Abstract
Background
Although the inclusion of patients’ preferences and needs is essential for therapy adherence, the assessment of patient-reported outcome measures in clinical trials is often neglected. Therefore, the aim of this study was to quantify several patient-reported outcome measures in psoriasis patients undergoing systemic therapy in a real-life clinical setting.
Methods
This clinical trial has been designed as a prospective, multiarm study to investigate the treatment satisfaction, adherence to therapy, quality of life (QoL), and clinical response in a real-life clinical setting during the initial 6 months of treatment with apremilast, methotrexate, and fumaric acids in 80 patients suffering from plaque psoriasis.
Results
The treatment satisfaction for the three systemic therapies was rated ‘sufficient’ with a mean (±SD) Treatment Satisfaction Questionnaire for Medication (TSQM) score of 275.0 (±62.7). Most potential for improvement was seen in the ‘effectiveness’ domain (54.3 ± 21.5). The highest treatment satisfaction level in all four domains (convenience, effectiveness, global satisfaction, and side-effects) was seen in the methotrexate group with a mean TSQM score of 306.3 ± 50.9, followed by apremilast (267.1 ± 61.6) and fumaric acids (254.9 ± 65.0; p = 0.005). Analysis of the TSQM revealed a considerable discrepancy between patient-reported clinical response and the actual Psoriasis Area and Severity Index (PASI) reduction. This applies equally to the patient- vs. physician-reported side-effects.
Conclusions
This real-life study demonstrates that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underlines the importance of patient-reported outcome measures not only in clinical trials, but also for improved patient care.
Ethical approval
This study was approved by the local ethics committee (University of Heidelberg, Faculty of Medicine; S-298/2015).
Study registration
This study is registered at the German Clinical Trial Register (DRKS): DRKS00008721.
Disclosure statement
C. Fink has been an investigator for Novartis, Janssen, Boehringer Ingelheim, Abbvie, Leo, Galderma, Pfizer, Almirall, Merck, Celgene; speaker for Janssen, Novartis and advisory board member for Novartis.
C. Alt has been an investigator for Novartis, Janssen, Boehringer Ingelheim, Abbvie, Leo, Galderma, Pfizer, Almirall, Merck, Celgene.
K. Schäkel has been an investigator, speaker and/or advisory board member for Novartis, Janssen, Boehringer Ingelheim, Abbvie, Leo, Galderma, Pfizer, Almirall, Merck, Celgene.