Baseline PASI Score Research Articles

FC29 Risk of developing psoriatic arthritis in patients with psoriasis initiating treatment with different classes of biologics

Abstract It is debated whether this risk of psoriatic arthritis (PsA) is different according to the class of the biologic the patient with psoriasis (PsO) is receiving. To investigate the risk of PsA in patients receiving different classes of biologics. A retrospective observational study involving consecutive bio-naïve patients. The cumulative incidence rate of PsA using an event per person-years analysis was estimated in patients stratified according to the class of the biologic (TNF-a, IL-17 or IL-23 inhibitors). Cox proportional hazards models involving time-dependent explanatory variables were fitted to estimate the hazard risk (HR) of PsA. Six hundred and twenty-two patients, 388 (62.4%) males, mean age 46.9 years, were included. They have been treated with TNF-a (n = 317, 50.9%), IL-17 (n = 164, 26.4%) or IL-23 inhibitors (n = 141, 22.7%), and followed for 2820.2 person-year (a mean of 4.73 ± 2.12 years per person). Incidence rates of PsA were 2.60 [95% confidence interval (CI) 1.95–3.49], 1.58 (95% CI, 0.82–3.04) and 1.14 (95% CI, 0.51–2.54) cases per 100 patients/year in the TNF-a, IL-17 and IL-23 inhibitors groups, respectively. The variables associated with higher risk of incident PsA were baseline PASI score [adjusted hazard ratio, aHR 1.18 (95% CI 1.12–1.25) P < 0.001], family history of PsA [aHR 2.78 (95% CI 1.90–3.52), P = 0.005] and nail involvement [hazard ratio 1.85 (1.07–3.21) P = 0.029]. Treatment with IL-17 or IL-23 inhibitors was associated with a lower risk of PsA compared with TNF-a inhibitors [aHR 0.43 (95% CI 0.20–0.93) P = 0.031] and [aHR 0.58 (95% CI 0.24–0.75) P = 0.015], respectively. Treatment with IL-17 or IL-23 inhibitors is associated with lower risk of PsA.

Development and external validation of a prediction model for the risk of relapse in psoriasis after discontinuation of biologics.

Some patients with psoriasis experience relapses shortly after discontinuation of biologics. However, there is a lack of risk prediction tools to identify those at high risk of relapse. To develop and validate a risk prediction model for psoriasis relapse after biologics discontinuation. Publications from PubMed, EMBASE, Medline, and the Cochrane Library were systematically searched and meta-analyses were conducted to identify risk factors for psoriasis relapse after biologics discontinuation. Statistically significant risk factors were identified and used to create a risk assessment model weighted by the impact of each factor. The model was externally validated using a cohort of 416 Chinese psoriasis patients. Eight studies (N = 2066) were included in the meta-analysis. Body mass index (BMI), smoking, disease duration, comorbid psoriatic arthritis (PsA), remission speed and extent during treatment, history of biologic therapy, and therapy duration were identified as correlates of relapse in the meta-analysis and were incorporated into the prediction model. The median age of the 416 patients in the validation cohort was 41.5 (IQR 32, 53) years, with 63% male, and a baseline PASI score of 15.4 (IQR 10.5, 21). It was verified that the area under the curve (AUC) of the prediction model was 0.796 (95% CI, 0.753-0.839), with an optimal cut-off value of 11.25 points, sensitivity of 65.1%, and specificity of 82.2%. Multivariate models using available clinical parameters can predict relapse risk in psoriasis patients after biologics discontinuation. Early individual identification of patients at risk of relapse, and screening of candidate cohorts for long-term treatment or dose reduction may benefit both patients and physicians.

The impact of tildrakizumab on quality of life in patients suffering from moderate-to-severe psoriasis: a 36-week prospective, monocentric, real-life, observational study.

