Absolute Versus Relative Psoriasis Area and Severity Index in Clinical Practice

Viladomiu, Elena del Alcázar; Doménech, Nuria Lamas; Redonnet, M. Salleras

doi:10.1016/j.adengl.2018.03.021

Cited by 7 publications

(10 citation statements)

References 10 publications

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“…Other cut-offs, however, are reported in the literature -such as PASI < 7 defining mild psoriasis and > 12 defining severe psoriasis (7). Lastly, PASI scores of 3 and 5 have also been used as target outcomes (8). In linear regression analysis, no significant correlation was found between RDW and PASI or CRP, nor with age, gender, or the psoriasis comorbidities listed in Table I.…”

Section: Introductionmentioning

confidence: 99%

Increased red blood cell distribution width in patients with plaque psoriasis

Gisondi¹,

Geat²,

Lippi³

et al. 2021

J Med Biochemistry

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Background: Red blood cell distribution width (RDW) is frequently increased in inflammatory disorders and the magnitude of its elevation correlates with disease severity. This study was hence aimed to explore RDW values in patients with psoriasis. Methods: The study population consisted of 366 adult patients with mild to severe plaque psoriasis and 366 age- and sex-matched healthy blood donor controls. For each psoriatic patient demographic, clinical and laboratory data were regularly collected. Results: RDW and MCV were significantly higher in psoriatic patients compared to controls (13.95 vs. 13.40% and 90.4 vs. 89 fL; both p<0.01). In order to assess whether RDW elevations were related to psoriasis severity, we divided our psoriatic patient population into two groups based on a PASI cut-off of 10. No significant differences were observed between the two groups (i.e. PASI > 10 and ≤ 10) in terms of RDW (p=0.36). Adopting different PASI cut-offs (i.e. 3, 5, 7, 12) did also not result in statistically significant differences (p= 0.93, 0.48, 0.22, 0.42, respectively). In linear regression analysis, no significant correlation was also found between RDW and PASI or CRP, nor with age, gender or the psoriasis comorbidities listed in Table I. Furthermore, no significant difference of RDW values was noted between psoriatic patients with and without PsA (p = 0.27). Conclusions: The results of this study confirm that RDW is elevated in psoriatic patients, though the magnitude of its increase did not appear to be associated with disease severity.

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Section: Introductionmentioning

confidence: 99%

Increased red blood cell distribution width in patients with plaque psoriasis

Gisondi¹,

Geat²,

Lippi³

et al. 2021

J Med Biochemistry

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“…Nevertheless, while relative PASI responses are reported generally for all clinical trials in psoriasis, absolute PASI is rarely available or hardly accessible as a post hoc analysis [24]. Therefore, when this data is lacking, some solution is needed as in clinical practice, absolute PASI score may perform better as a measure of therapeutic success than the relative reduction in PASI score [21, 25]. Deriving absolute scores becomes advantageous for psoriasis studies that report only baseline characteristics and relative disease severity improvements.…”

Section: Discussionmentioning

confidence: 99%

Application of the Statistical Method to Convert Published PASI 50/75/90/100 into Absolute PASI Response Rate in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Tildrakizumab Based on Data from the Two Pivotal Phase 3 Studies reSURFACE 1 and reSURFACE 2

