Reduction In Psoriasis Area And Severity Index Research Articles

Short-term effectiveness and potential factors of ustekinumab based on real-world data in Chinese psoriasis patients

Background As one of the most effective biologic treatments for psoriasis, the short-term effectiveness of ustekinumab has yet to be studied extensively. Objective The purpose of this study was to evaluate the short-term effectiveness and potential factors within four weeks after the first-dose ustekinumab treatment based on real-world data. Methods The study enrolled 98 patients with moderate-to-severe psoriasis, given ustekinumab 45 mg at week 0, week 4, and then every 12 weeks. Based on clinical data collected at baseline and week 4, we investigated the short-term effectiveness of ustekinumab after the first dose and potential factors associated with the treatment. For evaluation, we collected demographic information, body data, medical history, laboratory examination results, Psoriasis Area and Severity Index (PASI), body surface area (BSA), and dermatology life quality index (DLQI). Response rates were calculated based on the number of patients that achieved a 75/90/100% reduction in PASI (PASI 75/90/100), and the primary treatment goal was to achieve PASI 75. Results The response rates for PASI 75/90/100 at week 4 were 30.5%, 18.9%, and 16.8%, respectively. For PASI 75, the response rate was higher in patients without metabolic syndrome (MS) (without MS vs. with MS: 36.9% vs. 5.9%, p = 0.013); the serum triglyceride (TG) level was significantly lower in patients achieving PASI 75 (expressed as mean ± standard deviation, achieved vs. unachieved: 1.82 ± 1.79 vs. 3.59 ± 8.89, p = 0.010). For PASI 100, the response rates were higher in female patients (female vs. male: 26.3% vs. 10.5%, p = 0.044) and patients with a family history of psoriasis (with family history vs. without family history: 44.4% vs. 13.9%, p = 0.042). In addition, the possibility of achieving PASI 75/90/100 went up along with the serum high-density lipoprotein cholesterol (HDL-C) level (expressed as adjusted odds ratio < 95% confidence interval>: PASI 75: 28.484 < 2.035-248.419>, p = 0.011; PASI 90: 28.226 < 2.828-281.729>, p = 0.004; PASI 100: 12.175 < 1.876-79.028>, p = 0.009). Conclusion In this study, nearly one-third of patients achieved PASI 75 after only the first-dose ustekinumab treatment. Sex, family history of psoriasis, MS, serum TG level might affect the short-term effectiveness, and serum HDL-C level may be a potential factor. The possibility of achieving treatment goals (PASI 75/90/100) at week 4 increased along with serum HDL-C levels.

Roflumilast Cream 0.3% in Patients With Chronic Plaque Psoriasis: Individual Patient PASI and PASI-HD Responses: Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

Background: Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 inhibitor approved as a nonsteroidal, once-daily treatment for patients with plaque psoriasis. Pooled efficacy and safety results from two Phase 3 clinical trials (DERMIS-1 and DERMIS-2) have been presented previously. The Psoriasis Area and Severity Index (PASI) is used to assess the severity of plaque psoriasis in clinical trials; however, PASI is not precise when the area of involvement is &lt;10% of a given anatomic region. A modified version of the PASI, the PASI-high discrimination (PASI-HD), allows more precise assessment of psoriasis in body regions where &lt;10% area is affected. We present individual patient responses using PASI and PASI-HD.&#x0D; Methods: Patients aged ≥2 years with at least mild plaque psoriasis involving 2-20% body surface area were randomized 2:1 to apply roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. PASI and PASI-HD were used to measure disease severity; individual patient PASI and PASI-HD responses were plotted graphically. Safety and tolerability were also evaluated and were reported previously.&#x0D; Results: Roflumilast- and vehicle-treated patients had similar baseline demographic and disease characteristics. At Week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved IGA Success (39.9% vs. 6.5%; P&lt;0.0001). Statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving a 50% reduction in PASI (72.1% vs. 25.5%; P&lt;0.0001), 75% reduction (40.3% vs. 6.5%, P&lt;0.0001), 90% reduction (19.7% vs 2.3%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.001). Likewise, statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving 50% reduction in PASI-HD (79.4% vs. 33.1%; P&lt;0.0001), 75% reduction (59.9% vs. 17.9%, P&lt;0.0001), 90% reduction (39.9% vs 9.1%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.0001). Roflumilast cream demonstrated low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable to vehicle. At the first application of roflumilast cream 0.3% (day 1), 96% of patients reported no or mild sensation, increasing to 99% of patients at Weeks 4 and 8.&#x0D; Conclusions: Roflumilast cream 0.3% provided greater improvement in IGA Success, PASI, and PASI-HD versus vehicle with favorable safety and tolerability in patients with psoriasis in two Phase 3 trials. PASI-HD provided higher discrimination of effects of treatment in areas with &lt;10% involvement than the traditional PASI.&#x0D; ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389&#x0D; Financial Disclosures: Arcutis Biotherapeutics, Inc.

