Journal of Dermatological Treatment

Objective: Patients with atopic dermatitis (AD) have low treatment satisfaction. In this study, we evaluated the humanistic burden, treatment satisfaction, and treatment expectations in patients with AD in the United States. Methods: Adults with AD recruited through the National Eczema Association and clinical sites completed a web-based survey comprising the Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), Dermatology Life Quality Index; Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis; Treatment Satisfaction Questionnaire for Medication (TSQM); and answered questions on healthcare provider visits, treatment history, and treatment goals. Descriptive analyses were performed to compare participants by severity. Results: Among 186 participants (mean [standard deviation] age 39.7 [15.3] years, 79.6% female), 26.9%, 44.6%, and 26.3% of the participants had mild, moderate, or severe AD, respectively based on PO-SCORAD. Greater disease severity was associated with a greater impact on work and daily life, decreased TSQM scores, and increased healthcare provider visits. Corticosteroid topical cream or ointment (53.8%) and oral antihistamines (31.2%) were most commonly used for the treatment of AD. Participants reported declining/stopping/changing AD treatment due to the potential for side effects or lack of efficacy. "Leading normal lives" (28.0%) and "being itch-free" (33.9%) were important treatment goals. Conclusion: Individuals with AD, especially severe disease, face a considerable humanistic burden even while using treatment.

Drug tolerability and drug safety are sometimes used interchangeably, but they represent somewhat different concepts. This editorial examines the differences between drug tolerability and safety. A literature search was conducted on MEDLINE (PubMed) to assess the differences between drug tolerability and safety. Drug tolerability is predominantly dependent on patients' subjective experiences, whereas drug safety is determined by a carefully regulated process based on objective measures. For a drug to be useful, it must be tolerable and safe.

Dupilumab is a monoclonal antibody that selectively targets the alpha subunit of the interleukin-4-Receptor and it is approved for the treatment of atopic dermatitis in adults, children and adolescents. Real life data on effectiveness and safety of dupilumab in adolescents are limited. In this study, 30 patients who started dupilumab between the ages of 12 and 18 were evaluated. All patients completed at least 16 weeks of therapy, with 25 reaching week 52. In our experience, the mean Eczema Area and Severity Index decreased from 23.25 ± 4.15 at baseline to 2.06 ± 1.99 at week 52.

Background Long-term real-life data on secukinumab use in psoriasis are limited. Objectives Determine the long-term effectiveness of secukinumab in moderate-to-severe psoriasis in real-life. Methods Multicenter retrospective study analyzing data from adult patients treated with secukinumab for at least 192 weeks and up to 240 weeks in Southern Italy, between 2016 and 2021. Clinical data, including concurrent comorbidities and prior treatments were collected. Effectiveness was assessed by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) scores at the initiation of secukinumab and at weeks 4, 12, 24, 48, 96, 144, 192, and 240. Results 275 patients (174 males), mean age 50.80 ± 14.78 years, were included; 29.8% had an uncommon localization, 24.4% psoriatic arthritis, 71.6% comorbidities. PASI, BSA, and DLQI improved significantly from week 4, and continued to improve over time. Between week 24 and 240, PASI score was mild (≤10) in 97–100% of patients, 83–93% had mild affected BSA (BSA ≤3), and 62–90% reported no effect of psoriasis on their quality of life (DLQI 0-1). Only 2.6% of patients reported adverse events and no patient discontinued the treatment during the study period. Conclusions Secukinumab effectiveness in the long-term treatment of psoriasis is confirmed in real-world.

Background: Topical medication is the mainstay for treatment of mild psoriasis. However, dissatisfaction with topicals is common and rates of non-adherence are high. Assessing patients' perspectives can help to identify unmet needs. Objective: Our aim was to investigate satisfaction of patients with psoriasis with topical therapy and to determine influencing factors. Methods: Patients were recruited from the Department of Dermatology, University Medical Center Mannheim, Germany. Satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication version 1.4 with the domains effectiveness, side effects, convenience, and global satisfaction (scale 0-100 each). The impact of sociodemographic and disease characteristics was determined by multivariate regression. Results: Averaged across the cohort (n = 122, mean age 52.5 years, 58.2% male), the side effects domain had the highest mean satisfaction score (89.7), followed by convenience (72.5), global satisfaction (60.8) and effectiveness (55.0). Comparing specific medications, combinations of corticosteroids and vitamin D analogues were rated best in effectiveness. Treatment satisfaction was influenced by age, partnership, ability to apply topicals independently, disease-related quality-of-life impairment, sole or adjunctive use of topicals and pruritus. Conclusions: Participants were particularly satisfied with safety but rather dissatisfied with effectiveness of topicals. Topical therapy should be adapted to individual needs with special attention to effectiveness.

