Moderate Plaque Psoriasis Research Articles

Drugs for plaque psoriasis.

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.

COMPARISON OF EFFICACY OF TAZAROTENE/BETAMETHASONE VERSUS CALCIPOTRIOL/BETAMETHASONE IN PATIENTS WITH MILD TO MODERATE PLAQUE PSORIASIS

Plaque psoriasis is a chronic inflammatory skin disorder that significantly impacts patients' quality of life. Combination therapies, such as Tazarotene/Betamethasone and Calcipotriol/Betamethasone, are widely used for its management. Evaluating the efficacy of these combination therapies is essential for optimizing treatment outcomes. Objective: To evaluate the efficacy of Tazarotene/Betamethasone compared to Calcipotriol/Betamethasone in patients with mild to moderate plaque psoriasis. Methods: Following ethical committee approval, this randomized comparative study was conducted in the Department of Dermatology, PIMS, Islamabad, from January 2024 to June 2024. One hundred seventy patients with mild to moderate plaque psoriasis were enrolled and randomly assigned to two groups. Group A received Tazarotene 0.045% cream combined with Betamethasone dipropionate 0.05% ointment, while Group B was treated with Calcipotriol 0.005% combined with Betamethasone dipropionate 0.05% ointment. Both therapies were applied once daily for 12 weeks. The treatment response was assessed by evaluating changes in the Psoriasis Area and Severity Index (PASI) scores and Body Surface Area (BSA) affected. Data were analyzed using SPSS Version 26, and comparisons between the groups were made using t-tests, with significance set at p < 0.05. Results: The mean age of participants was 39.52±11.07 years. In Group A, 35.3% were male and 64.7% were female, while in Group B, 41.2% were male and 58.8% were female. Baseline PASI scores and BSA affected were comparable between the groups. After 12 weeks, Group A showed a more significant reduction in PASI scores (4.72±1.01 vs. 5.20±0.93, p=0.00) and BSA affected (3.49±0.86% vs. 4.21±0.86%, p=0.00) compared to Group B. Conclusion: Both combination therapies resulted in significant improvements in PASI scores and reductions in BSA affected. However, Tazarotene/Betamethasone was more effective than Calcipotriol/Betamethasone, likely due to the keratolytic properties of Tazarotene. These findings suggest that Tazarotene/Betamethasone may offer superior efficacy in managing mild to moderate plaque psoriasis.

Topical psoriasis therapy: An innovative classic

Introduction. Psoriasis affects various aspects of the quality of life of patients, causing psycho-emotional stress, anxiety and depression, therefore treatment of patients in terms of long-term control is the main goal of therapy.Aim. To study the effectiveness of drugs containing calcipotriol and betamethasone in the treatment of plaque psoriasis of smooth skin, scalp, palmoplantar mild to moderate severity.Material and methods. We observed 59 patients and 32 patients with moderate plaque psoriasis (PASI > 10 and < 20 points). In the groups, patients were randomized into subgroups with mild and moderate severity of psoriasis.Results. In patients with mild and moderate plaque psoriasis, after 4 weeks there was a decrease in the PASI index by 89.1% and 64.1%, respectively, the DLQI index decreased by 53.8% and 61.9%, the sPGA index by 71.8% and 64.9% for mild and moderate degrees, respectively. In patients with mild and moderate palmoplantar psoriasis, after 4 weeks there was a decrease in the PPASI index by 64.2% and 62.1%, respectively, the DLQI index decreased by 56.4% and 56.7%, and the sPGA index by 63.4 % and 66.7% for mild and moderate degrees, respectively. In patients with mild to moderate psoriasis of the scalp, after 4 weeks there was a decrease in the PSSI index by 75.1% and 72.6%, the DLQI index decreased by 64.6% and 69.6%, and the sPGA index by 62.3% and 67.6% for mild and moderate degrees, respectively.Conclusion. A 52-week follow-up demonstrated the effectiveness and safety of therapy with combination drugs (Daivobet® and Xamiol®) in patients with plaque psoriasis, including scalp psoriasis and palmoplantar psoriasis. It also showed a pronounced positive effect on the quality of life of patients, including in terms of long-term control of the disease.

Preference for Cal/BDP Cream or Foam in Patients With Mild to Moderate Plaque Psoriasis.

