A systematic review investigating at what proportion clinical images are shared in prospective randomized controlled trials involving patients with psoriasis and biological agents

Abstract

For many patients including those with psoriasis, scientific manuscripts comprising clinical outcomes including psoriasis area severity index (PASI) and/or physician global assessment (PGA) may be difficult to understand. However, most patients can relate to images at baseline and follow-up, particularly for dermatological diseases. This study aimed to assess the proportion of shared clinical images in psoriasis trials. A systematic review adhering to the PRISMA guidelines was performed. The review was limited to randomized controlled trials, and among these, only investigations involving biological agents for treatment of psoriasis were included. The Embase, MEDLINE and Scopus databases were searched for eligible studies published from inception to October 26, 2021. In total, 152 studies were included. When combining these, 62,871 patients were randomized. Overall, 203 images were shared depicting 60 patients in the manuscripts yielding an overall sharing rate of 0.1%. Patient images are seldom incorporated in clinical trial manuscripts which impairs interpretation for patients. Inclusion of image material would strengthen the patients’ perspective and understanding on what treatment effects that can be expected. As such, this systematic review should be an invitation to the pharmaceutical industry, other sponsors, and editorial offices to improve easy transfer of information to patients using image data.

Keywords:

• Data sharing
• pharmaceuticals
• biologic
• psoriasis
• randomized controlled trial
• skin imaging
• systematic review

Acknowledgments

We thank the medical library of Sahlgrenska University Hospital and Linda Hammarbäck and Helen Sjöblom at the Biomedical Library at the University of Gothenburg for helping us generate the search strings used for this investigation.

Disclosure statement

SP: With no relation to the present manuscript, SP has received honoraria as consultant and/or speaker from AbbVie, Amgen, Astra Zeneca, Beiersdorf, Bristol Myers Squibb, Galderma, Janssen Pharmaceuticals, Leo Pharma, Novartis, and Sanofi.

FA: none.

AE: With no relation to the present manuscript, AE has received research funding from Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co., Ltd, Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Galapagos NV, Union Therapeutics, Mylan, Bristol Myers Squibb, and Janssen Pharmaceuticals.