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Article ; Online: Matching Drug Prices to Their Clinical Benefit-The Final Frontier?

Wilson, Edward C F / Yiu, Zenas Z N

2024 Volume 160, Issue 4, Page(s) 387–388

MeSH term(s)	Humans ; Drug Costs ; Cost-Benefit Analysis
Language	English
Publishing date	2024-02-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2701761-8
ISSN	2168-6084 ; 2168-6068
ISSN (online)	2168-6084
ISSN	2168-6068
DOI	10.1001/jamadermatol.2023.6231
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Article ; Online: A sprinkle of methotrexate to go with biologics: a safe recipe?

Alabas, Oras A / Yiu, Zenas Z N

The British journal of dermatology

2023 Volume 190, Issue 3, Page(s) 302–303

MeSH term(s)	Humans ; Methotrexate/adverse effects ; Biological Products/adverse effects ; Cohort Studies ; Biological Factors ; Psoriasis/drug therapy ; Biological Therapy
Chemical Substances	Methotrexate (YL5FZ2Y5U1) ; Biological Products ; Biological Factors
Language	English
Publishing date	2023-11-21
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1093/bjd/ljad505
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Article ; Online: Association of Lipid-Lowering Drugs With Risk of Psoriasis: A Mendelian Randomization Study.

Zhao, Sizheng Steven / Yiu, Zenas Z N / Barton, Anne / Bowes, John

JAMA dermatology

2023 Volume 159, Issue 3, Page(s) 275–280

Abstract: Importance: Lipid pathways have been implicated in the pathogenesis of psoriasis, and some lipid-lowering drugs, such as statins, are hypothesized to have disease-modifying properties. However, large population-level studies are scarce, and causal ... ...

Abstract	Importance: Lipid pathways have been implicated in the pathogenesis of psoriasis, and some lipid-lowering drugs, such as statins, are hypothesized to have disease-modifying properties. However, large population-level studies are scarce, and causal interpretation of results from traditional observational designs is limited by confounding. Objective: To investigate the causal association between genetically proxied lipid-lowering drugs and psoriasis risk. Design, setting, and participants: This 2-sample mendelian randomization study was performed from August to October 2022 and included population-level genome-wide association studies of psoriasis in the UK Biobank and FinnGen studies and low-density lipoprotein (LDL) by the Global Lipids Genetics Consortium. The inverse variance-weighted method was used with pleiotropy robust methods and colocalization as sensitivity analyses. Exposures: Genetically proxied inhibition of 3-hydroxy-3-methylglutaryl CoA reductase (HMGCR, targeted by statins), Niemann-Pick C1-like 1 (NPC1L1, targeted by ezetimibe), and proprotein convertase subtilisin/kexin type 9 (PCSK9, targeted by, eg, alirocumab), using LDL as the biomarker. Main outcomes and measures: Risk of psoriasis. Results: Data from 12 116 patients with psoriasis and approximately 1.3 million individuals with LDL measurement were analyzed. Genetically proxied PCSK9 inhibition was associated with reduced risk of psoriasis (odds ratio, 0.69 per standard deviation reduction in LDL; 95% CI, 0.55-0.88; P = .003), which was replicated in FinnGen (odds ratio, 0.71; 95% CI, 0.57-0.88; P = .002). Sensitivity analyses did not provide statistical evidence of bias from pleiotropy or genetic confounding. No robust association was found for HMGCR or NPC1L1 inhibition. Conclusions and relevance: This mendelian randomization study suggests that PCSK9 is implicated in psoriasis pathogenesis, and its inhibition is associated with reduced psoriasis risk. These findings potentially pave the way for future studies that may allow personalized selection of lipid-lowering drugs for those at risk of psoriasis.
MeSH term(s)	Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Proprotein Convertase 9/genetics ; Genome-Wide Association Study ; Mendelian Randomization Analysis ; Lipids
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; Lipids
Language	English
Publishing date	2023-01-25
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2701761-8
ISSN	2168-6084 ; 2168-6068
ISSN (online)	2168-6084
ISSN	2168-6068
DOI	10.1001/jamadermatol.2022.6051
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Article ; Online: Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis.