The combined use of topical calcipotriol/betamethasone dipropionate (Cal/BDP) is commonly used and demonstrated to be effective for the management of psoriasis and is shown to confer local anti-inflammatory and immunoregulatory effects. The use of the two agents in combination is synergistic. Despite the demonstrated efficacy of topically applied combination Cal/BDP, successful management of a chronic, relapsing inflammatory skin disease such as psoriasis in the real-world setting may be hindered if patients do not adhere to the dosing or frequency of application recommendations from their prescriber. Patient preference for and satisfaction with the topical treatment vehicle have been shown to influence adherence. A recent analysis has determined that patients perceived Cal/BDP cream vehicle with PAD technology as having favorable characteristics. This randomized, split-body study was undertaken to further assess patient satisfaction with Cal/BDP cream and Cal/BDP foam formulations. This was a split-body, subject-blind study. Study cream was administered in a single application to one side of the scalp and/or body; study foam was applied to the contralateral side. Patient self-administered questionnaires were completed before and after product application after a single site visit. Mean overall Vehicle Preference Measure (VPM) scores were higher for Cal/BDP cream than Cal/BDP foam (P=0.0043). Cal/BDP cream also achieved higher individual scores for ease of application, feeling to the touch, smell, and feeling on the skin (P<0.03). With regards to scalp application, subject assessments show that the cream was significantly more preferred in terms of limiting daily disruption (P=0.0008) Conclusion: Results of this study suggest that patients may prefer Cal/BDP cream over Cal/BDP foam for the management of psoriasis on the body and the scalp. Cal/BDP cream outperformed Cal/BDP foam on several specific measures of satisfaction and overall satisfaction measures. J Drugs Dermatol. 2024;23(8):607-611.  doi:10.36849/JDD.7993.

The safety and efficacy of adipose tissue-derived exosomes in treating mild to moderate plaque psoriasis: A clinical study

AimThis study evaluates the safety and efficacy of autologous adipose-derived mesenchymal stem cell-derived exosomes as a treatment for Psoriasis, a chronic immune-related skin and joint disorder, compared to current treatments like topicals, phototherapy, and systemic. Materials and methodsThe study isolated exosomes from Mesenchymal Stem Cells(MSCs) of healthy adipose tissue using ultracentrifugation. 12 patients with plaque psoriasis were divided into three groups and given single doses of exosomes. Tissue samples were collected pre- and post-treatment and examined for inflammatory(TNFα, IL23, IL17, IFNγ, CD3) and anti-inflammatory (FOXP3, IL10) markers. The severity of the lesion was also evaluated. Key findingsIn this study, it was found that erythema and induration (P < 0.05) decreased significantly in patients receiving 200 μg. Still, this reduction in scaling was not significant, the thickness was significantly reduced in patients receiving 100 and 200 μg doses (P < 0.05). H&E evaluation showed that the decreasing trend in these patients was not significant (P > 0.05). IHC evaluation in patients receiving doses of 100 and 200 μg showed a decrease in the presence of IL17 (P < 0.05, <0.001) & CD3(P < 0.001, <0.05) and a considerable increase in FOXP3(P ≤ 0.001), in the tissue samples of the patients. Examining the expression of inflammatory factors also shows that dose 200 μg decreased the expression of IL17(P > 0.05), IFNγ(P > 0.05), IL23(P < 0.05), & TNFα(P ≤ 0.05) and increased the expression of the anti-inflammatory factor IL10(P < 0.05). SignificanceThe study indicates that a 200 μg dose is optimal for patients, but a larger patient population is needed for more reliable results. Additionally, higher doses or multiple injections with specific intervals can increase confidence.

Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT.

Psoriasis involvement in special areas (e.g., scalp or nails) is associated with a great disease burden yet it is often inadequately treated with topical treatments. The efficacy and tolerability of apremilast plus existing topical therapy in Japanese patients with mild to moderate plaque psoriasis were demonstrated in PROMINENT, a phase 3b, multicenter, open-label, single-arm study. We evaluated the efficacy of apremilast across disease severities and special areas involved in these patients. In PROMINENT, patients received apremilast 30mg twice daily for 16weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from Weeks 16 to 32. We performed a post hoc analysis, assessing apremilast efficacy and safety in Japanese patients stratified by baseline static Physician Global Assessment (sPGA) score (2 [mild] or 3 [moderate]) and special area involvement. Of patients with baseline sPGA = 2 and sPGA = 3, 62.7% and 30.7%, respectively, achieved sPGA score 0 or 1 at Week 32. At Week 32, improvements in skin, nail, scalp, and quality of life assessments were observed regardless of baseline sPGA score. Improvements in these endpoints at Week 32 were also observed in patients with special area (scalp or nail) involvement (n = 134). Incidence of adverse events was similar between patients with baseline sPGA = 2 and sPGA = 3. Apremilast in combination with topical therapy may be a beneficial treatment for Japanese patients, who have limited systemic treatment options for mild to moderate psoriasis or psoriasis in special areas. NCT03930186.

