Comparative Effectiveness and Durability of Biologics in Clinical Practice: Month 12 Outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO)

A Pinter; A Costanzo; S Khattri; S D Smith; J M Carrascosa; Y Tada; E Riedl; A Reich; A Brnabic; N Haustrup; A Lampropoulou; I Lipkovich; Z Kadziola; C Paul; C Schuster

doi:10.1007/s13555-023-01086-9

Comparative Effectiveness and Durability of Biologics in Clinical Practice: Month 12 Outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO)

Dermatol Ther (Heidelb). 2023 Dec 19. doi: 10.1007/s13555-023-01086-9. Online ahead of print.

Authors

A Pinter¹, A Costanzo^{2

3}, S Khattri⁴, S D Smith⁵, J M Carrascosa⁶, Y Tada⁷, E Riedl⁸, A Reich⁹, A Brnabic¹⁰, N Haustrup¹⁰, A Lampropoulou¹⁰, I Lipkovich¹⁰, Z Kadziola¹⁰, C Paul¹¹, C Schuster^{8

10}

Affiliations

¹ University Hospital Frankfurt, Frankfurt am Main, Germany. Andreas.Pinter@kgu.de.
² Division of Dermatology, Humanitas Research Hospital, Pieve Emanuele, Milan, Italy.
³ Dermatology IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
⁴ Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁵ ANU Medical School, ANU College of Health and Medicine, The Australian National University, Canberra, Australia.
⁶ Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma of Barcelona, IGTP, Carretera de Canyet, S/N, 08916, Badalona, Barcelona, Spain.
⁷ Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
⁸ Department of Dermatology, Medical University of Vienna, Vienna, Austria.
⁹ Department of Dermatology, Institute of Medical Sciences, Medical College of Rzeszow University, Rzeszow, Poland.
¹⁰ Eli Lilly and Company, Indianapolis, USA.
¹¹ Université Paul Sabatier Toulouse III, Toulouse, France.

PMID: 38113010
DOI: 10.1007/s13555-023-01086-9

Abstract

Introduction: Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12 months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting.

Methods: The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA). Secondary objective comparisons included the proportion of patients who achieved PASI90, PASI100, a Dermatology Life Quality Index (DLQI) score of 0 or 1, and three different actions of durability of treatment response. Unadjusted response rates are presented alongside the primary analysis, which uses frequentist model averaging (FMA) to evaluate the adjusted comparative effectiveness.

Results: Compared to the other biologics cohort, the anti-IL-17A cohort had a higher response rate (68.0% vs. 65.1%) and significantly higher odds of achieving the primary outcome at month 12. The two cohorts had similar response rates for PASI100 (40.5% and 37.1%) and PASI90 (53.9% and 51.7%) at month 12, with no significant differences between the cohorts in the adjusted analyses. At month 12, the response rates across the individual biologics were 53.5-72.6% for the primary outcome, 27.6-48.3% for PASI100, and 41.7-61.4% for PASI90.

Conclusions: These results show the comparative effectiveness of biologics at 6 and 12 months in the real-world setting.

Trial registration: ClinicalTrials.gov identifier EUPAS24207.

Keywords: Biologics; Effectiveness; Health outcomes; Interleukin; Ixekizumab; Psoriasis; Real-world evidence.