Real-world effectiveness and safety of bimekizumab in Japanese patients with psoriasis: A single-center retrospective study.

Bimekizumab, which suppresses both interleukin (IL)-17A and IL-17F, has recently been approved as a biologic for psoriasis. We aimed to evaluate the real-world effectiveness and safety of bimekizumab for psoriasis and to identify predictive factors for its treatment responsiveness. We analyzed 36 Japanese patients with psoriasis (19 with psoriasis vulgaris and 17 with psoriatic arthritis) from May 2022 to September 2023. All patients received bimekizumab (320 mg every 4 weeks) until week 16. Seventeen patients (43.2%) had experienced bio-switch. The median (interquartile range) baseline total psoriasis area and severity index (PASI) was 6 (3.2-20.0). Total PASI rapidly and significantly decreased at week 4 by a median 79.8% from baseline, and gradually decreased thereafter. The PASI on the trunk, and upper and lower limbs rapidly and significantly decreased at week 4 compared to baseline and plateaued thereafter. The neutrophil-to-lymphocyte ratio and neutrophil number significantly decreased at week 16 compared to baseline. At weeks 4, 8, 12, and 16, the achievement rate of absolute PASI ≤2 was 72.2%, 80.6%, 92.9%, and 96.4%, respectively; that of absolute PASI ≤1 was 41.7%, 61.3%, 85.7%, and 82.1%; that of PASI 75 was 55.5%, 52.9%, 69.7%, and 75.8%; that of PASI 90 was 36.1%, 50.0%, 57.6%, and 62.9%; and that of PASI 100 was 19.4%, 38.2%, 51.5%, or 57.6%, respectively. Linear multivariate regression analysis revealed that younger age was associated with a higher percentage reduction of total PASI at weeks 4 and 8. There were no serious or fatal adverse events during treatment. In conclusion, bimekizumab rapidly and remarkably reduced the total PASI together with high achievement rates of absolute PASI ≤1 and ≤2, and with favorable safety in real-world clinical practice. Younger age may be a predictive factor for a good treatment response to bimekizumab.

Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Individual Patient Response from the Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

Roflumilast cream 0.3% in patients with chronic plaque psoriasis: individual patient response from the pooled DERMIS-1 and DERMIS-2 phase 3 trials&#x0D; &#x0D; James Del Rosso1 on behalf of the authors&#x0D; &#x0D; INTRODUCTION: Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 inhibitor approved as a nonsteroidal, once-daily treatment for patients with plaque psoriasis. The efficacy and safety of the pooled results of two Phase 3 clinical trials (DERMIS-1 and DERMIS-2) in patients aged ≥2 years with plaque psoriasis have been previously presented. We present individual patient responses using the Psoriasis Area and Severity Index (PASI).&#x0D; METHODS: Patients aged ≥2 years with at least mild plaque psoriasis involving 2-20% of body surface area were randomized 2:1 to apply roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8; IGA of Clear or Almost Clear was a secondary endpoint. PASI was used to measure disease severity; individual patient PASI responses were plotted graphically. Safety and tolerability were also evaluated and have been previously reported.&#x0D; RESULTS: Roflumilast- and vehicle-treated patients had similar baseline demographic and disease characteristics. At Week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved IGA Success (39.9% vs. 6.5%; P&lt;0.0001) and IGA of Clear or Almost Clear (48.0% vs. 9.5%; nominal P&lt;0.0001). Statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving a 50% reduction in PASI (72.1% vs. 25.5%; P&lt;0.0001), 75% reduction (40.3% vs. 6.5%, P&lt;0.0001), 90% reduction (19.7% vs 2.3%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.001). At the first post-treatment timepoint evaluated (Week 2), 85.7% of roflumilast-treated patients had a measurable improvement in PASI, increasing to 95.0% by the last timepoint (Week 8). Roflumilast cream demonstrated low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable with vehicle. Approximately 96% of patients reported no or mild sensation after the first application of roflumilast cream 0.3%, improving to more than 99% of patients at Week 4 and Week 8, similar to vehicle.&#x0D; CONCLUSIONS: Roflumilast cream 0.3% provided greater improvement in IGA Success, IGA of Clear or Almost Clear, and PASI versus vehicle with favorable safety and tolerability in patients with psoriasis in two Phase 3 trials.&#x0D; Sponsored by Arcutis Biotherapeutics, Inc.&#x0D; ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389

