Multiarm study comparing patient-reported and clinical outcome measures in patients undergoing antipsoriatic therapy with non-biological systemic agents in a real-world setting

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.

Keywords:

• Psoriasis
• patient reported outcome measures
• TSQM
• quality of life
• therapy adherence

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.

Additional information

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.