Psoriasis may significantly impact on patients' health related quality of life (HRQoL). Clinical assessment has been combined with HRQoL scores to evaluate the ways that cutaneous disease is a burden to patients. Tildrakizumab is a humanized IgG1 monoclonal antibody targeting interleukin-23 p19 and is approved for the management of moderate-to-severe plaque psoriasis. The aim of our study was to evaluate the impact of tildrakizumab treatment on psychological field in patients affected by moderate-to-severe plaque psoriasis. a 36-weeks observational study was carried out enrolling psoriasis patients who initiated treatment with tildrakizumab 100 mg. DLQI and Skindex-16 questionnaire were administered at baseline, week 12, week 24 and week 36. PASI, BSA and pruritus (p)-VAS were also assessed at baseline and at each follow-up. A total of 34 patients were enrolled. Baseline PASI and BSA score were 28.4±5.6 and 38.8±21.4, respectively. Similarly, the impact of psoriasis on HRQoL was collected (DLQI: 26.4±3.2, Skindex-16: 68±5.8, p-VAS: 8.2). Clinical improvement was assessed since week 12 (PASI: 12.4±4.2; BSA: 16.5±7.3), continuing to week 24 (PASI: 4.2±2.8; BSA: 6.1±3.1) and 36 (PASI: 3.6±3.2; BSA: 4.2±1.37). Clinical improvement was accompanied by an improvement in quality of life at week 16 (DLQI: 15.5±2.9; Skindex-16: 28.2±4.2; p-VAS: 3.8) , 24 (DLQI: 8.2±1.4, Skindex-16: 16.2; p-VAS: 2.6) and 36 (DLQI: 3.1±2.4; Skindex-16: 9.3±2.8; p-VAS: 2.8). Our study also confirmed the safety of tildrakizumab in real life settings, with no treatment discontinuation for inefficacy or adverse events reported during the study. our results confirm tildrakizumab as an effective option for the improvement of psoriasis patients' HRQoL.

Unveiling the impact of psoriasis on liver health: does methotrexate play a villainous role?

Psoriasis might bring about an increased risk of liver diseases like nonalcoholic fatty liver disease and fibrosis. The impact of methotrexate on liver function is still a cause for concern, because of the studies suggesting an increased risk of liver damage and others finding no association. The focus of this study was the liver functions in psoriatic patients investigating the impact of long-term use of methotrexate on liver in psoriasis. A retrospective investigation including 140 patients with psoriasis receiving methotrexate treatment for at least 6 months and a control group consisted of 105 healthy ones was conducted. Liver function tests (AST, ALT, PLT) were assessed, and the association of baseline PASI with FIB-4 and APRI values was investigated. Additionally, FIB-4 and APRI values at baseline, 3rd, and 6th months of methotrexate treatment for psoriasis were compared. Compared with the controls, psoriatic patients exhibited significantly higher FIB-4 scores (p = 0.004). A moderate and significant correlation was observed between baseline PASI score and baseline FIB-4 score in psoriatic patients (p < 0.001, rho = 0.626). Long-term methotrexate use had no effect on APRI or FIB-4 (p = 0.104 and p = 0.475, respectively). Psoriatic patients face an elevated risk of liver fibrosis. Long-term methotrexate use does not adversely affect liver function in psoriatic patients. Noninvasive tools like APRI and FIB-4 scores can be employed to evaluate the risk of liver disease in these patients.

Aging Impact in Response to Different Classes of Biological Treatment in Psoriatic Patients: A Real-Life Observational Study

Over the last decade, the treatment landscape for moderate to severe psoriasis has undergone transformative changes with the advent of biotechnological drugs. Monoclonal antibodies targeting the IL-17 and IL-23 pathways have displayed remarkable clinical efficacy and safety, even among patients with complex comorbidities. These innovations have extended across various age groups within the psoriatic population. However, a scarcity of age-specific data remains regarding the efficacy and safety of these medications. Our study tries to bridge this gap by systematically presenting data obtained from the analysis of 1055 patients treated for psoriasis with anti-IL17 and anti-IL23 drugs during a 1-year period. The effectiveness and safety of anti-IL-17 and anti-IL23 drugs for moderate to severe psoriasis were assessed across four different age groups ranging from patients less than 26 years old to patients older than 65 years, divided in four year ranges. In the studied population, baseline PASI score was significantly higher in the age group of individuals over 65 years compared to those under 26 years old. Patients over 65 years also exhibited a slower rate of improvement in PASI-90 and PASI &lt; 3 at the 16-week mark compared to other age groups. However, no clinically significant differences in treatment response were found when comparing overall responses among different age groups. In age groups older than 26 years, anti-IL17 drugs seems faster in the achievement of PASI-100 when compared to anti-IL23 drugs. This trend became more pronounced with increasing age. The investigation provides insights into treatment responses and patient characteristics, highlighting the influence of age as a significant variable in patient management.

Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study

BackgroundGuselkumab is a selective interleukin (IL)-23 inhibitor targeting the IL-23p19 subunit. In the phase 3b COSMOS trial, guselkumab demonstrated efficacy in treating participants with active psoriatic arthritis (PsA) and inadequate response (IR; lack of efficacy or intolerance) to tumor necrosis factor inhibitors (TNFi).MethodsAdults with active PsA (≥ 3 swollen joints, ≥ 3 tender joints) and IR to one or two TNFi (TNFi-IR) were randomized 2:1 to guselkumab at Weeks 0, 4, then every 8 weeks (Q8W) or placebo➔guselkumab Q8W at Week 24 with possible early escape at Week 16. Levels of serum cytokines, including interferon γ (IFNγ), IL-10, and tumor necrosis factor α (TNFα); T helper 17 (Th17) effector cytokines IL-17A, IL-17F, and IL-22; and acute phase proteins C-reactive protein (CRP), IL-6, and serum amyloid A (SAA), were assessed and compared with demographically matched healthy controls; guselkumab pharmacodynamics through Week 24 were also assessed. Associations between baseline biomarker levels and 1) baseline disease activity (28-joint disease activity score using CRP [DAS28-CRP], psoriasis area and severity index [PASI], and % body surface area [BSA] affected by psoriasis) and 2) clinical response (including ≥ 20% improvement in American College of Rheumatology criteria [ACR20] response) at Week 24 were assessed.ResultsBaseline serum levels of IL-6, IL-10, IL-17A, IL-17F, IL-22, TNFα, and IFNγ were significantly higher in COSMOS TNFi-IR participants than in healthy controls. Baseline IL-6, CRP, and SAA levels were associated with baseline DAS28-CRP. IL-17A and IL-17F levels were associated with baseline PASI score and psoriasis BSA. Baseline swollen or tender joint counts did not associate with baseline biomarker levels. At Week 24, significant decreases from baseline in CRP, SAA, IL-17A, IL-17F, and IL-22 levels were seen in guselkumab-, but not placebo-, treated participants. IL-17F and IL-22 levels at Week 24 in guselkumab-treated participants did not significantly differ from those of healthy controls. Guselkumab-treated participants achieving ACR20 response at Week 24 exhibited higher baseline IL-22 and IFNγ levels versus nonresponders.ConclusionsResults from COSMOS participants with active, TNFi-IR PsA suggest guselkumab reduces levels of effector cytokines associated with the IL-23/IL-17 pathway, including those associated with baseline arthritis and skin disease activity.Trial registrationClinicalTrials.gov: NCT03796858.

Matching-adjusted indirect comparison (MAIC) of deucravacitinib versus adalimumab for the treatment of patients with moderate to severe plaque psoriasis over 2 years

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US for the treatment of adults with moderate to severe plaque psoriasis (PsO). A previous indirect treatment study showed comparable efficacy between deucravacitinib and first-generation biologics at week 52. The objective of this study was to compare the long-term efficacy of deucravacitinib to that of adalimumab based on long-term extension (LTE) trials, after adjusting for differences in patient characteristics at baseline. &#x0D; Methods: Open-label LTE trials that were feasible for indirect treatment comparison were identified for each treatment (deucravacitinib: POETYK PSO-LTE [NCT04036435]; adalimumab: REVEAL extension [NCT00195676]). Patients who were initially randomized to placebo and switched to continuous active treatment after Week 16 were selected as cohorts due to the comparability of study design and outcomes of interest. Patients with prior adalimumab were excluded from the deucravacitinib cohort. The primary outcome was PASI 75 at Week 112 since randomization and secondary outcomes were PASI 75 at Week 52 and PASI 90 at Weeks 52 and 112; missing PASI data was imputed using the last observation carried forward (LOCF) method. Matching-adjusted indirect comparison was conducted where individual patient-level data from POETYK PSO-LTE were reweighted to achieve balance with the summary baseline characteristics in the REVEAL extension trial: age, sex, race, weight, duration of psoriasis, body surface area affected, prior treatment history, baseline PASI and placebo PASI 75/90 responses at Week 16. Sensitivity analyses explored the effect of adjusting for prior treatment or not as well as history of psoriatic arthritis and patient's overall severity of disease.&#x0D; Results: Patients from POETYK PSO-LTE (N=329) were on average older, with lower weight, but with more prior systemic treatment exposure, higher baseline PASI score and higher placebo PASI 75/90 response at Week 16 than those in REVEAL (N=345). After adjustment, baseline differences between the two trials were mitigated. Results showed adjusted PASI 75 and PASI 90 response rate at Week 112 since randomization was higher for patients who were treated with deucravacitinib compared to those who were treated with adalimumab after 16 weeks of placebo: PASI 75= 67.2% vs 54% (mean difference [95% CI]= 13.2% [4, 22.5]); PASI 90= 41.3% vs 34% (7.3% [-2, 16.7]). Adjusted PASI 75 and PASI 90 at Week 52 were similar between the two cohorts. Results from the sensitivity analyses confirmed the base case findings.&#x0D; Conclusion: This indirect comparison analysis suggests that patients with moderate to severe plaque psoriasis with continuous active treatment on deucravacitinib had better long-term response than adalimumab and highlights the therapeutic role of deucravacitinib.

