Reaching complete or near-complete resolution of psoriasis: benefit and risk considerations

Blauvelt, Andrew; Griffiths, Cem; Lebwohl, Mark; Mrowietz, Ulrich; Puig, L.; Ball, Susan; Zhang, L.; Edson-Heredia, Emily; Warner, Margaret R.; Zhu, Baojin; Lin, C‐Y.; Nikaï, E.; Dey, David L.; Mallbris, Lotus; Reich, Kristian

doi:10.1111/bjd.15463

Cited by 14 publications

(17 citation statements)

References 7 publications

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“…Patients showing less than total skin clearance at incrementally higher absolute PASI levels had cor-respondingly less overlap with the responders on these HRQoL measures, indicating a substantial reduction in patient satisfaction with increasing amounts of residual disease. This inverse relationship between PASI level and HRQoL benefit was also observed between absolute DLQI, PatGA, and Itch NRS scores and absolute PASI band response and is in broad agreement with previous studies, which used a variety of HRQoL measures (13,17,18). However, the baseline PASI level (baseline PASI < 20 versus PASI ≥ 20) did not substantially impact PASI response or HRQoL outcomes.…”

Section: Discussionsupporting

confidence: 91%

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes

Puig¹,

Dossenbach²,

Berggren³

et al. 2019

Acta Derm Venerol

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Psoriasis treatment goals defined in terms of the absolute Psoriasis Area and Severity Index (PASI) scores offer certain advantages in the clinical setting, but a consensus on a treatment goal based on absolute PASI has not yet been achieved. The current study was conducted in order to evaluate different absolute PASI treatment targets relative to other measures of the response to treatment based on the data derived from two large clinical studies of patients with moderate-to-severe plaque psoriasis. These data indicate that PASI ≤ 2 represents significantly meaningful clinical and health-related quality of life improvements and may be a suitable treatment target for moderate-to-severe plaque psoriasis. Treatment goals defined by the absolute Psoriasis Area and Severity Index (PASI) scores offer certain advantages in the clinical setting. In order to investigate potential treatment targets, this study evaluated absolute PASI outcomes relative to other measures of response using data from two randomized clinical trials of patients with moderate-to-severe psoriasis treated with ixekizumab, etanercept, or placebo (n=2,567). Response was assessed throughout 12 weeks as the proportion of patients achieving absolute PASI band cutoffs who also reached established response criteria. Most PASI band ≤2 responders also achieved PASI 90 (70.1-100%), static Physician's Global Assessment (0,1) (91.3-96.1%), Dermatology Life Quality Index (0,1) (63.0-67.7%), Patient Global Assessment of Disease Severity (0,1) (80.3-86.7%), and Itch Numeric Rating Scale improvement ≥4 (87.2-87.6%). Agreement sharply decreased for less stringent PASI criteria. These data indicate that PASI ≤2 represents significantly meaningful clinical and health-related quality of life improvements and may be a suitable treatment target for moderate-to-severe plaque psoriasis.

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Section: Discussionsupporting

confidence: 91%

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes

Puig¹,

Dossenbach²,

Berggren³

et al. 2019

Acta Derm Venerol

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“…4). In a previously published analysis of Week 12 data, a similar association was described, with 82.3% of patients reporting a DLQI (0,1) among PASI 100 responders [46]. While further studies are needed, our long-term data (Fig.…”

Section: Discussionsupporting

confidence: 85%

“…While further studies are needed, our long-term data (Fig. 4) suggest maintaining clear skin (PASI 100) over long periods may have an even greater impact on QoL than patients achieving PASI 100 at 12 weeks with ixekizumab [46].…”

Section: Discussionmentioning

confidence: 84%

Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials

Reich

Foley

Torii

et al. 2020

Dermatol Ther (Heidelb)

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Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years. Methods: Data were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI B 5/ B 3/ B 2/ B 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare. 11925636.

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“…While this symptom relief is highly promising, it also suggests that itch can remain a persistent problem for some patients despite treatment with highly effective therapy. Notably, in an integrated analysis of two Phase III ixekizumab clinical trials (UNCOVER-1 and UNCO-VER-2) 63.8% of patients with complete skin clearance at Week 12 (i.e., PASI 100) also reported no itching (i.e., Itch NRS = 0) (18). In the integrated analysis as well as the present study, the extent and location of itch was not qualified.…”

Section: Discussioncontrasting

confidence: 72%

Long-term Impact of Ixekizumab on Psoriasis Itch Severity: Results from a Phase III Clinical Trial and Long-term Extension

Kimball¹,

Luger²,

Gottlieb³

et al. 2018

Acta Derm Venerol

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Itching is a prevalent plaque psoriasis symptom. Ixekizumab, an IL-17A antagonist, has demonstrated rapid, significant improvements in itch severity over 12 weeks in Phase III psoriasis trials (UNCOVER-1, UNCOVER-2). We assessed the long-term (through 60 weeks) effect of ixekizumab maintenance therapy (80-mg ixekizumab every 4 weeks [IXEQ4W]) on itch severity, using the Itch Numeric Rating Scale, in psoriasis patients who received ixekizumab, placebo, or etanercept for 12 weeks in the Phase III UNCOVER-3 trial. After 12 weeks, patients either continued or switched to IXEQ4W. Mean improvements in itch severity achieved with 12 weeks of ixekizumab (-4.7 to -5.1) were maintained through 60 weeks with IXEQ4W (-4.9 to -5.0). Patients who initially received placebo or etanercept experienced rapid itch severity improvements after switching to ixekizumab at Week 12 (Week 12, placebo: -0.6; etanercept: -3.8; Week 60, placebo/IXEQ4W: -4.9; etanercept/IXEQ4W: -4.7). Ixekizumab maintenance therapy sustained improvements in itch severity through 60 weeks.

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Reaching complete or near-complete resolution of psoriasis: benefit and risk considerations

Cited by 14 publications

References 7 publications

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes

Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials

Long-term Impact of Ixekizumab on Psoriasis Itch Severity: Results from a Phase III Clinical Trial and Long-term Extension

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