Change In Psoriasis Area And Severity Index Research Articles

Effectiveness of calcipotriol/betamethasone dipropionate aerosol foam in patients with small versus large plaque psoriasis in routine practice in South Korea.

Small plaque psoriasis is the typical form of chronic plaque psoriasis affecting adults in South Korea. The effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) aerosol foam for large and small psoriasis plaques has not previously been examined. We performed a post hoc analysis of a recent, 4-week observational study of Cal/BD aerosol foam use in routine clinical practice in South Korea. Investigator Global Assessment response ([IGA] 0/1 at week 4), Patient Global Assessment response ([PaGA] 0/1 at week 4), change in Psoriasis Area and Severity Index (PASI), changes in psoriasis symptom scores, change in the Dermatology Life Quality Index (DLQI), and the proportion of patients achieving DLQI ≤5 were analyzed for patients with small (≤5 cm; n = 131) or large (>5 cm; n = 35) baseline plaque size. IGA response rates were similar for patients with small and large plaques (59.5% and 51.4% respectively). Similarly, there was no significant difference between the small and large groups in mean change in PASI (-2.20 vs -3.34), the proportions of patients with DLQI ≤5 (62.3% vs 54.3%) or PaGA 0/1 (29.2% vs 40.0%). Mean improvements in DLQI (-4.04 vs -6.20) and in psoriasis symptoms including itching (-1.50 vs -2.83), sleep loss (-0.67 vs -1.89), dryness (-1.57 vs -2.97), scaling (-1.21 vs -3.57), and redness (-1.17 vs -3.11) were greater in patients with large plaques than those with small plaques. Itching and DLQI differences were not statistically significant after adjustment for baseline characteristics. Stratification by body surface area affected eliminated statistically significant differences between the groups for most outcomes. In conclusion, this analysis suggests that Cal/BD aerosol foam is an effective, well-accepted treatment for adult patients with the small plaques typical of chronic plaque psoriasis in South Korea, as well as for those with large plaques.

Real-World Long-Term Effectiveness of Risankizumab Among Patients with Moderate-to-Severe Psoriasis: Analysis from an International Medical Chart Review (RAPID) Study.

Real-world data on the efficacy of risankizumab (RZB) in clinical moderate-to-severe plaque psoriasis (PsO) are limited. The RAPID study assessed real-world clinical and patient-reported outcomes in RZB-treated PsO patients using data collected from dermatologists in Canada, the Czech Republic, Germany, Japan, and Poland. This ongoing, retrospective chart review collected data from medical records of RZB-treated adults with moderate-to-severe PsO (09/2022-06/2023). Eligible patients received RZB, had ≥ 12months of medical records after RZB initiation (index date), and had Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA), or static Physician's Global Assessment (sPGA) scores ≥ 3months before and up to 18months after the index date. The proportion of patients achieving a clear/almost clear PsO (IGA/sPGA = 0/1), PASI ≤ 1, Dermatology Life Quality Index (DLQI) = 0/1, and a 90%/100% improvement from baseline in PASI as well as the mean changes in PASI, DLQI, itch, and skin pain scores at 12 and 18 months were reported for patients with non-missing assessments at baseline and 12months. Most patients (66.4%) were male, 74.0% were biologic naïve, and 73.0% had scalp PsO. Mean baseline IGA/sPGA was 3.7 ± 0.5, with a mean PASI of 23.3 ± 11.8. After 12months, 86.1% of patients reported IGA/sPGA ≤ 1, and 75.7% achieved PASI90; these further increased to 91.1% and 80.5% at 18months. DLQI, itch, and skin pain scores improved over time. These data demonstrated the durable, real-world effectiveness of RZB in patients with moderate-to-severe PsO through continued improvement in disease and symptom severity over 18months, with most of the patients reporting clear/almost clear skin.

