Comparative Effectiveness of Biologics Across Subgroups of Patients with Moderate-to-Severe Plaque Psoriasis: Results at Week 12 from the PSoHO Study in a Real-World Setting

Lynde, Charles; Riedl, Elisabeth; Maul, Julia‐Tatjana; Torres, Tiago; Pinter, Andreas; Fabbrocini, Gabrielle; Daniele, Flavia; Brnabic, Alan; Reed, Catherine; Wilhelm, Stefan; Holzkämper, Thorsten; Schuster, Christopher; Puig, Luís

doi:10.1007/s12325-022-02379-9

Cited by 12 publications

(21 citation statements)

References 33 publications

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“…These results should be interpreted in the context of the PSoHO study design and its recently published primary data and patient subgroup analyses 16,17 . Observational studies have inherent limitations, and the number of patients providing PSSD data varied at each week.…”

Section: Discussionmentioning

confidence: 90%

“…These results should be interpreted in the context of the PSoHO study design and its recently published primary data and patient subgroup analyses. 16,17 Observational studies have inherent limitations, and the number of patients providing PSSD data varied at each week. Accordingly, data are presented as observed and treatment comparisons using the MMRM and GLMM were adjusted for different confounding variables.…”

Section: Discussionmentioning

confidence: 99%

“…Psoriasis Study of Health Outcomes is an ongoing 36‐month prospective, international, non‐interventional cohort study reflecting treatment within real‐world settings of patients with moderate‐to‐severe PsO ( n = 1981) who initiate their first biologic or are switched to a new biologic therapy (including biosimilars). Study design and patient enrolment details have been published previously 16,17 . Biologics included are anti‐IL‐17A inhibitors (ixekizumab [IXE] or secukinumab [SEC]) and any other originator or biosimilar biological medication (adalimumab [ADA], brodalumab, certolizumab, etanercept, guselkumab [GUS], infliximab, risankizumab [RIS], tildrakizumab and ustekinumab [UST]) indicated for the treatment of moderate‐to‐severe PsO.…”

Section: Methodsmentioning

confidence: 99%

“…Study design and patient enrolment details have been published previously. 16,17 Biologics included are anti-IL-17A inhibitors (ixekizumab [IXE] or secukinumab [SEC]) and any other originator or biosimilar biological medication (adalimumab [ADA], brodalumab, certolizumab, etanercept, guselkumab [GUS], infliximab, risankizumab [RIS], tildrakizumab and ustekinumab [UST]) indicated for the treatment of moderate-to-severe PsO. Only treatment groups with more than 100 patients with PSSD data are shown (IXE, SEC, GUS, RIS, ADA and UST).…”

Section: Patients and Study Designmentioning

confidence: 99%

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Speed of clinical improvement in the real‐world setting from patient‐reported Psoriasis Symptoms and Signs Diary: Secondary outcomes from the Psoriasis Study of Health Outcomes through 12 weeks

Reich

Pinter

Maul

et al. 2023

Acad Dermatol Venereol

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BackgroundRapid skin improvement is a key treatment goal of patients with moderate‐to‐severe psoriasis (PsO).ObjectivesTo compare the speed of clinical improvement of approved biologics on the symptoms and signs of psoriasis assessed by patients using the validated Psoriasis Symptoms and Signs Diary (PSSD) through 12 weeks.MethodsPsoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non‐interventional study that compares the effectiveness of anti‐interleukin (IL)‐17A biologics versus other biologics, together with pairwise comparisons of ixekizumab versus five individual biologics in patients with PsO. Using the PSSD 7‐day recall period, patients assessed the symptoms (itch, skin tightness, burning, stinging and pain) and signs (dryness, cracking, scaling, shedding/flaking, redness and bleeding) of their psoriasis (0–10). Symptom and sign summary scores (0–100) are derived from the average of individual scores. Percentage change in summary scores and proportion of patients with clinically meaningful improvements (CMI) in PSSD summary and individual scores are evaluated weekly. Longitudinal PSSD data are reported as observed with treatment comparisons analysed using mixed model for repeated measures (MMRM) and generalized linear mixed models (GLMM).ResultsAcross cohorts and treatments, eligible patients (n = 1654) had comparable baseline PSSD scores. From Week 1, the anti‐IL‐17A cohort achieved significantly larger score improvements in PSSD summary scores and a higher proportion of patients showed CMIs compared to the other biologics cohort through 12 weeks. Lower PSSD scores were associated with a greater proportion of patients reporting their psoriasis as no longer impacting their quality‐of‐life (DLQI 0,1) and a high level of clinical response (PASI100). Results also indicate a relationship between an early CMI in PSSD score at Week 2 and PASI100 score at Week 12.ConclusionsTreatment with anti‐IL‐17A biologics, particularly ixekizumab, resulted in rapid and sustained patient‐reported improvements in psoriasis symptoms and signs compared with other biologics in a real‐world setting.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Patients and Study Designmentioning

confidence: 99%

See 2 more Smart Citations

Speed of clinical improvement in the real‐world setting from patient‐reported Psoriasis Symptoms and Signs Diary: Secondary outcomes from the Psoriasis Study of Health Outcomes through 12 weeks

