183 results on '"Egeberg, Alexander"'
Search Results
2. Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib.
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Craiglow, Brittany, Lee, Yang Won, Vañó-Galván, Sergio, Egeberg, Alexander, Dutronc, Yves, Durand, Frederick, Pierce, Evangeline, Yu, Guanglei, Chen, Yun-Fei, and Mostaghimi, Arash
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COMPULSIVE hair pulling ,BARICITINIB ,ALOPECIA areata ,CLINICAL trials ,MENTAL depression ,SCALP - Abstract
Introduction: Alopecia areata (AA) is an autoimmune disease associated with high rates of emotional and psychosocial distress. The analysis reported here describes the evolution of measures assessing health-related quality of life (HRQoL) and symptoms of anxiety and depression up to week 104 in patients who achieved sustained scalp hair regrowth during treatment with baricitinib in the BRAVE-AA phase III trials. Methods: This post-hoc analysis included data from the double-blind, parallel-group, randomized, placebo-controlled phase III trials BRAVE-AA1 (ClinicalTrials.gov number: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov number: NCT03899259). Adults with severe AA (defined as a Severity of Alopecia Tool [SALT] score ≥ 50) randomized to baricitinib 4 mg or baricitinib 2 mg at baseline who achieved SALT score ≤ 20 by week 36 and maintained SALT score ≤ 20 through week 104 on the same dose of baricitinib were included in this analysis of integrated data. Scalp hair regrowth (SALT score) and improvements in Skindex-16 AA Scale and Hospital Anxiety and Depression Scale (HADS) domain scores were analyzed over the 104-week period using descriptive statistics. Results: In total, 131 patients (88 on baricitinib 4 mg and 43 on baricitinib 2 mg) were included in this analysis. Across the two groups, the mean age (standard deviation) was 37.2 years (12.7), and 84 (64.1%) patients were female. The interquartile range) for time to achieve a SALT score ≤ 20 for patients treated with baricitinib 4 mg and baricitinib 2 mg was 13.1 and 19.6 weeks, respectively. By week 104, 91% (baricitinib 2 mg) and 96% (baricitinib 4 mg) of patients had achieved a SALT score ≤ 10 on baricitinib treatment. In both groups, progressive improvements in the Skindex-16 AA and HADS domain scores were observed up to week 104. Conclusion: This analysis of adults with severe AA treated with baricitinib revealed that achievement of sustained clinically meaningful scalp hair regrowth (SALT score ≤ 20) was associated with improvements in both measures of HRQoL and symptoms of anxiety and depression up to week 104. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Increased loss‐of‐function filaggrin gene mutation prevalence in atopic dermatitis patients across northern latitudes indicates genetic fitness: A systematic review and meta‐analysis.
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Khatib, Casper Milde, Klein‐Petersen, Amalie Wandel, Rønnstad, Amalie Thorsti Møller, Egeberg, Alexander, Christensen, Maria Oberländer, Silverberg, Jonathan Ian, Thomsen, Simon Francis, Irvine, Alan David, and Thyssen, Jacob Pontoppidan
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FILAGGRIN ,ATOPIC dermatitis ,GENETIC mutation ,LATITUDE ,POPULATION geography ,BRITISH authors - Abstract
Loss‐of‐function (LoF) mutations in the filaggrin gene (FLG) constitute the strongest genetic risk for atopic dermatitis (AD). A latitude‐dependent difference in the prevalence of LoF FLG mutations was systematically evaluated. A systematic review and meta‐analysis were performed to estimate the prevalence of LoF FLG mutations in AD patients and the general population by geography and ethnicity. Risk of bias was assessed by Newcastle‐Ottawa Scale and Jadad score. StatsDirect, version 3 software was used to calculate all outcomes. PubMed and EMBASE were searched until 9th December 2021. Studies were included if they contained data on the prevalence of LoF FLG mutations in AD patients or from the general population or associations between AD and LoF FLG mutations and were authored in English. Overall, 248 studies and 229 310 AD patients and individuals of the general population were included in the quantitative analysis. The prevalence of LoF FLG mutations was 19.1% (95% CI, 17.3–21.0) in AD patients and 5.8% (95% CI, 5.3–6.2) in the general population. There was a significant positive association between AD and LoF FLG mutations in all latitudes in the Northern hemisphere, but not in all ethnicities. The prevalence of LoF FLG mutations became gradually more prevalent in populations residing farther north of the Equator but was negligible in Middle Easterners and absent in most African populations. FLG LoF mutations are common and tend to increase with northern latitude, suggesting potential clinical implications for future AD management. The existence of possible genetic fitness from FLG LoF mutations remains unknown. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Integrated Safety Update of Abrocitinib in 3802 Patients with Moderate-to-Severe Atopic Dermatitis: Data from More than 5200 Patient-Years with Up to 4 Years of Exposure.
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Simpson, Eric L., Silverberg, Jonathan I., Nosbaum, Audrey, Winthrop, Kevin, Guttman-Yassky, Emma, Hoffmeister, Karin M., Egeberg, Alexander, Valdez, Hernan, Fan, Haiyun, Farooqui, Saleem A., Chan, Gary, Alderfer, Justine, Romero, William, and Chittuluru, Kanti
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RISK factors of pneumonia ,ATOPIC dermatitis ,RISK assessment ,HERPES zoster ,PATIENT safety ,RESEARCH funding ,SKIN tumors ,LYMPHOCYTE count ,LYMPHOPENIA ,VEINS ,SEVERITY of illness index ,ORAL drug administration ,AGE distribution ,POPULATION geography ,DESCRIPTIVE statistics ,JANUS kinases ,THROMBOEMBOLISM ,NEUROTRANSMITTER uptake inhibitors ,HERPES simplex ,MORBID obesity ,CONFIDENCE intervals ,REGRESSION analysis ,PROPORTIONAL hazards models ,DISEASE risk factors ,DISEASE complications - Abstract
Background: Abrocitinib, an oral, once-daily, Janus kinase 1-selective inhibitor, is efficacious in moderate-to-severe atopic dermatitis with a manageable long-term safety profile. Objective: We aimed to provide updated integrated long-term safety results for abrocitinib from available data accrued up to a maximum of almost 4 years in patients with moderate-to-severe atopic dermatitis from the JADE clinical development program. Methods: Analysis included 3802 patients (exposure: 5213.9 patient-years) from the phase II monotherapy study (NCT02780167) and the phase III studies JADE MONO-1 (NCT03349060), JADE MONO-2 (NCT03575871), JADE TEEN (NCT03796676), JADE COMPARE (NCT03720470), JADE DARE (NCT04345367; 200 mg only), JADE REGIMEN (NCT03627767), and JADE EXTEND (NCT03422822; data cutoff 25 September, 2021). Data from patients receiving one or more doses of abrocitinib 200 mg or 100 mg were pooled in a consistent-dose cohort (patients were allocated to receive the same abrocitinib dose throughout exposure in the qualifying parent study and/or long-term study) or a variable-dose cohort (patients received open-label abrocitinib 200 mg; responders were randomized to abrocitinib 200 mg, 100 mg, or placebo, and could then receive abrocitinib 200 mg plus topical corticosteroids as rescue therapy). Incidence rates of adverse events of special interest were assessed. Cox regression analysis of risk factors for herpes zoster and serious infections was performed. Results: Overall, this safety analysis of long-term data up to a maximum of ~ 4 years of abrocitinib exposure does not indicate any changes from the previously reported risk profile. The most frequent serious infections (per Medical Dictionary for Regulatory Activities preferred term) with consistent-dose abrocitinib 200 mg and 100 mg were herpes zoster (0.5% and 0.2%), pneumonia (0.2% with either dose), and herpes simplex (0.1% with either dose). Risk factors for herpes zoster were a history of herpes zoster, abrocitinib 200-mg dose, age ≥ 65 years, absolute lymphocyte count < 1 × 10
3 /mm3 before the event, and residing in Asia. For serious infections, > 100 kg body weight was a risk factor. Incidence rate/100 patient-years (95% confidence interval) with the consistent abrocitinib 200-mg and 100-mg dose combined was higher in older (aged ≥ 65 years) patients versus younger (aged 18 to < 65 years) patients for serious adverse events (17.6 [11.7‒25.4] vs 6.7 [5.8‒7.8]), malignancy excluding non-melanoma skin cancer (2.4 [0.6‒6.0] vs 0.1 [0.0‒0.4]), non-melanoma skin cancer (2.4 [0.6‒6.1] vs 0.2 [0.1‒0.4]), lymphopenia (3.5 [1.3‒7.6] vs 0.1 [0.0‒0.3]), and venous thromboembolism (1.7 [0.4‒5.1] vs 0.1 [0.0‒0.3]). Incident rate/100 patient-years (95% confidence interval) of non-melanoma skin cancer with the consistent abrocitinib 200-mg and 100-mg dose combined was higher in current/former smokers (0.9 [0.4‒1.6]) vs never-smokers (0.0 [0.0‒0.1]). Conclusions: This safety update showed a consistent profile for abrocitinib with no new safety signals and continues to support that abrocitinib has a manageable long-term safety profile in patients with moderate-to-severe atopic dermatitis. Risk of specific adverse events was higher in certain patient populations, especially those aged ≥ 65 years. [Video abstract available.] Clinical Trial Registration: NCT02780167; study start date: April, 2016; primary completion date: March, 2017; study completion date: April, 2017. NCT03349060; study start date: 7 December, 2017; study completion date: 26 March, 2019. NCT03575871; study start date: 29 June, 2018; study completion date: 13 August, 2019. NCT03720470; study start date: 29 October, 2018; primary completion date: 27 December, 2019; study completion date: 6 March, 2020. NCT03796676; study start date: 18 February, 2019; study completion date: 8 April, 2020. NCT03627767; study start date: 11 June, 2018; primary completion date: 2 September, 2020; study completion date: 7 October, 2020. NCT04345367; study start date: 11 June, 2020; primary completion date: 16 December, 2020; study completion date: 13 July, 2021. NCT03422822; study start date: 8 March, 2018; study completion date: ongoing (estimated completion date: 31 January, 2026). Plain Language Summary: Abrocitinib is an approved treatment for people with moderate or severe atopic dermatitis, also known as AD or atopic eczema. Abrocitinib is a tablet that is taken by mouth once a day. This safety analysis looked at the side effects of treatment in a large group of adults and adolescents with moderate or severe AD who took abrocitinib up to a maximum of almost 4 years. This analysis also looked at which people were more likely to have certain side effects after taking abrocitinib. The results from this analysis were similar to those of previous safety analyses with abrocitinib, with no new side effects. Infections such as shingles, pneumonia, or herpes simplex can occur during treatment with abrocitinib. Shingles was more likely to occur in people who previously had shingles before taking abrocitinib, or who took the higher dose of abrocitinib (200 mg), or were 65 years of age or older, or had certain blood test results, or lived in Asia. People who are 65 years of age or older and took abrocitinib were more likely to develop some types of cancer, have certain abnormal blood test results, or develop blood clots in the veins than people with AD who were younger and took abrocitinib. Current or former smokers with AD who took abrocitinib were more likely to develop skin cancer (but not melanoma) than people with AD who took abrocitinib but have never smoked. This analysis further shows that abrocitinib had manageable safety in patients with moderate-to-severe AD. Dex5AhfAxs29XQspjFnxYi Video abstract: Integrated safety update of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis: data from more than 5200 patient-years with up to 4 years of exposure (MP4 63720 KB) [ABSTRACT FROM AUTHOR]- Published
- 2024
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5. Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial.