Efficacy of Secukinumab in Moderate to Severe Psoriasis Vulgaris: A Prospective Study

Objective: Psoriasis is a chronic inflammatory skin disorder that potentially needs long-term treatment. Multiple remedies treating psoriasis have been accepted in which Secukinumab is a totally humanized, IL-17A monoclonal used for the treatment of moderate to severe plaque psoriasis. Hence, this study focused to evaluate the effectiveness of Secukinumab in moderate to severely affected psoriasis patients. Methodology: This was a Prospective interventional multicenter study conducted by using consecutive sampling technique. The ethical approval was approved from the Institutional Review Board. The duration of study was about one year after synopsis approval. A total of 138 adult patients between 18-65 years of both genders with diagnosed cases of psoriasis vulgaris having lesions on scalp, face, hands, and genital areas were included. Treatment started by the single dosage of 300 mg Secukinumab that was administered subcutaneously once weekly for 4 weeks and followed up by once a month for 52 weeks. Paired t-test was used to evaluate the association between baseline and at various weeks of follow ups. Results: The study results showed that out of 138 patients, 112(81.2%) were males and 26(18.8%) were females and their mean age was 40.47±9.55 years. As far as severity of Psoriasis is concerned, 55(39.9%) were moderately affected while 83(60.1%) were severely affected. Concerning distribution of Psoriasis, Plaque Psoriasis was observed in 117(84.8%) patients, 57(41.3%) reported Scalp Psoriasis, 137(99.3%) reported Pustular psoriasis, and Itching was reported in 120(87.0%) patients. Comparison of baseline PASI scores with different weeks in moderately and severely affected psoriasis patients revealed that there was statistically significant rapid reduction observed from mean of baseline PASI scores till 12 weeks (p&lt;0.001), Conclusion: This study concluded that Secukinumab is an extremely effectual, rapid-acting biological therapy with no evident side effects. Furthermore, it was observed that secukinumab significantly reduced the baseline PASI score till 12 week rapidly in moderately and severely affected psoriasis patients. Keywords: Psoriasis vulgaris, PASI score, rapid-acting biological therapy, Secukinumab,

Super-response to guselkumab treatment in patients with moderate-to-severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance.

Psoriasis is a chronic immune-mediated inflammatory skin disease that often leads to a diminished quality of life. Goals of treating patients with psoriasis have shifted with more focus on achieving near or complete clearance of the skin. Guselkumab, a fully human monoclonal antibody targeting interleukin-23, is effective in treating moderate-to-severe psoriasis. To describe the baseline characteristics of patients with moderate-to-severe psoriasis achieving super-response (Psoriasis Area and Severity Index [PASI] 100 response at Weeks 20 and 28) after commencing guselkumab treatment. Pooled data from VOYAGE 1 and VOYAGE 2 studies identified super-response; baseline demographic, disease and pharmacokinetic characteristics were compared with non-super-response. A stepwise logistic regression analysis identified which factors were potentially predictive of super-response status, with significance level of 0.1. A subset of patients randomized to guselkumab comprised this post hoc analysis (n = 664); 271 patients achieved super-response vs. 393 with non-super-response. Patient age at study entry and baseline body weight (≤90 kg vs. >90 kg), PASI, and Investigator's Global Assessment (IGA) score were significant predictors of super-response status, with odds ratios (95% confidence intervals) of 0.98 (0.967-0.993; P = 0.003), 1.42 (1.026-1.977; P = 0.034), 0.97 (0.955-0.993; P = 0.007) and 0.66 (0.433-0.997; P = 0.048), respectively. More patients with super-response achieved an early response: Week 2 PASI 75 (5.5% vs. 1.8%) and Week 8 PASI 100 (22.5% vs. 3.3%) vs. non-super-response. Median serum guselkumab concentrations through Week 28 were slightly greater in patients with super-response vs. non-super-response. Guselkumab was more likely to achieve early clinical responses (complete skin clearance) in younger patients, less obese patients and patients with less severe psoriasis.

