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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: Subcutaneous methotrexate in patients with moderate-to-severe psoriasis: a critical appraisal.

Tsakok, T / Jabbar-Lopez, Z K / Smith, C H

The British journal of dermatology

2018 Volume 179, Issue 1, Page(s) 50–53

Abstract: Aim: Warren et al. set out to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate-to-severe chronic plaque psoriasis.: Setting and design: This was a prospective, double-blind, randomized (3 : 1), ...

Abstract	Aim: Warren et al. set out to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate-to-severe chronic plaque psoriasis. Setting and design: This was a prospective, double-blind, randomized (3 : 1), placebo-controlled study, conducted across 16 centres in Germany, France, the Netherlands and the U.K. Study exposure: Methotrexate-naive adults with a diagnosis of moderate-to-severe chronic plaque psoriasis for at least 6 months before baseline were randomly assigned to receive weekly subcutaneous injections of either methotrexate at a starting dose of 17·5 mg, or placebo for 16 weeks (first phase). Dose escalation to 22·5 mg per week was implemented after 8 weeks if patients did not achieve ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50). Treatment was combined with folic acid 5 mg per week. The first phase of the study was followed by an open-label period from 16 to 52 weeks (second phase), in which both groups received weekly methotrexate injections. At week 24, dose escalation to 22·5 mg per week was possible in patients not achieving PASI 50. Outcomes: Psoriasis severity was measured using PASI. The authors also used two other psoriasis severity measures and two quality-of-life measures, looked at safety indices and performed a substudy analysing paired skin biopsies at baseline and week 16 (histopathology, immunohistochemistry and expression of interleukin-17A, interferon-γ and tumour necrosis factor-α). Primary outcome measures: The primary outcome was the proportion of patients reaching PASI 75 at week 16. Results: In total 120 patients were included in this trial, most of whom were middle-aged white men with long-standing psoriasis, and the mean body mass index was 30·1 kg m Conclusion: Warren et al. conclude that the 52-week risk-benefit profile of subcutaneous methotrexate is favourable in patients with psoriasis.
MeSH term(s)	Adult ; Double-Blind Method ; France ; Germany ; Humans ; Male ; Methotrexate ; Middle Aged ; Netherlands ; Prospective Studies ; Psoriasis ; Treatment Outcome
Chemical Substances	Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2018-05-09
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.16424
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Article ; Online: Methotrexate vs. ciclosporin in the treatment of severe atopic dermatitis in children: a critical appraisal.

Tsakok, T / Flohr, C

The British journal of dermatology

2014 Volume 170, Issue 3, Page(s) 496–8; discussion 498–9

Abstract: Aim: El-Khalawany et al. (Eur J Pediatr 2012; 172: 351-6) aimed to compare the efficacy and safety of methotrexate vs. ciclosporin in the treatment of children with severe atopic eczema.: Setting and design: This multicentre, parallel group (ratio 1 : ...

Abstract	Aim: El-Khalawany et al. (Eur J Pediatr 2012; 172: 351-6) aimed to compare the efficacy and safety of methotrexate vs. ciclosporin in the treatment of children with severe atopic eczema. Setting and design: This multicentre, parallel group (ratio 1 : 1), randomized controlled trial was conducted in a secondary care setting in Egypt. Study exposure: Children with severe atopic eczema were randomly assigned to receive either methotrexate (7.5 mg weekly) or ciclosporin (2.5 mg kg(-1) daily) for 12 weeks, followed by a 12-week follow-up period. Outcomes: Eczema severity was measured using the SCORing of Atopic Dermatitis (SCORAD) index. The authors also recorded the number of patients on each therapy experiencing adverse effects. Primary outcome measures: The primary outcome was the mean change in SCORAD after 12 weeks of treatment. Results: Forty patients with a mean age of 11.6 ± 1.52 years were included in the trial. At week 12, patients in the methotrexate group had a mean ± SD absolute reduction in SCORAD of 26.25 ± 7.03, compared with 25.02 ± 8.21 in the ciclosporin group (P = 0.93). Both drugs were associated with minor adverse effects, none of which necessitated changing the treatment regimen. Conclusions: El-Khalawany et al. conclude that both methotrexate and ciclosporin in low doses are clinically effective, relatively safe, and well tolerated as treatments for severe atopic eczema in children.
MeSH term(s)	Cyclosporine/therapeutic use ; Dermatitis, Atopic/drug therapy ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Male ; Methotrexate/therapeutic use
Chemical Substances	Immunosuppressive Agents ; Cyclosporine (83HN0GTJ6D) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2014-02-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.12820
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Article ; Online: The effectiveness of habit reversal on treatment outcome and quality of life in patients with chronic eczema: a prospective observational study in the U.K.

