Clinical outcomes at 1 year in early Psoriasis Area and Severity Index responders compared with non-responders: Subgroup analysis of UNCOVER-3 trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Rosmarin D
PROVIDER: S-EPMC9060090 | biostudies-literature | 2021 Sep
REPOSITORIES: biostudies-literature
Publications
Clinical outcomes at 1 year in early Psoriasis Area and Severity Index responders compared with non-responders: Subgroup analysis of UNCOVER-3 trial.
Rosmarin D D Smith S S Shrom D D Burge R R See K K McKean-Matthews M M Ridenour T T Lin C-Y CY Gorelick J J
Skin health and disease 20210511 3
Similar Datasets
Project description:BackgroundThe self-assessment psoriasis area severity index (SAPASI) is a patient-administered psoriasis assessment tool for which we present a validated translation from English to Swedish.MethodsValidity was evaluated in this single-centre study using the psoriasis area severity index (PASI) as the standard. Test-retest reliability was assessed using repeated SAPASI measurements.ResultsSignificant correlations (p < 0.0001) using Spearman's correlation coefficient (r) were found between PASI and SAPASI scores (r = 0.60) for 51 participants (median baseline PASI 4.4, interquartile range [IQR]: 1.8-5.6) and repeated SAPASI measurements (r = 0.70) among 38 participants (median baseline SAPASI 4.0, IQR: 2.5-6.1). Bland-Altman plots showed generally higher SAPASI scores than PASI scores.ConclusionThe translated version of SAPASI is valid and reliable, although patients generally tend to overrate their disease severity compared to PASI. Keeping this limitation in mind, SAPASI has the potential of being implemented as a time- and cost-efficient assessment tool in a Scandinavian context.
| S-EPMC10614249 | biostudies-literature
Project description:BackgroundThe Psoriasis Area and Severity Index (PASI) score is commonly used in clinical practice and research to monitor disease severity and determine treatment efficacy. Automating the PASI score with deep learning algorithms, like Convolutional Neural Networks (CNNs), could enable objective and efficient PASI scoring.ObjectivesTo assess the performance of image-based automated PASI scoring in anatomical regions by CNNs and compare the performance of CNNs to image-based scoring by physicians.MethodsImaging series were matched to PASI subscores determined in real life by the treating physician. CNNs were trained using standardized imaging series of 576 trunk, 614 arm and 541 leg regions. CNNs were separately trained for each PASI subscore (erythema, desquamation, induration and area) in each anatomical region (trunk, arms and legs). The head region was excluded for anonymity. Additionally, PASI-trained physicians retrospectively determined image-based subscores on the test set images of the trunk. Agreement with the real-life scores was determined with the intraclass correlation coefficient (ICC) and compared between the CNNs and physicians.ResultsIntraclass correlation coefficients between the CNN and real-life scores of the trunk region were 0.616, 0.580, 0.580 and 0.793 for erythema, desquamation, induration and area, respectively, with similar results for the arms and legs region. PASI-trained physicians (N = 5) were in moderate-good agreement (ICCs 0.706-0.793) with each other for image-based PASI scoring of the trunk region. ICCs between the CNN and real-life scores were slightly higher for erythema (0.616 vs. 0.558), induration (0.580 vs. 0.573) and area scoring (0.793 vs. 0.694) than image-based scoring by physicians. Physicians slightly outperformed the CNN on desquamation scoring (0.580 vs. 0.589).ConclusionsConvolutional Neural Networks have the potential to automatically and objectively perform image-based PASI scoring at an anatomical region level. For erythema, desquamation and induration scoring, CNNs performed similar to physicians, while for area scoring CNNs outperformed physicians on image-based PASI scoring.