A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis

Ustekinumab is a safe and effective treatment for moderate-to-severe psoriasis. To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed ustekinumab biosimilar SB17 with reference ustekinumab (UST) in subjects with moderate to severe plaque psoriasis. In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at Week 0, 4, and every 12 weeks. The primary endpoint was the percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through Week 28. 249 subjects were randomized to SB17, 254 to UST. Adjusted difference of PASI change from baseline at Week 12 of -0.6% (95% confidence interval [CI; -3.780, 2.579]) was within the equivalence margin. Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) were also comparable. Overall treatment-emergent adverse events (TEAEs) were comparable (SB17: 48.2%, UST: 48.8%). The overall incidence of anti-drug antibodies (ADAs) up to Week 28 was 13.3% with SB17 and 39.4% with UST. Data were only through Week 28. SB17 was clinically biosimilar to UST up to Week 28.

Effects of biologic drug therapy on body weight, appetite, and blood lipid profile in patients with psoriasis

Obesity and dyslipidemia are frequently observed in patients with psoriasis. This study aimed to evaluate the effects of biological therapy on body weight (BW), body mass index (BMI), appetite, and blood lipid profiles in patients with psoriasis. A total of 83 patients receiving biologic therapy (n=44) [anti-tumor necrosis factor alpha (anti-TNFα) (n=5), interleukin (IL)-12/23 inhibitor (n=13), IL-17 inhibitor (n=20), and IL-23 inhibitor (n=6)] and conventional therapy (n=39) [methotrexate (MTX) (n=25) and acitretin (n=14)] were included in the study. The patient’s baseline and current BW, BMI, waist circumference, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), plasma triglyceride values, and Psoriasis Area and Severity Index (PASI) were retrospectively screened. Appetite was assessed with the Simplified Nutritional Appetite Questionnaire (SNAQ). The mean BW percent change values were found to increase by 2.40±2.30 kg, 2.38±4.13 kg, and 0.40±3.47 kg in patients taking anti-TNFα, IL-12/23 inhibitor, and IL-17 inhibitor agents, respectively, decrease by -0.60±0.89 kg in those receiving an IL-23 inhibitor; increase by 0.52±3.40 kg and 1.38±2.79 kg in those receiving MTX and acitretin, respectively. The triglyceride percent change rates increased with MTX (27.46±52.87 mg/dl) (p=0.029). Anti-TNFα and ixekizumab increased HDL percent change rates (21.44±20.99 mg/dl and 24.4±35.40 mg/dl, respectively) (p=0.044 and p=0.005). Although the SNAQ scores were similar in patients using conventional and biological drugs, a negative correlation was observed between the SNAQ scores and the PASI change (p=0.049, r=-0.221). In addition, an increase in BMI had a negative correlation with the PASI change (p=0.01, r=-0.282). Anti-TNFα and IL-12-23 inhibitors increased BW. While MTX increased triglyceride levels, anti-TNFα and ixekizumab increased HDL levels. In the treatment of psoriasis, the presence of obesity and blood lipid profiles should be considered in the selection of the appropriate treatment for each patient.

The Effect of an Interdisciplinary Dermatological-Rheumatological Consultation on the Outcome of Patients with Psoriasis with Musculoskeletal Pain: A Prospective, Single-Center Cohort Study.

Psoriatic arthritis (PsA), a disease with complex inflammatory musculoskeletal manifestations, complicates psoriasis in up to 30% of patients. In this study, we aimed to determine the effect of an interdisciplinary dermatological-rheumatological consultation (IDRC) for patients with psoriasis with musculoskeletal symptoms. This prospective study enrolled 202 patients with psoriasis. Patients with musculoskeletal pain (MSP) (n = 115) participated in an IDRC 12weeks after enrollment. The outcome was evaluated after 24weeks. In 12/79 (15.2%) patients seen in the IDRC, the prior diagnosis was changed: eight with a first diagnosis of PsA, four with a diagnosis of PsA rescinded. Treatment was modified in 28% of patients. Significant improvements in Psoriasis Area and Severity Index (PASI) (from 5.3 to 2.0; p < 0.001) and Dermatology Life Quality Index (DLQI) (from 6.7 to 4.5; p = 0.009) were observed. By comparing changes in PASI and DLQI over the study period, an improvement in PASI of 0.7 ± 1.4 points (p = 0.64) and in DLQI of 2.9 ± 1.5 points (p = 0.051) could be attributed to participation in the IDRC. An IDRC of patients with psoriasis with MSP leads to a valid diagnosis of PsA and improvement in quality of life. Based on these results, an IDRC is a valuable and time efficient way for psoriasis patient with MSP to receive optimal care.