Deucravacitinib in Moderate Plaque Psoriasis: Efficacy in the Phase 3 POETYK PSO-1 and PSO-2 Trials

Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, was efficacious and well tolerated in adults with moderate to severe plaque psoriasis in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials. We report clinical efficacy of deucravacitinib in the patient subgroup from these trials with baseline plaque psoriasis of moderate severity.&#x0D; Methods: PSO-1 and PSO-2 randomized patients with moderate to severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA involvement ≥10% at baseline) 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Placebo patients crossed over to deucravacitinib at Week 16 in both trials. In PSO-1, deucravacitinib-treated patients received continuous deucravacitinib through Week 52. In PSO-2, PASI 75 responders at Week 24 on deucravacitinib were rerandomized to placebo or deucravacitinib (1:1) through Week 52. In patients meeting criteria for plaque psoriasis of moderate severity, defined as sPGA 3 and BSA 10%-15% at baseline, in the pooled PSO-1/PSO-2 trials, PSO-1 alone, and the PSO-1 placebo crossover population, deucravacitinib efficacy vs placebo was evaluated by PASI 75, PASI 90, and sPGA 0/1 (clear/almost clear) responses (nonresponder imputation) and PASI change from baseline (mBOCF). The Clopper-Pearson method was used to calculate 95% CIs.&#x0D; Results: PSO-1/PSO-2 moderate psoriasis subgroup PASI 75 response rates were higher with deucravacitinib vs placebo at Week 16 (49.1% [95% CI, 42.5%-55.7%] vs 11.7% [95% CI%, 5.9%-17.4%]) and continued to increase through Week 24 (63.8% [95% CI, 57.5%-70.1%]). PSO-1 PASI 75 response rates were higher with deucravacitinib vs placebo at Week 16 (54.1% [95% CI, 42.1%-65.7%] vs 12.0% [95% CI, 4.5%-24.3%]), Week 24, and were sustained until Week 52. Week 52 PASI 75 response rates for deucravacitinib and placebo crossover groups were comparable (74.3% [95% CI, 62.8%-83.8%] and 67.4% [95% CI, 51.5%-80.9%], respectively). PASI 90 and sPGA 0/1 response rates and change from baseline PASI followed similar patterns, with marked improvement vs placebo at Week 16; peak responses were observed at Week 24 and sustained through Week 52. Efficacy results were comparable to those previously reported for moderate to severe psoriasis.&#x0D; Conclusion: Deucravacitinib efficacy was confirmed in moderate plaque psoriasis and was consistent with published data in the PSO-1 and PSO-2 overall study population with moderate to severe plaque psoriasis.&#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D;

PSORIATICUM: Topical Hypericum Perforatum for Moderate Plaque Psoriasis: Study Protocol for a Randomized Controlled Trial

Introduction: Psoriasis is an autoimmune chronic inflammatory disorder in which an increased amount of Tumor Necrosis Factor Alpha (TNF-α) leads to the formation of psoriatic plaques. Hypericum perforatum (HP) is a flowering plant used as an herbal medication due to its antimicrobial, wound-healing, and anti-inflammatory properties. Pilot studies have reported its ability to decrease the levels of TNF-α and severity of psoriatic plaques in moderate forms of psoriasis with fewer side effects and lower costs compared to standard treatment. More extensive studies are needed to confirm this. Objectives: To assess the effectiveness of topical HP in decreasing the mean total PASI score at the end of 12 weeks in patients with moderate plaque psoriasis. Methods: PSORIATICUM is a phase II, single-center, two-arm parallel, double-blinded randomized clinical trial that has the purpose of evaluating the efficacy of HP versus a control vehicle based on the decrease of the PASI score. The primary outcome is the total PASI score in the treatment group, compared to the control group at the end of the 12 weeks of testing. Normality will be evaluated using Kolmogorv-Smirnov, having the statistical significance of the findings tested using a two-tail Student’s T test for independent means or Mann-Whitney-Wilcoxon test. The secondary outcomes include the mean PASI change at weeks 4 and 8. Discussion: PSORIATICUM will provide information about the usefulness of Hypericum perforatum to treat psoriasis, allowing for future trials to study a safe and accessible alternative treatment for the condition.