Aim To compare real-world dose escalation of risankizumab with other US Food and Drug Administration (FDA)-approved biologic treatments for management of moderate-to-severe psoriasis (PsO) in the United States. Methods The Merative® MarketScan® Research Database was used to identify adults with ≥2 medical claims for PsO, ≥3 claims of the index biologic medication in the maintenance period, and ≥6 months continuous enrollment pre-induction and ≥6 months after initiation of the maintenance period. Dose escalation was defined as ≥2 dosing intervals where the average daily dose was ≥30% higher than the expected daily dose (per FDA-approved dosing). Comparisons between risankizumab and other cohorts were made using chi-square tests and logistic regression models. Results At the 30% threshold, the percentage of patients with dose escalation in the full maintenance period was significantly lower with risankizumab (2.0%) compared with other drug classes (tumor necrosis factor, interleukin (IL)-12/23, IL-17, or other IL-23 inhibitors: 17.6%, 10.0%, 18.3%, or 7.1%, respectively; p < 0.0001 for each) and individual biologics (adalimumab, ustekinumab, secukinumab, ixekizumab, and guselkumab; 17.9%, 10.0%, 15.7%, 18.0%, and 7.2%, respectively; p < 0.0001). Conclusion A significantly lower proportion of risankizumab-treated patients with PsO had dose escalations compared with patients treated with other biologics.

Aim: This study aimed to evaluate the efficacy and safety of bimekizumab for psoriasis. Methods: The PubMed, Web of Science, Cochrane Library, and Embase databases were systematically searched until November 20, 2022, to identify randomized controlled trials (RCTs) reporting the efficacy and safety of bimekizumab. The identified studies were screened according to inclusion and exclusion criteria, and a meta-analysis was performed on the selected studies using the Stata (version 17.0) software to investigate the efficacy and safety of bimekizumab. Results: Six studies involving 1252 participants were considered. Compared with the control group which received placebo, the bimekizumab group had a larger number of patients with improvement in Psoriasis Area and Severity Index (PASI) of at least 75% (PASI75) (RR: 20.54, 95%CI: 12.41-33.99; P= 0.000), at least 90% (PASI90) (RR:16.99, 95%CI: 7.09-40.68; P = 0.000) and 100%(PASI100) (RR:14.57; 95%CI: 5.26-40.35; P = 0.000) and a larger number with improvement in Investigator Global Assessment (IGA) response (RR:22.57; 95%CI: 12.74-39.98;P = 0.000). There was no obvious difference between the bimekizumab and placebo groups in treatment of emergent adverse events (TEAEs) (RR:1.17; 95%CI: 0.93-1.47;P > 0.05) and serious TEAEs (RR: 0.67; 95%CI: 0.28-1.61;P> 0.05). Conclusions: Bimekizumab shows promising efficacy for the treatment of psoriasis with favorable safety records.

Since the worldwide spreading COVID-19 pandemic from early 2020 onwards, several cutaneous manifestations of SARS-CoV2 infection have been described. Similarly, with the start of the global vaccination campaign, reports of new onset or exacerbation of inflammatory dermatoses have been reported. In particular, numerous case reports of psoriasis flares after COVID-19 infection and/or vaccination have recently been published. Our study aimed to evaluate the effectiveness and safety of anti-interleukin (IL) biologic drugs for the treatment of severe flares of psoriasis following COVID-19 infection or vaccination. Twenty-eight patients with a diagnosis of moderate-to-severe psoriasis following COVID-19 infection or vaccination or patients with a severe flare of previously untreated mild plaque psoriasis, all treated with biologics, were enrolled in this study. After 16 weeks of treatment, the mean Psoriasis Area and Severity Index decreased from 13.65 to 0.77, with 16 patients (57.14%) achieving complete skin clearance. In our study, we underline a high-effectiveness profile of different biological drugs in treating psoriasis flares induced by COVID-19 vaccination and/or infection. Our data support the role of biologics in preventing severe flares of psoriasis despite possible concomitant inflammatory triggers, such as infections or vaccines.

Patients who completed the originating studies, BREEZE-AD1 (NCT03334396), BREEZE-AD2 (NCT03334422), and BREEZE-AD7 (NCT03733301), were eligible for enrolment in the multicentre, phase 3, long-term extension study BREEZE-AD3 (NCT03334435). At week 52, responders and partial responders to baricitinib 4 mg were re-randomized (1:1) into the sub-study to dose continuation (4 mg, N = 84), or dose down-titration (2 mg, N = 84). Maintenance of response was assessed from week 52 to 104 of BREEZE-AD3. Physician-rated outcomes included vIGA-AD (0,1), EASI75, and mean change from baseline in EASI. Patient-reported outcomes included DLQI, POEM total score, HADS, and from baseline: WPAI (presenteeism, absenteeism, overall work impairment, daily activity impairment) and change from baseline in SCORAD itch and sleep loss. With continuous treatment with baricitinib 4 mg, efficacy was maintained up to week 104 in vIGA-AD (0,1), EASI75, EASI mean change from baseline, SCORAD itch, SCORAD sleep loss, DLQI, POEM, HADS, and WPAI (all scores). Patients down-titrated to 2 mg maintained most of their improvements in each of these measures. The sub-study of BREEZE AD3 supports flexibility in baricitinib dosing regimens. Patients who continued treatment with baricitinib 4 mg and down-titrated to 2 mg maintained improvements in skin, itch, sleep, and quality of life for up to 104 weeks.