Efficacy of and Safety of Secukinumab in Psoriasis Vulgaris: A Prospective Study

Objective: Psoriasis is an immune mediated inflammatory skin disorder that potentially requires lifelong management. Different therapies treating psoriasis have been recognized wherein Secukinumab is a fully humanized, IL-17A monoclonal antibody that has been approved by US Food and Drug administration for the treatment of moderate to severe plaque psoriasis. Therefore, this study targeted to assess the efficacy of Secukinumab in patients with moderate to severe psoriasis.&#x0D; Methodology: This was a Prospective interventional multicenter study conducted by using consecutive sampling technique. The duration of study was about one year. The sample size was 138. Adult patients between 18-65 years of either gender with clinical diagnosis of psoriasis vulgaris involving scalp, face, hands, or genital areas, were include. Treatment initiated by the administration of a single dose of 300 mg Secukinumab subcutaneously for 4 weeks then monthly for 52 weeks. Paired t-test was applied to assess the difference in the PASI score at various follow ups.&#x0D; Results: The study results showed that out of 138 patients, 112(81.2%) were males and 26(18.8%) were females and their mean age was 40.47±9.55 years. As far as distribution of disease is concerned, 117(84.8%) patients reported Plaque Psoriasis, 57(41.3%) patients reported Scalp Psoriasis, 9(6.5%) patients reported nail Psoriasis, 11(8.0%) patients reported Palmoplantar Psoriasis, and 5(3.6%) patients reported Erythrodermic psoriasis. For the comparison of Secukinumab treatment under PASI scores, there was statistically significant reduction observed from mean of baseline PASI scores till 1 week (p&lt;0.001), till 2 week (p&lt;0.001), till 4 week (p&lt;0.001), till 8 week (p&lt;0.001). The improvement in mean PASI score from baseline to 1 year was 91%.&#x0D; Conclusion: This study concluded that Secukinumab is a highly effective, rapid-acting biological therapy with no obvious adverse effects. Additionally, it was seen that secukinumab significantly reduced the baseline PASI score till 8 week rapidly in moderate and severe psoriasis.

MTHFR Gene Polymorphism Association With Psoriatic Arthritis Risk and the Efficacy and Hepatotoxicity of Methotrexate in Psoriasis

AimsTo assess whether MTHFR rs1801131 and rs1801133 SNPs are associated with concomitant psoriatic arthritis (PsA) and investigate the efficacy and hepatotoxicity of MTX in patients with psoriasis in the Han Chinese population.MethodsThis prospective, single-arm, interventional study recruited a total of 309 patients with psoriasis, 163 with psoriatic arthritis and 146 without psoriatic arthritis, who completed a 12-week MTX treatment and 1,031 healthy controls. Patients' characteristics including age, gender, disease duration, height, weight, smoking status, alcohol consumption, medical history, disease severity and liver function test results were accessed and recorded. Single nucleotide polymorphism (SNP) genotyping of rs1801131 and rs1801133 in the MTHFR gene was performed.ResultsThe rs1801133 CC genotype was more frequent in patients with PsA than those with PsO and healthy controls (42.3% vs. 28.8% vs. 33.1%, p < 0.05). The 90% reduction from baseline PASI score (PASI 90) response rates to MTX were significantly higher in patients with the rs1801133 TT genotype than those with the CT and CC genotype (33.96% vs. 19.31% vs. 14.41%, OR = 2.76, p = 0.006). The rs1801133 CT+TT genotype was more frequent in PsA patients with abnormal liver function than in those with normal liver function (p < 0.05). In addition, patients with the rs1801131 CT genotype had lower PASI 75 response rates to MTX (OR = 0.49, p = 0.01), and lower risk of ALT elevation (OR = 0.46, p = 0.04).ConclusionsThis study provided some evidence for MTHFR polymorphism association with the risk of PsA and the efficacy and hepatotoxicity of the low-dose MTX in the Chinese population. Given the relatively small sample size and potentially missed diagnosis of PsA, the results from this study warrant further investigation.

The effectiveness and safety of ixekizumab in psoriasis patients under clinical practice conditions: A Spanish multicentre retrospective study.

The objective of the study was to evaluate efficacy and safety of ixekizumab in psoriasis patients under clinical practice conditions. Observational, retrospective, multicentre study that included patients with ixekizumab from March 2017 to March 2019. ≥ 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and absolute PASI <2 were the parameters used to assess treatment response. Adverse events (AEs) were collected. Of the 301 patients included, 111 were women (36.9%), mean age was 48.5 (±13.5) years. Mean baseline PASI score was 13.5 (±7.7). More than half of the patients (68.5%) had received at least one biological drug before. At 3 months, 208 (76.5%) patients achieved PASI <2 and 156 (57.3%) PASI 90. At 12 months, 130 (73.4%) patients achieved absolute PASI <2 and 104 (58.7%) PASI 90. Multivariate analysis revealed that prior use of biologics was influential in achieving PASI <2 at both 3 and 12 months (OR 2.82, P = .006; OR 9.51, P < .001, respectively). Sixty-five patients (21.59%) exhibited at least one AE, injection site reaction was the most common (39; 36.8%). Likewise in trials, ixekizumab displayed an excellent profile of safety and efficacy also in real-life. Effectiveness appears superior in biologic-naive patients.

Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies.

BackgroundRisankizumab is a humanized IgG monoclonal antibody that selectively inhibits interleukin‐23 through binding the p19 subunit. In Phase 3 trials, risankizumab demonstrated superior efficacy compared with adalimumab and ustekinumab in patients with moderate‐to‐severe plaque psoriasis. Here, we evaluated the impact of baseline characteristics on efficacy of risankizumab compared with ustekinumab in patients with moderate‐to‐severe plaque psoriasis.MethodsThis analysis included all patients initially randomized to risankizumab or ustekinumab from the replicate, double‐blinded, randomized, placebo‐controlled phase 3 trials, UltIMMa‐1 (NCT02684370) and UltIMMa‐2 (NCT02684357). Patients received either risankizumab (150 mg) or ustekinumab (weight‐based; 45 or 90 mg per label) at weeks 0, 4, 16, 28 and 40. Efficacy was assessed as the proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at weeks 16 and 52 by baseline patient demographics, disease characteristics and prior biologic exposure. Mean per cent improvement in PASI was calculated by body weight and body mass index at week 52. Missing efficacy data were imputed as non‐responders for categorical variables and last observation carried forward for continuous variables. Logistic regression analyses assessed for interactions between treatment and five independent variables (age, sex, weight, baseline PASI score and presence of psoriatic arthritis) at both weeks 16 and 52.ResultsBaseline patient demographics, disease characteristics and prior biologic exposure were similar between patients randomized to risankizumab (n = 598) and ustekinumab (n = 199). At weeks 16 and 52, risankizumab demonstrated superior efficacy compared with ustekinumab across these patient characteristics (P < 0.01). Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001 for all).ConclusionsRisankizumab demonstrated consistent and superior efficacy compared with ustekinumab regardless of patient demographics, disease characteristics or prior biologic exposure.

A study to compare the efficacy and safety of narrow band-UVB alone as well as in combination with topical calcipotriol in patients with psoriasis vulgaris

Psoriasis is a complex disease that requires carefully designed therapy in order to achieve sustained remission. The disease can be effectively controlled by various therapeutic options, used alone or in combination. Phototherapy may be combined with topical or systemic agents to achieve higher clearance rates, longer disease free intervals and a lower carcinogenic risk. The combination of NB-UVB with calcipotriol increases the therapeutic efficacy of phototherapy as well as UVB reduces the irritation caused by calcipotriolThe chief purpose of this study was to compare the efficacy and safety of Narrow Band-UVB alone and in combination with topical calcipotriol in patients with psoriasis vulgaris.Patients with chronic plaque type psoriasis of 100 numbers involving less than 20% of body surface area were randomly allocated to any one of the following 2 groups. Group A- Narrow Band UVB phototherapy. &amp; Group B- Narrow Band UVB with topical calcipotriol ointmentIn group A (NB-UVB), the mean baseline PASI score was 12.1 and the mean PASI score at the end of 12 weeks was 2.54. There was 79% reduction in PASI score at the end of 12 weeks. 31 patients showed good response and 13 patients showed more than 70% clearance.When NB-UVB group was compared with NB-UVB and calcipotriol combination group, there was a significant difference (p&amp;#60;0.05) in PASI scores at 4 weeks, 8 weeks and 12 weeks.Further studies with additional numbers of patients are essential to compare the efficacy and safety of Narrow Band-UVB alone as well as in combination with topical calcipotriol in patients with psoriasis vulgaris

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

We report results from a phase IIa study of efficacy and safety of PF-06700841, an oral TYK2/Jak1 inhibitor, in patients with moderate-to-severe plaque psoriasis (NCT02969018). Patients were randomized to PF-06700841 30 mg once daily (QD), 60 mg QD, or placebo (4-week induction), followed by 10 mg QD, 30 mg QD, 100 mg once weekly, or placebo (8-week maintenance). The primary endpoint was week 12 change from baseline in PASI score. Secondary endpoints were the proportion of patients achieving 75% and 90% reduction from baseline PASI at week 12. In total, 212 patients in 35 sites were treated; mean (SD) baseline PASI score was 20.8 (7.68). Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups. The greatest change from baseline (least squares mean change -17.3 [95% confidence interval, -20.0 to -14.6]) was observed in the 30-mg QD continuous treatment group. Overall, 136 patients experienced treatment-emergent adverse events, including six serious adverse events in five patients and 13 discontinuations in treatment groups because of adverse events. No herpes zoster cases or major adverse cardiac events including thromboembolic events occurred. PF-06700841 was generally effective and well tolerated in patients with moderate-to-severe plaque psoriasis.