Tsakok, T / Roberts, E / Bridgett, C / Staughton, R C D

The British journal of dermatology

2017 Volume 177, Issue 2, Page(s) 554–556

MeSH term(s)	Eczema ; Habits ; Humans ; Prospective Studies ; Quality of Life ; Treatment Outcome
Language	English
Publishing date	2017
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.15092
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Article ; Online: Atopic dermatitis: the skin barrier and beyond.

Tsakok, T / Woolf, R / Smith, C H / Weidinger, S / Flohr, C

The British journal of dermatology

2018 Volume 180, Issue 3, Page(s) 464–474

Abstract: Background: Atopic dermatitis is the most common chronic inflammatory skin disorder, affecting up to 20% of children and 10% of adults in industrialized countries. This highly debilitating condition poses a considerable burden to both the individual and ...

Abstract	Background: Atopic dermatitis is the most common chronic inflammatory skin disorder, affecting up to 20% of children and 10% of adults in industrialized countries. This highly debilitating condition poses a considerable burden to both the individual and society at large. The pathophysiology of atopic dermatitis is complex, encompassing both genetic and environmental risk factors. Methods: This is a narrative review based on a systematic literature search. Conclusions: Dysregulation of innate and adaptive immunity plays a key role; however, recent epidemiological, genetic and molecular research has focused interest on skin barrier dysfunction as a common precursor and pathological feature. Current understanding of the aetiology of atopic dermatitis highlights disruption of the epidermal barrier leading to increased permeability of the epidermis, pathological inflammation in the skin, and percutaneous sensitization to allergens. Thus, most novel treatment strategies seek to target specific aspects of the skin barrier or cutaneous inflammation. Several studies have also shown promise in preventing atopic dermatitis, such as the early use of emollients in high-risk infants. This may have broader implications in terms of halting the progression to atopic comorbidities including food allergy, hay fever and asthma.
MeSH term(s)	Adaptive Immunity/drug effects ; Asthma/drug therapy ; Asthma/epidemiology ; Asthma/immunology ; Comorbidity ; Dermatitis, Atopic/drug therapy ; Dermatitis, Atopic/epidemiology ; Dermatitis, Atopic/immunology ; Dermatologic Agents/pharmacology ; Dermatologic Agents/therapeutic use ; Disease Progression ; Epidermis/drug effects ; Epidermis/immunology ; Epidermis/metabolism ; Food Hypersensitivity/drug therapy ; Food Hypersensitivity/epidemiology ; Food Hypersensitivity/immunology ; Humans ; Immunity, Innate/drug effects ; Permeability/drug effects ; Randomized Controlled Trials as Topic ; Rhinitis, Allergic, Seasonal/drug therapy ; Rhinitis, Allergic, Seasonal/epidemiology ; Rhinitis, Allergic, Seasonal/immunology ; Risk Factors ; Treatment Outcome
Chemical Substances	Dermatologic Agents
Language	English
Publishing date	2018-10-10
Publishing country	England
Document type	Journal Article ; Systematic Review
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.16934
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Article ; Online: Real-World Implementation and Outcomes of Adalimumab Therapeutic Drug Monitoring in Psoriasis: A National Specialized Center Experience.

Raharja, Antony / Arkir, Zehra / Rinaldi, Giulia / Tsakok, Teresa / Dasandi, Tejus / Guard, Sarah / McGuire, Arlene / Pink, Andrew E / Woolf, Richard / Barker, Jonathan N / Smith, Catherine H / Mahil, Satveer K

The Journal of investigative dermatology

2023 Volume 143, Issue 9, Page(s) 1708–1716.e4

Abstract: Serum adalimumab concentration is a biomarker of treatment response but therapeutic drug monitoring (TDM) is yet to be implemented in routine psoriasis care. We incorporated adalimumab TDM in a national specialized psoriasis service and evaluated it ... ...