Edwards, Steven J / Karner, Charlotta / Jhita, Tracey / Barton, Samantha / Marceniuk, Gemma / Yiu, Zenas Z N / Wittmann, Miriam

Health technology assessment (Winchester, England)

2024 Volume 28, Issue 4, Page(s) 1–113

Abstract: Background: Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is ... ...

Abstract	Background: Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is characterised by dry, inflamed skin accompanied by intense itchiness (pruritus). Objectives: To appraise the clinical and cost effectiveness of abrocitinib, tralokinumab and upadacitinib within their marketing authorisations as alternative therapies for treating moderate-to-severe atopic dermatitis compared to systemic immunosuppressants (first-line ciclosporin A or second-line dupilumab and baricitinib). Data sources: Studies were identified from an existing systematic review (search date 2019) and update searches of electronic databases (MEDLINE, EMBASE, CENTRAL) to November 2021, from bibliographies of retrieved studies, clinical trial registers and evidence provided by the sponsoring companies of the treatments under review. Methods: A systematic review of the clinical effectiveness literature was carried out and a network meta-analysis undertaken for adults and adolescents at different steps of the treatment pathway. The primary outcome of interest was a combined response of Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4; where this was consistently unavailable for a step in the pathway, an analysis of Eczema Area and Severity Index 75 was conducted. A de novo economic model was developed to assess cost effectiveness from the perspective of the National Health Service in England. The model structure was informed through systematic review of the economic literature and by consulting clinical experts. Effectiveness data were obtained from the network meta-analysis. Costs and utilities were obtained from the evidence provided by sponsoring companies and standard UK sources. Results: Network meta-analyses indicate that abrocitinib 200 mg and upadacitinib 30 mg may be more effective, and tralokinumab may be less effective than dupilumab and baricitinib as second-line systemic therapies. Abrocitinib 100 mg and upadacitinib 15 mg have a more similar effectiveness to dupilumab. Upadacitinib 30 and 15 mg are likely to be more effective than ciclosporin A as a first-line therapy. Upadacitinib 15 mg, abrocitinib 200 and 100 mg may be more effective than dupilumab in adolescents. The cost effectiveness of abrocitinib and upadacitinib for both doses is dependent on the subgroup of interest. Tralokinumab can be considered cost-effective as a second-line systemic therapy owing to greater cost savings per quality-adjusted life-year lost. Conclusions: The primary strength of the analysis of the three new drugs compared with current practice for each of the subpopulations is the consistent approach to the assessment of clinical and cost effectiveness. However, the conclusions are limited by the high uncertainty around the clinical effectiveness and lack of data for the primary outcome for comparisons with baricitinib and for the adolescent and adult first-line populations. Future work and limitations: The most significant limitation that Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4 could not be obtained for the adolescent and adult first-line systemic treatment populations is due to a paucity of data for dupilumab and ciclosporin A. A comparison of the new drugs against one another in addition to current practice would be beneficial to provide a robust view on which treatments are the most cost-effective. Study registration: This study is registered as PROSPERO CRD42021266219. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: 135138) and is published in full in
MeSH term(s)	Child ; Adult ; Adolescent ; Humans ; Child, Preschool ; Dermatitis, Atopic/drug therapy ; Cyclosporine/therapeutic use ; State Medicine ; Treatment Outcome ; Cost-Benefit Analysis ; Eczema ; Antibodies, Monoclonal ; Purines ; Heterocyclic Compounds, 3-Ring ; Sulfonamides ; Pyrazoles ; Pyrimidines ; Azetidines
Chemical Substances	tralokinumab (GK1LYB375A) ; baricitinib (ISP4442I3Y) ; abrocitinib (73SM5SF3OR) ; upadacitinib (4RA0KN46E0) ; Cyclosporine (83HN0GTJ6D) ; Antibodies, Monoclonal ; Purines ; Heterocyclic Compounds, 3-Ring ; Sulfonamides ; Pyrazoles ; Pyrimidines ; Azetidines
Language	English
Publishing date	2024-02-11
Publishing country	England
Document type	Meta-Analysis ; Systematic Review
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/LEXB9006
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Article ; Online: Biosimilars for the Treatment of Psoriasis: A Systematic Review of Clinical Trials and Observational Studies.