Apremilast or Methotrexate: The Arrows in the Quiver for Psoriasis.

In the Indian subcontinent, psoriasis cases have skyrocketed in the last decade. Dry and hot weather aggrandizes the annual incidences. Nowadays, dermatologists harness methotrexate and apremilast to manage chronic plaque psoriasis. There needs to be more comparative studies on these drugs. The primary objective was change in Psoriasis Area and Severity Index (PASI) at six months from the baseline. Change in Dermatology Life Quality Index (DLQI) at six months from the baseline and incidences of adverse events served as the secondary objectives. This randomized, open-label, 24-week study was executed in Srirama Chandra Bhanja (SCB) Medical College, Cuttack, India, from June 2021 to October 2022. The participants were randomized in a 1:1 ratio to receive tablets of either methotrexate 10-15mg weekly once or apremilast 10-30mg twice daily. Efficacy and safety analyses were performed at baseline, eight, 16, and 24 weeks. We used R software (version 4.1.1; R Foundation for Statistical Computing, Vienna, Austria) for data analysis. Seventy (82.3%) of 85 enrolled participants completed the study. The mean age of the study population was 41.08±5.17 years. Twenty-two (31.4%) of them were females. The median change in PASI from baseline was -37.25 (-39.00 to -34.25) for apremilast and -34.75 (-37.75 to -31.75) for methotrexate (p=0.006). The median change in DLQI from baseline was -19.50 (-22.00 to -17.00) for apremilast and -21.00 (-25.50 to -17.50) for methotrexate (p=0.079). No serious adverse events were noticed. Apremilast was more effective than methotrexate in psoriasis treatment. The statistically significant difference was found only in PASI scores.

Real-World Outcomes of Adalimumab Treatment for Moderate and Severe Psoriasis in Korean Patients (RAPSODI Study).

Psoriasis imposes a significant treatment burden on patients, particularly impacting well-being and quality of life (QoL). The psychosocial impact of psoriasis treatments remains unexplored in most patient populations. To assess the impact of adalimumab on health-related QoL (HRQoL) in Korean patients with psoriasis. This 24-week, multicenter, observational study, assessed HRQoL in Korean patients treated with adalimumab in a real-world setting. Patient-reported outcomes (PROs) including European Quality of Life-5 Dimension scale (EQ-5D), EQ-5D VAS, SF-36, and DLQI were evaluated at week 16 and 24, versus baseline. Patient satisfaction was assessed using TSQM. Among 97 enrolled patients, 77 were assessed for treatment effectiveness. Most patients were male (52, 67.5%) and mean age was 45.4 years. Median baseline body surface area and Psoriasis Area and Severity Index (PASI) scores were 15.00 (range 4.00~80.00) and 12.40 (range 2.70~39.40), respectively. Statistically significant improvements in all PROs were observed between baseline and week 24. Mean EQ-5D score improved from 0.88 (standard deviation [SD], 0.14) at baseline to 0.91 (SD, 0.17) at week 24 (p=0.0067). The number of patients with changes in PASI 75, 90, or 100 from baseline to week 16 and 24 were 65 (84.4%), 17 (22.1%), and 1 (1.3%); and 64 (83.1%), 21 (27.3%), and 2 (2.6%), respectively. Overall treatment satisfaction was reported, including effectiveness and convenience. No unexpected safety findings were noted. Adalimumab improved QoL and was well-tolerated in Korean patients with moderate to severe psoriasis, as demonstrated in a real-world setting. Clinical trial registration number (clinicaltrials.gov: NCT03099083).

Alcohol misuse is associated with poor response to systemic therapies for psoriasis: findings from a prospective multicentre cohort study.

