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

Authors

  • Nikolai Loft Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, DK-2900 Hellerup, Denmark
  • Alexander Egeberg
  • Mads Kirchheiner Rasmussen
  • Lars Erik Bryld
  • Christoffer V. Nissen
  • Tomas Norman Dam
  • Kawa Khaled Ajgeiy
  • Lars Iversen
  • Lone Skov

DOI:

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

Keywords:

psoriasis, biologics, drug survival, flares, PASI90, PASI100

Abstract

Early response to treatment with biologics might be important for the stability of psoriasis and long-term outcome. The aim of this study was therefore to assess whether risk of flares and drug survival are associated with disease activity in the first 6 months of treatment of psoriasis with biologics. Biologic-naïve patients from the Danish nationwide registry, DERMBIO, were grouped based on absolute Psoriasis Area and Severity Index (PASI) during the first 6 months of treatment, as: PASI = 0, PASI > 0–≤2, PASI > 2–≤ 4, and PASI > 4. Among 1,684 patients, 746 achieved PASI= 0, 485 PASI > 0–≤2, 246 PASI > 2–≤4, and 207 PASI > 4. Longer flare-free period and drug survival were observed for patients with lower PASI in the first 6 months of treatment (adjusted hazard ratios for flares (95% confidence interval) with PASI=  0 as reference: PASI > 0–≤2 (1.35 (1.11–1.72]), PASI > 2–≤ 4 (2.32 [1.80–2.99]), and PASI > 4 (2.38 [1.80–3.15])). In conclusion, a low PASI in the first 6 months of treatment with biologics in biologic-naïve patients with psoriasis was associated with a more stable disease course, lower risk of flares, and longer drug survival.

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References

Mrowietz U, De Jong E, Kragballe K, Langley R, Nast A, Puig L, et al. A consensus report on appropriate treatment optimization and transitioning in the management of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol 2014; 28: 438-453.

DOI: https://doi.org/10.1111/jdv.12118

Puig L. PASI 90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol 2015; 29: 645-648.

DOI: https://doi.org/10.1111/jdv.12817

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.

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

Hesselvig JH, Egeberg A, Loft ND, Zachariae C, Kofoed K, Skov L. Correlation between dermatology life quality index and psoriasis area and severity index in patients with psoriasis treated with ustekinumab. Acta Derm Venereol 2018; 98: 335-339.

DOI: https://doi.org/10.2340/00015555-2833

Strober B, Papp KA, Lebwohl M, Reich K, Paul C, Blauvelt A, et al. Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol, 2016; 75: 77-82.e77.

DOI: https://doi.org/10.1016/j.jaad.2016.03.026

Coimbra S, Oliveira H, Belo L, Figueiredo A, Rocha-Pereira P, Santos-Silva A. Principal determinants of the length of remission of psoriasis vulgaris after topical, NB-UVB, and PUVA therapy. Am J Clin Dermatol 2013; 14: 49-53.

DOI: https://doi.org/10.1007/s40257-012-0002-8

Ferrières L, Konstantinou M, Bulai Livideanu C, Hegazy S, Tauber M, Amelot F, et al. Long-term continuation with secukinumab in psoriasis: association with patient profile and initial psoriasis clearance. Clin Exp Dermatol 2019; 44: e230-e234.

DOI: https://doi.org/10.1111/ced.13999

Magis Q, Jullien D, Gaudy-Marqueste C, Baumstark K, Viguier M, Bachelez H, et al. Predictors of long-term drug survival for infliximab in psoriasis. J Eur Acad Dermatol Venereol 2017; 31: 96-101.

DOI: https://doi.org/10.1111/jdv.13747

Gordon KB, Betts KA, Sundaram M, Signorovitch JE, Li J, Xie M, et al. Poor early response to methotrexate portends inadequate long-term outcomes in patients with moderate-to-severe psoriasis: evidence from 2 phase 3 clinical trials. J Am Acad Dermatol 2017; 77: 1030-1037.

DOI: https://doi.org/10.1016/j.jaad.2017.08.017

Tan H, Valdez H, Griffiths CE, Mrowietz U, Tallman A, Wolk R, et al. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat 2017; 28: 3-7.

DOI: https://doi.org/10.1080/09546634.2016.1214671

Zhu B, Edson-Heredia E, Cameron G, Shen W, Erickson J, Shrom D, et al. Early clinical response as a predictor of subsequent response to ixekizumab treatment: results from a phase II study of patients with moderate-to-severe plaque psoriasis. Br J Dermatol 2013; 169: 1337-1341.

DOI: https://doi.org/10.1111/bjd.12610

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.

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

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 STEPI n study. J Eur Acad Dermatol Venereol 2018; 32: 1930-1939.

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

Norlin J, Nilsson K, Persson U, Schmitt-Egenolf M. Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health-related quality of life improvements and implications for treatment goals. Br J Dermatol 2020; 182: 965-973.