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Wienholtz, Nita K. F., Christensen, Casper E., Do, Thien P., Frifelt, Lith E. W., Snellman, Josefin, Lopez-Lopez, Cristina L., Egeberg, Alexander, Thyssen, Jacob P., and Ashina, Messoud
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- 2024
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6. Fatigue is associated with disease severity in adult patients with hidradenitis suppurativa.
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Chodziuk, Astrid, Holgersen, Nikolaj, Nielsen, Valdemar W., Thyssen, Jacob P., Egeberg, Alexander, and Thomsen, Simon F.
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- 2024
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7. Estimating the burden of skin diseases using patient‐reported daily time trade‐off as a measure of disease impact and unmet needs.
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Andersen, Yuki M. F., Zachariae, Claus, Thomsen, Simon Francis, Thyssen, Jacob Pontoppidan, and Egeberg, Alexander
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- 2024
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8. Adherence to therapy of ixekizumab and secukinumab in psoriatic arthritis patients using first- or second-line IL-17A inhibitor treatment: a Danish population-based cohort study.
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Hansen, Rebekka L, Jørgensen, Tanja S, Egeberg, Alexander, Rosenø, Nana A L, Skougaard, Marie, Stisen, Zara R, Dreyer, Lene, and Kristensen, Lars Erik
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CLINICAL drug trials ,THERAPEUTIC use of monoclonal antibodies ,PATIENT compliance ,PSORIATIC arthritis ,RESEARCH funding ,VISUAL analog scale ,QUESTIONNAIRES ,SEX distribution ,REPORTING of diseases ,TREATMENT effectiveness ,AGE distribution ,LONGITUDINAL method ,DRUG efficacy ,INTERLEUKINS ,EVALUATION ,CHEMICAL inhibitors - Abstract
Objectives To assess the effectiveness and tolerability of first- and second-line interleukin (IL)-17A inhibitor treatment in PsA patients from 2014 to 2021 using data from the Danish Rheumatology Registry (DANBIO) by investigating adherence to therapy. Method PsA patients recorded in the DANBIO who received a first- or second-line IL-17A inhibitor treatment were included in this study. All patients included had previously received one or more TNF inhibitor treatment. Baseline characteristics were analysed in subgroups as first-line IL-17A inhibitor treatment and second-line IL-17A inhibitor treatment. Adherence to therapy of first- or second-line IL-17A inhibitor treatments was reported as Kaplan–Meier plots. Results A total of 534 patients were included in the study, with 534 first-line switchers (secukinumab: 510, ixekizumab: 24) and 102 second-line switchers (secukinumab: 35, ixekizumab: 67). Baseline characteristics showed a similar HAQ and visual analogue scale (VAS) for pain. VAS global, 28-joint DAS with CRP and the previous number of biologic DMARD treatments were similar, with a greater value for second-line switchers. First-line ixekizumab-treated patients present a younger age, greater percentage of females, a lower disease duration and a lower CRP value. Concomitant MTX use was greater for the first-line secukinumab-treated patients. First- and second-line switchers had a similar adherence to therapy. Second-line secukinumab and second-line ixekizumab switchers showed a similar adherence to treatment. Conclusion PsA patients receiving first- or second-line IL-17A inhibitors showed homogeneous baseline characteristics and similar adherence to therapy. Treatment failure of the first IL-17A inhibitor treatment should not preclude a second-line IL-17A inhibitor treatment. [ABSTRACT FROM AUTHOR]
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- 2024
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9. The Agreement between Consumer-Driven Self-Assessment of Psoriasis Severity and Physician-Assessed Severity Based on Patient-Taken Photographs Is Weak: A Cross-Sectional Study.
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Ali, Zarqa, Al-Mousawi, Ali, Björnsson, Benóný Þór, Egeberg, Alexander, Riemer, Christian, and Thomsen, Simon Francis
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SELF-evaluation ,PSORIASIS ,INTRACLASS correlation ,CROSS-sectional method ,PHOTOGRAPHS - Abstract
Introduction: Digital advancements have given access to huge amounts of real-world data (RWD) widely used for dermatological research. Objectives: The objective of this study was to investigate the agreement between consumer-driven self-assessed psoriasis severity and physician-assessed severity based on photographs. Methods: Customer IDs in the NØIE database (Danish skincare company) from 2009 to 2022 with a smartphone photograph of psoriasis vulgaris on the body and a corresponding completed questionnaire were included. Smartphone photographs were evaluated by a physician-assessing erythema, induration, and scaling on a scale from 0 to 4 based on Psoriasis Area Severity Index (PASI). Self-assessment was done on a scale from 0 to 10 and converted to 0–4 scale (0 converted to 0; 1–3 to 1; 4–6 to 2; 7–8 to 3; and 9–10 to 4). Intraclass correlation coefficients with 95% confidence intervals (CIs) were calculated. Results: In total, 187 patients (63% women) with mean age of 38 years were included. Self-assessment scores were higher than physicians' assessment scores for all groups, and scaling was closest to the physicians' assessment, while erythema and induration had a greater distance between the physicians' and patients' assessment. The correlation between self-assessed and physician-assessed psoriasis severity for all patients was 0.23 (95% CI: 0.0–0.92); 0.34 (95% CI: 0.0–0.95) for chronic patients; and 0.09 (−0.01 to 0.82) for non-chronic patients. The agreement was better for men (0.53 [−0.02 to 0.98]) than for women (0.12 [−0.01 to 0.84]). Conclusion: There was weak agreement between self-assessed psoriasis severity and photographically assessed severity by the physician. Consumer-driven RWD should be interpreted with caution. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Impact of the COVID-19 Pandemic on Care for Patients With Skin Cancer.
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Smith, Brandon, Engel, Priya, Javadi, Sogol Stephanie, Egeberg, Alexander, and Wu, Jashin J.
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COVID-19 pandemic ,CANCER patient care ,DERMATOLOGISTS - Abstract
This research letter discusses the impact of the COVID-19 pandemic on care for patients with skin cancer. The study used survey data from the 2020-2021 National Health Interview Survey to evaluate access to care during the pandemic for patients with a self-reported history of skin cancer. The results showed that patients with a history of skin cancer were more likely to delay or forego medical care due to the pandemic and were more likely to have had a virtual medical visit in the past 12 months. The study suggests that telemedicine may serve as a viable alternative to in-person care for patients with skin cancer. [Extracted from the article]
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- 2024
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11. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60.
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Egeberg, Alexander, Hawkes, Jason E., Somani, Najwa, Burge, Russel, See, Kyoungah, Gallo, Gaia, McKean-Matthews, Missy, Gooderham, Melinda, Han, George, and Armstrong, April
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ITCHING ,PATIENT reported outcome measures ,SCALP ,QUALITY of life ,CLINICAL trials ,TREATMENT effectiveness - Abstract
Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe plaque psoriasis. Since scalp psoriasis can be burdensome and challenging to treat with non-systemic therapies, this post hoc analysis focused on scalp psoriasis in patients with moderate-to-severe plaque psoriasis and baseline scalp involvement. The analysis considered a holistic concept of clearance through 5 years of ixekizumab treatment. Methods: Ixekizumab-treated patients with baseline scalp involvement were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials (integrated UNCOVER-1/2 and UNCOVER-3). Analyses were performed on a subpopulation of patients who achieved complete resolution of scalp psoriasis at Week 60 (i.e., Week 60 Psoriasis Scalp Severity Index [PSSI-0] responders) and on the overall patient population (i.e., Week 60 PSSI-0 responders and non-responders), which was used as a reference. Clinical outcomes (PSSI), patient-reported outcomes (Itch Numeric Rating Scale [NRS] score, Skin Pain Visual Analogue Scale [VAS]), quality of life (Dermatology Life Quality Index [DLQI]), and concurrent outcomes were assessed from baseline through 5 years. Descriptive statistics of observed data were reported. Results: After 60 weeks of ixekizumab treatment, 88.4% (UNCOVER-1/2) and 75.9% (UNCOVER-3) of patients with baseline scalp involvement achieved complete clearance (PSSI-0) of scalp psoriasis. Substantial improvements in the clinical outcomes (PSSI), patient-reported outcomes (Itch NRS, Skin Pain VAS), and quality of life (DLQI) were achieved by Week 60 and sustained through Week 264 in the Week 60 PSSI-0 responders and in the overall patient population. Additionally, a significant proportion of Week 60 PSSI-0 responders achieved concurrent complete scalp and skin clearance and quality of life improvement through 5 years. Conclusions: Continued treatment with ixekizumab provided long-term sustained scalp clearance over 5 years to patients with moderate-to-severe plaque psoriasis and baseline scalp involvement, and holistic improvements occurred across clinical outcomes, patient-reported outcomes, and quality of life. Clinical Trial Numbers: NCT01474512 (UNCOVER-1), NCT01597245 (UNCOVER-2), and NCT01646177 (UNCOVER-3). [ABSTRACT FROM AUTHOR]
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- 2024
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12. Characteristics and Management of Patients with Alopecia Areata and Selected Comorbid Conditions: Results from a Survey in Five European Countries.