Inhibition of Receptor-Interacting Protein Kinase1 in Chronic Plaque Psoriasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.

Receptor-interacting protein kinase1 (RIPK1), a key mediator of inflammation through necroptosis and proinflammatory cytokine production, may play a role in the pathogenesis of immune-mediated inflammatory diseases such as chronic plaque psoriasis. An experimental medicine study of RIPK1 inhibition with GSK2982772 immediate-release formulation at doses up to 60mg three times daily in mild to moderate plaque psoriasis indicated that efficacy may be improved with higher trough concentrations of GSK2982772. This multicenter, randomized, double-blind, placebo-controlled, repeat-dose study (NCT04316585) assessed the efficacy, safety, pharmacokinetics, and pharmacodynamics of 960mg GSK2982772 (once-daily modified-release formulation) in patients with moderate to severe plaque psoriasis. Twenty-nine patients were randomized 2:1 to GSK2982772 (N = 19) or placebo (N = 10) for 12weeks. GSK2982772 was well tolerated with trough concentrations greater than tenfold higher than the previous phase1 study with immediate release. Despite near complete RIPK1 target engagement in blood and modest reduction in circulating inflammatory cytokines, the proportion of patients achieving 75% improvement from baseline in Psoriasis Area Severity Index score at week12 was similar between GSK2982772 and placebo (posterior median 1.8% vs 4.9%, respectively), with an estimated median treatment difference of - 2.3%. This analysis incorporated historical placebo data through the use of an informative prior distribution on the placebo arm. Week4 changes in skin biopsy gene expression suggested sufficient local drug exposure to elicit a pharmacodynamic response. Administration of the RIPK1 inhibitor GSK2982772 to patients with moderate to severe plaque psoriasis did not translate into meaningful clinical improvements.

The therapeutic efficacy and mechanism action of Si Cao formula in the treatment of psoriasis: A pilot clinical investigation and animal validation

Ethnopharmacological relevancePsoriasis is a chronic inflammation and relapsing disease that affected approximately 100 million individuals worldwide. In previous clinical study, it was observed that the topical application of Si Cao Formula (SCF) ameliorated psoriasis skin lesions and reduced the recurrence rate of patients over a period of three months. However, the precise mechanism remains unclear. Aim of the studyThe objective of this study was to assess the effectiveness and safety of SCF in patients diagnosed with psoriasis and explore the molecular mechanisms that contribute to SCF's therapeutic efficacy in psoriasis treatment. Materials and methodsA randomized, controlled, and pilot clinical study was performed. This study assessed 30 individuals diagnosed with mild to moderate plaque psoriasis. 15 of them underwent local SCF treatment, the others received calcipotriol intervention. The outcome measure focused on Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and recurrence rate. In addition, IMQ-induced psoriasis-like mice model were used to assess the impact of SCF on ameliorating epidermal hyperplasia, suppressing angiogenesis, and modulating immune response. Furthermore, we performed bioinformatics analysis on transcriptome data obtained from skin lesions of mice model. This analysis allowed us to identify the targets and signaling pathways associated with the action of SCF. Subsequently, we conducted experimental validation to confirm the core targets. ResultsOur clinical pilot study demonstrated that SCF could ameliorate skin lesions in psoriasis patients with comparable efficacy of calcipotriol in drop of PASI and DLQI scores. SCF exhibited a significantly reduced recurrence rate within 12 weeks (33.3%). Liquid Chromatography Mass Spectrometry (LC-MS) identified 41 active constituents of SCF (26 cations and 15 anions). Animal experiments showed SCF ameliorates the skin lesions of IMQ-induced psoriasis like mice model and suppresses epidermal hyperkeratosis and angiogenesis. There were 845 up-regulated and 764 down-regulated DEGs between IMQ and IMQ + SCF groups. GO analysis revealed that DEGs were linked to keratinization, keratinocyte differentiation, organic acid transport epidermal cell differentiation, and carboxylic acid transport interferon-gamma production. KEGG pathway analysis showed that SCF may play a vital part through IL-17 and JAK/STAT signaling pathway. In addition, SCF could reduce the number of positive cells expressing PCNA, CD31, pSTAT3, CD3, and F4/80 within the epidermis of psoriatic lesions, as well as the expression of Il-17a and Stat3 in IMQ-induced psoriasis mice. ConclusionsOur research suggests that SCF serves as a reliable and efficient local approach for preventing and treating psoriasis. The discovery of plausible molecular mechanisms and therapeutic targets associated with SCF may support its broad implementation in clinical settings.

Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis

Atopic dermatitis (AD) and plaque psoriasis are inflammatory skin diseases with unmet need for effective topical treatments with few application site reactions. To assess the efficacy and safety of the topical phosphodiesterase 4 inhibitor PF-07038124 in patients with AD and plaque psoriasis. This phase 2a, randomized, double-blind clinical trial was conducted from December 21, 2020, to August 18, 2021, at 34 sites across 4 countries. Eligible patients (aged 18-70 years) had mild to moderate AD (covering 5%-20% body surface area) or plaque psoriasis (covering 5%-15% body surface area). Data were analyzed until December 15, 2021. Patients were randomized (1:1) to PF-07038124, 0.01%, topical ointment or vehicle once daily for 6 weeks. The primary end point was the percent change from baseline (CFB) in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures included treatment-emergent adverse events, including application site reactions. Overall, 104 patients were randomized (mean [SD] age, 43.0 [15.4] years; 55 [52.9%] women; 4 [3.8%] Asian, 13 [12.5%] Black, and 87 [83.7%] White), including 70 with AD (41 women [58.6%]; mean [SD] ages, 41.4 [16.6] years in the PF-07038124 group and 36.1 [13.9] years in the vehicle group) and 34 with plaque psoriasis (20 men [58.8%]; mean [SD] ages, 51.8 [12.3] years in the PF-07038124 group and 51.2 [10.8] years in the vehicle group). Baseline characteristics were generally balanced. At week 6, the PF-07038124 groups showed significantly greater improvements compared with vehicle groups in EASI (least-squares mean CFB, -74.9% vs -35.5%; difference, -39.4% [90% CI, -58.8% to -20.1%]; P < .001) and PASI scores (CFB, -4.8 vs 0.1; difference, -4.9 [90% CI, -7.0 to -2.8]; P < .001). The number of patients with treatment-emergent adverse events was comparable between treatment groups in patients with AD (PF-07038124, 9 [25.0%]; vehicle, 9 [26.5%]) and plaque psoriasis (PF-07038124, 3 [17.6%]; vehicle, 6 [35.3%]). There were no application site reactions with PF-07038124 treatment. Topical PF-07038124 was well tolerated and demonstrated superior efficacy compared with vehicle in patients with mild to moderate AD and plaque psoriasis. ClinicalTrials.gov Identifier: NCT04664153.

Efficacy and Safety of Risankizumab Compared with Apremilast in Patients with Moderate Plaque Psoriasis: Mean PASI and BSA Results From the Phase 4 IMMpulse Trial

Introduction&#x0D; The IMMpulse study (NCT04908475) demonstrated superior efficacy of risankizumab (RZB) compared to apremilast (APR) in systemic-eligible patients with moderate plaque psoriasis (PsO).&#x0D; Material and Methods&#x0D; This phase 4, multi-center, randomized, open-label, assessor-blinded, active comparator study compared RZB to APR in adult systemic-eligible patients with moderate plaque PsO. In period A, patients were randomized 1:2 to receive RZB (150 mg) or APR (30 mg twice daily) for 16 weeks. In period B, all APR-treated patients were re-randomized 1:1 to RZB or APR stratified by their ≥ 75% improvement in psoriasis area and severity index (PASI75) response. All RZB patients in period A continued treatment till week 52. Pre-specified efficacy endpoints included change in PASI and body surface area (BSA) from baseline. Continuous endpoints were assessed using mixed-effect model repeat measures to handle missing data.&#x0D; Results&#x0D; Baseline characteristics were similar between the treatment arms. At week 16, PASI75 was achieved by 84.7% (RZB-treated) and 18.8% (APR-treated) patients. Mean PASI improved from 14.6 at baseline to 1.7 (RZB-treated), and from 14.5 at baseline to 8.8 (APR-treated) patients. Mean BSA improved from 13.1% to 2.6% with RZB, and from 13.1% to 10.6% for APR-treated patients. APR-treated patients not achieving PASI75 at week 16 who switched to RZB achieved a mean PASI of 0.7 at week 52, compared to 3.1 at week 52 in patients who continued with APR. In these same patients, those that switched to RZB achieved a mean BSA of 1.4% at week 52 compared to 6.3% for patients who continued APR. Most frequently observed treatment emergent adverse events were COVID-19 and nasopharyngitis for RZB, and diarrhea, nausea, and headache for APR.&#x0D; Conclusions&#x0D; These results demonstrate minimal residual disease observed with continuous RZB treatment and support the opportunity to elevate treatment outcomes with RZB in systemic-eligible patients with moderate plaque PsO.