004 Does methotrexate affect treatment persistence or effectiveness of adalimumab for psoriasis? A trial emulation cohort study

Abstract It is unclear whether concomitant methotrexate enhances the effectiveness and/or persistence of adalimumab in treating psoriasis. The OPTIMAP study (Optimizing Adalimumab Treatment in Psoriasis with Concomitant Methotrexate), a randomized controlled trial testing adalimumab against adalimumab + methotrexate, could not adequately answer this question due to under-recruitment. The aim of the current study is to replicate key aspects of the OPTIMAP trial design in a cohort study to provide a more precise estimate for the effect of concomitant methotrexate on adalimumab persistence and effectiveness. We conducted a cohort study using the British Association of Dermatologists Biologics and Immunomodulators Register, a national pharmacovigilance registry for people on systemic treatments for psoriasis, between 2007 and 2021. We included participants ≥ 18 years old who had at least one record of a Psoriasis Area and Severity Index (PASI) ≥ 8 and were naïve to adalimumab. We used the same exclusion criteria as in the OPTIMAP study. Participants received either adalimumab (Humira®) in the comparison arm or adalimumab (Humira) in addition to methotrexate and folic acid, with dosage as determined by the clinician in the intervention arm from initiation at cohort entry, and were censored if they deviated from the treatment strategy. The primary outcome is in the difference in the survival function for adalimumab at 1 year. The secondary outcome was the difference in the proportion of patients achieving a 75% reduction in PASI (PASI 75) at 1 year. We used inverse probability treatment weighting to correct for known differences in participant characteristics precomparison. Missing outcomes were accounted for using inverse probability of censoring weighting. We fitted a flexible parametric survival model and a generalized linear model with an identity link for the primary and secondary outcomes, respectively. There were 219 and 1376 participants in the intervention and comparison arms, respectively. Drug survival for the monotherapy arm at 1 year was 77.5% [95% confidence interval (CI) 75.3–79.8], and for the intervention arm, it was 75.3% (95% CI 66.9–84.7), with a difference of −2.3% (95% CI −11.4 to 6.9). The risk difference for PASI 75 at 1 year was −10.7% (95% CI −29.3 to 8.0), with a PASI 75 rate of 43.5% for the intervention arm (95% CI 25.4–61.9) and 54.2% for the comparison arm (95% CI 49.6–58.7). We did not find any significant difference for the persistence and effectiveness of adalimumab in people with psoriasis on methotrexate vs. those who were not on methotrexate in this study. This result is in keeping with the reported first-year outcomes of OPTIMAP. Clinicians and patients should consider alternative strategies to improve treatment outcomes in people with severe psoriasis.

Measurement properties of the Patient Global Assessment numerical rating scale in moderate-to-severe psoriasis.

Patient Global Assessment (PtGA) has been recommended as one of the core domains in psoriasis clinical trials. Among multiple versions of PtGA, the single-question 11-point PtGA numeric rating scale (NRS) remains to be validated in patients with plaque psoriasis. To evaluate the psychometric charateristics of a 11-point PtGA NRS for disease severity in patients with moderate-to-severe plaque psoriasis. Data were analyzed from 759 patients with moderate-to-severe psoriasis in the Shanghai Psoriasis Effectiveness Evaluation CoHort (SPEECH), a prospective, multicenter, and observational registry assessing the comparative effectiveness and safety of biologics (adalimumab, ustekinumab, secukinumab or ixekizumab), conventional systemic therapies (acitretin or methotrexate), or phototherapy. The test-retest reliability of the PtGA NRS showed good agreement (intraclass correlation coefficient range 0.79-0.83). No floor or ceiling effects of PtGA NRS were observed. The PtGA NRS was significantly correlated with Psoriasis Area and Severity Index (PASI), static Physician Global Assessment (sPGA), body surface area, Dermatology Quality of Life Index (DLQI), and Hospital Anxiety and Depression Scale. Relatively large correlations of PtGA NRS with PASI and DLQI Symptoms and feelings domain (all correlations ≥ 0.4 except at baseline) supported convergent validity. The presence of psoriatic arthritis or joint symptoms had no significant association with the PtGA NRS. In multivariate regression analyses, the PtGA NRS at baseline was predicted by age, lesion extent, lesion intensity, patients' symptoms and feelings, and impact on work or school. The PtGA NRS displayed known-groups validity with the PASI, sPGA and DLQI score bands. The PtGA NRS was responsive to change in PASI and DLQI after treatment. Anchor- and distribution-based approaches supported -3 as the minimal important difference for PtGA NRS. An absolute PtGA NRS ≤ 2 during follow-ups was concordant with the state of minimal disease activity based on PASI 90 or PASI 90 plus DLQI 0/1. Sensitivity analysis using subgroup comparison and multiple imputation model yielded consistent conclusions. The PtGA NRS showed good reliability, validity, and responsiveness in patients with psoriasis, and was feasible in clinical trials and daily practice.

