Effectiveness of Biologics, Patient-Reported Outcomes, and Clinical Photography in a Subset of Patients with Moderate-to-Severe Psoriasis: Week 12 Results from the Psoriasis Study of Health Outcomes (PSoHO)

Abstract

Purpose

Since skin is highly accessible, clinical photography is a useful tool to visually substantiate the real-world effectiveness outcomes of biologic-treated adults with moderate-to-severe psoriasis (PsO). We report the effectiveness and patient-reported outcomes at Week 12 between anti-interleukin (IL)-17A biologics and other biologics as well as ixekizumab and guselkumab in patients with available clinical photography at baseline and Week 12.

Patients and Methods

The Psoriasis Study of Health Outcomes (PSoHO) is an international, non-interventional, cohort study investigating the effectiveness of biologics in adults with moderate-to-severe psoriasis at Week 12. Outcomes included the proportion of patients who achieved 90% improvement in Psoriasis Area and Severity Index (PASI90) and/or static Physician Global Assessment (sPGA) 0/1 (primary endpoint), PASI100, PASI90, Dermatology Life Quality Index (DLQI), and Itch Numeric Rating Scale (NRS) (secondary endpoints) at Week 12. Data are reported descriptively.

Results

This analysis included 59 biologic-treated (23 anti-IL-17A; 36 other biologics) patients with available clinical photographs from the overall PSoHO study (n=1981). At baseline, the mean (standard deviation [SD]) age was 45.7 (11.1) years, 71.2% were male, 52.5% were bio-experienced and the median (interquartile range) duration of disease was 10.5 (12.4) years. Mean (SD) PASI was 16.9 (9.3) and sPGA was 3.5 (0.8). At Week 12, 65.2%/47.2% of the anti-IL-17A/other biologics cohort achieved the primary outcome. Response rates for PASI90/100 were numerically higher with anti-IL-17A than with other biologics. Patients receiving anti-IL-17A had numerically better outcomes for DLQI 0/1 and Itch NRS than those receiving other biologics at Week 12. Clinical photographs confirmed skin improvements in ixekizumab- and guselkumab-treated patients.

Conclusion

This subgroup analysis showed that anti-IL-17A biologics are effective at rapidly improving signs and symptoms of PsO and improving quality of life. Additionally, serial photography provided visual evidence of biologic treatment response over time.

Keywords:

• psoriasis
• ixekizumab
• guselkumab
• real-world
• clinical photography

Abbreviations

BMI, body mass index; BSA, body surface area; CI, confidence intervals; DLQI, Dermatology Life Quality Index; ENCEPP, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance; IL-17A, anti-interleukin 17A; IQR, interquartile range; IXE, ixekizumab; GUS, guselkumab; mNAPSI, modified Nail Psoriasis Severity Index; NRS, Numeric Rating Scale; PASI90, 90% improvement in Psoriasis Area and Severity Index; PASI100, 100% improvement in Psoriasis Area and Severity Index; PROs, patient-reported outcomes; PSoHO, Psoriasis Study of Health Outcomes; PsO, psoriasis; PSoRA, Austrian Psoriasis Registry; PSSD, Psoriasis Signs and Symptoms Diary; PsA, psoriatic arthritis; RCTs, randomized controlled trials; SD, standard deviation; sPGA, static Physician Global Assessment.

Data Sharing Statement

Data available from the corresponding author upon request.

Consent for Publication

All authors consent to the publication of the manuscript.

Acknowledgments

The authors would like to acknowledge Jane Snowball and Sheridan Henness, PhD (Rx Communications, Mold, UK) for medical writing assistance with the preparation of this manuscript, funded by Eli Lilly and Company. Photographs in Figures 3 and 4 are subject to Copyright © 2023 Eli Lilly and Company. All rights reserved.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

With no relation to the present manuscript Julia-Tatjana Maul has served as advisor and/or received speaking fees and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, BMS, Celgene, Eli Lilly, LEO Pharma, Janssen-Cilag, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, and UCB. Jens Gerwien, Michaela Müller, Alan Brnabic, and Christopher Schuster are employees and minor share holders of Eli Lilly. Tsen-Fang Tsai is an investigator and/or consultant for Boehringer Ingelheim, AbbVie, Bristol-Myers Squibb, Celgene, Eli-Lilly, Janssen-Cilag, Novartis, Pfizer, and Sanofi, outside the submitted work.

Additional information

Funding

This study was funded by Eli Lilly and Company.