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Efficacy by Baseline Body Surface Area (BSA) Involvement and Baseline Psoriasis Area and Severity Index (PASI)

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. In the phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib was significantly more efficacious than placebo and apremilast. This analysis evaluated deucravacitinib efficacy by two measures of baseline disease severity, BSA involvement and PASI scores.&#x0D; Methods: Patients were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily in both trials, which included 16-week placebo-controlled and 24-week apremilast-controlled periods from Day 1. Of patients randomized to deucravacitinib, those in PSO-1 were treated continuously for 52 weeks; in PSO-2, Week 24 PASI 75 responders were rerandomized to continued deucravacitinib or placebo. Patients randomized to placebo crossed over to deucravacitinib at Week 16 and were treated through Week 52. Efficacy outcomes, including ≥75%/≥90%/100% reductions from baseline in PASI (PASI 75/90/100) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1), were evaluated using nonresponder imputation in disease severity subgroups defined by baseline BSA involvement (10%-&lt;15%, 15%-&lt;20%, 20%-&lt;30%, ≥30%) and PASI score (12-&lt;15, ≥15). Results are reported through Week 24 in the pooled PSO-1/PSO-2 population (apremilast-controlled) and through Week 52 in the PSO-1 population (continuous deucravacitinib treatment).&#x0D; Results: In the pooled PSO-1/PSO-2 population (N=1686), 391 (23.2%) had baseline BSA involvement of 10%-&lt;15% (deucravacitinib, n=194), 371 (22.0%) had 15%-&lt;20% (deucravacitinib, n=183), 391 (23.2%) had 20%-&lt;30% (deucravacitinib, n=198), and 533 (31.6%) had ≥30% (deucravacitinib, n=268). For baseline PASI scores, 387 (23.0%) had a score of 12-&lt;15 (deucravacitinib, n=183) and 1298 (77.0%) had a score of ≥15 (deucravacitinib, n=660). Deucravacitinib-treated patients had comparable PASI 75 response rates across all subgroups at Week 16 (BSA subgroups, 50.5%-58.2%; PASI subgroups, 48.6%-57.0%) and at Week 24 (BSA subgroups, 62.0%-64.1%; PASI subgroups, 59.9%-63.8%), with superior responses versus those in patients receiving placebo or apremilast evaluated in each subgroup. Similar findings were observed for all other efficacy measures. In PSO-1, efficacy was maintained through Week 52 with continuous deucravacitinib treatment across BSA (PASI 75, 67.1%-75.7%; sPGA 0/1, 52.1%-61.2%) and PASI subgroups (PASI 75, 65.6%-73.1%; sPGA 0/1, 54.7%-58.8%).&#x0D; Conclusion: Deucravacitinib was efficacious in patients with moderate or severe plaque psoriasis regardless of extent of baseline BSA involvement or PASI scores.