A Real-Life Study on the Use of Tildrakizumab in Psoriatic Patients.

Tildrakizumab is a humanized IgG1κ monoclonal antibody that selectively targets the p19 subunit of interleukin IL-23, thereby inhibiting the IL-23/IL-17 axis, which is primarily implicated in the immunopathogenesis of psoriasis. Tildrakizumab is approved for the treatment of moderate-to-severe plaque-type psoriasis in adults based on the evidence of two randomized and controlled phase-III clinical trials (reSURFACE 1 and reSURFACE 2). Here, we report our real-life experience treating 53 psoriatic patients (19 female and 34 male) who were administered tildrakizumab every 12 weeks and received follow-ups over 52 weeks. Descriptive and inferential statistical analyses were performed, in particular the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI) and, if applicable, the Nail Psoriasis Severity Index (NAPSI) and Palmoplantar Psoriasis Physician Global Assessment (PPPGA). These were assessed at baseline and after different timepoints (weeks) during the follow-up period. We described and evaluated demographical and epidemiological characteristics in our cohort group, focusing on comorbidities. In this group, 35.9% of patients were female and 64.1% were male, with 47.1% being smokers and with a mean age of 51.2 years. A total of 37.7% of these patients was affected by scalp psoriasis; regarding comorbidities, hypertension was the most frequent (32.5%), followed by psoriatic arthritis (PsA) (18.60%) and diabetes (13.9%). At week 52, 93%, 90.2% and 77% of patients achieved a PASI reduction ≥75% (PASI 75), PASI 90 and PASI 100, respectively. In addition, NAPSI, PPPGA and DLQI scores were significantly reduced by week 52. In our cohort of complex psoriasis patients, disease remission began at the end of the fourth week of treatment and remained constant from week 16 to week 52.

Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study.

IntroductionApremilast is approved for the treatment of psoriasis and psoriatic arthritis. However, data on the efficacy and safety of apremilast in clinical practice are limited. We assessed the real-world use and effectiveness of apremilast in patients with moderate to severe plaque psoriasis visiting dermatologist practices in Belgium, from the perspectives of the patient and the physician.MethodsThis prospective observational study enrolled adults aged 18 years or more initiating apremilast between 6 April 2017 and 30 June 2018, per Belgian reimbursement criteria. Primary outcome was the Patient Benefit Index for Skin Diseases (PBI-S). Secondary outcomes included the Patient Global Assessment (PtGA), Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and body surface area (BSA). Patients were followed up for up to 18 months. ResultsOverall, 122 enrolled patients received at least one dose of apremilast, of which 89 received treatment for more than 150 days and were included in the reference population. Treatment goals most frequently identified (at least 70% of patients) as “very important” in the PBI-S were related to physical impairments. After 6 months of apremilast treatment, 61–78% of patients reported they had achieved these goals; only 12.5% assessed their disease as severe (PtGA, 53.6% at apremilast initiation) and over half reported a DLQI score of 5 or less, indicating improved quality of life. As assessed by the physician, 68.4% and 35.1% of patients achieved at least a 50% and 75% reduction in PASI, respectively, at month 6. Apremilast was well tolerated with no new safety signals identified.ConclusionsOur real-world data indicate that apremilast fulfils the expectations of Belgian patients with moderate to severe psoriasis, and from the perspectives of both the patient and physician, apremilast has a positive impact on their disease.Trial RegistrationClinicalTrials.gov Identifier NCT03097003.

Probiotic supplementation improves clinical outcomes and quality of life indicators in patients with plaque psoriasis: A randomized double-blind clinical trial.