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Vañó-Galván, Sergio, Egeberg, Alexander, Piraccini, Bianca Maria, Marwaha, Simran, Reed, Catherine, Johansson, Erin, Durand, Frederick, and Bewley, Anthony
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ALOPECIA areata ,COMORBIDITY ,BALDNESS ,ATOPIC dermatitis ,DISEASE management ,PHYSICIANS - Abstract
Introduction: Alopecia areata (AA) is an autoimmune condition that causes non-scarring hair loss and can impose a high psychosocial burden on patients. The presence of comorbid conditions may impact the management of AA in clinical practice. This analysis aims to describe disease characteristics and management of AA in patients with concomitant atopic, autoimmune, and psychiatric comorbid conditions. Methods: Data were collected from the Adelphi Disease Specific Programme™, a cross-sectional survey of physicians and their adult patients with AA conducted in France, Germany, Italy, Spain, and the UK between October 2021 and June 2022. Patients' disease severity was based on physician's definition. Physician-reported data on demographics, AA clinical characteristics, comorbid conditions, and information related to AA therapies were analyzed. Analyses were descriptive. Results: Overall, 239 dermatologists provided data for 2083 patients, of which 558 patients (27%) had at least one atopic, autoimmune, or psychiatric comorbid conditions. The most common comorbid conditions were atopic dermatitis, autoimmune thyroid disease, and anxiety. The mean (standard deviation) patient age for the three comorbidity groups was 37.6 years (12.1) and 56% of the patients were women (n = 313). In the three comorbidity groups, 51%, 50%, and 55% of patients with atopic, autoimmune, and psychiatric comorbidities had severe AA with disease progression reported as worsening in 30%, 28%, and 30%, respectively, whereas in the group with no comorbidities, 37% were described as having severe AA and 21% getting worse. Scalp hair loss was the primary sign reported across the three groups of comorbid conditions (atopic, 91%; autoimmune, 91%; psychiatric, 88%). Patients with preselected comorbidities presented more frequently AA-related signs and symptoms beyond scalp hair loss than patients without comorbid conditions. These patients were also more likely to receive topical calcineurin inhibitors, topical immunotherapy, conventional systemic immunosuppressants, and oral Janus kinase inhibitors for the treatment of their AA. Conclusion: This analysis provided insights into the burden and management of AA in patients presenting with atopic, autoimmune, and psychiatric comorbid conditions in five European countries. [ABSTRACT FROM AUTHOR]
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- 2024
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13. Predicting Psoriatic Arthritis in Psoriasis Patients – A Swiss Registry Study.
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Nielsen, Mia-Louise, Petersen, Troels C., Maul, Lara Valeska, Thyssen, Jacob P., Thomsen, Simon F., Wu, Jashin J., Navarini, Alexander A., Kündig, Thomas, Yawalkar, Nikhil, Schlapbach, Christoph, Boehncke, Wolf-Henning, Conrad, Curdin, Cozzio, Antonio, Micheroli, Raphael, Erik Kristensen, Lars, Egeberg, Alexander, and Maul, Julia-Tatjana
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- 2024
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14. Characteristics of Patients With Psoriasis Treated With Various Biologics – A Danish Cohort Study.
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Schwarz, Christopher Willy, Skov, Lone, Egeberg, Alexander, Passey, Alun, Lee, Jennifer, Gorecki, Patricia, and Loft, Nikolai
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- 2024
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15. Demographics, characteristics and medical treatment among adults with hand eczema in Denmark. A cross‐sectional validation and registry‐based study.
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Christensen, Maria Oberländer, Yüksel, Yasemin Topal, Vittrup, Ida, Nymand, Lea Krog, Thein, David, Nørreslet, Line Brok, Toft‐Hansen, Jakob Maarbjerg, Janstrup, Anne Klose, Zachariae, Claus, Sommerlund, Mette, Bregnhøj, Anne, Egeberg, Alexander, Agner, Tove, Thomsen, Simon Francis, and Thyssen, Jacob Pontoppidan
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Background: The international classification of diseases, 10th revision (ICD‐10) includes several unvalidated diagnostic codes for hand eczema (HE). Knowledge is sparse on HE patient characteristics. Objectives: To validate selected HE ICD‐10 codes in the Danish National Patient Registry (DNPR) and describe disease characteristics, lifestyle factors and medication use in adult HE patients. Methods: Nineteen HE ICD‐10 codes were selected and validated based on patient charts. Five cohorts were constructed based on the diagnostic code, DL30.8H (HE unspecified), in the DNPR: (i) patients with DL30.8H code (n = 8386), (ii) patients with DL30.8H code, but without atopic dermatitis (AD) (n = 7406), (iii) sex‐ and age‐matched general population (n = 8386) without HE. Two additional cohorts nested in the DNPR included participants from the Danish Skin Cohort, (iv) patients with DL30.8H code but without AD (n = 1340) and (v) general population cohort (n = 9876). Results: ICD‐10 codes revealed positive predictive values ≥90% except irritant contact dermatitis (unspecified) (79.7%) and hyperkeratotic hand and foot eczema (84.1%). HE patients were most often women, middle‐aged or older, of Danish ethnicity, had an atopic medical history and were smokers. Topical corticosteroid prescriptions were almost doubled in HE cohorts compared to general populations. Conclusion: We validated several HE ICD‐10 codes and identified important HE patient characteristics. [ABSTRACT FROM AUTHOR]
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- 2024
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16. Sex differences in adverse events from systemic treatments for psoriasis: A decade of insights from the Swiss Psoriasis Registry (SDNTT).
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Verardi, Fabio, Maul, Lara Valeska, Borsky, Kim, Steinmann, Simona, Rosset, Nina, Pons, Hector Ortega, Sorbe, Christina, Yawalkar, Nikhil, Micheroli, Raphael, Egeberg, Alexander, Thyssen, Jacob P., Heidemeyer, Kristine, Boehncke, Wolf‐Henning, Conrad, Curdin, Cozzio, Antonio, Pinter, Andreas, Kündig, Thomas, Navarini, Alexander A., and Maul, Julia‐Tatjana
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Background: Psoriasis is a disease that often requires prolonged systemic treatment. It is important to determine the safety of available therapies. There is currently little insight into sex‐specific differences in the safety of systemic psoriasis therapies. Objectives: To examine the real‐world, long‐term safety of systemic psoriasis therapies with sex stratification in drug‐related adverse events (ADRs). Methods: Ten‐year data from adults with moderate‐to‐severe psoriasis requiring systemic treatment (conventional systemic therapies [CST], biologics) were obtained from the Swiss psoriasis registry (SDNTT). ADRs were categorized according to the international terminology Medical Dictionary for Regulatory Activities (MedDRA). Safety was assessed by calculating event rates per 100 patient‐years (PY). We used descriptive statistics for patient and disease characteristics, and binomial and t‐tests to compare treatment groups and sex. Results: In total, 791 patients (290 females) were included with a mean age of 46 years. 358 (45%) received CSTs and 433 (55%) biologics; both groups had similar baseline characteristics except for more joint involvement in patients using biologics (26.86% vs. 14.8%, p < 0.0001). CSTs were associated with a 2.2‐fold higher ADR rate (40.43/100 PY vs. 18.22/100 PY, p < 0.0001) and an 8.0‐fold higher drug‐related discontinuation rate than biologics (0.16/PY vs. 0.02/PY, p < 0.0001). Trends showed non‐significant higher serious adverse event rates per 100 PY for biologics (8.19, CI 6.87–9.68) compared to CSTs (7.08, CI 5.39–9.13) (p = 0.3922). Sex stratification revealed a significantly higher overall ADR rate for all treatments in females (1.8‐fold for CSTs [57.30/100 PY vs. 31.69/100 PY] and 2.0‐fold for biologics [27.36/100 PY vs. 13.9/100 PY], p < 0.0001), and drug‐related discontinuation rates for most CSTs in females. Conclusion: Females were associated with a significantly higher rate of ADRs and drug‐related discontinuation rates. Sex stratification should be taken into consideration when designing studies in the patient‐tailored management of psoriasis. [ABSTRACT FROM AUTHOR]
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- 2024
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17. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials.