et al. 2022

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Background: Absolute Psoriasis Area and Severity Index (PASI) is a key endpoint in psoriasis management. Petto et al. [Pharm Stat. 2019;18(1):4–21] developed a statistical method to estimate the proportion of patients reaching absolute PASI response given baseline PASI score and proportion of patients achieving relative improvements at predefined time points. Objectives: To test this method on clinical data from two phase 3 tildrakizumab trials (reSURFACE 1/2) comparing estimated absolute PASI ≤1/≤2/≤3/≤5 responses with reference responses from clinical databases. Methods: Reference PASI responses of ≤1/≤2/≤3/≤5 were extracted from clinical databases. Estimation of absolute PASI ≤1/≤2/≤3/≤5 response rates at week (W) 12 and W28 by treatment and trial were performed. Differences between estimated and reference responses were analysed. Bland-Atman limits of agreement and Passing-Bablok regression to assess variations between estimated and reference responses were performed. Results: Differences between estimated and reference absolute PASI ≤1/≤2/≤3/≤5 responses at W12 and W28 by treatment and trial were of little clinical relevance with an overall mean difference in PASI response proportion of −2.2% (e.g., for the tildrakizumab 100-mg arm, original proportions of patients achieving PASI of ≤1/≤2/≤3/≤5 at W28 were 38.5%/52.2%/63.5%/73.9% and 39.8%/54.8%/63.6%/76.9% [reSURFACE 1 and 2, respectively] vs. estimated proportions of 33.2%/49.8%/62.5%/78.3% and 34.3%/51.6%/64.5%/79.9%). Limits of agreement were −7.1% to 1.4% at W12 and –6.8% to 4.3% at W28. Scatterplots revealed linearity that stood the cusum test in Passing-Bablok regression with slope 1.14 (95% confidence intervals: 1.06 to 1.20). Conclusion: Good estimates of absolute PASI response rates were achieved with the application of the statistical method to tildrakizumab data reported in the phase 3 studies, in particular in the verum study arms. Our data support the method provided by Petto et al. [2019] to estimate proportions of psoriasis patients reaching absolute PASI value thresholds using relative PASI improvements.

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“…There is a growing consensus that PASI scores of ≤3 may constitute better measures of therapeutic success. 15 Achieving this feat by a great proportion of our patients is clinically meaningful as the ultimate goal of any psoriasis treatment is to achieve almost clear/clear skin, which has the additional benefit of improving patients’ quality of life. In a psoriasis worldwide survey, 84% of all respondents experienced discrimination and/or humiliation due to psoriasis, and many reported negative effects on work, intimate relationships, sleep, and mental health.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of IL-23 Inhibitor Guselkumab in Real-World Chinese Patients with Psoriasis During a 20-Week Period

Chan¹,

Tong²,

Ngan³

et al. 2021

PTT

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Background Interleukin-23 inhibitors are novel treatment options for psoriasis, and their efficacy and safety have been widely demonstrated in phase 3 clinical trials. Nonetheless, their real-world data remain limited, especially in Asia. Objective To evaluate the real-world effectiveness of interleukin-23 inhibitor guselkumab in Chinese patients with psoriasis. Methods In this retrospective single-center study, Chinese patients with psoriasis receiving a standard dose of guselkumab from November 2018 to May 2020 were included in the study cohort. Disease assessment was performed at baseline (Week 0), and at Week 4, 12, and 20 thereafter, using Psoriasis Area and Severity Index (PASI) score. Results Data of 68 adult patients with psoriasis were retrieved for analysis. At Week 20, 72.1%/47.1% of the patients achieved PASI 90/100 response respectively, and 76.5% achieved a PASI score <3. Baseline mean PASI score was 17.5, which significantly reduced to 2.0 at Week 20 (P=0.000). No previous use of biologics was a single significant factor associated with achieving PASI 90/100 and PASI score <3 responses at Week 20 (all Ps<0.05), while there were no statistically significant differences between males and females and body weight >75 and ≤75 kg in achieving these responses (all Ps>0.05). Adverse events were experienced by five patients (7.4%), and all were mild in severity. Conclusion In this first real-world study on guselkumab among Chinese patients with psoriasis, this biologics was shown to be safe and effective in reaching an optimal clinical response up to 20 weeks.

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Absolute Versus Relative Psoriasis Area and Severity Index in Clinical Practice

Cited by 7 publications

References 10 publications

Increased red blood cell distribution width in patients with plaque psoriasis

Increased red blood cell distribution width in patients with plaque psoriasis

Application of the Statistical Method to Convert Published PASI 50/75/90/100 into Absolute PASI Response Rate in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Tildrakizumab Based on Data from the Two Pivotal Phase 3 Studies reSURFACE 1 and reSURFACE 2

Effectiveness of IL-23 Inhibitor Guselkumab in Real-World Chinese Patients with Psoriasis During a 20-Week Period

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