The impact of probiotics on psoriasis, a systemic inflammatory disease, remains obscure, thus we decided to evaluate quality of life (QOL), oxidative stress, inflammatory markers and clinical outcome in psoriasis patients. Fifty patients with plaque psoriasis randomized into two groups, group 1 received probiotic drink with Lactobacillus strains for 8 weeks while group 2 haven't received any probiotic supplements at this period. The Dermatology Life Quality Index (DLQI) and Beck's questionnaire (BDI) were used to investigate the quality of life and depression, respectively. The effects of supplementation on malondialdehyde (MDA), hs-CRP, IL-6, total antioxidant capacity (1) and psoriasis area and severity index (PASI), psoriasis symptom scale (PSS) were measured at the beginning of the study and after week 8th. Total BDI scores significantly improved in the probiotic group in comparison with the placebo group (-6.15±2.10 vs. 1.39±1.80, P=0.017) and DLQI (-9.50±4.1 vs. 0.12±0.6, P=0.045) as well. Group 1 had a considerable reduction in PASI and PSS scores compared to the placebo group (-5.26±3.75 vs. 0.48±1.37, P=0.049) and (-4.85±3.10 vs. 0.43±0.80, P=0.047), respectively. In addition, the intervention group have shown increase in TAC levels (45.99±23.33 vs-13.54±30.7mmol/L, P=0.030), and decrease in hs-CRP levels (-1.55±0.85 vs.-0.49+0.27mg/L, P=0.015), IL-6 levels (-4.04±1.30 vs.-1.50+0.38mg/L, P=0.050) and MDA levels (-71.08±35.73 vs.-9.8+15.6nmol/mL, P=0.013) compared to the placebo group. Probiotics improve patients' quality of life and inflammatory biomarkers in psoriatic patients. Further studies are mandatory to propose probiotics as routinely prescribed therapy in inflammatory dermatoses. This trial was registered at www.irct.ir as IRCT20180712040438N2.

Absolute Psoriasis Area and Severity Index as a valuable marker to determine initial treatment response in psoriasis patients treated with guselkumab in routine clinical care.

Guselkumab is an anti-interleukin-23p19 monoclonal antibody approved as a first-line medication in patients with moderate-to-severe plaque-type psoriasis and second-line in active psoriatic arthritis. In the clinic, patients who have shown a lack of previous treatment efficacy and/or tolerability are often prescribed guselkumab. These patients generally have less severe psoriasis compared to clinical trial cohorts, reflected in lower Psoriasis Area and Severity Index (PASI). To evaluate treatment response in a real-world setting, we conducted a multicenter-retrospective chart review in three specialized dermatological centers. Seventy-four patients who received guselkumab treatment were included in the study and baseline characteristics were described. The mean PASI at baseline was 13.0 (± 6.7). After 12 weeks of treatment 40 patients could be followed up at the participating centers and efficacy was assessed: 72.5% of these patients achieved an absolute PASI ≤5 (55.0% ≤3; 42.5% ≤2) whereas only 57.5% of patients were able to gain a delta PASI reduction of at least 75%. Using the absolute PASI as a treatment goal rather than response rate revealed that guselkumab was highly effective in this real-world setting. In conclusion, the absolute PASI proved to be a more valuable tool to measure treatment outcome.

In vivo Skin Penetration, Radical Protection, and Structural Changes after Topical Application of a Herbal Oil Cream Compared to Topical Calcipotriol in Mild to Moderate Psoriasis

Background: The chronicity of psoriasis often requires continuous topical treatment. Materials and Methods: Here, the radical protection of a cream containing various herbal oils was evaluated in vivo by electron paramagnetic resonance (EPR) spectroscopy and its skin penetration by Raman microscopy in intact and barrier-disturbed skin. Changes in skin barrier properties were evaluated after 4 weeks of daily topical application using in vivo laser scanning microscopy (LSM) and transepidermal water loss in 26 healthy volunteers. A randomized, controlled, double-blind, three-arm parallel clinical study evaluated the efficacy of the herbal oil cream compared to a 0.05% calcipotriol-containing cream and to a vehicle cream, in 135 patients with mild to moderate plaque psoriasis with the change in Psoriasis Area and Severity Index (PASI) from baseline to week 12 as the primary endpoint. Results: EPR spectroscopy disclosed a significantly higher radical formation in untreated than skin treated with the herbal oil cream (p ≤ 0.05). LSM measurements indicated a protective skin barrier effect in treated compared to untreated skin. In the clinical trial, the topical application of herbal oils showed a significant reduction of the PASI score compared to topical calcipotriol at week 12 (p = 0.016). The mean reduction in PASI was 49% for the herbal oil cream, 38% for calcipotriol, and 55% for the vehicle cream. The percentage of patients, who reached PASI 50 and 75 at any time point, was 55.9% and 29.4% for the herbal oil cream, 47.4% and 15.8% for calcipotriol, and 23 (60.5%) and 13 (34.2%) for the vehicle, respectively (p > 0.05). The vehicle, originally designed as a placebo, contained a main ingredient of the herbal oil cream and therefore showed corresponding results. Conclusion: The herbal oil cream demonstrated effectiveness in the treatment of mild to moderate plaque psoriasis.