Phan, Duc Binh / Elyoussfi, Sarah / Stevenson, Michael / Lunt, Mark / Warren, Richard B / Yiu, Zenas Z N

JAMA dermatology

2023 Volume 159, Issue 7, Page(s) 763–771

Abstract: Importance: Biosimilars have the potential to reduce costs for the management of moderate-to-severe psoriasis compared with originators. However, the extrapolation of evidence enables the approval of a biosimilar for use in indications held by the ... ...

Abstract	Importance: Biosimilars have the potential to reduce costs for the management of moderate-to-severe psoriasis compared with originators. However, the extrapolation of evidence enables the approval of a biosimilar for use in indications held by the originator without directly being studied in clinical trials. Thus, biosimilars can be approved for psoriasis based on extrapolated evidence from other diseases. The availability of evidence for the effectiveness and safety of biosimilars for the treatment of psoriasis is therefore unclear. Objective: To compare the efficacy/effectiveness and safety of biosimilars with originator biologics for the treatment of patients with psoriasis. Evidence review: MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and The European Union Clinical Trials Register were searched in August 2022. Eligible studies were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. All analyses were conducted from September 2022 to November 2022. Findings: Fourteen trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. Twelve trials compared biosimilars with originators in originator-naive patients (starters), and 11 trials compared switching from originator to biosimilar (switchers) with continuous originator treatments. There was no clinically or statistically significant difference in rates of achieving 75% improvement in Psoriasis Area and Severity Index scores and risks of adverse events (AEs) at week 16 and week 52 between the comparators. Two cohort studies showed no difference in effectiveness and safety outcomes between originators and biosimilars, whereas 1 study reported more AEs in patients who switched to biosimilars of adalimumab at 12 months. Three trials showed low risk of bias, whereas 11 trials had moderate risk of bias. All cohort studies had moderate to high risk of bias. Conclusions and relevance: In this systematic review, there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators for the treatment of patients with psoriasis. Most of the available evidence was based on randomized clinical trials, although high-quality real-world evidence was lacking. Future studies are needed to examine the long-term effectiveness and safety of biosimilars for the treatment of patients with psoriasis.
MeSH term(s)	Humans ; Etanercept/adverse effects ; Biosimilar Pharmaceuticals/adverse effects ; Infliximab/adverse effects ; Adalimumab/adverse effects ; Psoriasis/drug therapy ; Psoriasis/chemically induced
Chemical Substances	Etanercept (OP401G7OJC) ; Biosimilar Pharmaceuticals ; Infliximab (B72HH48FLU) ; Adalimumab (FYS6T7F842)
Language	English
Publishing date	2023-05-31
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2701761-8
ISSN	2168-6084 ; 2168-6068
ISSN (online)	2168-6084
ISSN	2168-6068
DOI	10.1001/jamadermatol.2023.1338
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Article ; Online: The predictive accuracy of cardiovascular risk prediction tools in inflammatory arthritis and psoriasis: an observational validation study using the Clinical Practice Research Datalink.

Hughes, David M / Coronado, Jose Ignacio Cuitun / Schofield, Pieta / Yiu, Zenas Z N / Zhao, Sizheng Steven

Rheumatology (Oxford, England)

2023

Abstract: Objectives: Cardiovascular risk prediction tools developed for the general population often underperform for individuals with rheumatoid arthritis (RA), and their predictive accuracy are unclear for other inflammatory conditions that also have increased ...

