Identifying Predictors of PASI100 Responses up to Month 12 in Patients with Moderate-to-severe Psoriasis Receiving Biologics in the Psoriasis Study of Health Outcomes (PSoHO)

Authors

  • April W. Armstrong University of California, Los Angeles, CA, USA
  • Elisabeth Riedl Department of Dermatology, Medical University of Vienna, Vienna, Austria
  • Patrick M. Brunner Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, United States
  • Stefano Piaserico Dermatology Unit, Department of Medicine, University of Padova, Padua, Italy
  • Willie I. Visser Division of Dermatology, Department of Medicine, Tygerberg Academic Hospital and Stellenbosch University, Cape Town, South Africa
  • Natalie Haustrup Eli Lilly and Company, Indianapolis, USA
  • Bruce W. Konicek Eli Lilly and Company, Indianapolis, USA
  • Zbigniew Kadziola Eli Lilly and Company, Indianapolis, USA
  • Mercedes Nunez Eli Lilly and Company, Indianapolis, USA
  • Alan Brnabic Eli Lilly and Company, Indianapolis, USA
  • Christopher Schuster Department of Dermatology, Medical University of Vienna, Vienna, Austria; Eli Lilly and Company, Indianapolis, USA

DOI:

https://doi.org/10.2340/actadv.v104.40556

Keywords:

Psoriasis, biologics, treatment, nail psoriasis, pasi100

Abstract

Despite the abundance of data concerning biologic treatments for patients with psoriasis, clinicians are often challenged with discerning the optimal treatment for each patient. To inform this selection, this study explored whether a patient’s baseline characteristics or disease profile could predict the likelihood of achieving complete skin clearance with biologic treatment. Machine-learning and other statistical methods were applied to the substantial data collected from patients with moderate-to-severe psoriasis in the ongoing, international, prospective, observational Psoriasis Study of Health Outcomes (PSoHO). The 3 measures of complete skin clearance were a psoriasis area and severity index (PASI)100 response at (a) week 12, (b) month 12, and (c) week 12 and maintain ed at month 6 and month 12 (PASI100 durability). From these real-world data, the absence of nail psoriasis emerged  as the most consistent feature that may be used by clinicians to predict high-level treatment responses with biologic treatment. Other significant predictors of skin clearance with biologic treatments were the absence of hypertension and a lower body surface area affected by psoriasis. Overall, this study evidences the substantial challenge of identifying reliable clinical markers of treatment response for patients with psoriasis and highlights the importance of regular screening for psoriatic nail involvement.

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References

Egeberg A, Ottosen M, Gniadecki R, Broesby-Olsen S, Dam T, Bryld LE, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol 2018; 178: 509-519.

https://doi.org/10.1111/bjd.16102 DOI: https://doi.org/10.1111/bjd.16102

Gniadecki R, Bang B, Bryld L, Iversen L, Lasthein S, Skov L. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris. Br J Dermatol 2015; 172: 244-252.

https://doi.org/10.1111/bjd.13343 DOI: https://doi.org/10.1111/bjd.13343

Mason KJ, Barker JN, Smith CH, Hampton PJ, Lunt M, McElhone K, et al. Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR. JAMA Dermatol 2018; 154: 581-588.

https://doi.org/10.1001/jamadermatol.2018.0183 DOI: https://doi.org/10.1001/jamadermatol.2018.0183

Warren RB, Marsden A, Tomenson B, Mason KJ, Soliman MM, Burden AD, et al. Identifying demographic, social and clinical predictors of biologic therapy effectiveness in psoriasis: a multicentre longitudinal cohort study. Br J Dermatol 2019; 180: 1069-1076.

https://doi.org/10.1111/bjd.16776 DOI: https://doi.org/10.1111/bjd.16776

Lynde C, Riedl E, Maul J-T, Torres T, Pinter A, Fabbrocini G, et al. Comparative effectiveness of biologics across subgroups of patients with moderate-to-severe plaque psoriasis: results at week 12 from the PSoHO Study in a real-world setting. Adv Ther 2023; 40: 869-886.

https://doi.org/10.1007/s12325-022-02379-9 DOI: https://doi.org/10.1007/s12325-022-02379-9

Piaserico S, Riedl E, Pavlovsky L, Vender RB, Mert C, Tangsirisap N, et al. Comparative effectiveness of biologics for patients with moderate-to-severe psoriasis and special area involvement: week 12 results from the observational Psoriasis Study of Health Outcomes (PSoHO). Front Med 2023; 10: 1185523.

https://doi.org/10.3389/fmed.2023.1185523 DOI: https://doi.org/10.3389/fmed.2023.1185523

Du AX, Ali Z, Ajgeiy KK, Dalager MG, Dam TN, Egeberg A, et al. Machine learning model for predicting outcomes of biologic therapy in psoriasis. J Am Acad Dermatol 2023; 88: 1364-1367.

https://doi.org/10.1016/j.jaad.2022.12.046 DOI: https://doi.org/10.1016/j.jaad.2022.12.046

Emam S, Du AX, Surmanowicz P, Thomsen SF, Greiner R, Gniadecki R. Predicting the long-term outcomes of biologics in patients with psoriasis using machine learning. Br J Dermatol 2020; 182: 1305-1307.

https://doi.org/10.1111/bjd.18741 DOI: https://doi.org/10.1111/bjd.18741

Nielsen ML, Petersen TC, Maul JT, Wu JJ, Rasmussen MK, Bertelsen T, et al. Multivariable predictive models to identify the optimal biologic therapy for treatment of patients with psoriasis at the individual level. JAMA Dermatol 2022; 158: 1149-1156.