Abstract	Serum adalimumab concentration is a biomarker of treatment response but therapeutic drug monitoring (TDM) is yet to be implemented in routine psoriasis care. We incorporated adalimumab TDM in a national specialized psoriasis service and evaluated it using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) implementation science framework. We undertook pre-implementation planning (validating local assays) and implementation interventions targeted to patients (pragmatic sampling at routine reviews), clinicians (introduction of a TDM protocol), and healthcare systems (adalimumab TDM as a key performance indicator). Over 5 months, 170 of 229 (74%) individuals treated with adalimumab received TDM. Clinical improvement after TDM-guided dose escalation occurred in 13 of 15 (87%) nonresponders with serum drug concentrations <8.3 μg/ml (median PASI reduction of 3.2 [interquartile range = 2.2-8.2] after 23.4 weeks) and in all nonresponders who had TDM-guided switch in biologic due to supratherapeutic drug concentrations (>8.3 μg/ml; n = 2) or positive antidrug antibody (n = 2) (PASI reduction of 7.8 [interquartile range = 7.5-12.9] after 20.0 weeks). Proactive TDM led to dose reduction in five individuals with clear skin and subtherapeutic or supratherapeutic drug concentrations; four (80%) sustained clear skin after 50 weeks (range = 42-52). Adalimumab TDM based on pragmatic serum sampling is clinically viable and may lead to patient benefit. Context-specific implementation interventions and systematic implementation assessment may bridge the biomarker research-to-practice gap.
MeSH term(s)	Humans ; Adalimumab/therapeutic use ; Drug Monitoring/methods ; Psoriasis/diagnosis ; Psoriasis/drug therapy ; Remission Induction ; Treatment Outcome
Chemical Substances	Adalimumab (FYS6T7F842)
Language	English
Publishing date	2023-03-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80136-7
ISSN	1523-1747 ; 0022-202X
ISSN (online)	1523-1747
ISSN	0022-202X
DOI	10.1016/j.jid.2023.01.033
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Article ; Online: Should testosterone replacement be offered to hypogonadal men treated previously for prostatic carcinoma?

Landau, D / Tsakok, T / Aylwin, S / Hughes, S

Clinical endocrinology

2012 Volume 76, Issue 2, Page(s) 179–181

Abstract: Androgen administration can cause prostate cancer progression, and androgen deprivation therapy is a commonly used therapeutic modality in the treatment of prostate cancer. In trying to answer the posed clinical question, this article reviews the risks ... ...

Abstract	Androgen administration can cause prostate cancer progression, and androgen deprivation therapy is a commonly used therapeutic modality in the treatment of prostate cancer. In trying to answer the posed clinical question, this article reviews the risks and benefits of testosterone replacement therapy in this setting and the published data from clinical series. Recommendations are made based on the available evidence.
MeSH term(s)	Androgen Antagonists/therapeutic use ; Hormone Replacement Therapy ; Humans ; Hypogonadism/drug therapy ; Male ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms/drug therapy ; Testosterone/therapeutic use
Chemical Substances	Androgen Antagonists ; Testosterone (3XMK78S47O) ; Prostate-Specific Antigen (EC 3.4.21.77)
Language	English
Publishing date	2012-02
Publishing country	England
Document type	Journal Article
ZDB-ID	121745-8
ISSN	1365-2265 ; 0300-0664
ISSN (online)	1365-2265
ISSN	0300-0664
DOI	10.1111/j.1365-2265.2011.04233.x
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Article ; Online: Does early life exposure to antibiotics increase the risk of eczema? A systematic review.

Tsakok, T / McKeever, T M / Yeo, L / Flohr, C

The British journal of dermatology

2013 Volume 169, Issue 5, Page(s) 983–991

Abstract: A number of studies have suggested that early life exposure to antibiotics can lead to an increased risk of developing eczema. This systematic review and meta-analysis of observational studies, involving children or young adults aged 0-25 years, assessed ...

Abstract	A number of studies have suggested that early life exposure to antibiotics can lead to an increased risk of developing eczema. This systematic review and meta-analysis of observational studies, involving children or young adults aged 0-25 years, assessed the impact of antibiotic exposure either in utero or during the first 12 months of life on subsequent eczema risk. Twenty studies examined the association between prenatal and/or postnatal exposure to antibiotics and development of eczema. The pooled odds ratio (OR) for the 17 studies examining postnatal antibiotic exposure was 1.41 [95% confidence interval (CI) 1.30-1.53]. The pooled OR for the 10 longitudinal studies was 1.40 (95% CI 1.19-1.64), compared with a pooled OR of 1.43 (95% CI 1.36-1.51) for the seven cross-sectional studies. There was a significant dose-response association, suggesting a 7% increase in the risk of eczema for each additional antibiotic course received during the first year of life [pooled OR 1.07 (95% CI 1.02-1.11)]. Finally, the pooled OR for the four studies relating to antenatal exposure was 1.30 (95% CI 0.86-1.95). We conclude that exposure to antibiotics in the first year of life, but not prenatally, is more common in children with eczema.
MeSH term(s)	Adolescent ; Anti-Bacterial Agents/adverse effects ; Child ; Child, Preschool ; Dose-Response Relationship, Drug ; Eczema/chemically induced ; Female ; Humans ; Infant ; Observational Studies as Topic ; Pregnancy ; Prenatal Exposure Delayed Effects/chemically induced ; Risk Factors ; Young Adult
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2013-11
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S. ; Review
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.12476
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Article ; Online: Systematic review of deep learning image analyses for the diagnosis and monitoring of skin disease.

