Comparative effectiveness of biologics in clinical practice: week 12 primary outcomes from an international observational psoriasis study of health outcomes (PSoHO)
Por:
Pinter, A, Puig, L, Schakel, K, Reich, A, Zaheri, S, Costanzo, A, Tsai, TF, Smith, SD, Lynde, C, Brnabic, A, Reed, C, Hill, J, Schuster, C, Riedl, E, Paul, C
Publicada:
1 nov 2022
Ahead of Print:
1 jul 2022
Resumen:
Background Clinical trials study treatment outcomes under stringent conditions, capturing incompletely the heterogeneity of patient populations and treatment complexities encountered in real-world practice. Objectives To compare the effectiveness of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis. Methods The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year observational cohort study in adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. Primary study endpoint is the proportion of patients achieving 90% improvement in Psoriasis Area and Severity Index (PASI 90) and/or static Physician Global Assessment (sPGA) 0/1 at Week 12 (W12) in the anti-IL-17A cohort (ixekizumab [IXE], secukinumab) vs. all other approved biologics. Secondary outcomes include the proportion of patients who achieve PASI 75/90/100, absolute PASI scores <= 5, <= 2 and <= 1, Dermatology Life Quality Index (DLQI) score of 0/1 at W12 between the two cohorts and among the individual biologics. Comparative effectiveness analyses were conducted using Frequentist Model Averaging (FMA), a novel causal inference machine learning approach. Missing data for binary outcomes were imputed as non-response. Results Patient profiles in the anti-IL-17A cohort and other biologics cohort were similar, with more frequent comorbid psoriatic arthritis and less frequent exposure to conventional treatments in the patients receiving anti-IL-17A biologics. At W12, 71.4% of patients who received an anti-IL-17A biologic achieved PASI 90 and/or sPGA 0/1 compared to 58.6% of patients who received other biologics (odds ratios [OR], 1.9; 95% confidence intervals [CI], [1.6, 2.4]). Similar findings were observed for secondary outcomes. Conclusions These results reflect the high efficacy and early onset of skin clearance of IL-17A inhibitors observed in randomized clinical trials and confirm the effectiveness of anti-IL-17A biologics in the real-world setting.
Filiaciones:
Pinter, A:
Univ Hosp Frankfurt, Dept Dermatol Venereol & Allergol, Frankfurt, Germany
Puig, L:
Univ Autanoma Barcelona, Dept Dermatol, Hosp Santa Creu & St Pau, Barcelona, Spain
Schakel, K:
Univ Hosp, Dept Dermatol, Heidelberg, Germany
Reich, A:
Rzeszow Univ, Inst Med Sci, Dept Dermatol, Med Coll, Rzeszow, Poland
Zaheri, S:
Imperial Coll Healthcare NHS Trust, Dept Dermatol, London, England
Costanzo, A:
Humanitas Res Hosp, Div Dermatol, Milan, Italy
Dermatol IRCCS Humanitas Res Hosp, Milan, Italy
Tsai, TF:
Natl Taiwan Univ Hosp, Dept Dermatol, Taipei, Taiwan
Natl Taiwan Univ, Coll Med, Taipei, Taiwan
Smith, SD:
Australian Natl Univ, ANU Coll Hlth & Med, ANU Med Sch, Canberra, ACT, Australia
Lynde, C:
Univ Toronto, Dept Med, Toronto, ON, Canada
Brnabic, A:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Reed, C:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Hill, J:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Schuster, C:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Med Univ Vienna, Dept Dermatol, Vienna, Austria
Riedl, E:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Med Univ Vienna, Dept Dermatol, Vienna, Austria
Paul, C:
Paul Sabatier Univ, Toulouse, France
Larrey Hosp, Toulouse, France
All Open Access; Hybrid Gold
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