Background Dose reduction (DR) of adalimumab, etanercept and ustekinumab has proven to be (cost-)effective in psoriasis patients with low disease activity. Further implementation is needed to establish application of DR for eligible patients. Objectives To evaluate implementation of protocolized biologic DR in daily practice. Methods A pilot implementation study was performed in 3 hospitals during 6 months. By combining education and protocol development, involved healthcare providers (HCPs) were directed towards adoption of protocolized DR. DR of adalimumab, etanercept, and ustekinumab was achieved by stepwise injection interval prolongation. Implementation outcomes (fidelity, feasibility) were assessed. Factors for optimizing implementation were explored in interviews with HCPs. Uptake was measured in patients by chart review. Results The implementation strategy was executed as planned. Implementation fidelity was less than 100% as not all provided tools were used across study sites. HCPs indicated feasibility of implementing protocolized DR, although time-investment was needed. Identified additional factors for successful implementation included support for patients, uptake of DR into guidelines, and supportive electronic health record systems. During the 6 months intervention period, 52 patients were eligible for DR of whom 26 (50%) started DR. The proposed DR protocol was followed in 22/26 patients (85%) on DR. Conclusion Additional staff for support, extra time during consultations, education on DR for HCPs and patients, and effective tools such as a feasible protocol can lead to more patients on biologic DR.

Background: Platelet-rich plasma (PRP) is an adjunctive treatment in androgenetic alopecia (AGA). Its role as a monotherapy, when compared to FDA-approved therapies in moderate grades of androgenetic alopecia is not established. Objectives: We sought to study the efficacy and safety of standardized non-activated PRP preparation against topical minoxidil in AGA. Methods: Men aged 20-50 with Grade III and IV (Modified Hamilton-Norwood) AGA were randomized to receive 5% Minoxidil (x6 months) or PRP injections (monthly x3). The primary endpoints were global photographic assessment at week 24, change in target area hair counts, density, and anagen hair at week 12. Other outcomes were subjects' satisfaction and adverse events. Results: In total, 64 participants were randomized. At week 24, 56% responded to Minoxidil arm and 38% to PRP (p= 0.124). There was a significant increase in target area hair count and density at week 12 within the groups. The difference between the groups was not statistically significant. Adverse events occurred in 53% and 37% of the PRP and minoxidil groups, respectively. Patient satisfaction was better with Minoxidil. Conclusion: PRP is effective in the treatment of moderate grades of androgenetic alopecia in men, although perhaps not different from minoxidil. Side effects occur more frequently with PRP.

Since silicone is a permanent filler, inflammatory reactions can occur even several years after its injection. Clinical and pathologic features of silicone granulomatous reaction (SG) are variable. Delayed granulomatous reactions to non-biodegradable fillers are often refractory to treatment. Pathogenesis of SG formation remains unclear. Immunologic cross-reaction with T-cell and macrophage activation with release of cytokines, such as interferon gamma and tumor necrosis factor alpha (TNF-α) have been proposed. This may be triggered by a granulomatous response to secondary-site events. Adalimumab is an IgG1 monoclonal antibody whose origin is completely human. It has demonstrated efficacy and safety in the treatment of other granulomatous skin diseases. Nevertheless, the role of anti-TNF drugs in the treatment of SG remains barely understood. In the literature, etanercept has been shown to be effective in two cases of factitial panniculitis. Herein, we report a case of granulomatous foreign body reaction to cosmetic filler treated with adalimumab with complete clinical response maintained over time, fact, to our knowledge, not previously reported in the literature. Both the initial rapid response and the favorable therapeutic duration were similar to those of the best therapeutic options reported. Consequently, anti-TNF therapy could be an interesting option for managing this entity.

Objectives: To describe the results of a structured literature review of real-world outcomes with ixekizumab in patients with psoriasis (PsO) and/or psoriatic arthritis (PsA). Methods: Literature databases, conference proceedings and additional sources were searched for relevant publications. Real-world studies of ≥25 ixekizumab-treated patients with PsO and/or PsA were included. Data on clinical effectiveness, treatment persistence/patterns, economic outcomes, patient-reported outcomes (PROs) and safety were extracted. Results: Fifty-one publications were included. Most studies focused on patients with PsO, and the number of publications with a focus on PROs was low. Studies of treatment patterns found that in general, ixekizumab had similar or better persistence versus other biologics, and rates or risk of switching similar to or less than comparator drugs. Adherence to ixekizumab was high, and patients were less likely to discontinue ixekizumab than other biologics. Ixekizumab was effective in the real world, with a safety profile consistent with that reported in clinical trials. Conclusions: Real-world use of ixekizumab in PsO and PsA is effective and safe, with generally high treatment persistence and adherence. Further work is required to determine the impact of ixekizumab on PROs in PsO, and to gather more data on real-world use of ixekizumab in PsA.

