Predictors of Response to Biologics in Patients with Moderate-to-severe Psoriasis: A Danish Nationwide Cohort Study
Keywords:psoriasis, biologics, lifestyle, smoking, bodyweight
Identifying patient characteristics associated with
achieving treatment response to biologics in patients with psoriasis could prevent expensive switching between biologics. The aim of this study was to identify
patient characteristics that predict the efficacy of treatment for biologics that inhibit tumour necrosis factor-α, interleukin-12/-23, and -17A. The study investigated biologic-naïve patients from the DERMBIO registry treated with adalimumab, etanercept, infliximab, secukinumab, or ustekinumab. Multivariable logistic models were conducted to assess associations between patient characteristics and treatment response. A total of 2,384 patients were included (adalimumab n = 911; etanercept n = 327; infliximab n = 152; secukinumab n = 323; ustekinumab n = 671). Smoking (odds ratio 0.74; 95% confidence interval (CI) 0.56–0.97; p = 0.03) and higher bodyweight (odds ratio 0.989; 95% CI 0.984–0.994; p < 0.001) reduced the odds of achieving response defined as Psoriasis Area and Severity Index ≤2.0 after 6 months of treatment. In conclusion, higher bodyweight and smoking were associated with a reduced probability of treatment response for tumour necrosis factor-α inhibitors, ustekinumab, and secukinumab.
Jabbar-Lopez ZK, Yiu ZZN, Ward V, Exton LS, Mohd Mustapa MF, Samarasekera E, et al. Quantitative evaluation of biologic therapy options for psoriasis: a systematic review and network meta-analysis. J Invest Dermatol 2017; 137: 1646-1654.
Loft ND, Egeberg A, Rasmussen MK, Bryld LE, Gniadecki R, Dam TN, et al. Patient-reported outcomes during treatment in patients with moderate-to-severe psoriasis: a danish nationwide study. Acta Derm Venereol 2019; 99: 1224-1230.
Foster SA, Zhu B, Guo J, Nikai E, Ojeh C, Malatestinic W, et al. Patient characteristics, health care resource utilization, and costs associated with treatment-regimen failure with biologics in the treatment of psoriasis. J Manag Care Spec Pharm 2016; 22: 396-405.
Gniadecki R, Bang B, Bryld LE, 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.
Mahlich J, Alba A, Hadad L El, Leisten M-K, Peitsch WK. Drug survival of biological therapies for psoriasis treatment in germany and associated costs: a retrospective claims database analysis. Adv Ther 2019; 36: 1684-1699.
Sbidian E, Mezzarobba M, Weill A, Coste J, Rudant J. Persistence of treatment with biologics for patients with psoriasis: a real-world analysis of 16 545 biologic-naive patients from the French National Health Insurance database (SNIIRAM). Br J Dermatol 2019; 180: 86-93.
Egeberg A, Bryld LE, Skov L. Drug survival of secukinumab and ixekizumab for moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2019; 81: 173-178.
Egeberg A, Ottosen MB, Gniadecki R, Broesby-Olsen S, Dam TN, 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.
van den Reek JMPA, van Vugt LJ, van Doorn MBA, van der Kraaij GE, de Kort WJA, Lucker GPH, et al. Initial results of secukinumab drug survival in patients with psoriasis: a multicentre daily practice cohort study. Acta Derm Venereol 2018; 98: 648-654.
Yiu ZZN, Mason KJ, Hampton PJ, Reynolds NJ, Smith CH, Lunt M, et al. Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Br J Dermatol 2020; 183: 294-302.
Loft ND, Skov L, Iversen L, Gniadecki R, Dam TN, Brandslund I, et al. Associations between functional polymorphisms and response to biological treatment in Danish patients with psoriasis. Pharmacogenomics J 2018; 18: 494-500.
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.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007; 370: 1453-1457.
Thygesen SK, Christiansen CF, Christensen S, Lash TL, Sørensen HT. The predictive value of ICD-10 diagnostic coding used to assess Charlson comorbidity index conditions in the population-based Danish National Registry of Patients. BMC Med Res Methodol 2011; 11: 83.
Madsen M, Davidsen M, Rasmussen S, Abildstrom SZ, Osler M. The validity of the diagnosis of acute myocardial infarction in routine statistics: a comparison of mortality and hospital discharge data with the Danish MONICA registry. J Clin Epidemiol 2003; 56: 124-130.
Krarup LH, Boysen G, Janjua H, Prescott E, Truelsen T. Validity of stroke diagnoses in a national register of patients. Neuroepidemiology 2007; 28: 150-154.
Egeberg A, Gislason GH, Hansen PR. Risk of major adverse cardiovascular events and all-cause mortality in patients with hidradenitis suppurativa. JAMA Dermatol 2016; 152: 429-434.