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Egeberg, Alexander, Conrad, Curdin, Gorecki, Patricia, Wegner, Sven, Buyze, Jozefien, Acciarri, Lorenzo, and Thaçi, Diamant
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BIOTHERAPY ,CLINICAL trials ,BODY surface area ,PSORIASIS ,LOGISTIC regression analysis ,GINGIVITIS ,BODY mass index - Abstract
Introduction: This study aimed to understand treatment response dynamics, including factors associated with favorable response, among patients with moderate-to-severe psoriasis who received guselkumab, adalimumab, or secukinumab. Methods: These post hoc analyses used data from the phase III clinical trials ECLIPSE and VOYAGE 1, which were conducted between September 2021 and November 2022. On the basis of absolute Psoriasis Area and Severity Index (aPASI) scores, patients were divided into short-term response types (SRT1–6, based on week 20–48 response) and long-term response types (LRT1–4, based on week 52–252 response). Response types (RTs) were based on aPASI cutoffs deemed clinically relevant by the investigators; SRT1/LRT1 were the most favorable response types. Baseline characteristics were compared across RTs, and logistic regression analyses established factors associated with SRT1/LRT1. Results: Overall, 1045, 662, and 272 patients were included in the ECLIPSE short-term, VOYAGE 1 short-term, and VOYAGE 1 long-term analyses, respectively. Mean age, body mass index (BMI), baseline aPASI score, and body surface area were lower in SRT1 than SRT6. In VOYAGE 1, adalimumab treatment, high BMI, and current/former smoking status resulted in less favorable responses. In the VOYAGE 1 long-term analysis, patients in LRT4 had the highest baseline aPASI score, were older, and were more often obese compared with other LRT groups. Regression analyses showed that SRT1 (both treatments) in VOYAGE 1 and ECLIPSE, and LRT1 (guselkumab group) in the VOYAGE 1 long-term analysis, were associated with week 16 aPASI response. In VOYAGE 1, SRT1 was associated with psoriasis duration and smoking status. Conclusions: Early treatment response and baseline characteristics, including smoking, psoriasis duration, and obesity, may be associated with longer-term response to biologics. Trial Registration Numbers: ECLIPSE: NCT03090100, VOYAGE 1: NCT02207231. [ABSTRACT FROM AUTHOR]
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- 2024
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18. Atopic dermatitis phenotypes based on cluster analysis of the Danish Skin Cohort.
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Nymand, Lea, Nielsen, Mia-Louise, Vittrup, Ida, Halling, Anne-Sofie, Francis Thomsen, Simon, Egeberg, Alexander, and Thyssen, Jacob P
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CLUSTER analysis (Statistics) ,ATOPIC dermatitis ,PHENOTYPES ,DISEASE duration ,PATIENT reported outcome measures - Abstract
Background Despite previous attempts to classify atopic dermatitis (AD) into subtypes (e.g. extrinsic vs. intrinsic), there is a need to better understand specific phenotypes in adulthood. Objectives To identify, using machine learning (ML), adult AD phenotypes. Methods We used unsupervised cluster analysis to identify AD phenotypes by analysing different responses to predetermined variables (age of disease onset, severity, itch and skin pain intensity, flare frequency, anatomical location, presence and/or severity of current comorbidities) in adults with AD from the Danish Skin Cohort. Results The unsupervised cluster analysis resulted in five clusters where AD severity most clearly differed. We classified them as 'mild', 'mild-to-moderate', 'moderate', 'severe' and 'very severe'. The severity of multiple predetermined patient-reported outcomes was positively associated with AD, including an increased number of flare-ups and increased flare-up duration and disease severity. However, an increased severity of rhinitis and mental health burden was also found for the mild-to-moderate phenotype. Conclusions ML confirmed the use of disease severity for the categorization of phenotypes, and our cluster analysis provided novel detailed information about how flare patterns and duration are associated with AD disease severity. [ABSTRACT FROM AUTHOR]
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- 2024
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19. Use of systemic and biological therapy in patients with moderate-to-severe psoriasis.
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Liljendahl, Mie S, Loft, Nikolai, Nguyen, Tri-Long, Skov, Lone, and Egeberg, Alexander
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BIOTHERAPY ,PSORIASIS ,DANES - Abstract
To our knowledge, this is the first study to estimate the proportion of patients with moderate-to-severe psoriasis at a national level based on clinical characteristics, and furthermore to estimate the proportion of patients who are candidates for systemic therapy but do not receive it. This study shows that in the Danish population a large proportion of patients with moderate-to-severe psoriasis are candidates for systemic therapy but do not receive the therapy. Time on conventional systemic therapy for patients with moderate-to-severe psoriasis was shorter today than in previous time periods; more patients initiated biological therapy as second-line therapy; and the median time from initiation of systemic therapy to initiation of biological therapy has decreased in more recent years. Background: Patients with moderate-to-severe psoriasis are candidates for systemic treatment, but it is unknown how many receive such therapy at a national level in Denmark. Objectives: We aimed to determine the prevalence of conventional systemic therapy use in patients with moderate-to-severe psoriasis and, further, to investigate the time to discontinuation of conventional systemic therapy and initiation of biological therapy among biologic-naïve patients. Methods: This registry-based study identified a cohort of patients with psoriasis in Denmark. We estimated the prevalence of moderate-to-severe psoriasis at a national level using registry data. Inverse probability weighting was used to mitigate potential selection bias in the prevalence estimate of moderate-to-severe psoriasis. Analyses were then performed on the weighted cohort. Results: Of patients with psoriasis in Denmark, 10.9% were estimated to have moderate-to-severe psoriasis, of whom 62.3% received either conventional systemic or biological therapy, meaning 37.7% who were considered candidates for systemic therapy did not receive any systemic treatment. The study demonstrated that, comparing previous time periods with more recent years: (i) time on conventional systemic therapy for patients with moderate-to-severe psoriasis has become shorter, with a median (interquartile range) of 3.0 years (0.6–10.0) in 1985–1994 vs. 0.6 years (0.3–2.0) in 2014–2018; (ii) more patients initiated biologics as second-line therapy, with 69.5% in 2010–2013 vs. 71.2% in 2014–2018; and (iii) the median time from initiation of systemic therapy to initiation of biological therapy decreased from 13.3 years (11.5–16.8) in 2010–2013 to 1.9 years (1.7–2.4) in 2014–2018. Conclusions: This study found that nearly 37.7% of Danish patients with moderate-to-severe psoriasis do not receive systemic treatment even though they would qualify for this. Furthermore, for patients treated with conventional systemics, drug survival decreased during the observation period. [ABSTRACT FROM AUTHOR]
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- 2024
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20. Freedom from disease in plaque psoriasis: Comparing the perceived importance of voting round 2 statements from a Delphi consensus of patients, physicians and nurses.
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van Ee, Ilse, Deprez, Elfie, Egeberg, Alexander, Conrad, Curdin, Corazza, Valeria, Donati, Ludovica, Lambert, Jo, Lăpădatu, Rozalina, Meyer, Anette, Paul, Carle, Penzer‐Hick, Rebecca, Stephen, Karen, van der Zon, Jim, and Bewley, Anthony
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DELPHI method ,PATIENTS' attitudes ,PSORIASIS ,MEDICAL personnel ,PHYSICIANS ,DERMATOLOGISTS - Abstract
This article discusses the importance of considering patients' perspectives in the treatment of psoriasis, a chronic skin disease that can significantly impact quality of life. The study conducted a Delphi consensus involving psoriasis patients, physicians, and nurses to determine the definition of freedom from disease in psoriasis. The results showed that while there was a high level of consensus among all groups, there were some differences in the perceived importance of various aspects of freedom from disease. For example, physicians placed greater importance on the management of clinical symptoms, while patients were more concerned about the cost of treatments. The study also found that patients with milder psoriasis placed greater importance on psychosocial elements and healthcare team support, while patients with more severe psoriasis were less concerned with the cost of treatment. Additionally, females placed greater importance on psychosocial elements, such as worrying about other people's reactions to their skin. The findings suggest the need for personalized treatment plans and shared decision-making between patients and healthcare professionals. However, it is important to note that the study has limitations, such as the potential lack of representativeness in certain groups. [Extracted from the article]
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- 2024
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21. Long-term drug survival of adalimumab, infliximab, secukinumab and ustekinumab in hidradenitis suppurativa: a Danish nationwide cohort study.
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Ring, Hans Christian, Thorsen, Jonathan, Kirby, Brian, Ingram, John R, Rosenø, Nana Aviaaja Lippert, Holgersen, Nikolaj, Nielsen, Valdemar W, Aagaard, David Nikolai Thein, Maul, Julia-Tatjana, Wu, Jashin J, Thyssen, Jacob P, Egeberg, Alexander, and Thomsen, Simon F
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HIDRADENITIS suppurativa ,ADALIMUMAB ,INFLIXIMAB ,COHORT analysis ,BIOTHERAPY ,DRUGS - Abstract
This article presents a Danish nationwide cohort study on the long-term drug survival of biologics in the treatment of hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The study analyzed data from 452 patients who were treated with various biologics between 2005 and 2021. The results showed that the median drug survival time for adalimumab was approximately 8 months, with bio-naïve patients having a significantly longer drug survival time compared to non-naïve patients. The study also reported real-life drug survival data on secukinumab in HS. The findings suggest the need for further research into more effective biologics for HS. [Extracted from the article]
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- 2024
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22. Attitudes towards clinical research in adult patients with hidradenitis suppurativa during the COVID-19 pandemic: Insights from a survey.
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Holgersen, Nikolaj, Nielsen, Valdemar W., Ali, Zarqa, Brøgger-Mikkelsen, Mette, Flege, Marius M., Thyssen, Jacob P., Egeberg, Alexander, and Thomsen, Simon F.