Background: The risk of SARS-CoV-2 infection does not appear to be increased for psoriasis patients using biologics compared to those on other treatments, but evidence is still limited. Objectives: (1) to estimate the prevalence of SARS-CoV-2 infection in patients with psoriasis, (2) to compare SARS-CoV-2 infection rates for different psoriasis treatments groups (biologic vs. systemic conventional vs. topical therapy) corrected for confounders and (3) to describe patients with severe COVID-19 for all treatment groups. Methods: In this cross-sectional cohort study all patients received a questionnaire to gather data on psoriasis treatment, SARS-CoV-2 infections and related risk factors. Simultaneously, they underwent a blood test to screen for antibodies to SARS-CoV-2 N-antigen. Prevalence of SARS-CoV-2 infections was calculated and logistic regression and Cox proportional-hazards models were performed to determine the association between treatment group and SARS-CoV-2 infection risk, corrected for confounders. Patients with severe COVID-19 disease were described and the mortality rate per treatment group was calculated for the target population. Results: Patients were included between April 12, 2021 and October 31, 2021. Of 551 patients, 59 (10.7% (CI95% 8.3-13.6)) had experienced a SARS-CoV-2 infection, based on questionnaire data combined with serological data. In our study cohort, corrected for confounders, biologic or non-biologic systemic therapy users did not appear to have increased SARS-CoV-2 infection risk compared to patients using other treatment. Only 4 hospitalizations (0.7% (CI95% 0.2-1.0) were reported in our study population and no ICU admissions were reported. The rough mortality rate in the target cohort was 0.32% (CI95% 0.13-0.66) in all treatment groups. Conclusions: Corrected for risk-mitigating behaviour and vaccination status, a higher SARS-CoV-2 incidence for biologics or non-biologics systemics compared to other treatments could not be proven. Severe cases were infrequent in all treatment groups. This finding further strengthens treatment recommendations that systemic therapies for patients with psoriasis do not require preventive cessation for reduction of SARS-CoV-2 infection risk.

Background Dose reduction of biologics for psoriasis is applied in daily practice, although guidelines are lacking. Striving for clear criteria is important, as it leads to consistent application of dose reduction.Objective To achieve consensus on criteria for biologic dose reduction in psoriasis patients with stable and low disease activity.Methods An online Delphi procedure (eDelphi) was conducted. Dutch dermatologists were invited to participate in a maximum of 3 voting rounds. Proposed statements were selected based on literature review and included criteria for application of dose reduction and dosing schedules. Biologic dose reduction was defined as 'application of injection interval prolongation'. Proposed statements were rated using a 9-point Likert scale; consensus was reached when ≥70% of all voters rated 'agree' (7-9) and <15% rated 'disagree' (1-3).ResultsA total of 27 dermatologists participated and reached consensus on 15 recommendations over 2 voting rounds. Agreed statements included criteria for dose reduction eligibility, criteria for dose reduction (dis)continuation, and dosing schedules for adalimumab, etanercept, and ustekinumab. Based on the eDelphi outcomes, an algorithm fit for implementation in current practice was developed.Conclusions Recommendations of this national consensus process can guide clinicians, and consequently their patients, towards consistent application of biologic dose reduction.

Background Excessive sebum production is a factor in acne development. Tazarotene 0.045% lotion has demonstrated reductions in acne lesions and acne-induced sequalae. Objective Evaluate efficacy, changes in skin oiliness, and safety with tazarotene 0.045% lotion in participants with moderate-to-severe acne and oily skin. Methods In two phase 3, double-blind, 12-week studies (NCT03168321; NCT03168334), participants aged ≥9 years with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene 0.045% lotion or vehicle lotion (N = 1,614). This pooled, post hoc analysis included only participants self-categorized with oily skin at baseline on the Acne Quality of Life questionnaire item 19 (scores: 0 [extremely oily] to 6 [not at all oily]). Inflammatory/noninflammatory lesion counts, treatment success, skin oiliness, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were evaluated. Results In all participants with oily skin (n = 793), tazarotene provided greater reductions in inflammatory/noninflammatory lesions (P < 0.001, both) and greater treatment success rates versus vehicle (P < 0.01) at week 12. Over two-thirds of polymeric lotion-treated participants had subjective skin oiliness reductions by week 12, with around a third reporting ‘low/not’ oily skin. Tazarotene TEAE rates were similar to the overall population. Conclusion Once-daily treatment with tazarotene 0.045% polymeric emulsion lotion may help improve patient-perceived skin oiliness in those with moderate-to-severe acne.

Objectives To evaluate the preoperative and postoperative survivin [an apoptosis inhibitor (IAP) protein] peripheral blood levels and C-Reactive Protein (CRP), in patients with basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), in an effort to identify their potential role as diagnostic and prognostic biomarkers. Methods Measurement of survivin protein and CRP was performed, preoperatively and 15 days post-surgery along with the evaluation of any age or gender association, in non-melanoma skin cancer patients. Results Results showed no correlation of survivin and CRP levels in peripheral blood, to BCC or SCC, before and after surgical excision. Additionally, our findings confirm the early onset of BCC in patients above 50 years of age along with the appearance of SCC, even later in life. No gender association was established. Conclusions These results provide a first evaluation of the potential use of CRP and survivin from serum samples, as potential prognostic and diagnostic biomarkers for BCC and SCC. A larger scale analysis, involving a higher number of patients with non-melanotic cancers, that would also include skin biopsies, can substantiate the results from the present pilot study.