Egeberg A, Mallbris L, Gislason GH, Skov L, Hansen PR. Risk of multiple sclerosis in patients with psoriasis: a Danish nationwide cohort study. J Invest Dermatol 2016; 136: 93-98. DOI: https://doi.org/10.1038/JID.2015.350
Egeberg A, Hansen PR, Gislason GH, Skov L, Mallbris L. Risk of self-harm and nonfatal suicide attempts, and completed suicide in patients with psoriasis: a population-based cohort study. Br J Dermatol 2016; 175: 493-500.
van Buuren S, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat Softw 2011; 45: 1-67.
Norton EC, Dowd BE, Maciejewski ML. Marginal effects - quantifying the effect of changes in risk factors in logistic regression models. JAMA 2019; 321: 1304-1305.
Mandrekar JN. Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol 2010; 5: 1315-1316.
Warren RB, Smith CH, Yiu ZZN, Ashcroft DM, Barker JNWN, Burden AD, et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol 2015; 135: 2632-2640.
Pinter A, Gerdes S, Papavassilis C, Reinhardt M. Characterization of responder groups to secukinumab treatment in moderate to severe plaque psoriasis. J Dermatolog Treat 2020; 31: 769-775.
Mostafa NM, Nader AM, Noertersheuser P, Okun M, Awni WM. Impact of immunogenicity on pharmacokinetics, efficacy and safety of adalimumab in adult patients with moderate to severe chronic plaque psoriasis. J Eur Acad Dermatol Venereol 2017; 31: 490-497.
Wilkinson N, Tsakok T, Dand N, Bloem K, Duckworth M, Baudry D, et al. Defining the therapeutic range for adalimumab and predicting response in psoriasis: a multicenter prospective observational cohort study. J Invest Dermatol 2019; 139: 115-123.
Strober B, Menter A, Leonardi C, Gordon K, Lambert J, Puig L, et al. Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the Phase III UltIMMa-1 and UltIMMa-2 Studies. J Eur Acad Dermatology Venereol 2020; 34: 2830-2838.
Galluzzo M, Tofani L, Lombardo P, Petruzzellis A, Silvaggio D, Egan CG, et al. Use of guselkumab for the treatment of moderate-to-severe plaque psoriasis: a 1 year real-life study. J Clin Med 2020; 9: 2170.
Umezawa Y, Saeki H, Nakagawa H. Some clinical factors affecting quality of the response to ustekinumab for psoriasis. J Dermatol 2014; 41: 690-696.
Højgaard P, Glintborg B, Hetland ML, Hansen TH, Lage-Hansen PR, Petersen MH, et al. Association between tobacco smoking and response to tumour necrosis factor α inhibitor treatment in psoriatic arthritis: results from the DANBIO registry. Ann Rheum Dis 2015; 74: 2130-2136.
Hyrich KL, Watson KD, Silman AJ, Symmons DPM. Predictors of response to anti-TNF-α therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Rheumatology 2006; 45: 1558-1565.
Glintborg B, Højgaard P, Lund Hetland M, Steen Krogh N, Kollerup G, Jensen J, et al. Impact of tobacco smoking on response to tumour necrosis factor-alpha inhibitor treatment in patients with ankylosing spondylitis: results from the Danish nationwide DANBIO registry. Rheumatol (UK) 2016; 55: 659-668.
Anzengruber F, Augustin M, Radtke MA, Thaci D, Yawalkar N, Streit M, et al. Smoking does not alter the therapy response to systemic anti-psoriatic therapies: a two-country, multi-centre, prospective, non-interventional study. Acta Derm Venereol 2019; 99: 871-877.
Mahil SK, Wilson N, Dand N, Reynolds NJ, Griffiths CEM, Emsley R, et al. Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR). Br J Dermatol 2020; 182: 1158-1166.
Loft N, Egeberg A, Rasmussen MK, Bryld LE, Nissen CV, Dam TN, et al. Response to biologics during the first six months of therapy in biologic-naïve patients with psoriasis predicts risk of disease flares: a Danish nationwide study. Acta Derm Venereol 2021; 101: adv00357.
Iversen L, Eidsmo L, Austad J, de Rie M, Osmancevic A, Skov L, et al. Secukinumab treatment in new-onset psoriasis: aiming to understand the potential for disease modification - rationale and design of the randomized, multicenter STEPIn study. J Eur Acad Dermatol Venereol 2018; 32: 1930-1939.
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Copyright (c) 2021 Christopher Willy Schwarz, Nikolai Loft, Mads Kirchheiner Rasmussen, Christoffer V. Nissen, Tomas Norman Dam, Kawa Khaled Ajgeiy, Alexander Egeberg, Lone Skov
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