Abstract	Objectives: Cardiovascular risk prediction tools developed for the general population often underperform for individuals with rheumatoid arthritis (RA), and their predictive accuracy are unclear for other inflammatory conditions that also have increased cardiovascular risk. We investigated performance of QRISK-3, Framingham Risk Score (FRS) and Reynolds Risk Score (RRS) in RA, psoriatic disease (psoriatic arthritis (PsA) and psoriasis) and ankylosing spondylitis (AS). We considered osteoarthritis as a non-inflammatory comparator. Methods: We utilised primary care records from the Clinical Practice Research Datalink (CPRD) Aurum database to identify individuals with each condition and calculated 10-year cardiovascular risk using each prediction tool. Discrimination and calibration of each tool in each disease was assessed. Results: Time-dependent AUC for QRISK3 was 0.752 for RA (95% CI 0.734-0.777), 0.794 for AS (95% CI 0.764-0.812), 0.764 for PsA (95% CI 0.741-0.791),0.815 for psoriasis (95% CI 0.789-0.835), and 0.698 for osteoarthritis (95% CI 0.670-0.717) indicating reasonably good predictive performance. AUC for FRS were similar, and slightly lower for RRS. FRS was reasonably well calibrated for each condition but underpredicted risk for patients with RA. RRS tended to underpredict CVD risk, whilst QRISK3 overpredicted CVD risk, especially for the most high-risk individuals. Conclusions: CVD risk for individuals with RA, AS and psoriatic disease were generally less accurately predicted using each of the 3 CVD risk prediction tools than reported accuracies in the original publications. Individuals with osteoarthritis also had less accurate predictions suggesting inflammation is not the sole reason for underperformance. Disease specific risk prediction tools may be required.
Language	English
Publishing date	2023-11-15
Publishing country	England
Document type	Journal Article
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/kead610
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Article ; Online: Cardiovascular Safety of Biologics Targeting Interleukin (IL)-12 and/or IL-23: What Does the Evidence Say?

de Brito, Marianne / Yiu, Zenas Z N

American journal of clinical dermatology

2021 Volume 22, Issue 5, Page(s) 587–601

Abstract: There is substantial evidence regarding the association between psoriasis and the elevated risk of cardiovascular (CV) disease. Many patients with psoriasis may also be concerned that their treatments may be associated with a further increase in the risk ...

Abstract	There is substantial evidence regarding the association between psoriasis and the elevated risk of cardiovascular (CV) disease. Many patients with psoriasis may also be concerned that their treatments may be associated with a further increase in the risk of CV disease. In this article, we summarize the data regarding the biological role of interleukin (IL)-12/23 in atherogenesis. We performed a literature search for currently known CV safety data from trials and observational studies of treatments targeting IL-12/23 in psoriasis, i.e. the p40 inhibitors ustekinumab and briakinumab, and the p19 inhibitors guselkumab, risankizumab, and tildrakizumab. On balance, extensive evidence supports the CV safety of ustekinumab, with over 14 years of follow-up data in multiple cohort studies and randomized controlled trials (RCTs). One self-controlled study concluded ustekinumab may precipitate short-term raised CV risk, but the study had limitations hindering interpretation. The safety evidence from RCTs on the p19 inhibitors are reassuring thus far, but these studies may not detect rare CV events in real-world patients. We concluded that the overall evidence does not show that ustekinumab is associated with an increase in the risk of CV disease in patients with psoriasis, but further data are awaited to assess the CV safety of p19 inhibitors for the treatment of psoriasis.
MeSH term(s)	Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized/adverse effects ; Cardiovascular Diseases/chemically induced ; Cardiovascular Diseases/prevention & control ; Dose-Response Relationship, Drug ; Humans ; Interleukin-12/adverse effects ; Interleukin-12/therapeutic use ; Interleukin-23/adverse effects ; Interleukin-23/therapeutic use ; Molecular Targeted Therapy ; Psoriasis/drug therapy
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Interleukin-23 ; Interleukin-12 (187348-17-0)
Language	English
Publishing date	2021-07-22
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	1502476-3
ISSN	1179-1888 ; 1175-0561
ISSN (online)	1179-1888
ISSN	1175-0561
DOI	10.1007/s40257-021-00612-9
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Article ; Online: International melanoma and non melanoma skin cancer mortality trends: is it time to refocus our attention?

Venables, Zoe C / Gran, Sonia / Levell, Nick J / Yiu, Zenas Z N / Proby, Charlotte M

Clinical and experimental dermatology

2023 Volume 49, Issue 5, Page(s) 514–516

MeSH term(s)	Humans ; Skin Neoplasms/mortality ; Skin Neoplasms/pathology ; Melanoma/mortality ; Global Health/statistics & numerical data ; Mortality/trends ; Male ; Female
Language	English
Publishing date	2023-12-07
Publishing country	England
Document type	Letter ; Journal Article
ZDB-ID	195504-4
ISSN	1365-2230 ; 0307-6938
ISSN (online)	1365-2230
ISSN	0307-6938
DOI	10.1093/ced/llad438
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Article ; Online: How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting.

