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

Abstract

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.

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

“…This analysis demonstrates the therapeutic benefit of IXE compared with other biologics in providing patients with NPF-defined target or acceptable responses at week 12. The complementary clinical trial and real-world data presented here provide additional evidence supporting the rapid skin resolution achieved with IXE treatment, which has previously been proven to improve health-related quality of life in patients [ 11 , 16 , 19 ].…”

“…Rapid skin improvement is one of the most important treatment goals targeted by patients with plaque psoriasis [ 5 , 6 ]. Skin improvements have been associated with a lower Dermatology Life Quality Index (corresponding to less impaired health-related quality of life) in patients with plaque psoriasis from RCTs [ 11 , 19 ] and real-world observational studies [ 16 ]. Clinical improvements in ixekizumab-treated patients were accompanied by rapid improvements in health-related quality-of-life measures in the UNCOVER 2 and 3 trials [ 20 ].…”

“…However, inclusion of real-world data from the PSoHO observational study, which was conducted across 23 countries, may offset some of these limitations. Detailed descriptions of the limitations of PSoHO have previously been published [ 14 – 16 , 26 ]. Additionally, as an observational study, PSoHO has inherent limitations, including measured and unmeasured confounding and other bias compared with RCTs.…”

“…PSoHO is an ongoing 3-year, prospective, international, observational study reflecting treatment with biologics within real-world settings. A detailed description of the study design has previously been published [ 14 – 16 ]. PSoHO includes adult patients from 23 countries who had a confirmed diagnosis of moderate-to-severe plaque psoriasis at least 6 months prior to baseline and who initiated or switched biologic treatment during routine medical care.…”

Effectiveness of Biologics, Patient-Reported Outcomes, and Clinical Photography in a Subset of Patients with Moderate-to-Severe Psoriasis: Week 12 Results from the Psoriasis Study of Health Outcomes (PSoHO)

“…The primary endpoint of the PSoHO study is to compare the proportion of patients treated with anti-IL-17A biologics versus all other biologics who achieved a PASI90 and/or sPGA 0/1 at Week 12 ± 4. Secondary outcomes include several patient-reported measures, 15 including the DLQI, 17 the Itch Numeric Rating Scale (NRS), 18 and the Psoriasis Signs and Symptoms Diary (PSSD), 19 , 20 and physician-reported measures including PASI100, PASI90, and absolute PASI scores ≤5, ≤2, and ≤1. For patients receiving IXE or GUS, baseline photographs were compared with the Week 12 photographs as an additional qualitative assessment to support the PASI and sPGA results.…”