosis, Lamellar/genetics ; Mutation ; Phospholipases
Chemical Substances	Acyltransferases (EC 2.3.-) ; Phospholipases (EC 3.1.-) ; PNPLA1 protein, human (EC 3.1.1.3) ; NIPAL4 protein, human
Language	English
Publishing date	2023-07-24
Publishing country	England
Document type	Letter
ZDB-ID	1128828-0
ISSN	1468-3083 ; 0926-9959
ISSN (online)	1468-3083
ISSN	0926-9959
DOI	10.1111/jdv.19340
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