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COVID-19 pandemic ,HIDRADENITIS suppurativa ,MEDICAL research ,ADULTS ,PEOPLE with mental illness - Abstract
This summary discusses two articles related to hidradenitis suppurativa (HS) and dermatologic care. The first article presents the findings of a survey that examined the attitudes of adult patients with HS towards clinical research during the COVID-19 pandemic. The study found that patients with HS had a more positive view towards research compared to dermatologic patients in general, and those who completed the questionnaire in 2021 had higher scores indicating a more positive view towards research compared to those in 2020. The second article focuses on the unmet needs of patients with HS and highlights the physical, emotional, and social impact of the condition on their lives. It also explores the potential of teledermatology in managing inflammatory skin conditions, particularly during the COVID-19 pandemic. Both articles provide valuable insights into the challenges faced by patients with HS and offer potential solutions to improve their care. [Extracted from the article]
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- 2024
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23. Risk for COVID-19 Infection in Patients With Vitiligo.
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Smith, Brandon, Shahsavari, Shahin, Oulee, Aislyn, Engel, Priya, Egeberg, Alexander, and Wu, Jashin J.
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VITILIGO ,COVID-19 ,COVID-19 pandemic - Abstract
This research letter discusses the risk of COVID-19 infection in patients with vitiligo, a depigmentation disorder resulting from the loss of melanocytes in the skin. The study found that patients with vitiligo had a significantly higher risk of contracting COVID-19 compared to those without vitiligo. The autoimmune process involved in vitiligo may alter the body's immune response to the infection. However, the underlying immune dysregulation in vitiligo in relation to COVID-19 is still unknown and requires further exploration. The study acknowledges limitations such as the use of diagnostic codes and the inability to control for all potential confounding variables. [Extracted from the article]
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- 2024
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24. Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review.
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Egeberg, Alexander, Linsell, Louise, Johansson, Erin, Durand, Frederick, Yu, Guanglei, and Vañó-Galván, Sergio
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ALOPECIA areata ,TERMINATION of treatment ,BALDNESS ,BARICITINIB ,TREATMENT effectiveness ,DATA extraction - Abstract
Treatments for alopecia areata (AA) have traditionally been prescribed off-label, and there has been no universal agreement on how to best manage the condition. Baricitinib is the first oral selective Janus kinase (JAK) inhibitor approved for the treatment of adults with severe AA. As a better understanding of the evidence supporting the management of AA in clinical practice is needed, we conducted a systematic literature review and subsequent narrative review to describe available evidence pertaining to the efficacy and tolerability of treatments currently recommended for adults with moderate-to-severe forms of AA. From 2557 identified records, a total of 53 records were retained for data extraction: 9 reported data from 7 randomized controlled trials (RCTs) versus placebo, and 44 reported data from unique RCTs with no placebo arm, non-randomized trials, or observational studies. Across drug classes, data were reported heterogeneously, with little consistency of data collection or clinical endpoints used. The most robust evidence was for the JAK inhibitor class, in particular the JAK1/JAK2 inhibitor baricitinib. Five RCTs (three for baricitinib) demonstrated a consistent benefit of JAK inhibitor therapy over placebo across various clinical outcomes in adult patients with at least 50% scalp hair loss. Overall, hair regrowth varied widely for the other drug classes and was generally low for patients with moderate-to-severe AA. Relapses were commonly observed during treatment and upon discontinuation. Adverse effects were generally consistent with the known safety profile of each intervention. The heterogeneity observed prevented the conduct of a network meta-analysis or an indirect comparison of different treatments. We found that the current management of patients with moderate-to-severe AA often relies on the use of treatments that have not been well evaluated in clinical trials. The most robust evidence identified supported the use of baricitinib, and other oral JAK inhibitors, in patients with severe AA. Plain Language Summary: To date, there has been no universal agreement on how to best manage alopecia areata (AA), suggesting that a better understanding of the evidence for the different treatment options is needed. Most of the treatments traditionally used for AA have not been approved for this indication. Baricitinib is the first oral selective Janus kinase (JAK) inhibitor approved for the treatment of adults with severe AA. Consequently, we extensively reviewed the available literature for evidence regarding the efficacy and tolerability of treatments currently recommended for adults with moderate-to-severe forms of AA. Although we found many potential reports, only 53 provided the type of information we believed to be relevant, with 9 describing findings from 7 randomized controlled trials versus placebo. Across treatments, there was little consistency of data collection or clinical endpoints used. The most robust evidence was for the JAK inhibitor class, in particular baricitinib, which was consistently more beneficial than placebo across various clinical outcomes in adults with at least 50% scalp hair loss. For the other classes of drugs, hair regrowth varied widely, was generally low for patients with moderate-to-severe hair loss, and commonly did not last. Reported adverse effects were generally as expected for each treatment. We found that the current management of patients with moderate-to-severe AA often relies on the use of treatments that have not been well evaluated in clinical trials. However, strong evidence supports the use of baricitinib, and other oral JAK inhibitors, in patients with severe AA. [ABSTRACT FROM AUTHOR]
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- 2023
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25. Predicting discontinuation of biologic therapy caused by adverse events in psoriasis patients—A Danish nationwide cohort study.
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Nielsen, Mia‐Louise, Petersen, Troels C., Maul, Julia‐Tatjana, Wu, Jashin J., Bertelsen, Trine, Skov, Lone, Thomsen, Simon F., Thyssen, Jacob P., and Egeberg, Alexander
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- 2023
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26. Prevalence and incidence of patients with generalized pustular psoriasis in Denmark—A nationwide registry‐based study.
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Haugaard, Jeanette Halskou, Thein, David, and Egeberg, Alexander
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- 2023
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27. Psychiatric co‐morbidity in patients with hidradenitis suppurativa: A cross‐sectional study of clinical characteristics and burden of disease.
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Holgersen, Nikolaj, Nielsen, Valdemar Wendelboe, Ring, Hans Christian, Rosenø, Nana Aviaaja Lippert, Egeberg, Alexander, Thyssen, Jacob Pontoppidan, and Thomsen, Simon Francis
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- 2023
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28. Disease‐ and treatment‐related expectations, attitudes, and beliefs among adult patients initiating or switching biological therapies for psoriasis.
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Clemmesen, Maria, Jørgensen, Astrid‐Helene Ravn, Nielsen, Valdemar Wendelboe, Holgersen, Nikolaj, Nissen, Christoffer Valdemar, Thyssen, Jacob Pontoppidan, Egeberg, Alexander, and Thomsen, Simon Francis
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- 2023
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29. Mapping the road to biologics in psoriasis and psoriatic arthritis: A nationwide drug utilization study.
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Thein, David, Rosenø, Nana A. L., Nielsen, Mia‐Louise, Kristensen, Lars Erik, Maul, Julia‐Tatjana, Wu, Jashin J., Thomsen, Simon Francis, Thyssen, Jacob P., and Egeberg, Alexander
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- 2023
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30. No associations between type 1 diabetes and atopic dermatitis, allergic rhinitis, or asthma in childhood: a nationwide Danish case-cohort study.
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Berg, Anna Korsgaard, Svensson, Jannet, Thyssen, Jacob P., Chawes, Bo, Zachariae, Claus, Egeberg, Alexander, and Thorsen, Steffen Ullitz
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TYPE 1 diabetes ,ALLERGIC rhinitis ,MEDICAL personnel ,ASTHMA in children ,ATOPIC dermatitis - Abstract
Studies examining the association between type 1 diabetes (T1D) and atopic diseases, i.e., atopic dermatitis, allergic rhinitis and asthma have yielded conflicting results due to different algorithms for classification, sample size issues and risk of referral bias of exposed cohorts with frequent contact to health care professionals. Using Danish national registries and well-established disease algorithms, we examined the bidirectional association between T1D and atopic diseases in childhood and adolescence using Cox Proportional Hazard regression compared to two different unexposed cohorts from a population of 1.5 million Danish children born from 1997 to 2018. We found no associations between T1D and atopic dermatitis, allergic rhinitis, or asthma (defined after age five). However, in multivariable analysis we found an increased risk of persistent wheezing (defined as asthma medication before age five) after T1D with an adjusted hazard ratio (aHR) of 1.70 [1.17–2.45]. We also identified an increased risk of developing T1D after persistent wheezing with aHR of 1.24 [1.13–1.36]. This study highlights similar risks of atopic diseases in children with T1D and of T1D in children with atopic disease after age of five years versus healthy controls. However, more research is needed to understand the possible early immunological effects of the link between persistent wheezing and T1D. [ABSTRACT FROM AUTHOR]
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- 2023
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31. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
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Kirkham, Bruce W., Egeberg, Alexander, Behrens, Frank, Pinter, Andreas, Merola, Joseph F., Holzkämper, Thorsten, Gallo, Gaia, Ng, Khai Jing, Bolce, Rebecca, Schuster, Christopher, Nash, Peter, and Puig, Luis
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NAIL diseases ,PSORIATIC arthritis ,PSORIASIS ,CLINICAL trials ,MONOCLONAL antibodies - Abstract
Nail psoriasis is a difficult-to-treat manifestation of psoriatic disease affecting up to 80% of patients with psoriatic arthritis (PsA) and 40–60% of patients with plaque psoriasis (PsO). Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of patients with PsA and patients with moderate-to-severe PsO. This narrative review aims to summarize nail psoriasis data generated from IXE clinical trials in patients with PsA (SPIRIT-P1, SPIRIT-P2, and SPIRIT-H2H) and/or moderate-to-severe PsO (UNCOVER-1, -2, -3, IXORA-R, IXORA-S, and IXORA-PEDS) with an emphasis on head-to-head clinical trial data. Across numerous trials explored, IXE treatment was associated with greater improvement in resolution of nail disease versus comparators at week 24, results which were maintained up to and beyond week 52. Additionally, patients experienced higher rates of resolution of nail disease versus comparators at week 24 and maintained high levels of resolution up to week 52 and beyond. In both PsA and PsO, IXE demonstrated efficacy in treating nail psoriasis, and therefore may be an effective therapy option. Trial Registration: ClinicalTrials.gov identifier UNCOVER-1 (NCT01474512), UNCOVER-2 (NCT01597245), UNCOVER-3 (NCT01646177), IXORA-PEDS (NCT03073200), IXORA-S (NCT02561806), IXORA-R (NCT03573323), SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295), SPIRIT-H2H (NCT03151551). [ABSTRACT FROM AUTHOR]
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- 2023
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32. Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial.