Background: CJM112 is a potent anti-IL-17A monoclonal antibody, whose clinical efficacy in psoriasis was recently documented. This study aimed to assess the effect of IL-17A blockade, using CJM112, in patients with moderate to severe acne. Methods: A randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study was conducted on patients with moderate to severe acne. Patients received CJM112 300 mg, 75 mg, or placebo subcutaneously during Treatment Period1 (0-12 weeks). Patients receiving placebo were re-randomized to receive CJM112 300 mg or 75 mg during Treatment Period 2 (12-24 weeks). The primary endpoint was the number of inflammatory facial lesions at Week 12. Results: As the futility criterion was met during the interim analysis, only 52/75 (69.3%) patients were recruited. In total, 48/52 (92.3%) and 26/41 (63.4%) completed Treatment Periods 1 and 2, respectively. All groups exhibited a reduction in facial inflammatory lesions, with no difference observed between CJM112 and placebo (CJM112 300 mg 27.6 ± 20.7; CJM112 75 mg 30.4 ± 34.8; placebo 23.6 ± 13.6; primary endpoint). Additionally, no differences were observed between groups in other secondary and exploratory endpoints at Week 12. Conclusions: Anti-IL-17A therapy was not significantly different compared to the placebo in reducing inflammatory lesions in patients with moderate to severe acne.

Tumor necrosis factor (TNF) inhibitors improved clinical outcomes for patients with psoriasis but are limited by their high cost. There are several biosimilar options approved for the treatment of psoriasis which provide a lower cost alternative and the potential to increase treatment availability for both biologically naïve and bioexperienced patients. Numerous phase III randomized controlled trials (RCTs) have investigated the effects of switching from biologics to biosimilars; biosimilars had comparable safety and efficacy to their reference products. Real-world evidence may provide complementary information on the expected performance of biosimilars. We analyzed data from real-world studies on switching from biologics for psoriasis to their biosimilars. Efficacy and safety profiles were comparable when switching from biologics to biosimilars of adalimumab, etanercept, and infliximab. These studies are limited by their sample sizes, duration of follow up, and single arm designs without control groups. Based on available real-world evidence, patients may safely and effectively undergo switching to biosimilar therapies for the treatment of psoriasis.

Objectives The objective of this systematic review was to evaluate the efficacies of different biologic therapies in treating TNFα-induced paradoxical psoriasis (PXP) and controlling inflammatory bowel disease (IBD) symptoms. Methods We conducted a literature search of the Ovid EMBASE, Ovid Medline, Web of Science Core Collection, and Cochrane Central Register of Controlled Trials databases from their inception to October 3, 2021. We considered all peer-reviewed, randomized controlled trials, chart reviews, and observational studies that discussed the TNFα-induced PXP treatment outcomes in IBD patients of switching to different biologic therapies. Results Switching to ustekinumab (UST) resulted in complete or partial resolution of TNFα-induced PXP in 83.1% of patients (74 out of 89 patients), while switching to either vedolizumab (VDZ) or secukinumab led to complete resolution in 100% of patients (8 out of 8 patients). 75.4% of patients who were switched to UST remained in IBD remission, 4.6% in partial remission, and 20.0% in flare of IBD. Conclusions UST has the sufficient data to demonstrate the efficacy in treating TNFα-induced PXP and controlling IBD symptoms concurrently. More data is needed to validate the efficacies of VDZ and SEC in treating TNFα-induced PXP in IBD patients.

Background Clinical trials have shown promising results for interleukin-23 inhibitors in the treatment of psoriasis. The drugs have been used in clinical practice since 2017. Objective To investigate the drug survival and effectiveness of interleukin-23 inhibitors in the treatment of psoriasis and psoriatic arthritis in a real-world setting. Methods The study was a retrospective analysis of patients treated with either guselkumab, tildrakizumab or risankizumab at the Department of Dermatology, Aarhus University Hospital, during the period from June 11, 2018, to July 14, 2021. Results A total of 80 patients were included. During the study, 19 patients discontinued treatment with an interleukin-23 inhibitor, and mean treatment duration (SD) was 61.4 weeks (43.7). Seventy-six patients (95%) had previous use of ≥1 biologic. One-year drug survival was 81.0%. Among patients, 64.3% achieved a PASI ≤2 at weeks 12-17; 61.3%, at weeks 40-60. There was no statistically significant difference between the drugs regarding the chance of achieving PASI ≤2 (P > .05). Twenty-two patients (27.5%) had psoriatic arthritis. Among these, 40.9% and 36.4% achieved complete remission and partial remission, respectively. Conclusions Interleukin-23 inhibitors appear to have high and similar drug survival and effectiveness in patients with difficult-to-treat psoriasis and psoriatic arthritis.