| S-EPMC9298301 | biostudies-literature
Project description:BI 730357 is investigated as an oral treatment of plaque psoriasis. We analyzed the impact of three dosage regimens on the Psoriasis Area and Severity Index (PASI) response with modeling based on phase I and II data from 109 healthy subjects and 274 patients with moderate-to-severe plaque psoriasis. The pharmacokinetics (PK) was characterized by a two-compartment model with dual absorption paths and a first-order elimination. Higher baseline C-reactive protein was associated with lower clearance and patients generally had lower clearance compared with healthy subjects. A bounded integer PK/pharmacodynamic model characterized the effect on the observed PASI. The maximum drug effect was largest for patients with no prior biologic use, smaller for patients with prior use of non-interleukin-17 inhibitors, and smallest for patients with prior interleukin-17 inhibitor use. The models allowed robust simulation of large patient populations, predicting a plateau in PASI outcomes for BI 730357 exposure above 2000 nmol/L.
| S-EPMC10272300 | biostudies-literature
Project description: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).
| S-EPMC8322374 | biostudies-literature
Project description: Not available
| S-EPMC7891613 | biostudies-literature
Project description:BackgroundThe product of Physician Global Assessment and Body Surface Area (PGA × BSA) is a new outcome measure for psoriasis severity and response to therapy. The objective of this study was to evaluate PGA × BSA as an alternative to Psoriasis Area and Severity Index (PASI) for psoriasis assessments.MethodsThe relationship between PASI and PGA × BSA was assessed in a post hoc analysis of pooled data from the PRISTINE (NCT00663052) and PRESTA (NCT00245960) trials in patients with moderate-to-severe psoriasis who received etanercept 50 mg/week. Data were analyzed using Spearman and intra-class correlation coefficients, effect sizes, scatterplots, Bland-Altman plots, and Kappa statistics.ResultsSpearman correlations at baseline, week 12, and week 24 were strong for PGA × BSA versus PASI (r=0.78, 0.87, and 0.90, respectively; all P<0.0001) as were intra-class correlations (0.76 [95% confidence interval 0.73-0.80], 0.80 [0.76-0.83], and 0.85 [0.82-0.87], respectively). The effect size was -1.53 for PASI and -0.94 for PGA × BSA (baseline to week 24). Scatterplots and Bland-Altman plots detected a trend across the range of measurement. Kappa statistics (at 12 and 24 weeks) between PASI50/75/90 and 50/75/90% improvement in PGA × BSA showed good agreement (0.58-0.69 at week 12 and 0.63-0.67, respectively; all P<0.0001). At baseline, the Spearman correlation coefficients were 0.96, 0.51, 0.19, and 0.17 for PGA × BSA versus BSA, PGA, Patient Global Assessment, and Dermatology Life Quality Index, respectively (all P<0.001).ConclusionPGA × BSA has advantages over PASI for measuring moderate-to-severe psoriasis; it is intuitive, sensitive, and easy to use.
| S-EPMC6181091 | biostudies-literature
Project description:BackgroundIn practice, the goal of treatment for patients with psoriasis is to achieve almost clear or clear skin and maintain disease control, regardless of baseline disease severity. However, identifying absolute Psoriasis Area and Severity Index (PASI) values for new treatment goals is challenging, as most clinical trials report relative PASI 50, 75, 90 or 100 improvements but rarely absolute PASI values achieved.ObjectiveOur objective was to illustrate a statistical conversion method that was developed to derive absolute PASI values from available clinical trial data on relative PASI improvements. The results of network meta-analyses (NMAs) based on these derived data were then compared with those of NMAs based on the corresponding relative PASI improvement data for selected biologics for moderate-to-severe psoriasis.MethodsThe PASI statistical conversion method was applied to relative PASI improvement data for 11 biologic treatment regimens and placebo at 12 weeks using data from 50 published studies. The respective proportions of patients reaching absolute PASI values ≤1, 2, 3 or 5 were then calculated. Frequentist NMAs (Rücker method) were subsequently used to compare efficacy results across relative and absolute PASI data.ResultsThe ranking of included treatment regimens for patients achieving absolute PASI 0 to 8 was aligned with results for relative PASI scores (from 100 to 60) at end of induction therapy. Across the range of PASI scores considered, the most effective treatment regimens based on both absolute and relative PASI NMAs were brodalumab 210 mg every 2 weeks and ixekizumab 80 mg every 2 weeks, followed by guselkumab 100 mg every 8 weeks and risankizumab 150 mg every 12 weeks.ConclusionData generated using this mathematical model will be useful to inform ongoing scientific discussions on treatment goals in the absence of primary absolute PASI data for all available treatments for moderate-to-severe plaque psoriasis.