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Tillett, William, Egeberg, Alexander, Sonkoly, Enikö, Gorecki, Patricia, Tjärnlund, Anna, Buyze, Jozefien, Wegner, Sven, and McGonagle, Dennis
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- 2023
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33. The Association Between Fatigue and Adult Atopic Dermatitis: A Cross-Sectional Study.
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Thyssen, Jacob P., Nymand, Lea K., Maul, Julia-Tatjana, Schmid-Grendelmeier, Peter, Wu, Jashin J., Frøstrup, Anne Grete, Gren, Susanne Thiesen, Thomsen, Simon Francis, and Egeberg, Alexander
- Abstract
Background: There is currently limited insight into the broader impact of atopic dermatitis (AD) on mental health. Although studies indicate that AD patients may experience fatigue, no study has so far examined fatigue in more granular detail, for example, occurrence of general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue, or correlated fatigue measures with AD severity and symptoms intensity. Objectives: To examine fatigue subtypes and their prevalence in adults with AD, as well as their possible association with AD severity. Methods: A survey was conducted in adults with AD who had been managed in a hospital setting. The Patient-Oriented SCORing Atopic Dermatitis was used to determine AD severity. Patient reported outcomes, including multidimensional fatigue inventory, were included. Results: Data from 2729 adults with AD were analyzed. The total and individual fatigue scores increased consistently with lower socioeconomic scores, higher AD severity, Dermatology Life Quality Index, itch, pain, and sleep scores. Increased fatigue scores were associated with AD severity in adjusted analyses. Conclusions: Among adults with AD, fatigue scores increased with disease severity as well as intensity of AD symptoms. Fatigue is a hitherto underappreciated symptom of AD that clinicians should be cognizant about. [ABSTRACT FROM AUTHOR]
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- 2023
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34. Financial Insecurity Among US Adults With Psoriasis.
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Smith, Brandon, Engel, Priya, Devjani, Shivali, Collier, Michael R., Egeberg, Alexander, and Wu, Jashin J.
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MEDICAID ,PSORIASIS ,ADULTS ,MEDICARE - Abstract
The article focuses on the financial insecurity of adults with psoriasis in the U.S. It study examined the prevalence and sociodemographic characteristics of adult psoriasis patients aged 20 and older who experienced financial insecurity using data from the 2009–2014 National Health and Nutrition Examination Survey (NHANES). It mentions the findings revealed that certain sociodemographic groups, such as the elderly, college graduates, married individuals, and U.S. citizens.
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- 2023
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35. Prevalence of ichthyoses in Denmark: a nationwide registry-based study.
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Thein, David, Maul, Julia-Tatjana, Schmid-Grendelmeier, Peter, Thyssen, Jacob P, and Egeberg, Alexander
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ICHTHYOSIS ,NEONATAL intensive care ,NOSOLOGY - Abstract
A study published in the British Journal of Dermatology provides insight into the prevalence of ichthyoses in Denmark. Ichthyosis is a group of genetic skin disorders characterized by dry and scaly skin. The study found that the prevalence of ichthyoses in Denmark is 1.6 per 10,000 people, with ichthyosis vulgaris being the most common type. The prevalence varied by age and sex, with higher rates in younger age groups and a higher prevalence in women over 50 years old. However, the study may underestimate the true prevalence and further research is needed. [Extracted from the article]
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- 2024
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36. Topical corticosteroids in the era of new topical therapies: Balancing efficacy and safety for long‐term use.
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Egeberg, Alexander and Thyssen, Jacob P.
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CORTICOSTEROIDS ,ADRENAL insufficiency ,ECZEMA ,ARYL hydrocarbon receptors ,SKIN diseases ,PHYSICIANS ,CLOBETASOL - Abstract
The article discusses the use of topical corticosteroids (TCS) in the treatment of inflammatory skin diseases. While TCS have been widely used and proven effective, prolonged use or application in areas with high absorption rates can lead to adverse effects such as striae formation, adrenal suppression, and Cushing syndrome. Recent studies have also associated TCS use with an increased risk of osteoporosis and fractures, particularly in women and younger individuals. The article emphasizes the need to reassess the position of TCS in treatment guidelines and consider alternative non-steroidal therapies with minimal systemic absorption. [Extracted from the article]
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- 2024
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37. Association of homelessness and skin conditions: a Danish population-based cohort study.
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Nilsson, Sandra F, Ali, Zarqa, Laursen, Thomas M, Thyssen, Jacob P, Egeberg, Alexander, Nordentoft, Merete, Hjorthøj, Carsten, and Thomsen, Simon F
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HOMELESSNESS ,SKIN cancer ,HOMELESS persons ,HOMELESS shelters ,COHORT analysis ,SKIN tumors - Abstract
Background Research has linked homelessness with an increased risk of skin conditions. However, representative studies of diagnosis-specific information on skin conditions in people experiencing homelessness are lacking. Objectives To examine the association between homelessness and diagnosed skin conditions, prescribed medication and type of -consultation. Methods This cohort study included data from the Danish nationwide health, social and administrative registers from 1 January 1999 to 31 December 2018. All people of Danish origin living in Denmark and aged at least 15 years at some point during the study period were included. Homelessness, measured by homeless shelter contacts, was the exposure. The outcome was any diagnosis of a skin disorder and specific skin disorders recorded in the Danish National Patient Register. Information on diagnostic consultation type (i.e. dermatological, nondermatological and emergency room) and dermatological prescriptions was studied. We estimated adjusted incidence rate ratio (aIRR) (adjusted for sex, age and calendar year) and cumulative incidence. Results In total, 5 054 238 individuals (50.6% female) were included in the study population, accounting for 73 477 258 person-years at risk, with a start mean (SD) age of 39.4 (21.1) years. Of the total number of individuals, 759 991 (15.0%) received a skin diagnosis and 38 071 (0.7%) experienced homelessness. A 2.31-times [95% confidence interval (CI) 2.25–2.36] higher IRR of any diagnosed skin condition was associated with homelessness, higher for nondermatological and emergency room consultations. Homelessness was associated with a reduced IRR of a skin neoplasm diagnosis (aIRR 0.76, 95% CI 0.71–8.82) compared with no homelessness. By the end of follow-up, 2.8% (95% CI 2.5–3.0) of individuals experiencing homelessness had a skin neoplasm diagnosis vs. 5.1% (95% CI 4.9–5.3) of individuals not experiencing homelessness. Five or more shelter contacts during the first year from first contact was associated with the highest aIRR of any diagnosed skin condition (7.33, 95% CI 5.57–9.65) compared with no contacts. Conclusions Individuals experiencing homelessness have high rates of most diagnosed skin conditions, but a lower occurrence of skin cancer diagnosis. Diagnostic and medical patterns for skin disorders differed clearly between people experiencing homelessness and individuals without these experiences. The time after first homeless shelter contact is an important window of opportunity for mitigating and preventing skin disorders. [ABSTRACT FROM AUTHOR]
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- 2023
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38. The impact of comorbidities on interleukin-17 inhibitor therapy in psoriatic arthritis: a Danish population-based cohort study.
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Petersen, Magnus B, Hansen, Rebekka L, Egeberg, Alexander, Jørgensen, Tanja S, Merola, Joseph Frank, Coates, Laura C, and Kristensen, Lars Erik
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INTERLEUKIN-17 ,PSORIATIC arthritis - Published
- 2023
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39. A nationwide 104 weeks real‐world study of dupilumab in adults with atopic dermatitis: Ineffectiveness in head‐and‐neck dermatitis.
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Vittrup, Ida, Krogh, Niels Steen, Larsen, Henrik Hedegaard Pliess, Elberling, Jesper, Skov, Lone, Ibler, Kristina Sophie, Jemec, Gregor B. E., Mortz, Charlotte G., Bach, Rasmus Overgaard, Bindslev‐Jensen, Carsten, Dalager, Maiken Glud, Egeberg, Alexander, Agner, Tove, Deleuran, Mette, Vestergaard, Christian, and Thyssen, Jacob Pontoppidan
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DUPILUMAB ,ATOPIC dermatitis ,SKIN inflammation ,DRUG efficacy ,ADULTS - Abstract
Background: Evaluation of effectiveness and safety of new systemic treatments for atopic dermatitis (AD) after approval is important. There are few published data exceeding 52‐week therapy with dupilumab. Objectives: To examine the safety, effectiveness and drug survival of dupilumab in a Danish nationwide cohort with moderate‐to‐severe AD up to 104 weeks exposure. Methods: We included 347 adult patients with AD who were treated with dupilumab and registered in the SCRATCH registry during 2017–2022. Results: At all visits, we observed improvement in AD severity measured by Eczema Area and Severity Index (EASI) [median (IQR)]. EASI score at baseline was 18.0 (10.6–25.2), at week 4: 6.5 (3.5–11.6), at week 16: 3.7 (1.2–6.2), at week 52: 2.0 (0.8–3.6), at week 104: 1.7 (0.8–3.8). While drug survival was high (week 52: 90%; week 104: 86%), AD in the head‐and‐neck area remained present in most patients at high levels; proportion with head‐and‐neck AD at baseline was 76% and 68% at week 104. 35% of patients reported any AE. Conjunctivitis was the most frequent (25% of all patients) and median time to first registration of conjunctivitis was 201 days. Conclusions: While 2‐year drug survival was 86%, dupilumab was unable to effectively treat AD in the head‐and‐neck area, and conjunctivitis was found in 25% of patients. [ABSTRACT FROM AUTHOR]
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- 2023
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40. Access to psoriasis treatment in Brazil and Chile: A cross-sectional multicentre Global Healthcare Study on Psoriasis.