Reich

Pinter

Maul

et al. 2023

Acad Dermatol Venereol

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“…The therapeutic efficacy of IXE compared with other psoriasis biologics has been demonstrated across numerous head-to-head clinical trials [ 8 – 12 ]. In addition to these clinical data, real-world effectiveness of IXE has been proven through real-world studies [ 13 ], including PSoHO—an international, prospective, observational study comparing the effectiveness of anti-IL-17A biologics (IXE and SEC) with other approved biologics for the treatment of moderate-to-severe plaque psoriasis [ 14 – 17 ].…”

Section: Introductionmentioning

confidence: 99%

Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies

Armstrong,

González-Cantero,

Khattri

et al. 2024

Dermatol Ther (Heidelb)

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Introduction The National Psoriasis Foundation (NPF) recommends evaluating patient response to treatment at week 12, with a target response of ≤ 1% body surface area (BSA) affected by plaque psoriasis and an acceptable response of BSA ≤ 3% or ≥ 75% improvement. This post hoc analysis compared the achievement of NPF target and acceptable responses for ixekizumab (IXE) versus other biologics. Methods Outcomes were evaluated at week 12 for patients with moderate-to-severe plaque psoriasis from four head-to-head randomized clinical trials (RCTs; UNCOVER-2, UNCOVER-3, IXORA-R, and IXORA-S) and one real-world prospective observational study (Psoriasis Study of Health Outcomes; PSoHO). RCT patients were treated with IXE or etanercept (ETN; UNCOVER-2/3), guselkumab (GUS; IXORA-R), or ustekinumab (UST; IXORA-S). PSoHO patients were treated with anti-interleukin (IL)-17A biologics (IXE, secukinumab, SEC) and other approved biologics for the treatment of plaque psoriasis. Patients with missing outcomes were imputed as non-responder imputation. For RCT data, statistical comparisons between treatment groups were performed using Fisher’s exact test with no multiplicity adjustments. For real-world data, adjusted comparative analyses were performed using frequentist model averaging (FMA) and reported as odds ratio (OR). Results Across the four head-to-head clinical trials analyzed, significantly higher proportions of patients achieved target and acceptable responses at week 12 with IXE versus ETN, GUS, or UST. Likewise, the proportion of PSoHO patients achieving target and acceptable response at week 12 was higher with IXE compared with other individual biologics. Adjusted comparative analyses showed that IXE had significantly greater odds of target and acceptable response at week 12 versus SEC, GUS, risankizumab (RIS), adalimumab (ADA), UST, and tildrakizumab (TILD) and numerically greater odds of target and acceptable response at week 12 versus brodalumab (BROD). Conclusion Across both clinical studies and real-world settings, more patients treated with IXE achieved NPF target and acceptable responses at week 12 compared with those treated with other biologics. Trial Registration UNCOVER-2 (NCT01597245); UNCOVER-3 (NCT01646177); IXORA-R (NCT03573323); IXORA-S (NCT02561806); PSoHO (EUPAS24207). Supplementary Information The online version contains supplementary material available at 10.1007/s13555-024-01136-w.

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Itch improvement has a major and comparable effect on the Dermatology Life Quality Index in psoriasis and atopic dermatitis patients

Boehncke,

Reich,

Ständer

et al. 2024

JEADV Clinical Practice

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BackgroundItch is known to have a particularly high impact on psoriasis (PsO) and atopic dermatitis (AD) patients' quality of life. Although AD therapies have exhibited a high efficacy when it comes to itch control, itch control with PsO therapies is not as well documented.ObjectivesThe aim of this post‐hoc analysis is to better understand the impact of itch on the patients' quality of life in PsO as well as AD by providing a pairwise correlation between itch improvement and patients' quality of life and determine the predictive factors in patients achieving Dermatology Life Quality Index score of 0 or 1 [DLQI (0/1)].MethodsThree phase III clinical studies, one in PsO and two in AD, were assessed. Pairwise correlations between objective improvement of visible signs of disease, quality of life, and itch intensity were investigated at 16 weeks of treatment. Predictive analyses methods were applied on the data to assess the impact of clinical and itch improvement on the DLQI improvement.ResultsThis study shows that change in itch from baseline in AD and PsO patients correlate to change in DLQI from baseline. Change in itch from baseline was found to be the most important factor in predicting DLQI (0/1).ConclusionsThese results highlight the necessity to study itch in both PsO and AD clinical trials, and it is recommended that itch may be considered a coprimary or at minimum a secondary efficacy end‐point in all such clinical studies.

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Comparative Effectiveness of Biologics Across Subgroups of Patients with Moderate-to-Severe Plaque Psoriasis: Results at Week 12 from the PSoHO Study in a Real-World Setting

Cited by 12 publications

References 33 publications

Speed of clinical improvement in the real‐world setting from patient‐reported Psoriasis Symptoms and Signs Diary: Secondary outcomes from the Psoriasis Study of Health Outcomes through 12 weeks

Speed of clinical improvement in the real‐world setting from patient‐reported Psoriasis Symptoms and Signs Diary: Secondary outcomes from the Psoriasis Study of Health Outcomes through 12 weeks

Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies

Itch improvement has a major and comparable effect on the Dermatology Life Quality Index in psoriasis and atopic dermatitis patients

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