Asfour, Leila / Yiu, Zenas Z N / Warren, Richard B

Expert opinion on drug safety

2020 Volume 19, Issue 4, Page(s) 449–457

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Adverse Drug Reaction Reporting Systems ; Clinical Trials as Topic ; Dermatologic Agents/administration & dosage ; Dermatologic Agents/adverse effects ; Dermatology/methods ; Humans ; Pharmacovigilance ; Product Surveillance, Postmarketing ; Randomized Controlled Trials as Topic ; Registries ; Skin Diseases/drug therapy ; Skin Diseases/physiopathology
Chemical Substances	Dermatologic Agents
Language	English
Publishing date	2020-03-31
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2020.1746267
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Article ; Online: Effectiveness and survival of methotrexate versus adalimumab in patients with moderate-to-severe psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).

Alabas, Oras A / Mason, Kayleigh J / Yiu, Zenas Z N / Warren, Richard B / Lunt, Mark / Smith, Catherine H / Grifﬁths, Christopher E M

The British journal of dermatology

2023 Volume 189, Issue 3, Page(s) 271–278

Abstract: Background: Most information on the comparative effectiveness and survival of methotrexate (MTX) and adalimumab (ADA) in the treatment of psoriasis is from randomized control trials and may not translate to the everyday clinical setting.: Objectives: ...

Abstract	Background: Most information on the comparative effectiveness and survival of methotrexate (MTX) and adalimumab (ADA) in the treatment of psoriasis is from randomized control trials and may not translate to the everyday clinical setting. Objectives: To determine the real-world effectiveness and survival of MTX and ADA in patients with moderate-to-severe psoriasis registered in the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Methods: Eligible patients were registered in BADBIR, ≥ 16 years of age and receiving a first course of MTX or ADA between September 2007 and December 2021, with ≥ 6 months of follow-up. Effectiveness was defined as achieving an absolute Psoriasis Area and Severity Index (PASI) ≤ 2 reported ≥ 13 weeks after the treatment start date until the stop date. The average treatment effect (ATE) was estimated using inverse probability of treatment weighting with propensity score, including baseline covariates. ATE results were presented as risk ratios (RR). A flexible parametric model was used to estimate adjusted standardized average survival, defined as treatment discontinuation associated with ineffectiveness or the occurrence of adverse events (AEs) at 6, 12 and 24 months. Restricted mean survival time (RMST) at 2 years of treatment exposure was calculated. Results: In total, 6575 patients (median age 44 years; 44% female) were analysed; 2659 (40.4%) were prescribed MTX and 3916 (59.5%) ADA. The proportion of patients achieving PASI ≤ 2 was higher in the ADA cohort (77.4%) than in the MTX cohort (37.4%). ADA was more effective than MTX [RR 2.20, 95% confidence interval (CI) 1.98-2.45]. Overall survival associated with ineffectiveness or AEs was lower in the MTX cohort than in the ADA cohort at 6 months [survival estimate 69.7 (95% CI 67.9-71.5) vs. 90.6 (95% CI 89.8-91.4)], 1 year [survival estimate 52.5 (95% CI 50.4-54.8) vs. 80.6 (95% CI 79.5-81.8)] and 2 years [survival estimate 34.8 (95% CI 32.5-37.2) vs. 68.6 (95% CI 67.2-70.0)]. The difference in RMST (years) overall, or when stratified by ineffectiveness and AEs, was 0.53 (95% CI 0.49-0.58), 0.37 (95% CI 0.33-0.42) and 0.29 (95% CI 0.25-0.33), respectively. Conclusions: Patients on ADA were twice as likely to be clear or nearly clear of psoriasis and were less likely to discontinue their medication than patients on MTX. Findings from this real-world cohort provide important information to aid clinicians managing patients with psoriasis.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Adalimumab/adverse effects ; Adjuvants, Immunologic/therapeutic use ; Biological Factors/therapeutic use ; Biological Products/adverse effects ; Cohort Studies ; Dermatologists ; Etanercept/therapeutic use ; Immunologic Factors/therapeutic use ; Methotrexate/adverse effects ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Adalimumab (FYS6T7F842) ; Adjuvants, Immunologic ; Biological Factors ; Biological Products ; Etanercept (OP401G7OJC) ; Immunologic Factors ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2023-05-24
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1093/bjd/ljad179
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