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Maul, Julia-Tatjana, Fröhlich, Fabienne, Maul, Lara Valeska, Stunnenberg, Rieka, Valenzuela, Fernando, Cruz, Claudia De La, Vera-Kellet, Cristián, Armijo, Daniela, Cesar, Wagner G, Carvalho, Andre, Didaskalu, Johannes Alexander, Graf, Nicole, Egeberg, Alexander, Wu, Jashin J, Thyssen, Jacob P, Romiti, Ricardo, and Griffiths, Christopher E M
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PSORIASIS ,BODY surface area ,FISHER exact test ,CHILEANS ,BIOTHERAPY - Abstract
Background Sufficient data on access to systemic treatment for patients with psoriasis living in Latin America (LA) including Brazil and Chile are lacking. Understanding the availability and limiting factors of access to treatments can help to improve patient care and decrease long-term healthcare costs. Objectives In association with the Global Psoriasis Atlas, this cross-sectional survey study analysed the availability and insurance reimbursement of systemic treatments for adult patients with psoriasis in Brazil and Chile. Methods A multicentre, cross-sectional Global Healthcare Study on Psoriasis was performed in Brazil and Chile in 2020. For each eligible adult patient with psoriasis, doctors and nurses completed a 48-item questionnaire about clinical aspects of psoriasis including the Psoriasis Area Severity Index (PASI), body surface area (BSA) score and the Dermatology Life Quality Index (DLQI), as well as the availability of systemic treatments and insurance reimbursement status. Between-country differences were compared with Wilcoxon rank sum tests for continuous variables, and a χ
2 -test or Fisher's exact test, where appropriate, for categorical variables. The median and interquartile range (IQR) was calculated for non-normal distributed data. Results A total of 1424 patients with psoriasis from 43 centres [27 centres in Brazil (n = 826) and 16 in Chile (n = 598)], were included with a mean (SD) age of 49.1 (16.3) and 49.2 (15.1) years, respectively. Unstratified analyses revealed that patients with psoriasis in Chile had more severe disease than those in Brazil [PASI 11.6 vs. 8.4 (P < 0.001) and BSA 14.7 vs. 12.0 (P = 0.003), respectively]. For patients with moderate-to-severe psoriasis, defined as PASI and/or BSA ≥ 10, systemic nonbiologic drugs were available (81.2% in Brazil and 65.3% in Chile, P ≤ 0.001), but only 37.0% of patients in Brazil and 27.3% in Chile received biologics (P = 0.01). Lack of availability and/or lack of insurance reimbursement for biologic drugs for patients with moderate-to-severe psoriasis was reported for 22.2% (50 of 225) in Brazil and 67.9% (148 of 218) in Chile (P < 0.001). Patients with no access to biologic therapies due to lack of availability/insurance reimbursement had a median PASI of 9.15 (IQR 3.00–14.25) in Brazil and 12.0 (IQR 5.00–19.00) in Chile (P = 0.007), as well as a median BSA of 7.0 (IQR 3.00–15.00) and 12.0 (IQR 5.00–22.50) (P = 0.002), and median DLQI of 11.0 (6.00–15.00) and 21.0 (6.50–25.00) (P = 0.007), respectively. Conclusions Chilean patients had significantly more severe psoriasis compared with Brazilian patients in our study. While nonbiologic treatments for moderate-to-severe psoriasis were available in both LA countries, there is a high need for improvement in access to more effective psoriasis treatments including biologics. Our results highlight a significant gap between treatment recommendations in international psoriasis guidelines and real-world situations in Brazil and Chile. [ABSTRACT FROM AUTHOR]- Published
- 2023
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41. Short-term real-world experience with baricitinib treatment in Danish adults with moderate–severe atopic dermatitis.
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Vittrup, Ida, Elberling, Jesper, Skov, Lone, Ibler, Kristina Sophie, Jemec, Gregor B. E., Mortz, Charlotte G., Bach, Rasmus Overgaard, Bindslev-Jensen, Carsten, Dalager, Maiken Glud, Egeberg, Alexander, Kamstrup, Maria, Deleuran, Mette, Vestergaard, Christian, and Thyssen, Jacob P.
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ATOPIC dermatitis ,BARICITINIB ,ADULTS - Published
- 2023
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42. Use of methotrexate and risk of skin cancer: a nationwide case–control study.
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Polesie, Sam, Gillstedt, Martin, Schmidt, Sigrún Alba Jóhannesdóttir, Egeberg, Alexander, Pottegård, Anton, and Kristensen, Kasper
- Abstract
Background: Methotrexate (MTX) use has been suspected of increasing the risk of skin cancer. The aim of this investigation was to examine the association between the use of MTX and the risk of basal cell carcinoma (BCC), cutaneous squamous cell carcinoma (cSCC) and cutaneous malignant melanoma (CMM). Methods: In a nationwide Danish case–control study, we identified incident, histologically verified cases of BCC (n = 131,447), cSCC (n = 18,661) or CMM (26,068) from 2004 to 2018. We matched 10 controls to each case on sex and birth year using risk-set sampling and computed crude and adjusted odds ratios (ORs) using conditional logistic regression for the use of MTX (≥2.5 g) compared with never-use. Results: Use of MTX was associated with increased risk of BCC, cSCC and CMM with adjusted ORs of (95% confidence interval) 1.29 (1.20–1.38), 1.61 (1.37–1.89) and 1.35 (1.13–1.61), respectively. For BCC and cSCC, ORs increased with higher cumulative doses. When restricting the study population to patients with psoriasis, the ORs were 1.43 (1.23–1.67), 1.18 (0.80–1.74) and 1.15 (0.77–1.72), respectively. Conclusions: We observed an increased risk of BCC and cSCC associated with the use of MTX with evidence of a dose–response pattern; however, the association was not consistent when restricting the study population to patients with psoriasis. [ABSTRACT FROM AUTHOR]
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- 2023
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43. Exploring disease comorbidities and temporal disease progression of psoriasis: an observational, retrospective, multi-database, cohort study.
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Rosenø, Nana A L, Lørup, Erik Hillo, Richardson, Craig, Alarcon, Ivette, and Egeberg, Alexander
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PSORIASIS ,DISEASE progression ,ATRIAL flutter ,CROHN'S disease ,COHORT analysis - Abstract
Background Comorbidities associated with psoriasis are well documented. However, few studies have explored the comorbidity trajectories that patients with psoriasis commonly experience over time. This study reports the 5-year comorbidity trajectories of patients with psoriasis. Objectives To determine the long-term comorbidity trajectories of patients with psoriasis in Denmark. Methods This observational cohort study explored the Danish National Patient Registry (DNPR) between 1999 and 2013 to identify comorbidities diagnosed 5 years prior to or after a psoriasis diagnosis. Comorbidity occurrence in patients with psoriasis (psoriasis cohort) was compared with patients without psoriasis (the N group). Comparison groups, each the same size as the psoriasis cohort, were created by selecting random patients from the N group. If a comorbidity occurrence was higher in more than nine comparison groups than in the psoriasis cohort, it was not analysed and only comorbidities that occurred in ≥ 0·8% of the psoriasis cohort were analysed. The strength of association between a psoriasis diagnosis and a comorbidity diagnosis was measured using relative risk (RR). All psoriasis and comorbidity pairs that achieved RR > 1 (P < 0·001) (known as a Diagnosed Pair) were tested for directionality to identify the sequence of diagnoses using a binomial test. Diagnosed Pairs with a statistically significant direction (Bonferroni corrected P -value < 0·025) were then used to create comorbidity trajectory clusters 5 years before and after a psoriasis diagnosis. Results A total of 17 683 patients with psoriasis were compared with 10 000 comparison groups. A total of 121 comorbidities met the minimum criteria that ≥ 0·8% of the psoriasis cohort were diagnosed with the comorbidity within 5 years (before or after) of their psoriasis diagnosis. Thirty-eight of these comorbidities achieved RR > 1 (P < 0·001) with psoriasis, of which 19 achieved a significant direction from psoriasis to a comorbidity (including psoriasis to hypothyroidism), and four achieved a significant direction from a comorbidity diagnosis to a psoriasis diagnosis (including Crohn disease to psoriasis); four of five comorbidity trajectories with three sequential diagnoses achieved an RR > 1 (P < 0·001) and a significant direction from psoriasis to the first comorbidity to the second comorbidity (including psoriasis to hypertension to atrial fibrillation and flutter). Conclusions Comorbidity trajectories may support clinicians in conducting disease risk analyses of patients with psoriasis and help plan optimal treatment to prevent future high-risk comorbidities. [ABSTRACT FROM AUTHOR]
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- 2023
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44. The association between atopic dermatitis, cognitive function and school performance in children and young adults.