Efficacy and Safety of Secukinumab for the Treatment of Psoriasis: A Meta-Analysis of Pivotal Phase III Trials

Background: Secukinumab, a fully humanized monoclonal antibody against IL-17A, was approved for the treatment of moderate-to-severe plaque psoriasis in the USA and European Union in 2015. Objectives: Secukinumab, a fully humanized monoclonal antibody against IL-17A, was approved for the treatment of moderate-to-severe plaque psoriasis in the USA and European Union in 2015. The aim of this study was to systematically evaluate the efficacy and safety of secukinumab for the treatment of moderate and severe plaque psoriasis and provide an evidence-based reference for clinical practice. Methods: PubMed, Google Scholar, Cochrane Library, and Clinical Trials databases were searched. Pivotal phase III clinical trials were analysed. RevMan was used for the statistical analysis of the data. Results: Seven pivotal phase III clinical trials were analysed. All trials evaluated secukinumab in moderate-to-severe plaque psoriasis and had two common primary end points: the proportion of respondents to the Psoriasis Area and Severity Index (PASI) and the proportion of respondents to the Investigator’s Global Assessment (IGA). The total response ratios of PASI and IGA respondents in the secukinumab group were 82.8 and 71.3%, respectively, compared to placebo. Secukinumab was superior to etanercept, with risk ratios of 1.7 and 2.1, respectively. Secukinumab was generally well tolerated during the 1-year trial period. However, adverse events also occurred. Conclusion: Secukinumab was found to be more effective than etanercept and had an acceptable safety profile. Since psoriasis is an autoimmune disease that requires lifelong treatment, attention should be paid to its adverse effects.

EVALUATION OF EFFICACY AND SAFETY OF ORAL VITAMIN D3 AND VITAMIN E AS AN ADD-ON-THERAPY TO METHOTREXATE IN PATIENTS OF MODERATE CHRONIC PLAQUE PSORIASIS

Objective: This study was conducted with the aim to evaluate the efficacy and safety of oral Vitamin D3 and Vitamin E as an add-on-therapy to methotrexate (MTX) in patients of moderate chronic plaque psoriasis. Methods: In this prospective, open-labeled, randomized, and comparative clinical study, a total of 120 patients of age 20–60 years with moderate chronic plaque psoriasis attending the dermatology outpatient department were randomly allocated into three groups of 40 each, i.e., Group M, Group D, and Group E. Group M received MTX (7.5 mg) tablet orally weekly, Group D received MTX (7.5 mg) and Vitamin D3 (60,000 IU) sachet orally weekly, and Group E received MTX (7.5 mg) weekly and Vitamin E (400 mg) daily. Efficacy assessment was done through the following primary parameters-psoriasis area and severity index (PASI) score, dermatology life quality index (DLQI), and psoriasis disability index (PDI), and secondary parameters such as Vitamin D deficiency and insufficiency among the study participants and improvement of serum 25(OH)D concentration. Adverse events were monitored. Results: PASI and DLQI were calculated at the time of recruitment (baseline), 1 month, 2 months, 3 months, and 4 months, and PDI and serum Vitamin D were calculated at baseline and 4 months. On intergroup comparison of PASI score and PDI, statistically significant results were seen at 4 months. DLQI showed significant results at 2, 3, and 4 months. Significant results were found in Group D which signifies improvement in serum Vitamin D levels. Mild side effects were seen at the end of 4 months. Conclusion: The present study suggested that Vitamin D as an add-on therapy was found to cause a significant reduction in psoriatic lesions. It could be a promising drug in patients with psoriasis to improve the psoriatic lesions, when combined can reduce the dose of MTX, thereby minimizing the side effects.

43928 Long-term Safety and Efficacy of Risankizumab for the Treatment of Moderate to-Severe Plaque Psoriasis: Interim Analysis of Results From the LIMMitless Open-label Extension Trial Up to 5 Years of Follow-up

43928 Long-term Safety and Efficacy of Risankizumab for the Treatment of Moderate to-Severe Plaque Psoriasis: Interim Analysis of Results From the LIMMitless Open-label Extension Trial Up to 5 Years of Follow-up

Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial.