2020): Effect of narrow-band ultraviolet B phototherapy, methotrexate, and combined narrow-band ultraviolet B phototherapy with methotrexate on serum cathelicidin and vitamin D in patients with psoriasis vulgaris, Journal of Dermatological Treatment, ABSTRACT Objective: This study aimed to evaluate the efficacy of narrow-band ultraviolet B (NB-UVB) photother-apy, methotrexate, and combined NB-UVB phototherapy with methotrexate in the treatment of psor-iasis vulgaris and to assess their effects on serum cathelicidin and vitamin D. Methods: This study was conducted on 60 patients with psoriasis vulgaris. They were divided into three groups (20 patients each); Group (A) was treated with NB-UVB phototherapy. Group (B) was treated with methotrexate. Group (C) was treated with combined NB-UVB phototherapy with metho-trexate. Patients were assessed with Psoriasis Area and Severity Index (PASI score), serum cathelicidin and vitamin D at the first visit and after three months of treatments. Results: The highest mean PASI score percent improvement was reported in the combined NB-UVB phototherapy with methotrexate (92%). There was a significant increase in serum vitamin D after treatments with NB-UVB phototherapy and combined NB-UVB phototherapy with methotrexate (p < .001). There was a significant decrease in cathelicidin after three months of treatment with combined NB-UVB phototherapy with methotrexate (p < .01). Conclusion: This study could contribute to the hypothesis considering the role of cathelicidin and vitamin D in the pathogenesis of psoriasis. The combined NB-UVB phototherapy with methotrexate had the highest clinical improvement of psoriasis vulgaris. ARTICLE HISTORY

Background Methotrexate (MTX) is a systemic treatment for plaque-type psoriasis. At the time of approval, no dose-ranging studies were performed. Nowadays, a uniform dosing regimen is lacking. This might contribute to suboptimal treatment with the drug. Objective To summarize the literature involving the MTX dosing regimens in psoriasis patients. Methods In this SR, RCTs and documents with aggregated evidence (AgEv) on the MTX dosing regimen in psoriasis were summarized. All randomized controlled trials (RCTs) in which oral, subcutaneous or intramuscular MTX was used in patients with psoriasis and AgEv, were included. The MEDLINE, EMBASE and CENTRAL databases were searched up to June 20, 2022. This SR was registered in PROSPERO. Results Thirty-nine RCTs had a high risk of bias. Test dosages were given in only 3 RCTs. In the RCTs, MTX was usually prescribed in a start dose of 7.5 mg/week (n = 13). MTX was mostly given in a start dose of 15 mg/week, in the AgEv (n = 5). One guideline recommended a test dose, in other aggregated evidence a test dose was not mentioned or even discouraged. Conclusions There is a lack of high-quality evidence and available data for dosing MTX in psoriasis is heterogeneous.

Objective To describe real-world baseline characteristics and patient-reported outcomes (PROs) at 6- and 12-month follow-up visits among patients with psoriasis who initiated and maintained secukinumab, stratified by prior exposure to biologics. Methods This real-world study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry who initiated and maintained secukinumab through 6- and/or 12-month follow-up. Demographics, clinical characteristics, and PROs were collected. PROs included Dermatology Life Quality Index (DLQI); itch, skin pain, fatigue, and EuroQol visual analog scales; and Work Productivity and Activity Impairment. Mean (SD) differences between baseline and follow-up visits were calculated for all outcomes. Results Overall, 652 patients had a 6-month follow-up visit, 460 (70.6%) were biologic experienced and 192 (29.4%) were biologic naive. Biologic-experienced and biologic-naive patients reported mean (SD) improvements in all PROs measured at 6-month follow-up. Similar improvements were seen among patients with a 12-month follow-up visit (n = 390) and both 6- and 12-month follow-up visits (n = 326). Conclusions Biologic-experienced and biologic-naive patients with psoriasis who initiated and maintained secukinumab treatment reported improvements in PROs at 6- and/or 12-month follow-up visits. These findings suggest that secukinumab is a potential biologic for psoriasis at any point along the patient treatment journey.

Objective To assess the real-world clinical treatment outcomes with brodalumab in patients with moderate-to-severe plaque psoriasis in Greece. Materials and methods This was a longitudinal, retrospective, real-world analysis of data from medical records of 106 patients with moderate-to-severe plaque psoriasis, treated with brodalumab for up to 24 months at four University Dermatology Centers in Greece. Efficacy assessments of psoriasis severity [Psoriasis Area and Severity Index (PASI) and Body Surface Area affected (BSA) scores] and its impact on patients’ quality of life (QoL) [Dermatology Life Quality Index (DLQI) score] were evaluated at different timepoints up to 24 months. Results Treatment with brodalumab reduced both mean PASI (14.0–1.5, p < .001) and BSA scores (21.6–2.5, p < .001) across all visits. This effect was accompanied by reduction in mean DLQI score (12.8–2.1, p < .001) across all visits compared with baseline. Moreover, therapeutic efficacy was affected by prior biologic treatment exposure, as biologic naïve patients had greater reductions in all scores from baseline following treatment with brodalumab (numerical for mean PASI, significant for mean BSA and DLQI scores). Conclusion Brodalumab is effective long term, improving disease severity and health-related QoL in patients with moderate-to-severe plaque psoriasis in a real-world setting.