Comparative study of oral methotrexate and narrow band ultraviolet-B in chronic plaque psoriasis: a study from urban Karnataka

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Treatment of psoriasis continues to be a challenge. It is often frustrating experience for dermatologists. Methotrexate or PUVA or NBUVB when used properly, can produce good to excellent clinical benefit with minimal side effects. The objective of the study was to compare the efficacy and safety of oral methotrexate and NBUVB in the treatment of chronic plaque psoriasis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 100 patients of chronic plaque psoriasis attending the skin department of Navodaya Medical College and Hospital, Raichur from November 2012 to April 2014 were included in the study. Group A exhibited to Oral methotrexate and group B to NBUVB. Outcome was measured in terms of PASI 75 (it means 75% reduction in original PASI). Data was analysed using SPSS 19.0 version.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; In Group A mean age was 33.68 years and in Group B mean age 33.7 years. The difference in mean PASI at baseline, at 4 and 8 weeks using oral methotrexate as well as NBUVB was found to be highly significant (&amp;lt;0.001). PASI score was less in-group using methotrexate at 4 and 8 weeks interval (&amp;lt;0.05). Mean time taken for PASI 75 in the baseline PASI score in Group A was 9.62±1.3 weeks whereas in Group B it was 11.3±0.7 weeks. Side effects were higher in group B (60%) compared to group A (36%).&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Improvement in the PASI score was best with methotrexate than NBUVB. The side effects observed in a methotrexate were minimal compared to NBUVB.&lt;/p&gt;

Use of Ustekinumab in the Treatment of Libyan Psoriasis Vulgaris Patients

Abstract Introduction. Psoriasis is a relatively common chronic inflammatory disease. It clinically manifests as raised, well defined erythematous plaques with irregular borders and silvery scales. Psoriasis appears to be mediated by abnormal immune system functioning, including T lymphocyte and macrophage activation and release of various cytokins, such as interleukin 12 (IL-12) and IL-23. Recently a new biologic agent Ustekinumab has been used in the treatment of psoriasis. Our aim in this study was to assess the efficacy and tolerability of ustekinumab in moderate to severe psoriasis vulgaris and to observe and report any adverse reaction. Material and Methods. Thirty five psoriatic patients above the age of 18 years having moderate to severe psoriasis were included in this study. Ustekinumab is available in pre-filled syringe 45mg/0.5ml, 90mg/1.0ml for subcutaneous injection according to body weight at the intervals of 0, 4 weeks, and then every 12 weeks. It is given in hospital by a doctor or specialist nurse. The assessment of the patients’ condition and improvement was carried out after administering each dose using PASI score. Results. Thirty five patients were included in this study. Baseline PASI score of our patients ranged from 11.4 to 39.8 (mean: 21.1).There was a dramatic response to treatment with ustekinumab in which PASI decreased to 6.7 after the second dose, followed by subsequent responses that reached 2.6 after the 6th dose. After the second dose, 61% of the cases had marked improvement and 11% had clearance of their skin lesions. After the last, sixth dose there was a marked improvement in 65% of cases and the percentage of complete clearance increased to 24%. Ustekinumab had positive effect on psoriatic nail changes as well-there was a significant improvement in 50% of cases and complete clearance (cure) in 24% of cases. Conclusion: Ustekinumab is effective in the treatment of severe and resistant cases of psoriasis vulgaris. It is well tolerated by the patients. No reactions or serious side effects have been reported.

Tildrakizumab for the treatment of psoriasis

ABSTRACTIntroduction: Psoriasis is an immune-mediated skin disease amenable to targeted immunotherapy. Tildrakizumab is a humanized IgG1 monoclonal antibody targeting interleukin-23 p19 and is approved for use in moderate to severe psoriasis.Areas covered: This article reviews the mechanism of action, pharmacokinetics, safety, tolerability, and clinical efficacy of tildrakizumab, administered subcutaneously every 12 weeks, in treatment of moderate to severe psoriasis.Expert commentary: In two phase 3 clinical trials, tildrakizumab showed a consistent low occurrence of adverse events, underlining safety and tolerance. The long half-life permits subcutaneous injections every 12 weeks. Seventy eight percent of patients achieved PASI 75 (a > 75% improvement from baseline PASI) at 28 weeks, 58% achieved PASI 90, 29% achieved PASI 100 and 70% achieved a Physician’s Global Assessment score of clear or almost clear. A high proportion of patients maintained PASI response after 2 years of treatment. Tildrakizumab improved Dermatology Life Quality Index, psoriasis-related personal relationship problems and sexual difficulties. Baseline PASI score, PGA, and BMI were not predictive of PASI 90 response at week 12, however achievement of PASI 50 by week 8 was predictive of a PASI 90 response at week 12.