Psoriasis is a common skin disorder associated with physical and psychological burdens. Visible disfiguration can trigger a negative reaction which can cause much of the readily measurable psychological burden of the disease. Although many biological treatments provide some success in the initial clearance of lesions, there is a dispute about the long-term maintenance of the disease, as no current biological treatment has been shown to be curative. Topical therapies are still the most widely used agents as first-line and maintenance treatment for psoriasis. The present study aimed to investigate the safety, tolerability, and, to some extent, efficacy of GN-037 cream in patients with psoriasis and healthy volunteers. A randomized, double-blind, single-center, placebo-controlled phase 1 clinical study was conducted to evaluate the safety, tolerability, and clinical efficacy of GN-037 cream topically applied twice daily for 2weeks in healthy subjects (n = 12) and patients (n = 6) diagnosed with plaque-type psoriasis. Six healthy subjects received placebo. Patients with plaque psoriasis were evaluated by a dermatologist, and Physician Global Assessment (PGA) score was required to be ≥ 3 (moderate psoriasis) at screening. A total of 31 adverse events (AEs) occurred in 13 participants during the study: 9 AEs in healthy subjects receiving GN-037 cream, 3 AEs in healthy subjects receiving placebo, and 1 AE in one psoriatic patient. The most frequently reported AEs were reactions at the application site, including erythema, exfoliation, pruritus, and burning sensation. During the baseline evaluation, one patient had a PGA score of 3 (moderate) and five patients had a PGA score of 4 (severe). On day 14, in treatment, four patients experienced second grade and two patients third grade improvements compared with baseline, indicating a shift of patients from moderate and severe disease to mild disease and to almost clear (score 2 or 1). There were slight increases in plasma tumor necrosis factor (TNF)-α, interleukin-17 (IL-17) and interleukin-23 (IL-23) levels in both healthy volunteers and patients throughout the study, as compared with baseline. The results of this phase 1 trial conducted in 18 healthy volunteers and 6 patients with plaque psoriasis demonstrated a favorable safety and tolerability profile for GN-037; therefore, further clinical development of GN-037 in a phase 2 clinical trial has been initiated in patients with mild to moderate plaque psoriasis (NCT05706870). NCT05428202.

Apremilast treatment of plaque psoriasis (PsO) after systemic therapy in Spanish clinical practice: Data from the APPROPRIATE study

AbstractBackgroundDespite the proven efficacy and safety of apremilast to treat plaque psoriasis (PsO), data regarding its real‐world use and patient‐perceived benefits are limited.ObjectivesDescribe apremilast use, persistence and tolerability, and its patient‐perceived benefits and effectiveness in patients with PsO in Spanish clinical practice.MethodsObservational, prospective, multicenter study including patients with moderate‐to‐severe PsO initiating apremilast 3 months (±4 weeks) before enrolment, after at least one conventional systemic therapy and no biologics. Prospective data were collected 3 (at enrolment), 6 and 12 months (±4 weeks) after apremilast initiation. Primary outcome was a Patient Benefit Index (PBI) score ≥1 (minimum clinically relevant benefit) at 6 months.ResultsOf 153 patients enroled, 119 were included in the analysis; mean (standard deviation [SD]) age, 52.8 (15.2) years. At apremilast initiation, mean (SD) Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were 8.3 (4.9) and 10.5 (6.8), respectively. Most patients (81%) had comorbidities; PsO manifestations included scalp (47% of patients), palmoplantar (26%), nails (24%) and genitals (11%). Over three‐quarters (86%) of patients were continuing apremilast at Month 6, with most (91%) achieving a PBI ≥ 1% and 43% achieving a PBI ≥ 3; two‐thirds (68%) were continuing apremilast at Month 12, with 91% and 42% achieving a PBI ≥ 1 and ≥3, respectively. Mean (SD) pruritus scores decreased from 54.5 (32.1) at apremilast initiation to 23.4 (27.0) at Month 12; 57%, 69% and 69% of patients achieved a DLQI 0‒1, PASI &lt; 3 and BSA &lt; 3, respectively. Adverse events were consistent with the known safety profile.ConclusionsPatients initiating apremilast after conventional systemic therapy in Spanish clinical practice had moderate PsO at bothersome/visible locations and impaired quality of life. Most patients remained on apremilast for 12 months, with improved patient‐reported outcomes and skin involvement, and almost all patients reported some clinical benefit. Apremilast was well tolerated without new safety signals.

Efficacy of a Novel Formulation of Betamethasone Dipropionate 0.05% Spray Versus Augmented Betamethasone Dipropionate 0.05% Lotion In Patients &gt;= 18 Years of Age with Moderate Plaque Psoriasis: A Pooled Analysis

Efficacy of a Novel Formulation of Betamethasone Dipropionate 0.05% Spray Versus Augmented Betamethasone Dipropionate 0.05% Lotion In Patients &gt;= 18 Years of Age with Moderate Plaque Psoriasis: A Pooled Analysis

Real-world experience on the efficacy and safety of apremilast in bio-naïve patients with moderate plaque psoriasis.

Real-world experience on the efficacy and safety of apremilast in bio-naïve patients with moderate plaque psoriasis.