https://doi.org/10.1001/jamadermatol.2022.3171 DOI: https://doi.org/10.1001/jamadermatol.2022.3171

Brnabic A, Hess LM. Systematic literature review of machine learning methods used in the analysis of real-world data for patient-provider decision making. BMC Med Inform Decis Mak 2021; 21: 54.

https://doi.org/10.1186/s12911-021-01403-2 DOI: https://doi.org/10.1186/s12911-021-01403-2

Pinter A, Puig L, Schäkel K, Reich A, Zaheri S, Costanzo A, et al. Comparative effectiveness of biologics in clinical practice: week 12 primary outcomes from an International Observational Psoriasis Study of Health Outcomes (PSoHO). J Eur Acad Dermatol Venereol 2022; 36: 2087-2100.

https://doi.org/10.1111/jdv.18376 DOI: https://doi.org/10.1111/jdv.18376

Pinter A, Costanzo A, Khattri S, Smith SD, Carrascosa JM, Tada Y, et al. Comparative effectiveness and durability of biologics in clinical practice: month 12 outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO). Derm Ther 2024; 14: 1479-1493.

https://doi.org/10.1007/s13555-023-01086-9 DOI: https://doi.org/10.1007/s13555-023-01086-9

Shen L, Ding Y, Battioui C. A framework of statistical methods for identification of subgroups with differential treatment effects in randomized trials. Applied Statistics in Biomedicine and Clinical Trials Design: Selected Papers from 2013 ICSA/ISBS Joint Statistical Meetings. Dordrecht: Springer, 2015: p. 411-425.

https://doi.org/10.1007/978-3-319-12694-4_25 DOI: https://doi.org/10.1007/978-3-319-12694-4_25

Tang F, Ishwaran H. Random forest missing data algorithms. Statistical Analysis and Data Mining: The ASA Data Science J 2017; 10: 363-377.

https://doi.org/10.1002/sam.11348 DOI: https://doi.org/10.1002/sam.11348

Canal-García E, Bosch-Amate X, Belinchón I, Puig L. Nail psoriasis. Actas Dermosifiliogr 2022; 113: T481-T490.

https://doi.org/10.1016/j.ad.2022.01.032 DOI: https://doi.org/10.1016/j.ad.2022.01.032

Egeberg A, Kristensen LE, Puig L, Rich P, Smith SD, Garrelts A, et al. Network meta-analyses comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis at 24-28 and 48-52 weeks. J Derm Treatment 2023; 34: 2263108.

https://doi.org/10.1080/09546634.2023.2263108 DOI: https://doi.org/10.1080/09546634.2023.2263108

Riedl E, Pinter A, Zaheri S, Costanzo A, Brnabic A, Konicek B, et al. Baseline characteristics and mNAPSI change from baseline scores through month 12 for patients with moderate-to-severe plaque psoriasis and concomitant nail psoriasis treated with biologics from PSoHO. Dermatol Ther 2024; 14: 1327-1335.

https://doi.org/10.1007/s13555-024-01150-y DOI: https://doi.org/10.1007/s13555-024-01150-y

Ogdie A, Shin DB, Love TJ, Gelfand JM. Body surface area affected by psoriasis and the risk for psoriatic arthritis: a prospective population-based cohort study. Rheumatology 2022; 61: 1877-1884.

https://doi.org/10.1093/rheumatology/keab622 DOI: https://doi.org/10.1093/rheumatology/keab622

Wilson FC, Icen M, Crowson CS, McEvoy MT, Gabriel SE, Kremers HM. Incidence and clinical predictors of psoriatic arthritis in patients with psoriasis: a population-based study. Arthritis Rheum 2009; 61: 233-239.

https://doi.org/10.1002/art.24172 DOI: https://doi.org/10.1002/art.24172

Armstrong AW, Harskamp CT, Armstrong EJ. The association between psoriasis and hypertension: a systematic review and meta-analysis of observational studies. J Hypertens 2013; 31: 433-442; discussion 442-443.

https://doi.org/10.1097/HJH.0b013e32835bcce1 DOI: https://doi.org/10.1097/HJH.0b013e32835bcce1

Enos CW, Ramos VL, McLean RR, Lin TC, Foster N, Dube B, et al. Comorbid obesity and history of diabetes are independently associated with poorer treatment response to biologics at 6 months: a prospective analysis in Corrona Psoriasis Registry. J Am Acad Dermatol 2022; 86: 68-76.

https://doi.org/10.1016/j.jaad.2021.06.883 DOI: https://doi.org/10.1016/j.jaad.2021.06.883

Hu MY, Yang Q, Zheng J. The association of psoriasis and hypertension: focusing on anti-inflammatory therapies and immunological mechanisms. Clin Exp Dermatol 2020; 45: 836-840.

https://doi.org/10.1111/ced.14327 DOI: https://doi.org/10.1111/ced.14327

Published

2024-09-05

How to Cite

Armstrong, A. W., Riedl, E., Brunner, P. M., Piaserico, S. ., Visser, W. I., Haustrup, N., … Schuster, C. (2024). Identifying Predictors of PASI100 Responses up to Month 12 in Patients with Moderate-to-severe Psoriasis Receiving Biologics in the Psoriasis Study of Health Outcomes (PSoHO). Acta Dermato-Venereologica, 104, adv40556. https://doi.org/10.2340/actadv.v104.40556

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