Certolizumab pegol in the treatment of psoriasis: Real-life data.

Certolizumab pegol (CZP), the only Fc-free, PEGylated anti-tumor necrosis factor biologic agent. This study aims to investigate the effect and safety of CZP in moderate-to-severe chronic plaque psoriasis. We performed a retrospective observational analysis of the moderate-to-severe psoriasis patients under ceratolizumab pegol therapy. Primer endpoints were efficacy of CZP, defined as statistically significant improvement of Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA), and clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) in the 24 week of therapy. Secondary endpoints were safety of CZP especially during COVID-19 pandemic. Fifty-six moderate-to-severe psoriasis patients treated with CZP were evaluated retrospectively. We observed a rapid and significant reduction of PASI, PGA, and cDAPSA scores in W4. After loading dose, we observed loss of clinical efficacy of CZP in eight patients and optimized therapy by increasing the dosing of CZP. Dose escalation of CZP permitted the achievement and long-term maintenance of clinical improvement in these patients. We compare the clinical efficacy of CZP between naive and patients who has been treated with other biologic agents. There were no statistical differences in efficacy between these two groups. No side effects were observed during CZP treatment. There were no cases of death from COVID-related disease in our study population or patients hospitalized for COVID-19 related disease. Our results demonstrate that CZP is an effective and safe therapeutic option for patients with moderate-to-severe chronic plaque psoriasis.

Effectiveness and clinical predictors of drug survival in psoriasis patients receiving apremilast: A registry analysis

BackgroundLittle is known about the effectiveness and drug survival associated with apremilast under real-world conditions.ObjectiveTo investigate the influence of patient and disease characteristics on drug survival associated with apremilast and to elucidate clinical effectiveness with regard to the psoriasis area and severity index (PASI) reduction.MethodsThis was an observational, retrospective, multicenter analysis from the Austrian Psoriasis Registry.ResultsData from 367 patients were eligible for analysis. The 12-month drug survival rate associated with apremilast (ie, the proportion of patients on the drug) was 57.3% and decreased significantly in patients younger than 40 years (relative hazard ratio = 1.49, P = .007918). Sex; concomitant arthritis; previous biologic therapy; obesity; and palmoplantar, scalp, nail, and intertriginous involvement did not significantly affect drug survival. At 12 months, the response rates in patients receiving apremilast per protocol with a PASI of 50, 75, 90, and 100 were 80.0%, 56.4%, 38.2%, and 22.7%, respectively.LimitationsInclusion of a substantial number of patients with no record of absolute PASI at study entry and lack of PASI reduction follow-up data of 103 patients (28.1%) after starting apremilast treatment.ConclusionApremilast is a robust antipsoriatic drug for which the drug survival is not strongly influenced by most patient- or disease-related factors except age. Drug survival is significantly shorter in patients younger than 40 years.

Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study

Background: Topical agents are still the mainstay for the treatment of mild-to-moderate plaque psoriasis, in which fixed combinations play an important role. Tazarotene/betamethasone dipropionate (Taz/BD) cream is a novel fixed combination approved for treating plaque psoriasis in China, but its efficacy and safety have not been verified in a real-world environment. Objectives: The primary objective was to investigate the efficacy and safety of Taz/BD cream in treating plaque psoriasis. The secondary objectives were to assess its relapse after discontinuation and the efficacy and safety profiles during retreatment. Methods: A prospective, multicenter, large-scale observational study was conducted. Adult patients with chronic plaque psoriasis involving <20% of the body surface area were enrolled. Taz/BD cream was applied once daily for 4 weeks. Patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 4 were followed up to investigate relapse after drug withdrawal. Relapsed patients underwent another 4-week treatment. Results: In total, 2,299 eligible patients were enrolled, and 2,095 patients (91.1%) completed the 4-week study. The mean PASI improvement at week 4 was 53.7%, and the PASI 50/75 response rates were 62.5 and 26.8%, respectively. The mean PASI reduction in plaque induration, desquamation and erythema were 58.3, 61.0 and 40.0%, respectively (p < 0.001). Adverse reactions occurred in 445 patients (20.8%) at week 4. The most frequently reported adverse reactions were local skin irritation, including pruritus (10%), pain (6.7%), erythema (6.1%) and desquamation (1.8%). During the post-treatment period, 47 patients (24.0%) relapsed within 8 weeks after drug discontinuation. Forty-five patients were retreated for another 4 weeks, and the PASI 50/75 response rates were 72.7 and 40.9%, respectively. There were no unexpected safety signals during retreatment. Conclusion: Taz/BD cream is effective and well tolerated in treating mild-to-moderate plaque psoriasis under near real-world conditions and demonstrates efficacy and safety during retreatment.

