The majority of patients had an improvement in PRO response on DLQI and satisfaction at PASI 50 at weeks 12 and 24. Nearly 70% of patients who achieved PASI 50 were DLQI responders and nearly 80% of those who achieved PASI 50 were either very satisfied or satisfied with their treatment. Consistent with the PSI responses, DLQI improvement increased with higher levels of PASI response. Patients receiving etanercept tended to experience a greater degree of improvement by patient-reported satisfaction than by the clinical measure of PASI. These results highlight the importance of coupling PROs with clinical assessments.
Psoriasis is a multifactorial disease associated with predominant skin symptoms but also potential comorbid conditions characterized by chronic inflammation, cardiovascular disease, diabetes mellitus, hypertension and psychosocial impacts. Advancements in the understanding of psoriasis has led to development of new therapies. Along with these advancements, PRO measures including HRQoL have become increasingly important when determining treatment effectiveness, with impairments to HRQoL representing a large part of the patient’s disease burden. National survey findings report that the majority of patients with psoriasis experience emotional as well as physical symptoms, with 63% reporting that psoriasis negatively impacts their emotional well-being. Therefore, a key component to treatment effectiveness should be assessing symptom impacts and satisfaction through PROs in conjunction with the degree of clinical response. Indeed, this recognition has led to acknowledgement and greater emphasis placed on HRQoL assessments during the design of current clinical studies where HRQoL tools such as the PSI, DLQI), and Psoriasis Symptoms and Sign Diary (PSSD) are utilized.
While the negative impact of psoriasis on a patients’ PROs is well documented, the relationship between the degree of improvement in psoriasis and PROs has not always been clear. Unlike other autoimmune conditions, psoriasis may have a disproportionally larger negative effect on the patient’s mental health and PROs due to its visible presentation and outward appearance, which may help explain some of the inconsistencies between PRO and PASI assessments. Several studies have demonstrated that the correlation between PROs and PASI was not always high. This suggests that developing a comprehensive patient care plan by coupling PRO and clinical measures may more accurately capture therapy effectiveness in assessing the full spectrum of the patient’s well-being.
Strengths and Limitations
The single-arm, open-label nature of this phase 4 study as well as the small sample size may limit the interpretations that can be made from these findings.
One of the major strengths of this analysis is demonstrating that the patient’s perspective on their symptoms via PRO instruments can be considered in evaluating the treatment effect along with traditional clinical measures.