Predictors of Response to Biologics in Patients with Moderate-to-severe Psoriasis: A Danish Nationwide Cohort Study

Authors

  • Christopher Willy Schwarz Department of Dermatology and Allergy, Gentofte Hospitalsvej 15, 1. floor, DK-2900 Hellerup, Denmark
  • Nikolai Loft
  • Mads Kirchheiner Rasmussen
  • Christoffer V. Nissen
  • Tomas Norman Dam
  • Kawa Khaled Ajgeiy
  • Alexander Egeberg
  • Lone Skov

DOI:

https://doi.org/10.2340/actadv.v101.351

Keywords:

psoriasis, biologics, lifestyle, smoking, bodyweight

Abstract

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.

Downloads

Download data is not yet available.

References

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.

https://doi.org/10.1016/j.jid.2017.04.009 DOI: https://doi.org/10.1016/j.jid.2017.04.009

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.

https://doi.org/10.2340/00015555-3331 DOI: https://doi.org/10.2340/00015555-3331

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.

https://doi.org/10.18553/jmcp.2016.22.4.396 DOI: https://doi.org/10.18553/jmcp.2016.22.4.396

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.

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

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.

https://doi.org/10.1007/s12325-019-00969-8 DOI: https://doi.org/10.1007/s12325-019-00969-8

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.

https://doi.org/10.1111/bjd.16809 DOI: https://doi.org/10.1111/bjd.16809

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.

https://doi.org/10.1016/j.jaad.2019.03.048 DOI: https://doi.org/10.1016/j.jaad.2019.03.048

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.

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

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.

https://doi.org/10.2340/00015555-2900 DOI: https://doi.org/10.2340/00015555-2900

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.

https://doi.org/10.1111/bjd.18981 DOI: https://doi.org/10.1111/bjd.18981

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.

https://doi.org/10.1038/tpj.2017.31 DOI: https://doi.org/10.1038/tpj.2017.31

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

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.

https://doi.org/10.1016/S0140-6736(07)61602-X DOI: https://doi.org/10.1016/S0140-6736(07)61602-X

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.

https://doi.org/10.1186/1471-2288-11-83 DOI: https://doi.org/10.1186/1471-2288-11-83

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.

https://doi.org/10.1016/S0895-4356(02)00591-7 DOI: https://doi.org/10.1016/S0895-4356(02)00591-7

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.

https://doi.org/10.1159/000102143 DOI: https://doi.org/10.1159/000102143

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.

https://doi.org/10.1001/jamadermatol.2015.6264 DOI: https://doi.org/10.1001/jamadermatol.2015.6264

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.

https://doi.org/10.1111/bjd.14633 DOI: https://doi.org/10.1111/bjd.14633

van Buuren S, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat Softw 2011; 45: 1-67.

https://doi.org/10.18637/jss.v045.i03 DOI: https://doi.org/10.18637/jss.v045.i03

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.

https://doi.org/10.1001/jama.2019.1954 DOI: https://doi.org/10.1001/jama.2019.1954

Mandrekar JN. Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol 2010; 5: 1315-1316.

https://doi.org/10.1097/JTO.0b013e3181ec173d DOI: https://doi.org/10.1097/JTO.0b013e3181ec173d

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.

https://doi.org/10.1038/jid.2015.208 DOI: https://doi.org/10.1038/jid.2015.208

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.

https://doi.org/10.1080/09546634.2019.1626973 DOI: https://doi.org/10.1080/09546634.2019.1626973

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.

https://doi.org/10.1111/jdv.13884 DOI: https://doi.org/10.1111/jdv.13884

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.

https://doi.org/10.1016/j.jid.2018.07.028 DOI: https://doi.org/10.1016/j.jid.2018.07.028

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.

https://doi.org/10.1111/jdv.16521 DOI: https://doi.org/10.1111/jdv.16521

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.

https://doi.org/10.3390/jcm9072170 DOI: https://doi.org/10.3390/jcm9072170

Umezawa Y, Saeki H, Nakagawa H. Some clinical factors affecting quality of the response to ustekinumab for psoriasis. J Dermatol 2014; 41: 690-696.

https://doi.org/10.1111/1346-8138.12538 DOI: https://doi.org/10.1111/1346-8138.12538

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.

https://doi.org/10.1136/annrheumdis-2014-205389 DOI: https://doi.org/10.1136/annrheumdis-2014-205389

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.

https://doi.org/10.1093/rheumatology/kel149 DOI: https://doi.org/10.1093/rheumatology/kel149

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.

https://doi.org/10.1093/rheumatology/kev392 DOI: https://doi.org/10.1093/rheumatology/kev392

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.

https://doi.org/10.2340/00015555-3221 DOI: https://doi.org/10.2340/00015555-3221

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.

https://doi.org/10.1111/bjd.18333 DOI: https://doi.org/10.1111/bjd.18333

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.

https://doi.org/10.2340/00015555-3722 DOI: https://doi.org/10.2340/00015555-3722

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.

https://doi.org/10.1111/jdv.14979 DOI: https://doi.org/10.1111/jdv.14979

Downloads

Additional Files

Published

2021-10-26

How to Cite

Schwarz, C. W., Loft, N., Rasmussen, M. K., Nissen, C. V., Dam, T. N., Ajgeiy, K. K., Egeberg, A., & Skov, L. (2021). Predictors of Response to Biologics in Patients with Moderate-to-severe Psoriasis: A Danish Nationwide Cohort Study. Acta Dermato-Venereologica, 101(10), adv00579. https://doi.org/10.2340/actadv.v101.351