Objectives Fumaric acid esters (FAEs) are a well-established treatment option for long-term therapy of moderate to severe plaque psoriasis. This study examines effectiveness of FAEs for the treatment of plaque psoriasis in real-world practice at 12 months and if patient characteristics affect the odds of clinical response. Methods A descriptive, multivariable logistic regression analysis was conducted in a cohort drawn from the German registry PsoBest. Baseline patient characteristics were assessed as potential treatment effect modifiers. Results 444 patients (mean age 47.0 years, 39.0% female) were eligible for response analysis using nonresponder imputation at month 12. Of these, 39.6% achieved clinical response, i.e., Psoriasis Area and Severity Index (PASI) ≤3 or skin clearance. In logistic regression analysis (R² = 0.114), only baseline PASI was a significant factor: patients with PASI <10 had a 4 times higher odds (p ≤ 0.001, OR 4.088), patients with PASI of 10–20 a twofold higher odds of response (p ≤ 0.044, OR 1.961) compared to those with PASI >20. Neither sex, age, body weight, disease duration, comorbidity nor pre-treatment had an impact on the odds of response (p > 0.05). Conclusions FAEs showed a favorable response at 12 months, largely independent of patient characteristics.

Biologics may elicit the production of anti-drug antibodies (ADAs), the clinical significance of which is not fully understood. ADA development in psoriasis patients on IL-17 inhibitors was evaluated by incidence, impact on efficacy, and relationship with adverse events. We systematically searched PubMed, Cochrane, and Embase databases, identifying 456 references. 17 studies met inclusion criteria. ADA incidence was: 0% to 5.5% (secukinumab), 11% to 19.4% (ixekizumab), 0% to 3.3% (brodalumab), and 19% to 39% (bimekizumab). Neutralizing antibody incidence was: 0% to 1.5% (secukinumab), 0% to 3.5% (ixekizumab), and 0% (brodalumab). ADA presence alone with secukinumab, ixekizumab, and bimekizumab did not impact drug efficacy. Brodalumab was the only one of the IL-17 inhibitors, which showed a reduction in efficacy in ADA + patients. In one analysis, high ADA titers to ixekizumab were associated with diminished treatment response. ADAs to secukinumab and bimekizumab were not associated with adverse events. There were limited data on ADAs and safety with ixekizumab or brodalumab. Overall, when monitoring patients on secukinumab, ADAs, titers, and the presence of neutralizing antibodies were not prognostic of outcomes. However, monitoring for ADAs with brodalumab and measuring titers with ixekizumab may be of value clinically.

Background: Delusional infestation (DI) is one of the most challenging situations dermatologists and other dermatology providers may face in their practice. Dermatologists must know how to properly communicate with these patients. The process of acquiring delusional states can be a gradual development and not all delusional patients in dermatology are the same. Objective: The objective of this manuscript is to introduce the 'Koo-Brownstone Staging System' for Delusional Infestation (Morgellons disease) with the goal of improving communication and management for these patients. Methods: This staging system has been derived based on more than three decades of experience of the senior author supported by additional years of experience of the first author. Results: The following stages are presented and explained: formication only (stage 1), overvalued ideation of parasitosis (stage 2), pre-delusional (stage 3), delusional (stage 4) and terminally delusional (stage 5). Limitations: This staging system has been derived based on expert clinical experience rather than a direct reporting from this patient population themselves. Conclusions: This staging system will enhance awareness on the part of the health providers to enable them to categorize a given patient, which becomes critical in optimizing communications and management.

Background/objectives: Psoriasis, newly considered as a systemic inflammatory condition, has a high prevalence of cardiovascular diseases (CVD), including atherosclerosis and myocardial infarction. Measurement of carotid artery intima-media thickness (C-IMT) represents a non-invasive diagnostic tool for predicting cardiovascular disorders. We aimed to determine if psoriatic patients have an increased risk for the development of cardiovascular disorders by assessment of the presence of subclinical atherosclerosis in psoriasis patients. Methods: 40 adult psoriatic patients and 40 matched healthy controls were selected in this study. All participants were subjected to full history, examination, assessment of the severity of psoriasis using psoriasis area and severity index (PASI) score, measuring serum lipid profile (cholesterol, LDL and triglycerides) and C-IMT. Results: Psoriatic patients showed significantly higher serum lipid profile findings and C-IMT. There was a positive statistically significant correlation between C-IMT and each of age of the patients (r = 0.760, p < 0.001) and severity of psoriasis (PASI score). Conclusion: There is increased susceptibility to cardiovascular diseases in psoriatic patients represented by increased incidence of subclinical atherosclerosis and dyslipidemia in our patients.

Non-medical switching is when a patient's therapy is switched for reasons unrelated to health outcomes. Dermatologists are regularly affected by non-medical switching, as many of their complex patients are on expensive medications, which become first-line targets for cost-containment. This commentary examines the literature on non-medical switching and explores the push and pull factors used to drive medication regimen changes. The system-level cost savings of this practice are substantial and could be used to fund treatment for more vulnerable patients. While there is no substantiated evidence of worse outcomes post-switching, patients may suffer negative psychosocial consequences. Negative patient expectations, which are in part fueled by prescriber suspicion of non-medical switching, seem to contribute to this effect. While non-medical switching is not ideal for all patients, it has the potential to reduce cost while maintaining patient outcomes. The decision to switch should be made only after careful evaluation of the individual patient and their physical and psychological reserve.