Comparative Effectiveness of Adalimumab versus Secukinumab for the Treatment of Psoriatic Arthritis: A Matching-Adjusted Indirect Comparison.

IntroductionThe Phase III FUTURE I and II trials demonstrated the clinical efficacy of secukinumab in active psoriatic arthritis (PsA). In the absence of head-to-head trials, this study compared the clinical efficacy and cost effectiveness of adalimumab 40 mg versus secukinumab 150 and 300 mg for the treatment of active PsA.MethodsA matching-adjusted indirect comparison was conducted using individual patient data from the ADEPT trial of adalimumab and published data from FUTURE I and II. To adjust for the cross-trial differences, individual patients in ADEPT were re-weighted so that the mean baseline characteristics (including age, weight, gender, race, baseline methotrexate use, psoriasis ≥3% body surface area, baseline PASI score, presence of dactylitis and enthesitis, and HAQ-DI) matched those in the FUTURE trials. Response rates relative to placebo and incremental costs per responder (CPR) over 24 weeks for ACR 20/50/70 and PASI 75/90 were compared between adalimumab and secukinumab 150 and 300 mg from the German social health insurance (SHI) perspective.ResultsAfter matching, mean baseline characteristics were balanced across the ADEPT and the FUTURE I and II populations. The mean differences between adalimumab and secukinumab 150 mg in relative ACR 20/50/70 and PASI 75/90 response rates were 9.5, 3.0, 6.0, 13.1, and 6.7%, respectively (p > 0.05 for all comparisons). Post-match relative ACR 20/50/70 and PASI 75 to placebo were also higher with adalimumab compared to secukinumab 300 mg. Adalimumab had lower incremental costs per responder over 24 weeks for all outcomes compared with secukinumab 150 and 300 mg.ConclusionsIn the absence of direct comparisons between adalimumab and secukinumab, this study provides valuable and reliable evidence for physicians and payers. After adjusting for cross-trial differences in baseline characteristics, adalimumab was associated with higher relative ACR and PASI rates and lower incremental CPRs compared with secukinumab 150 mg or 300 mg at week 24 among patients with active PsA.FundingAbbVie.

English

Psoriasis is a chronic inflammatory disease with frequent relapses and remissions. The introduction of biologicas increased the remission periods, decreases relapse and hence improve the quality of life. Method: The study includes 17 adult patients of chronic plaque psoriasis, who received etanercept subcutaneously at a dosage of 50 mg once weekly for 24 weeks, followed by 6 months follow up. Results: At the end of 12 weeks 8 patients (47.05%) achieved more than 75% reduction of PASI and at the end of 24 weeks 9 patients(52.94%) achieved more than 75% reduction of PASI. Conclusion: Our study shows that etanercept has good efficacy without any significant side effects and it should be considered in patients with moderate to severe chronic plaque psoriasis not responding to other conventional modes of therapy. INTRODUCTION Psoriasis is a chronic inflammatory skin condition affecting approximately 2 % of the general population. Even though it has several clinical variants, chronic plaque type is the commonest that presents with silvery white scales on an erythematous base. Some patients may have associated joint involvement. The pathogenesis of psoriasis is complex it includes both innate and adaptive immune systems. Cytokines Th1 and Th17 cells have been incriminated in the pathogenesis of psoriasis. These cytokines secrete TNFα and IFN – α that leads to vasodilatation ,leukocyte migration and keratinocyte activation. This leads to activation of dendritic cells that creates a repeated cycle of inflammation. Biologics are the agents that targets genetic or immune mediator of pathophysiological process.. Among the biologics Infliximab, Etanercept, and Adalimumab targets TNF-α. Eternacept is a human fusion protein of the TNF receptor to Fc portion of IgG which binds to TNF –α to neutralize its effects. Various international studies have showed eternacept has good efficacy in chronic plaque type of psoriasis. With this background we conducted a study on efficacy of eternacept in chronic plaque psoriasis. *Corresponding author: Email: ramasamypp@yahoo.com http://dx.doi.org/10.20530/IJTA_31_18-21 ISSN 2320-138X © 2016 Table 1: Baseline PASI Score NO: AGE/SEX BASELINE PASI