Factors that might influence response to systemic treatment for moderate-to-severe psoriasis are varied, and generally, are poorly understood, aside from high bodyweight, suggesting that other unidentified factors may be relevant in determining response to treatment. The impact of alcohol misuse on treatment response has not been previously investigated. To investigate whether alcohol misuse is associated with poor response to treatment for psoriasis. This was a prospective cohort study in which response to systemic therapies was assessed using the Psoriasis Area and Severity Index (PASI). The CAGE (Cut down, Annoyed, Guilty, Eye opener) questionnaire was used to screen for alcohol misuse. A multivariable factional polynomial linear regression model was used to examine factors associated with change in PASI between baseline and follow-up. The cohort comprised 266 patients (biologic cohort, n = 134; conventional systemic cohort, n = 132). For the entire cohort, the median (interquartile range) PASI improved from 13 (10·0-18·3) at baseline to 3 (1·0-7·5) during follow-up. A higher CAGE score [regression coefficient: 1·40, 95% confidence interval (CI) 0·04-2·77]; obesity (1·84, 95% CI 0·48-3·20); and receiving a conventional systemic rather than a biologic therapy (4·39, 95% CI 2·84-5·95) were significantly associated with poor response to treatment; whereas a higher baseline PASI (-0·83, 95% CI -0·92 to -0·74) was associated with a better response to treatment. The poor response to therapy associated with alcohol misuse and obesity found in people with psoriasis calls for lifestyle behaviour change interventions and support as part of routine clinical care. Targeting interventions to prevent, detect and manage alcohol misuse among people with psoriasis is needed to minimize adverse health consequences and improve treatment response.

Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase3 Clinical Trials of Secukinumab.

IntroductionPatients with psoriasis (PsO) experience impaired health-related quality of life due to physical and psychosocial burdens. The objective of this study was to assess the correlation between change in Psoriasis Area and Severity Index (PASI) score and selected Dermatology Life Quality Index (DLQI) domain scores in patients with moderate-to-severe PsO and those with PsO and comorbid psoriatic arthritis (PsA).MethodsThis post hoc analysis of four phase 3 clinical trials included patients with moderate-to-severe PsO randomized to secukinumab 150/300 mg, etanercept, or placebo. Pairwise latent growth models were applied to assess the longitudinal correlation between change in PASI scores and changes in three DLQI domain scores (daily activities, leisure activities, and symptoms/feelings). The initial (baseline to week 12) and sustained (week > 12 to week 52) treatment exposures were analysed by population type (total, PsO only, and PsO with comorbid PsA) and treatment arm (secukinumab, etanercept, or placebo).ResultsAmong the total population (N = 2401), PASI change was positively correlated with change in each assessed DLQI domain; correlations were weak to moderate over the initial treatment exposure period (β range, 0.20–0.29; all P < 0.001) and moderate to strong over the sustained exposure period (β range, 0.63–0.69; all P < 0.001). Similar trends were observed regardless of the presence of comorbid PsA. These relationships were confirmed among patients treated with secukinumab, etanercept, or placebo.ConclusionsImprovements in PASI scores were directly moderately related to improvements in DLQI domain scores from initiation of treatment and extended over time, regardless of presence of comorbid PsA or treatment received.Clinical Trial RegistrationERASURE (NCT01365455), FIXTURE (NCT01358578), FEATURE (NCT01555125), and JUNCTURE (NCT01636687).

16392 Efficacy of tapinarof cream by body region in subjects with plaque psoriasis in a phase 2b randomized controlled study

Tapinarof is a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) in development for treatment of psoriasis and atopic dermatitis. In a phase 2b study, Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI) responses at week 12 were significantly higher in all tapinarof groups vs vehicle. Higher responses in tapinarof groups were maintained for 4 weeks after treatment versus vehicle. This post hoc analysis evaluated mean change in PASI from baseline by body region.

Liposomal and Ethosomal Gels for the Topical Delivery of Anthralin: Preparation, Comparative Evaluation and Clinical Assessment in Psoriatic Patients.