Shades of grey: what is paediatric psoriasiform dermatitis and what does it have in common with childhood psoriasis?

While the majority of children with a chronic itchy rash suffer from atopic dermatitis (AD) and other forms of dermatitis, psoriasis is in the differential diagnosis. Certain patterns such as guttate and napkin psoriasis are accepted as classic paediatric psoriasis (PP); however, there are many patients who do not fit these classic forms of PP nor fulfil the accepted criteria for AD. 'Psoriasiform dermatitis' (PD) is a term that has been used for these patients; however, it has not been formally defined. Identification of this group of patients, who although not having the typical clinical features of psoriasis, respond well to psoriasis-specific treatment, may assist treatment decisions for these patients. To describe PD and compare it with typical PP. Patients with classic PP (n=109) were compared with a control group with AD (n=449) and assessed for 21 clinical features associated with PP. Multivariate nonlinear regression analyses determined which features best separated the groups. Patients with dermatitis who demonstrated any of these 21 features (n=43), which were used to diagnose PD, were then compared with the PP and AD groups. They were managed with psoriasis-specific treatment and Psoriasis Area and Severity Index (PASI) was recorded. Of the 21 clinical features, 12 were found to clearly separate the classic PP and AD groups. Using the eight most significant (P<0.0001) features, we found these two groups clearly separated at a score of 3 out of 8. Children with PD with ≥4 of these features responded well to treatment for psoriasis with a mean reduction of PASI by 85% at 6weeks. We found that patients with dermatitis who have ≥4 psoriasis-associated features may have a condition that has been previously alluded to but not defined in the literature, 'psoriasiform dermatitis'. Treatments usually reserved for patients with psoriasis appear to be effective in these patients.

Association of Pathogenic Th17 Cells with the Disease Severity and Its Potential Implication for Biological Treatment Selection in Psoriasis Patients.

Psoriasis is an inflammatory autoimmune disease characterized by cutaneous lesions in plaques. It has been proposed that the immune response has a key role in the disease progression. Particularly, the Th17 cells through IL-17 can contribute to maintain the inflammatory process. The pathogenic Th17 phenotype has been described in human diseases and associated with high severity in inflammatory experimental models. However, it is not clear if the pathogenic phenotype could be present in the skin and peripheral blood as well as its possible association to severity in psoriasis. In the lesional skin, we found high infiltration of Th17 cells and the pathogenic phenotype, finding a correlation between the frequency of Th17 cells and the Psoriasis Area and Severity Index (PASI) score. In peripheral blood, we observed a pool of Th17 lymphocytes with potential to acquire pathogenic features. Interestingly, the percentage of pathogenic Th17 cells (CD4+ RORγt+ IFN-γ+) correlates with disease severity. Moreover, we distinguished three groups of patients based on their IL-17/IFN-γ production by Th17 lymphocytes, which seems to be related with a dynamic or stable potential to express these cytokines. Remarkably, we evaluated the cytokine production by Th17 cells as an immunological marker for the adequate selection of biologic therapy. We found that patients analyzed by this immunological approach and treated with antibodies against IL-17 and TNFα showed great improvement depicted by reduction in PASI and Dermatology Life Quality Index (DLQI) score as well as the percentage of Body Surface Area (BSA). Altogether, our results highlight the importance of the assessment of the pathogenic phenotype in Th17 cells as an immune personalized analysis with the potential to support the therapy choice in the clinical practice.

Shear wave elastography and microvascular ultrasound in response evaluation to calcipotriol+betamethasone foam in plaque psoriasis

Psoriasis (PsO) is a chronic skin disease. This study aims to evaluate clinical and subclinical response to calcipotriol+betamethasone foam, in patients with PsO, comparing, for the first time, data from...

