12 and 56.8% (36.2), 62.9% (37.8), and 73.5% (35.3) at week 24,
respectively. Pain improved by 52.0% (50.7), 60.2% (45.7), and
76.7% (41.7) at week 12 and 42.8% (61.1), 57.8% (47.2), and 59.4%
(49.1) at week 24, respectively. A similar pattern of response
was seen across the other items of the PSI (Table 3).
DISCUSSION
Patient-reported symptoms and their impact on quality of life are important outcomes in psoriasis management and treatment. In this open-label study of patients with moderate-to-severe plaque psoriasis who had received apremilast but did not have adequate response in the opinion of the investigator, meaningful improvements were achieved in the PRO measures of PSI, DLQI and patient satisfaction at weeks 12 and 24 of etanercept therapy. In addition, a correlation was observed between the degree of PRO improvement and higher levels of PASI achievement for those patients who achieved PASI 50, 75, or 90 when treated with etanercept 50 mg SC twice weekly for 12 weeks followed by 50 mg SC once weekly for an additional 12 weeks. Patients who achieved PASI 50 and above experienced greater improvement in signs and symptoms of psoriasis measured by the PSI than in the overall study population. PSI total score mean (SD) percent improvement at week 12 was 45.1% (39.0) in the overall study population and 57.0% (30.1) among patients who achieved PASI 50. The degree of PSI improvement tended to rise with the level of PASI response from PASI 50 to PASI 75 to PASI 90. This finding was consistent across each of the 8 individual PSI component scores and improvements were observed in all signs and symptoms measured by the PSI. Additionally, PSI appeared to respond more rapidly to etanercept treatment than clinical outcomes using the PASI. Of note, PSI responses were similar at weeks 12 and 24, even as the etanercept dosing decreased from twice weekly to once weekly between weeks 12 and 24.
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.
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.
CONCLUSION
This study found that patients with moderate-to-severe psoriasis
who received etanercept therapy after not adequately
responding to apremilast, experienced meaningful improvements
in symptoms and quality of life as assessed by PRO
measurements, including PSI, DLQI and patient assessment of
treatment satisfaction. Furthermore, PROs tended to increase
with the level of PASI response. Patient-reported improvements
in psoriasis and satisfaction with psoriasis treatment should be
considered along with traditional clinical measures when assessing
patients.
DISCLOSURES
JB, Clinical Trials- Amgen, Celgene, SUN, Eli-Lilly, Novartis,
