Drug Stratification Based on Real-World Evidence in Psoriasis: A Narrative Review

Reid C, Griffiths CEM. Psoriasis and treatment: past, present and future aspects. Acta Derm Venereol. 2020;100:69–79.

Article  Google Scholar 

Mason KJ, Barker J, Smith C, et al. Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR. JAMA Dermatol. 2018;154:581–8.

Article  PubMed  PubMed Central  Google Scholar 

Masson Regnault M, Castañeda-Sanabria J, Diep Tran MHT, et al. Users of biologics in clinical practice: would they be eligible for phase III clinical studies? Cohort study in the French Psoriasis Registry PSOBIOTEQ. J Eur Acad Dermatol Venereol. 2020;34:293–300.

Article  CAS  PubMed  Google Scholar 

U.S. Food and Drug Administration. FDA statement on voluntary withdrawal of Raptiva from the U.S. market. U.S. Food and Drug Administration website. 2009. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-statement-voluntary-withdrawal-raptiva-us-market. Accessed 10 Nov 2025.

Griffiths M, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.

Article  CAS  PubMed  Google Scholar 

Mitoma H, Horiuchi T, Tsukamoto H, et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor α-expressing cells: comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008;58:1248–57.

Article  CAS  PubMed  Google Scholar 

Ghoreschi K, Balato A, Enerbäck C, et al. Therapeutics targeting the IL-23 and IL-17 pathway in psoriasis. Lancet. 2021;397:754–66.

Article  CAS  PubMed  Google Scholar 

Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392:650–61.

Article  CAS  PubMed  Google Scholar 

Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178:114–23.

Article  CAS  PubMed  Google Scholar 

Papp K, Gordon K, Thaçi D, et al. Phase 2 trial of selective tyrosine kinase 2 inhibition in psoriasis. N Engl J Med. 2018;379:1313–21.

Article  CAS  PubMed  Google Scholar 

Hoy SM. Deucravacitinib: first approval. Drugs. 2022;82:1671–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73:37–49.

Article  CAS  PubMed  Google Scholar 

Torres T, Filipe P. Small molecules in the treatment of psoriasis. Drug Dev Res. 2015;76:215–27.

Article  CAS  PubMed  Google Scholar 

Sbidian E, Chaimani A, Guelimi R, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2023. https://doi.org/10.1002/14651858.CD011535.pub6.

Article  PubMed  PubMed Central  Google Scholar 

Lebwohl MG, Carvalho A, Asahina A, et al. Biologics for the treatment of moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis. Dermatol Ther (Heidelb). 2025. https://doi.org/10.1007/s13555-025-01423-0.

Article  PubMed  Google Scholar 

Shear NH, Betts KA, Soliman AM, et al. Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data. J Am Acad Dermatol. 2021;85:572–81.

Article  CAS  PubMed  Google Scholar 

Sbidian E, Mezzarobba M, Weill A, et al. Persistence of treatment with biologics for patients with psoriasis: a real-world analysis of 16 545 biologic-naïve patients from the French National Health Insurance database (SNIIRAM). Br J Dermatol. 2019;180:86–93.

Article  CAS  PubMed  Google Scholar 

Singal AG, Higgins PDR, Waljee AK. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol. 2014. https://doi.org/10.1038/ctg.2013.13.

Article  PubMed  PubMed Central  Google Scholar 

van den Reek JMPA, Kievit W, Gniadecki R, et al. Drug survival studies in dermatology:principles, purposes, and pitfalls. J Invest Dermatol. 2015;135:1–5.

Article  PubMed  Google Scholar 

Yiu ZZN, Becher G, Kirby B, et al. Drug survival associated with effectiveness and safety of treatment with guselkumab, ixekizumab, secukinumab, ustekinumab, and adalimumab in patients with psoriasis. JAMA Dermatol. 2022;158:1131–41.

Article  PubMed  PubMed Central  Google Scholar 

Mourad AI, Gniadecki R. Biologic drug survival in psoriasis: a systematic review & comparative meta-analysis. Front Med Lausanne. 2021;7:625755.

Article  PubMed  PubMed Central  Google Scholar 

Thomas SE, Barenbrug L, Hannink G, et al. Drug survival of IL-17 and IL-23 inhibitors for psoriasis: a systematic review and meta-analysis. Drugs. 2024;84:565–78.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Warren RB, Donnelly K, Kiri S, et al. Long-term efficacy and safety of bimekizumab and other biologics in moderate to severe plaque psoriasis: updated systematic literature review and network meta-analysis. Dermatol Ther (Heidelb). 2024;14:3133–47.

Article  PubMed  Google Scholar 

Potestio L, Ruggiero A, Martora F, et al. Long-term efficacy and safety of bimekizumab in real-world setting: a 52-week prospective study. Arch Dermatol Res. 2025;317:7–10.

Google Scholar 

Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab. N Engl J Med. 2001;345:3.

Article  Google Scholar 

Souto A, Maneiro JR, Salgado E, et al. Risk of tuberculosis in patients with chronic immune-mediated inflammatory diseases treated with biologics and tofacitinib: a systematic review and meta-analysis of randomized controlled trials and long-term extension studies. Rheumatology. 2014;53:1872–85.

Article  CAS  PubMed  Google Scholar 

Zhang Z, Fan W, Yang G, et al. Risk of tuberculosis in patients treated with TNF-α antagonists: a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2017;7:12567.

Article  Google Scholar 

Li J, Xiang X, Wang Z, et al. Safety of interleukin inhibitors in psoriatic patients with latent tuberculosis infection without chemoprophylaxis: a systematic review. Acta Derm Venereol. 2025;105:adv42081.

Article  PubMed  Google Scholar 

Ding L, Chen C, Yang Y, et al. Major cardiovascular events under biologic psoriasis therapies: a 19-year real-world analysis of FAERS data. Front Immunol. 2024;15:1–11.

Article  CAS  Google Scholar 

Ryan C, Leonardi CL, Krueger JG, et al. Association between biologic therapies for chronic plaque psoriasis and cardiovascular events a meta-analysis of randomized controlled trials. JAMA. 2011;306(8):864–71.

Article  CAS  PubMed  Google Scholar 

Egeberg A, Thyssen JP. Increased reporting of cerebrovascular accidents with use of risankizumab observed in the Food and Drug Administration Adverse Events Reporting System (FAERS). Br J Dermatol. 2023;188:793–4.

Article  PubMed  Google Scholar 

Woods RH. Potential cerebrovascular accident signal for risankizumab: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS). Br J Clin Pharmacol. 2023;89:2386–95.

Article  CAS  PubMed  Google Scholar 

Poizeau F, Nowak E, Kerbrat S, et al. Association between early severe cardiovascular events and the initiation of treatment with the anti-interleukin 12/23p40 antibody ustekinumab. JAMA Dermatol. 2020;156:1208–15.

Article  PubMed 

Comments (0)

No login
gif