Abstract
In psoriasis treatment, there is a high need to define meaningful endpoints and differences from the patient perspective to analyze patient-relevant differences of frequently used outcome methods for psoriasis under real-world conditions. A sample of 3116 patients from the German Psoriasis-Registry PsoBest was analyzed for clinical as well as patient-reported outcomes (PRO) after 3- and 6-month treatment. The parameters PASI, DLQI, and PBI were intercorrelated and related to two anchoring variables: (1) patient satisfaction with treatment and (2) perceived complete clearance. Baseline data were as follows: PASI 10.5 ± 9.1, DLQI 12.4 ± 3.4, and PBI 2.7 ± 0.3. There was an almost linear relationship between “complete patient satisfaction” and the relative differences in PASI in the range from PASI 25 to PASI 90. However, there was no additional benefit between PASI 90 and PASI 100. The same finding resulted from the anchoring variable “perception of complete healing”. When related to DLQI outcomes, relative PASI changes as well as absolute changes and PASI at 3 and 6 months showed relevant differences between the PASI classes 25 to 90 but not between PASI 90 and PASI 100. Under real-world conditions, changes in PASI and DLQI reflect patient-relevant benefits.
Highlights
Psoriasis is a chronic inflammatory skin disease manifested by the appearance of erythematous, scaly plaques mainly on the extensor sides
All patients enrolled from the start of the registry in January 2008 until the approval of IL-17 inhibitors were included if the following inclusion criteria were met: age over 18 years, presence of moderate or severe plaque-type psoriasis, initial initiation of systemic therapy, and the ability to provide written informed consent to participate in the study
In order to characterize differences in Psoriasis Area and Severity Index (PASI) outcomes in this study, two anchor variables were applied: one reflecting the extent of patient satisfaction with the treatment outcome and the second reflecting the patients’ perception of completely healed skin lesions. In this real-world population of patients and physicians, no obvious differences were found between PASI 90 and PASI 100 from the patients’ perspective. This finding is supported by the association of PASI and DLQI
Summary
Psoriasis is a chronic inflammatory skin disease manifested by the appearance of erythematous, scaly plaques mainly on the extensor sides. Psoriasis can occur on the joints, which is the case in about 30% of those affected [1,2]. Numerous other concomitant diseases, such as depression, cardiovascular, and metabolic diseases, are associated with psoriasis [3,4]. This leads to a severe reduction in the quality of life for sufferers [5,6]. Measuring treatment outcomes in psoriasis has become increasingly important for clinical research, clinical care, health services research, and health regulation [7]. Valid outcome tools are needed for the assessment of clinical efficacy [8], the use of treatment goals [9], and the evaluation of health technologies [10,11]
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