Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry

Abstract

Background

The impact of psoriasis in special areas (i.e., scalp, nails, palms, soles, genitals) on patient physical functioning, health-related quality of life (HRQoL), and work abilities has not been fully characterized. We assessed associations between disease severity and special area involvement in psoriasis symptoms, HRQoL, and work/activity impairment.

Methods

Patients with psoriasis from the CorEvitas Psoriasis Registry who initiated systemic treatment between 04/2015–06/2020 were included. Outcomes were change from baseline in psoriasis symptoms, Dermatology Life Quality Index (DLQI), and work/activity impairment at 6 months stratified by baseline disease severity and special area involvement.

Results

Among 2620 patients, increasing disease severity was associated with worsening patient-reported outcomes. Patients with (46.0%; N = 1205) versus without (54.0%; N = 1415) psoriasis in special areas reported greater HRQoL and work/activity impairment. Over 6 months, patients with unchanged or worsening disease severity had reduced HRQoL and increased symptom severity; incremental increases in patient HRQoL and decreases in symptom severity were associated with improved disease severity.

Conclusions

Higher disease severity and special area involvement was associated with worse outcomes and impaired work abilities. These data highlight the significant impact that adequate treatment of severe psoriasis and/or special area involvement may have on patient HRQoL and function.

Keywords:

• Psoriasis
• quality of life
• disease severity
• registry

Acknowledgments

The authors would like to thank all the investigators, their clinical staff, and patients who participate in the CorEvitas Psoriasis Registry. The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation (NPF). Medical writing services provided were by Samantha Francis Stuart, PhD, of Fishawack Facilitate Ltd, part of Fishawack Health, and funded by AbbVie. Editorial support was provided by Alicia Beeghly, MPH, PhD, of CorEvitas, LLC. The authors would like to thank Tin-Chi Lin for assistance with the statistical analysis and contributions to the CorEvitas Psoriasis Registry and this study.

Ethical approval

The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central Institutional Review Board (IRB), the New England Independent Review Board (NEIRB; no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from their respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC before the site’s participation and initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization before participating.

Authors contributions

All authors substantially contributed to study conception and design, interpretation of data, and drafting and critically revising for intellectual content. AS and JJ contributed to acquisition of data; AS, JJ, MP, HP, and VG contributed to interpretation of data.

Author disclosures

B Strober has served as a consultant (received honoraria) for AbbVie, Alamar, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Immunic Therapeutics, Kangpu Pharmaceuticals, Bristol-Myers-Squibb, Connect Biopharma, Dermavant, Evelo Biosciences, Janssen, Leo, Eli Lilly, Maruho, Meiji Seika Pharma, Mindera Health, Protagonist, Nimbus, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, and vTv Therapeutics; has stock options for Connect Biopharma and Mindera Health; has served as a speaker for AbbVie, Arcutis, Dermavant, Eli Lilly, Incyte, Janssen, Regeneron, and Sanofi-Genzyme; is a co-scientific director (consulting fee) for CorEvitas Psoriasis Registry; and as an investigator for CorEvitas Psoriasis Registry and serves as an Editor-in-Chief (honorarium) for the Journal of Psoriasis and Psoriatic Arthritis.

K Callis Duffin is an investigator for, has received research grants from, and served as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Stiefel, and Xenoport.

M Lebwohl is an employee of Mount Sinai and receives research funds from: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc., and is a consultant for Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Arcutis, Inc., Aristea Therapeutics, Avotres Therapeutics, Brickell Biotech, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, CorEvitas, Dermavant Sciences, Dr. Reddy, EPI, Evommune, Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Helsinn, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, Strata, Trevi, and Verrica.

A Sima and J Janak are employees of CorEvitas, LLC (formerly Corrona, LLC). CorEvitas is supported through contracted subscriptions with multiple pharmaceutical companies. The manuscript was a collaborative effort between CorEvitas and AbbVie with financial support provided by AbbVie.

M Patel, H Photowala, and V Garg are employees of AbbVie Inc., and may hold stock or stock options.

J Bagel has received research funds payable to Psoriasis Treatment Center from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, CorEvitas LLC, Dermavant Sciences, Dermira, Eli Lilly and Company, Glenmark Pharmaceuticals Ltd, Janssen Biotech, Kadmon Corporation, LEO Pharma, Lycera Corp, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sun Pharma, Taro Pharmaceutical Industries Ltd, and UCB; consultant fees from AbbVie, Amgen, Celgene Corporation, Bristol Myers Squibb, Eli Lilly and Company, Janssen Biotech, Novartis, Sun Pharmaceutical Industries, and UCB; and speakers fees from AbbVie, Celgene Corporation, Eli Lilly, Janssen Biotech, and Novartis.

Additional information

Funding

This study was sponsored by CorEvitas, LLC and the analysis was funded by AbbVie. Access to complete registry data were limited to CorEvitas and CorEvitas statisticians completed all the analysis. CorEvitas and AbbVie contributed to the study design and all authors had access to relevant data, contributed to the interpretation of the data, and in the review and approval of the publication. No honoraria or payments were made for authorship. CorEvitas has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, Inc., Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly and Company, Genentech, Gilead Sciences, Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Inc., Regeneron Pharmaceuticals, Inc., Sanofi, Sun Pharmaceutical Industries Ltd., and UCB S.A. Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.