| S-EPMC8248394 | biostudies-literature
Project description:IntroductionWe evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement.MethodsData were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156.ResultsAt week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4-6, 7-8, and 9-10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4-6, 7-8, and 9-10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment.ConclusionsRegardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis.FundingEli Lilly and Company.Trial registrationClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.
| S-EPMC6261114 | biostudies-literature
Project description:BackgroundRisankizumab has demonstrated durable, high rates of efficacy in patients with moderate-to-severe plaque psoriasis as assessed by the achievement of relative Psoriasis Area and Severity Index (PASI) improvement and Dermatology Life Quality Index (DLQI) 0/1.ObjectivesThe aim of this post hoc analysis is to assess the achievement of absolute PASI thresholds and related improvements in health-related quality of life (HRQoL) in patients with moderate-to-severe plaque psoriasis treated with (i) risankizumab compared with ustekinumab, and (ii) long-term (>52 weeks to 172 weeks) risankizumab.MethodsData from patients randomised to 150 mg risankizumab or 45 or 90 mg ustekinumab in replicate randomised controlled trials UltIMMa-1 and UltIMMa-2 were analysed for the achievement of absolute PASI thresholds PASI ≤ 3, PASI ≤ 1, and PASI = 0, time to achieve these thresholds, and combined PASI and DLQI endpoints. Data from pat ients initially randomised to risankizumab who continued on risankizumab in the open-label extension study LIMMitless were analysed for the achievement of absolute PASI levels, mean DLQI scores, and DLQI 0/1.ResultsSignificantly greater proportions of patients treated with risankizumab compared with ustekinumab achieved PASI ≤ 3, PASI ≤ 1, and PASI = 0, as well as combined endpoints for absolute PASI and DLQI [(PASI ≤ 3 and DLQI ≤ 5) or (PASI ≤ 1 and DLQI 0/1)]. The median time to first achieve PASI ≤ 3, PASI ≤ 1, and PASI = 0 was significantly lower for risankizumab-treated patients compared with ustekinumab-treated patients. Among patients treated with long-term risankizumab, more than 90% achieved PASI ≤ 3 though week 172 and more than 80% achieved DLQI 0/1. Low absolute PASI scores corresponded with low mean absolute DLQI scores through week 172 of continuous risankizumab treatment.ConclusionsRisankizumab treatment demonstrated high rates of rapid and durable efficacy as measured by absolute PASI thresholds and improvements in patient HRQoL.
| S-EPMC9314097 | biostudies-literature
Project description:BackgroundValidated, reliable, globally accepted outcome measurement instruments for hidradenitis suppurativa (HS) are needed. Current tools to measure the physical signs domain for HS rely on lesion counts, which are time-consuming and unreliable.ObjectivesTo assess the reliability and validity of the Hidradenitis suppurativa Area and Severity Index Revised (HASI-R) tool, a novel method for assessing HS severity, incorporating signs of inflammation and body surface area involved.MethodsThe measurement properties of the HASI-R tool were evaluated. The tool was created by combining the previously published HASI and Severity and Area Score for Hidradenitis instruments. Twenty raters evaluated 15 patients with HS in a hospital-based ambulatory dermatology clinic. The objectives of the study were to assess inter- and intra-rater reliability of the HASI-R and its components, as well as its construct and known-groups validity. Existing lesion count-based clinician-reported measures of HS and their components were also assessed. Raters were also asked their preferences regarding the various HS severity assessment tools.ResultsThe HASI-R had moderate inter-rater reliability [intra-class correlation coefficients (ICC) 0·60]. This was better than all other HS physical sign outcome measures evaluated, which had poor inter-rater reliability (ICC < 0·5). HASI-R had the highest intra-rater reliability (ICC 0·91). The HASI-R had good construct validity and demonstrated known-groups validity. The HASI-R was also the most preferred tool by all raters.ConclusionsResults from the clinometric assessment of the HASI-R are encouraging, and support continued evaluation of this clinician-reported outcome measure.
| S-EPMC8573730 | biostudies-literature