To enhance anthralin efficacy against psoriasis and reduce its notorious side effects, it was loaded into various liposomal and ethosomal preparations. The nanocarriers were characterized for drug encapsulation efficiency, size, morphology and compatibility between various components. Optimum formulations were dispersed in various gel bases and drug release kinetics were studied. Clinical efficacy and safety of liposomal and ethosomal Pluronic®F-127 gels were evaluated in patients having psoriasis (clinicaltrials.gov identifier is NCT03348462). Safety was assessed by recording various adverse events. Drug encapsulation efficiency ≥97.2% and ≥77% were obtained for liposomes and ethosomes, respectively. Particle sizes of 116 to 199 nm and 146 to 381 nm were observed for liposomes and ethosomes, respectively. Fourier-Transform infrared (FT-IR) spectroscopy and differential scanning calorimetry (DSC) studies confirmed the absence of interaction between anthralin and various nanocarrier components. Tested gel bases showed excellent ability to sustain drug release. At baseline, the patients had a median Psoriasis Area and Severity Index (PASI) of 3.4 for liposomes and 3.6 for ethosomes without significant difference. After treatment, mean PASI change was −68.66% and −81.84% for liposomes and ethosomes, respectively with a significant difference in favor of ethosomes. No adverse effects were detected in both groups. Anthralin ethosomes could be considered as a potential treatment of psoriasis.

Moderate-to-severe plaque psoriasis patients treated with ixekizumab: early real-world outcomes and adverse events

Introduction Data on real-world experiences for patients treated with ixekizumab is currently limited. Objectives Describe characteristics of ixekizumab-treated psoriasis patients and provide evidence of clinical outcomes using disease severity scores Body Surface Area (BSA) and Psoriasis Area and Severity Index (PASI) in the real world. Methods Chart review was performed for adult patients treated with ixekizumab at a single Canadian dermatology clinic (February 2017–August 2018). The cohort was stratified into responders (patients who remained on ixekizumab) and non-responders (patients who discontinued ixekizumab). Subgroup analyses were performed for responders to assess clinical improvement stratified by previous biologic exposure. Results Thirty-eight patients were included (mean observational time 32 weeks). At baseline, mean PASI and BSA were 10.8 and 11.6%, respectively. Mean changes in PASI and BSA were –7.8 and –6.7%, respectively, at week 4. PASI 100 was achieved in 70% of patients. Significant differences in mean change of BSA were seen between bio-naïve and bio-experienced patients. Conclusion This analysis represents the first investigation of early clinical outcomes in a small cohort of Canadian patients treated with ixekizumab. Overall, complete and rapid skin clearance was observed. Future studies including more patients and longer follow-up time are crucial to confirm these findings.

Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials.

In this exposure-response analysis, the dosing regimen for tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, was determined using data from 3 randomised controlled trials (P05495/NCT01225731: phase 2b, n = 355; reSURFACE 1/NCT01722331: phase 3, n = 772; reSURFACE 2/NCT01729754: phase 3, n = 1090). A maximum drug effect (Emax ) logistic-regression exposure-efficacy model was used to describe the week 12 Psoriasis Area and Severity Index (PASI) responses with average concentration of tildrakizumab during weeks 1-12 (Cavg12 ) as exposure metric. The impact of covariates (e.g., body weight, region) was tested. Exposure-safety, longitudinal pharmacokinetic-pharmacodynamic and risk-benefit analyses were also conducted. At week 12, Emax was estimated at 62.2, 37.9 and 14.6% of responders for PASI75/90/100, respectively. Exposure-response curves plateaued at exposures >5 μg mL-1 . Heavier subjects had a lower response rate to placebo as measured by PASI75/90/100 than lighter subjects. PASI100 placebo response was less in subjects with higher baseline PASI score and older age. Simulated week 12 PASI75 increased by ≤4% on increasing the dose from 100 to 200 mg every 12 weeks (Q12W). The pharmacokinetic-pharmacodynamic model adequately described the time course of PASI change after treatment in the entire population and in each subject. Risk-benefit profiles were favourable for the 100- and 200-mg doses in different weight subgroups. Patients with moderate-to-severe psoriasis should receive 100-mg subcutaneous tildrakizumab Q12W. Patients with high body weight (>90 kg) may benefit from a higher dose (200-mg Q12W).