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Vittrup, Ida, Andersen, Yuki M F, Skov, Lone, Wu, Jashin J, Agner, Tove, Thomsen, Simon F, Egeberg, Alexander, and Thyssen, Jacob P
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YOUNG adults ,PERFORMANCE in children ,ATOPIC dermatitis ,SCHOOL children ,COGNITIVE ability ,INTELLIGENCE tests ,GIFTED children - Abstract
Background Children with atopic dermatitis (AD) may have disturbed sleep, affected self-esteem and decreased quality of life, likely interfering with performance in school. Objectives To examine the association between hospital-managed paediatric AD, school performance and cognitive function. Methods In this cross-sectional study we linked data from the Danish national registers and identified three populations between 2001 and 2019. Population 1 comprised children with graduation grades registered from lower secondary school, population 2 comprised adolescents with registration of an upper secondary graduation mean, and population 3 comprised male conscripts with registration of an IQ test score. AD was defined as a hospital diagnostic code (inpatient or outpatient) prior to the exam or conscription date, and was stratified according to severity, activity and atopic comorbidity. Outcomes included graduation mean from lower and upper secondary school, special educational assistance in primary and lower secondary school, and IQ at conscription. Results In total, 770 611 (12 137 with AD), 394 193 (6261 with AD) and 366 182 (4539 with AD) children and adolescents were included in populations 1 (lower secondary graduation), 2 (upper secondary graduation) and 3 (conscription), respectively. In lower secondary school, children with severe AD had significantly lower overall, written and oral graduation grade means compared with children with mild AD: respectively, difference −0.29 [95% confidence interval (CI) −0.45 to −0.13, P < 0.001], difference −0.26 (95% CI −0.42 to −0.10, P = 0.0016) and difference −0.30 (95% CI −0.49 to −0.11, P = 0.0018). In upper secondary school, adolescents with AD performed similarly to their peers without AD. Young men with AD scored significantly lower IQ test means at conscription examination than male conscripts without AD: difference −0.60 (95% CI −0.87 to −0.32, P < 0.001). Conclusions AD, in particular when severe, is associated with lower school performance in childhood and IQ in young men, which can interfere with academic achievements in life. Optimization of treatment of children with AD and specific educational support to children with severe AD could be needed. [ABSTRACT FROM AUTHOR]
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- 2023
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45. Skin biomarkers predict development of atopic dermatitis in infancy.
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Rinnov, Maria Rasmussen, Halling, Anne‐Sofie, Gerner, Trine, Ravn, Nina Haarup, Knudgaard, Mette Hjorslev, Trautner, Simon, Goorden, Susan M. I., Ghauharali‐van der Vlugt, Karen J. M., Stet, Femke S., Skov, Lone, Thomsen, Simon Francis, Egeberg, Alexander, Rosted, Aske L. L., Petersen, Troels, Jakasa, Ivone, Riethmüller, Christoph, Kezic, Sanja, and Thyssen, Jacob P.
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LIQUID chromatography-mass spectrometry ,ATOPIC dermatitis ,ATOMIC force microscopy ,INFANTS - Abstract
Background: There is currently no insight into biomarkers that can predict the onset of pediatric atopic dermatitis (AD). Methods: Nested in a prospective birth cohort study that examined the occurrence of physician‐diagnosed AD in 300 children, 44 random children with onset of AD in the first year of life were matched on sex and season of birth with 44 children who did not develop AD. Natural moisturizing factor (NMF), corneocyte surface protrusions, cytokines, free sphingoid bases (SBs) of different chain lengths and their ceramides were analyzed from tape strips collected at 2 months of age before onset of AD using liquid chromatography, atomic force microscopy, multiplex immunoassay, and liquid chromatography mass spectrometry, respectively. Results: Significant alterations were observed for four lipid markers, with phytosphingosine ([P]) levels being significantly lower in children who developed AD compared with children who did not (median 240 pmol/mg vs. 540 pmol/mg, p < 0.001). The two groups of children differed in the relative amounts of SB of different chain lengths (C17, C18 and C20). Thymus‐ and activation‐regulated chemokine (TARC/CCL17) was slightly higher in children who developed AD, whereas NMF and corneocyte surface texture were similar. AD severity assessed by the eczema area and severity index (EASI) at disease onset was 4.2 (2.0;7.2). [P] had the highest prediction accuracy among the biomarkers (75.6%), whereas the combination of 5 lipid ratios gave an accuracy of 89.4%. Conclusion: This study showed that levels and SB chain length were altered in infants who later developed AD, and that TARC/CCL17 levels were higher. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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46. A fragment of type VI collagen alpha-6 chain is elevated in serum from patients with atopic dermatitis, psoriasis, hidradenitis suppurativa, systemic lupus erythematosus and melanoma.
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Holm Nielsen, Signe, Port, Helena, Møller Hausgaard, Cecilie, Holm, Jesper Grønlund, Thyssen, Jacob P., Groen, Solveig Skovlund, Karsdal, Morten, Nielsen, Valdemar Wendelboe, Egeberg, Alexander, Bay-Jensen, Anne-Christine, and Thomsen, Simon Francis
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HIDRADENITIS suppurativa ,SYSTEMIC lupus erythematosus ,ATOPIC dermatitis ,PSORIASIS ,MONOCLONAL antibodies ,FILAGGRIN ,COLLAGEN - Abstract
Extracellular matrix (ECM) remodeling of the skin is a continuous process necessary for maintaining tissue homeostasis. Type VI collagen (COL6) is characterized as a beaded filament, located in the dermal ECM, where COL6-α6-chain has been demonstrated upregulated in atopic dermatitis. The aim of this study was to develop and validate a competitive ELISA, targeting the N-terminal of COL6-α6-chain, named C6A6, and evaluate its associations with the dermatological condition's atopic dermatitis, psoriasis, hidradenitis suppurativa, systemic lupus erythematosus, systemic sclerosis, urticaria, vitiligo, and cutaneous malignant melanoma in comparison, to healthy controls. A monoclonal antibody was raised and employed in an ELISA assay. The assay was developed, technically validated, and evaluated in two independent patient cohorts. Cohort 1 showed C6A6 was significantly elevated in patients with atopic dermatitis (p < 0.0001), psoriasis (p < 0.0001), hidradenitis suppurativa (p = 0.0095), systemic lupus erythematosus (p = 0.0032) and melanoma (p < 0.0001) compared to healthy donors. Cohort 2 confirmed C6A6 being upregulated in atopic dermatitis compared to healthy controls (p < 0.0001), but also associated with disease severity (SCORAD, p = 0.046) and lowered in patients receiving calcineurin inhibitors (p = 0.014). These findings are hypothesis generating, and the utility of the C6A6 biomarker for disease severity and treatment response needs to be validated in larger cohorts and longitudinal studies. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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47. Development and internal validation of a diagnostic prediction model for psoriasis severity.
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Liljendahl, Mie Sylow, Loft, Nikolai, Egeberg, Alexander, Skov, Lone, and Nguyen, Tri-Long
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- 2023
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48. A systematic review investigating at what proportion clinical images are shared in prospective randomized controlled trials involving patients with psoriasis and biological agents.
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Polesie, Sam, Alinaghi, Farzad, and Egeberg, Alexander
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RANDOMIZED controlled trials ,PATIENTS' attitudes ,DIAGNOSTIC imaging ,PSORIASIS ,MEDICAL offices - Abstract
For many patients including those with psoriasis, scientific manuscripts comprising clinical outcomes including psoriasis area severity index (PASI) and/or physician global assessment (PGA) may be difficult to understand. However, most patients can relate to images at baseline and follow-up, particularly for dermatological diseases. This study aimed to assess the proportion of shared clinical images in psoriasis trials. A systematic review adhering to the PRISMA guidelines was performed. The review was limited to randomized controlled trials, and among these, only investigations involving biological agents for treatment of psoriasis were included. The Embase, MEDLINE and Scopus databases were searched for eligible studies published from inception to October 26, 2021. In total, 152 studies were included. When combining these, 62,871 patients were randomized. Overall, 203 images were shared depicting 60 patients in the manuscripts yielding an overall sharing rate of 0.1%. Patient images are seldom incorporated in clinical trial manuscripts which impairs interpretation for patients. Inclusion of image material would strengthen the patients' perspective and understanding on what treatment effects that can be expected. As such, this systematic review should be an invitation to the pharmaceutical industry, other sponsors, and editorial offices to improve easy transfer of information to patients using image data. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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49. Network meta-analyses comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis at 24–28 and 48–52 weeks.
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Egeberg, Alexander, Kristensen, Lars Erik, Puig, Luis, Rich, Phoebe, Smith, Saxon D., Garrelts, Alyssa, See, Kyoungah, Holzkaemper, Thorsten, Fotiou, Konstantinos, and Schuster, Christopher
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PSORIASIS ,LOGISTIC regression analysis ,BIOLOGICALS ,ADALIMUMAB - Abstract
Available network meta-analyses (NMAs) comparing the efficacy of biologics in nail psoriasis (NP) have not included recently approved biologics such as bimekizumab nor have they provided comparisons up to 1 year. We conducted two NMAs that update and extend results from a previous NMA comparing biologics for achieving complete resolution of NP. Bayesian NMAs were performed using a generalized linear model with a logit link to model the binary outcome of nail clearance at weeks 24–28 and 48–52. For the NMA at weeks 24–28, which included seven biologics and placebo, the absolute probability of achieving complete resolution of NP was highest for ixekizumab (46.4%; 95% credibility interval [CrI] 35.2–58.0), followed by brodalumab (37.1%; 95% CrI 17.1–62.2) and bimekizumab (30.3%; 95% CrI 12.7–53.9). For the NMA at weeks 48–52, which included six biologics, the absolute probability was highest for ixekizumab (77.2%; 95% CrI 51.1–93.4), followed by adalimumab (75.6%; 95% CrI 61.5–87.3) and brodalumab (71.9%; 95% CrI 38.4–93.2). Among biologics included in these two NMAs, ixekizumab has the highest absolute probability of achieving complete resolution of NP. Results may help to inform treatment decisions for patients with NP. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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50. Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest.
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Egeberg, Alexander, Jullien, Denis, Gaarn Du Jardin, Kristian, and Thaçi, Diamant
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CLINICAL trials ,SPECIAL events ,MAJOR adverse cardiovascular events ,PATIENT safety ,PSORIASIS - Abstract
Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur. Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis (n = 1800). PSOLAR registry was used as safety reference data for NNH estimation. Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg). Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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