Background: Limited health outcomes information exists for patients with mild to moderate plaque psoriasis (hereafter, referred to as psoriasis) prescribed topical treatment(s). Aim: We evaluated clinical characteristics of patients with systemic-naïve mild to moderate psoriasis after topical use in the United States. Methods: Data were drawn from 2017 to 2018 Adelphi Psoriasis Disease Specific Programme™, a point-in-time survey of physicians and adult psoriasis patients, capturing data on topical treatment at time of consultation prescribed to systemic-naïve patients with mild to moderate psoriasis (i.e. body surface area [BSA] ≤ 10%) at current treatment initiation. Patient clinical characteristics before/after topical use were evaluated descriptively. Results: Among 304 patients (median age 43.0 years; 53.6% female), mean time since diagnosis was 60.9 months. After a mean 6.9 months on their current topical, 14.5% of patients achieved ≥75% BSA reduction, 38.9% ≥50% BSA reduction, and 50.2% no BSA reduction. Residual psoriasis symptoms included scaling (76.5%), inflamed skin (65.9%), and itching (60.4%). Most patients (71.2%) had residual psoriasis in special body areas: nails (92.3%), palmoplantar (78.9%), scalp (75.9%), and face (65.8%). Conclusion: We found unmet need in topical treatment effectiveness in mild to moderate psoriasis patients, in terms of BSA reduction, symptoms, and special body areas affected.

Background and objectives: Once-daily, fixed-combination calcipotriol 50 μg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream. Methods: Anchored and unanchored MAIC analyses were conducted using individual patient data (IPD) from five Cal/BD foam trials and two trials of Cal/BD cream. Outcomes of interest were the proportion of patients with Physician's Global Assessment (PGA) success and the mean reduction in modified Psoriasis Area and Severity Index (mPASI). Results: In the anchored MAIC, patients were more likely to achieve PGA success after 4 weeks of Cal/BD foam than after 8 weeks of Cal/BD cream and had larger mean improvements in mPASI (p < .01 in EU mPASI analysis). In unanchored analyses, 4 weeks of Cal/BD foam treatment was statistically significantly more efficacious in inducing PGA success than 8 weeks of Cal/BD cream (p < .01 in five of six comparisons). Mean reductions in mPASI were consistently statistically significantly greater with Cal/BD foam than with Cal/BD cream. Conclusions: Use of Cal/BD foam consistently shows significantly greater improvements in PGA and mPASI outcomes, compared with Cal/BD cream.

Background: Lichen planus (LP) is a chronic inflammatory mucocutaneous disease. Systemic corticosteroids are the treatment of choice for generalized LP but their use is limited due to side effects. Oral mini pulse (OMP) therapy represents good alternative. Also, Methotrexate (MTX) can be used as alternative and safe modality in LP. Objectives: To compare the efficacy and safety of oral MTX versus OMP betamethasone in treatment of different types of LP. Patients and method: The study included 40 patients presenting with LP who were randomly divided into two groups. Group A for oral MTX 7.5 mg weekly & group B for OMP betamethasone 3 mg weekly for maximum 12 weeks. Basic laboratory investigations were done to both groups. Follow up investigations were done at 2nd, 4th, 8th and 12th week. Percentage of improvement in each patient was calculated on a scale according to appearance of new lesions, degree of pruritus/pain, subsidence of cutaneous lesions and clearance of oral lesion. Results: In MTX group, 55% of patients showed excellent improvement, 25% showed good improvement and 20% showed partial improvement. In OMP group, 85% of patients showed excellent improvement, 10% showed good improvement and 5% showed partial improvement. The reported clinical and laboratory adverse effects were tolerable and didn't lead to discontinuation of treatment. Conclusion: OMP betamethasone and low dose MTX may be considered effective and safe lines of treatment for different types of LP and may represent good and safe alternative options for conventional daily corticosteroid therapy.

Background: Special populations (SPs) involve people who require additional consideration in clinical research. Effectiveness of treatment or occurrence of side effects may be different in SPs with respect to not-SPs. Objectives: To retrospectively compare the effectiveness and safety of dupilumab in AD treatment of SPs versus not-SPs. Methods: A 52-weeks retrospective study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with dupilumab at labelled dosage. Patients were divided in Group A (SPs patients) and Group B (not-SPs patients). Disease severity was assessed using Eczema Area Severity Index (EASI), Pruritus-Numerical Rating Scale (P-NRS), and Dermatology Life Quality Index (DLQI) score at baseline and after 4 weeks (W4), W16, W24, and W52. Results: A total of 263 patients were enrolled and divided in Group A (25) and Group B (238). SPs included history of cancer, severe kidney failure, viral hepatitis, neurological diseases, acquired immunodeficiency syndrome, and transplanted patients. A statistically significant reduction of EASI, DLQI, and P-NRS was assessed in both groups at each follow-up visit (p < 0.0001), without significant differences between the groups. No differences were recorded for safety. Conclusions: There are not significant differences between SPs and not-SPs as regards effectiveness and safety of dupilumab in AD management.