The effect of statins on psoriasis severity: a meta-analysis of randomized clinical trials.

IntroductionStatins may reduce the severity of psoriasis, but the available evidence is unclear. We conducted a meta-analysis of randomized controlled studies (RCTs) that investigated the effect of statins on psoriasis severity assessed with the Psoriasis Area and Severity Index (PASI).Material and methodsTwo investigators searched independently the following databases: Medline, EMBASE, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov from inception to February 2019. Additionally, reference lists from all available articles were searched manually. We included only RCTs carried out among adult (≥ 16 years) patients with psoriasis who received oral statins for ≥ 8 weeks and had psoriasis severity assessed with the PASI at baseline and at the end of follow-up. We used random effects meta-analysis to calculate the mean difference (D) in PASI change between patients who received either a statin or a comparator.ResultsOf 279 records identified, there were 5 eligible RCTs, with a total of 223 patients, including 128 patients who received a statin (atorvastatin or simvastatin). The improvement in psoriasis severity (PASI) was significantly greater in patients who received statins than in those who received comparators (D = 2.76, 95% CI: 0.49–5.04, p = 0.017). In subgroup analyses, the improvement in PASI values was significant for simvastatin (D = 3.70, 95% CI: 2.52–4.89, p < 0.001) but not for atorvastatin (D = 2.30, 95% CI: –1.28–5.88, p = 0.210).ConclusionsOral statins may improve psoriasis, particularly in patients with severe disease. This observation should be verified in long-term, well-designed studies that will enable analyses adjusted for clinical variables.

Comparison of Drug Discontinuation, Effectiveness, and Safety Between Clinical Trial Eligible and Ineligible Patients in BADBIR

Patients with psoriasis enrolled in clinical trials of biologics may not be representative of the real-world population. There is evidence that patients ineligible for such trials have a greater risk of serious adverse events (SAEs), but the effect on drug discontinuation and effectiveness are unknown. To determine whether (1) drug discontinuation, (2) effectiveness, and (3) rates of SAEs differ in patients with psoriasis categorized as eligible or ineligible for clinical trials. An observational study using 157 dermatology centers in the United Kingdom and Republic of Ireland was carried out wherein we applied the eligibility criteria of clinical trials of biologic therapies for psoriasis to patients who were being followed up in the British Association of Dermatologists Biologic Interventions Register (BADBIR) and being prescribed biologics as part of standard clinical care. Patients with psoriasis registered to BADBIR who were taking etanercept (enbrel only; n = 1509), adalimumab (n = 4000), and ustekinumab (n = 1627) with at least 1 follow-up visit. Eligibility criteria were extracted from phase 3 licensing trials for etanercept, adalimumab, and ustekinumab for the treatment of moderate to severe psoriasis. Patients in BADBIR with a missing baseline Psoriasis Area and Severity Index (PASI) or baseline PASI value less than 10 (etanercept) or less than 12 (adalimumab; ustekinumab) but who would otherwise be eligible were investigated separately. Eligibility categories applied to BADBIR included: eligible, ineligible, insufficient baseline PASI only, and missing baseline PASI only. (1) Drug discontinuation: cumulative incidence at 12 months by stop reason per eligibility category and drug; (2) effectiveness: linear regression of absolute change in PASI from baseline to 6 and 12 months; and (3) SAEs: incidence rate ratio (IRR) at 12 months between eligibility categories per drug. The mean (SD) age of the 7136 patients included in the analysis was 45 (13) years and 2924 (41%) were women and 4212 (59%) were men. Of 7136 patients, 839 (56%) etanercept, 2219 (56%) adalimumab, and 754 (46%) ustekinumab registrations were categorized as eligible. The most common reasons for ineligibility were diabetes (etanercept, 143 [9%]; ustekinumab, 201 [12%]) and nonchronic plaque psoriasis (adalimumab, 157 [4%]). Patients categorized as ineligible (etanercept, 367 [24%]; adalimumab, 282 [7%]; ustekinumab, 394 [24%]) achieved a smaller absolute change in PASI after 6 and 12 months (adalimumab, ustekinumab), and had significantly higher rates of SAEs compared with the eligible category (etanercept: IRR, 1.9; 95% CI, 1.4-2.6; adalimumab: IRR, 2.0; 95% CI, 1.5-2.6; ustekinumab: IRR, 2.8; 95% CI, 2.1-3.8). No significant differences in drug discontinuation were observed between categories. Clinical trial effectiveness and safety outcomes are not representative of real-world patients in BADBIR patients categorized as ineligible for such trials.