Фототерапія в лікуванні псоріазу

SummaryObjective – to determine and evaluate the results of narrow-band phototherapy inthe treatment of psoriasis using a dermatological ultraviolet apparatus.Materials and methods. Irradiation of psoriatic rashes was carried out using aUVB-311 dermatological ultraviolet apparatus (Psorolight 100-3). Under oursupervision there were 36 patients. The treatment was carried out in the form ofmonotherapy according to the method of triple exposure per week.Results and its discussion. As a result of the treatment, 7 patients (64%) withpalmar-plantar psoriasis showed a marked improvement (Psoriasis Area and SeverityIndex (PASI) >75%), 4 patients (36%) achieved satisfactory improvement, PASI >50%.Clinical cure was observed in the majority of patients (19 people – 76%) with vulgarand exudative psoriasis (PASI reduction – 90–95%), others had significant improvement(PASI reduction from 75 to 80%).Conclusions: The treatment of psoriasis is often problematic due to its highresistance to existing drugs and treatment methods. An original method for treatingpatients with psoriasis is proposed. Apparatus for irradiation based on fluorescentlamps of a narrow-band spectrum of 311 nm was used as a physiotherapeutic treatment.The proposed method of treatment is effective, has good tolerance and minorcomplications. It can be recommended for widespread use in healthcare facilities.

AGGRESSIVE WEIGHT LOSS PROGRAM WITH A KETOGENIC INDUCTION PHASE FOR THE TREATMENT OF CHRONIC PLAQUE PSORIASIS

Chronic plaque psoriasis is an inflammatory skin disease associated with obesity,characterized by low-grade inflammation. Weight loss (WL) has been demonstrated to reduce psoriasis severity and inflammation. Very low-calorie ketogenic diet (VLCKD) has been associated with a significant reduction in visceral adipose tissue and keton bodies likely have anti-inflammatory proprieties. We evaluate the efficacy of an aggressive WL program with a ketogenic induction phase as first-line treatment of chronic plaque psoriasis. We conducted a single-arm trial conducted (NCT03531528). Adult overweight/obese patients (N=37)with stable chronic plaque psoriasis underwent a 10-week two-phase WL program consisting in a 4-week protein-sparing, VLCKD (<500 kcal/day; 1.2 grams of protein/kg of ideal body weight/day) and a 6-week balanced, hypocaloric (25-30 kcal/kg of ideal body weight/day), low glycemic index, Mediterranean-like diet. The primary endpoint was the reduction in the Psoriasis Area and Severity Index (PASI) at week 10. Major secondary endpoints included:improvement of PASI 50% and 75%,reduction in body surface area (BSA) involved,improvement of itch severity (visual-analogue scale) and Dermatology Life Quality Index (DLQI) at week 10. With a mean body weight reduction of 12.0%,dietary intervention resulted in a significant reduction in PASI: mean change, -10.6 [95%CI, -12.8 to -8.4] (P<0.001). A reduction in PASI 50% and 75% was recorded in 36 (97.3%) and 24 (64.9%) patients, respectively. Treatment resulted also in a significant reduction of BSA involved and an improvement in itch severity and DLQI (P<0.001 for all). In adult overweight patients with stable chronic plaque psoriasis an aggressive dietary WL program consisting in a ketogenic regimen followed by a balanced, hypocaloric Mediterranean-like diet appeared an efficacious first-line strategy for improving disease severity. Comparative studies with other dietary regimens and long-term efficacy data are warranted.

Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis.

Introduction:Apremilast is the new oral drug in the management of moderate-to-severe plaque psoriasis with well-established effectiveness and safety in long-term clinical trials and a few real-world studies. However, its effectiveness and safety in Indian setup have not been reported yet.Materials and Methods:This was retrospective, single-center, longitudinal, observational cohort study where the total study period was 24 weeks. Effectiveness parameters were the proportion of patients achieving psoriasis area and severity index (PASI) 50, 75, 90, and 100 response at week 16 and 24. Safety was measured as the proportion of patients reporting ≥1 adverse event (AE) during the study period.Results:Data of a total of 70 patients were included in our study. At week 16, 76.92%, 41.53%, 15.38%, and 6.15% patients achieved PASI 50, 75, 90, and 100, respectively. At week 24, 81.53%, 58.46%, 29.23%, and 10.76% patients achieved PASI 50, 75, 90, and 100, respectively. Mean percentage reduction in PASI was 67% at week 24 and DLQI score was reduced significantly to 3.4 from mean baseline DLQI score of 10.8 (P < 0.001). 40% of patients reported ≥1 AE during the study period. 5 out of 70 patients discontinued apremilast due to AE. Nausea was most common AE reported by 21.4% patients followed by diarrhea (18.57%), headache (17.4%), vomiting (8%), weight loss (7.69%), myalgia (6.15%), and gastritis (6.15%). Most of the AEs were of mild-to-moderate severity.Conclusion:The results of this study support the long-term use of apremilast monotherapy as an efficacious and safe treatment option for the management of moderate-to-severe plaque psoriasis.