Choy, Shern Ping / Kim, Byung Jin / Paolino, Alexandra / Tan, Wei Ren / Lim, Sarah Man Lin / Seo, Jessica / Tan, Sze Ping / Francis, Luc / Tsakok, Teresa / Simpson, Michael / Barker, Jonathan N W N / Lynch, Magnus D / Corbett, Mark S / Smith, Catherine H / Mahil, Satveer K

NPJ digital medicine

2023 Volume 6, Issue 1, Page(s) 180

Abstract: Skin diseases affect one-third of the global population, posing a major healthcare burden. Deep learning may optimise healthcare workflows through processing skin images via neural networks to make predictions. A focus of deep learning research is skin ... ...

Abstract	Skin diseases affect one-third of the global population, posing a major healthcare burden. Deep learning may optimise healthcare workflows through processing skin images via neural networks to make predictions. A focus of deep learning research is skin lesion triage to detect cancer, but this may not translate to the wider scope of >2000 other skin diseases. We searched for studies applying deep learning to skin images, excluding benign/malignant lesions (1/1/2000-23/6/2022, PROSPERO CRD42022309935). The primary outcome was accuracy of deep learning algorithms in disease diagnosis or severity assessment. We modified QUADAS-2 for quality assessment. Of 13,857 references identified, 64 were included. The most studied diseases were acne, psoriasis, eczema, rosacea, vitiligo, urticaria. Deep learning algorithms had high specificity and variable sensitivity in diagnosing these conditions. Accuracy of algorithms in diagnosing acne (median 94%, IQR 86-98; n = 11), rosacea (94%, 90-97; n = 4), eczema (93%, 90-99; n = 9) and psoriasis (89%, 78-92; n = 8) was high. Accuracy for grading severity was highest for psoriasis (range 93-100%, n = 2), eczema (88%, n = 1), and acne (67-86%, n = 4). However, 59 (92%) studies had high risk-of-bias judgements and 62 (97%) had high-level applicability concerns. Only 12 (19%) reported participant ethnicity/skin type. Twenty-four (37.5%) evaluated the algorithm in an independent dataset, clinical setting or prospectively. These data indicate potential of deep learning image analysis in diagnosing and monitoring common skin diseases. Current research has important methodological/reporting limitations. Real-world, prospectively-acquired image datasets with external validation/testing will advance deep learning beyond the current experimental phase towards clinically-useful tools to mitigate rising health and cost impacts of skin disease.
Language	English
Publishing date	2023-09-27
Publishing country	England
Document type	Journal Article ; Review
ISSN	2398-6352
ISSN (online)	2398-6352
DOI	10.1038/s41746-023-00914-8
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Article ; Online: Prevention of food allergy.

Tsakok, Teresa / Du Toit, George / Lack, Gideon

Chemical immunology and allergy

2015 Volume 101, Page(s) 253–262

Abstract: Despite a trend towards delayed weaning, food allergies (FAs) have increased in the past few decades and are now considered a public health concern, resulting in significant morbidity as well as occasional mortality. Whilst genetic factors are clearly ... ...

Abstract	Despite a trend towards delayed weaning, food allergies (FAs) have increased in the past few decades and are now considered a public health concern, resulting in significant morbidity as well as occasional mortality. Whilst genetic factors are clearly important in the development of FA, a rise in FAs has occurred over a short period of time and is therefore unlikely to be due to germ-line genetic changes alone. Thus, it seems plausible that one or more environmental exposures may, via epigenetic changes, result in the interruption of the 'default immunologic state' of tolerance to foods. Strategies are therefore required for the prevention of FA: primary prevention seeks to prevent the onset of IgE-sensitisation; secondary prevention seeks to interrupt the development of FA in IgE-sensitised children; and tertiary prevention seeks to reduce the expression of 'end-organ' allergic disease in children with established FA. This chapter will outline the major findings in this field, with the aim of equipping the clinician with an evidence-based approach to a burgeoning yet poorly understood clinical problem. We also highlight the methodological challenges hindering the interpretation of existing FA studies. Fortunately, there are now robust studies underway, the results of which are expected to guide public health recommendations with respect to how and when to introduce major allergenic foods to children, regardless of allergic risk.
MeSH term(s)	Diet ; Diet Therapy ; Dietary Supplements ; Female ; Food Hypersensitivity/diet therapy ; Food Hypersensitivity/epidemiology ; Food Hypersensitivity/prevention & control ; Humans ; Infant ; Infant Food ; Pregnancy ; Prenatal Nutritional Physiological Phenomena
Language	English
Publishing date	2015
Publishing country	Switzerland
Document type	Journal Article
ISSN	1662-2898 ; 1660-2242
ISSN (online)	1662-2898
ISSN	1660-2242
DOI	10.1159/000373911
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