Correlation Between Dermatology Life Quality Index and Psoriasis Area and Severity Index in Patients with Psoriasis Treated with Ustekinumab.

Monitoring of biological treatment efficacy for psoriasis is based on clinical evaluation and patient's quality of life. However, long-term correlation between Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in real life has not been studied in patients treated with ustekinumab. All patients with psoriasis treated with ustekinumab at our department were included (n = 120) in this study. Correlation analyses between the change in PASI and DLQI and the individual subquestions in DLQI were performed using Spearman's rank correlation coefficient. A correlation value of 0.57 (p-value <0.001) and 0.45 (p-value < 0.001) between PASI and DLQI were found in the period baseline - 4 months and baseline - 12 months, respectively. In DLQI subquestions, the greatest association was found for the questions on "Symptoms and feelings". Objective improvements in the severity of psoriasis were weakly to moderately associated with improvements in quality of life in patients with psoriasis treated with ustekinumab.

How is disease severity associated with quality of life in psoriasis patients? Evidence from a longitudinal population-based study in Sweden

BackgroundAssessing the impact of disease severity on generic quality of life (QOL) is a critical step in outcomes research and in the development of decision-analytic models structured around health states defined by clinical measures. While data from routine clinical practice found in healthcare registers are increasingly used for research, more attention should be paid to understanding the relationship between clinical measures of disease severity and QOL. The purpose of this work was therefore to investigate this relationship in psoriasis using a population-based dataset.MethodsSeverity was measured by the Psoriasis Area and Severity Index (PASI), which combines severity of erythema, induration, and desquamation into a single value ranging from 0 to 72. The generic EQ-5D-3L utility instrument, under the UK tariff, was used to measure QOL. The association between PASI and EQ-5D-3L was estimated using a population-based dataset of 2674 patients with moderate to severe psoriasis enrolled over ten years in the Swedish psoriasis register (PsoReg). Given the repeated measurement of patients in the register data, a longitudinal fixed-effects model was employed to control for unobserved patient-level heterogeneity.ResultsMarginal changes in PASI are associated with a non-linear response in EQ-5D-3L: Moving from PASI 10 to 9 (1 to 0) is associated with an increase of 0.0135 (0.0174) in EQ-5D-3L. Furthermore, unobserved patient-level heterogeneity appears to be an important source of confounding when estimating the relationship between QOL and PASI.ConclusionsUsing register data to estimate the impact of disease severity on QOL while controlling for unobserved patient-level heterogeneity shows that PASI appears to have a larger impact on QOL than previously estimated. Routine collection of generic QOL data in registers should be encouraged to enable similar applications in other disease areas.Trial registrationNot applicable.

Treatment with tumor necrosis factor inhibitors restores coronary microvascular function in young patients with severe psoriasis

Background and aimsIn patients with psoriasis, the chronic exposure to systemic inflammation can result in coronary microvascular dysfunction (CMD). In this self-controlled, prospective pilot study, we investigated whether a long-term treatment with TNF-α inhibitors effective against skin symptoms also improves coronary flow reserve in psoriasis patients (CFR). MethodsWe prospectively studied 37 consecutive psoriasis patients (31 male; age, 37.7 ± 8.5 years) without cardiovascular disease, before and after anti-TNF-α treatment. CFR in the left anterior descending coronary artery was detected by transthoracic Doppler echocardiography, at rest and during adenosine infusion. CFR was the ratio of hyperemic to resting diastolic flow velocity. A CFR≤2.5 was considered a marker of CMD. Psoriasis was assessed by Psoriasis Area and Severity Index (PASI). High sensitive C-reactive protein (hs-CRP) and serum TNF-α were assessed. ResultsOverall, CFR increased from 2.2 ± 0.7 to 3.02 ± 0.8 (p < 0.0001) after TNF-α inhibitors therapy. In patients with CMD, CFR increased from 1.88 ± 0.3 to 2.74 ± 0.5 (p < 0.0001). In patients with normal CFR, CFR increased from 3.0 ± 0.5 to 3.7 ± 0.9 (p = 0.08). CFR improvement after TNF-α inhibitors treatment was correlated with hs-CRP and TNF-α reduction (p = 0.004 and p = 0.02, respectively), but not with change in PASI (p = 0.5). ConclusionsThe present study demonstrates that TNF-α inhibitors treatment ameliorates CMD in patients with established psoriasis not responding to long-term conventional therapy. These findings suggest that a therapy specifically targeted against inflammation is able to positively affect coronary microvascular function.

Lack of effect of the glucagon-like peptide-1 receptor agonist liraglutide on psoriasis in glucose-tolerant patients--a randomized placebo-controlled trial.

It has been proposed that glucagon-like peptide-1 receptor (GLP-1R) agonists used for the treatment of patients with type 2 diabetes might also improve their psoriasis. To assess the efficacy and safety of the GLP-1R agonist liraglutide in glucose-tolerant patients with plaque psoriasis. A total of 20 obese (body mass index > 25 kg/m(2)), glucose-tolerant patients with plaque psoriasis (psoriasis area and severity index (PASI) of at least 8) were randomized 1:1 to once-daily subcutaneous injections with liraglutide or placebo for an 8-week period. The primary end points were improvement in PASI and dermatology life quality index (DLQI). Secondary end points included changes in weight and high sensitive C-reactive protein (hsCRP) levels, as well as adverse events. After 8 weeks of treatment, no significant change in PASI was found in the liraglutide group (mean±standard deviation: -2.6 ± 2.1) compared with the placebo group (-1.3 ± 2.4) (P = 0.228). No difference in DLQI was observed between the groups [-2.5 ± 4.4 (liraglutide) vs. -3.7 ± 4.8 (placebo); P = 0.564]. HsCRP did not change in any of the groups (0.26 ± 1 (placebo) vs. 0.25 ± 2.2 (liraglutide); P = 0.992). Liraglutide treatment resulted in a bodyweight loss of 4.7 ± 2.5 kg compared with 1.6 ± 2.7 kg in the placebo group (P = 0.014) accompanied by decreased cholesterol levels. No serious adverse events occurred during the 8-week observation period. The most common complaint was transient nausea, which occurred in 45% of the liraglutide-treated patients but in none from the placebo group. Liraglutide treatment for 8 weeks did not significantly change PASI, DLQI, or hsCRP in a small group of glucose-tolerant obese patients with plaque psoriasis compared with placebo. A significant weight loss and decrease in cholesterol levels was observed in liraglutide-treated patients.

Improvement in Psoriasis Area and Severity Index Score Predicts Improvement in Skin Pain Over Time in Patients with Psoriasis

Pain and discomfort are common and often severe skin symptoms in patients with psoriasis. However, no studies have investigated skin pain and discomfort over time, or factors that explain changes in these symptoms. The aims of the present study were to describe the changes in skin pain, skin discomfort and Psoriasis Area and Severity Index (PASI) over time, and to investigate whether change in PASI predicted change in skin pain intensity. A total of 129 patients participated in this exploratory, longitudinal study. Data were obtained through interviews and questionnaires. The results indicated reduction in skin symptoms and psoriasis severity over a period of 3 months. However, a majority of patients with skin pain at baseline reported also skin pain at follow-up. Furthermore, changes in PASI predicted changes in skin pain intensity. In conclusion, improvement in psoriasis severity predicts improvement in skin pain.