DOI: https://doi.org/10.1111/bjd.18361

Mahil S, Wilson N, Dand N, Reynolds N, Griffiths C, Emsley R, et al. Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR). Br J Dermatol 2020; 182: 1158-1166.

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

Puig L, Dossenbach M, Berggren L, Ljungberg A, Zachariae C. Absolute and relative Psoriasis Area and Severity Indices (PASI) for comparison of the efficacy of ixekizumab to etanercept and placebo in patients with moderate-to-severe plaque psoriasis: an integrated analysis of UNCOVER-2 and UNCOVER-3 outcomes. Acta Derm Venereol 2019; 99: 971-977.

DOI: https://doi.org/10.2340/00015555-3245

Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007; 4: e296.

DOI: https://doi.org/10.1371/journal.pmed.0040296

Gniadecki R, Kragballe K, Dam T, Skov L. Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. Br J Dermatol 2011; 164: 1091-1096.

DOI: https://doi.org/10.1111/j.1365-2133.2011.10213.x

Ahlehoff O, Skov L, Gislason G, Gniadecki R, Iversen L, Bryld L, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort. J Eur Acad Dermatol Venereol 2015; 29: 1128-1134.

DOI: https://doi.org/10.1111/jdv.12768

Ahlehoff O, Skov L, Gislason G, Lindhardsen J, Kristensen SL, Iversen L, et al. Pharmacological undertreatment of coronary risk factors in patients with psoriasis: observational study of the Danish nationwide registries. PLoS One 2012; 7: e36342.

DOI: https://doi.org/10.1371/journal.pone.0036342

Egeberg A, Iversen L, Gniadecki R, Hvid L, Dam T, Bryld L, et al. Characteristics of patients receiving ustekinumab compared with secukinumab for treatment of moderate-to-severe plaque psoriasis - nationwide results from the DERMBIO registry. J Eur Acad Dermatol Venereol 2017; 31: 1183-1187.

DOI: https://doi.org/10.1111/jdv.14200

Loft N, Skov L, Bryld L, Gislason G, Egeberg A. Treatment history of patients receiving biologic therapy for psoriasis - a Danish nationwide study. J Eur Acad Dermatol Venereol 2017; 31: e362-e363.

DOI: https://doi.org/10.1111/jdv.14156

Loft ND, Skov L, Rasmussen MK, Gniadecki R, Dam TN, Brandslund I, et al. Genetic polymorphisms associated with psoriasis and development of psoriatic arthritis in patients with psoriasis. PloS One 2018; 13: e0192010.

DOI: https://doi.org/10.1371/journal.pone.0192010

Loft N, Skov L, Iversen L, Gniadecki R, Dam T, Brandslund I, et al. Associations between functional polymorphisms and response to biological treatment in Danish patients with psoriasis. Pharmacogenomics J 2018; 18: 494.

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

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.

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

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

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

Lin J-H, Lee W-C. Complementary log regression for sufficient-cause modeling of epidemiologic data. Sci Rep 2016; 6: 1-6.

DOI: https://doi.org/10.1038/srep39023

Schafer JL. Analysis of incomplete multivariate data. London: Chapman & Hall, CRC Press, 1997.

DOI: https://doi.org/10.1201/9781439821862

Levin EC, Gupta R, Brown G, Malakouti M, Koo J. Biologic fatigue in psoriasis. J Dermatolog Treat 2014; 25: 78-82.

DOI: https://doi.org/10.3109/09546634.2013.826341

No D, Amin M, Reddy S, Egeberg A, Wu J. Sites of recurrence in patients following clearance of psoriasis with biologic therapy. J Eur Acad Dermatol Venereol 2017; 31: e297-e298.

DOI: https://doi.org/10.1111/jdv.14072

Stinco G, Balato N, Buligan C, Campanati A, Dastoli S, Di NM, et al. A multicentre retrospective case-control study on suspension of TNF-inhibitors and outcomes in psoriatic patients (STOP study). G Ital Dermatol Venereol 2019; 154: 392-399.

DOI: https://doi.org/10.23736/S0392-0488.18.06156-4

Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007; 143: 719-726.

DOI: https://doi.org/10.1001/archderm.143.6.719

Tsakok T, Wilson N, Dand N, Loeff FC, Bloem K, Baudry D, et al. Association of serum ustekinumab levels with clinical response in psoriasis. JAMA Dermatol 2019; 155: 1235-1243.

DOI: https://doi.org/10.1001/jamadermatol.2019.1783

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.

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

Gniadecki R, Leonardi C, Gordon K, Gu Y, Geng Z, Nader A, et al. Long-term optimization of outcomes with flexible adalimumab dosing in patients with moderate to severe plaque psoriasis. J Eur Acad Dermatol Venereol 2018; 32: 1297-1304.

DOI: https://doi.org/10.1111/jdv.14926

Armstrong AW, Siegel MP, Bagel J, Boh EE, Buell M, Cooper KD, et al. From the Medical Board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. J Am Acad Dermatol 2017; 76: 290-298.

DOI: https://doi.org/10.1016/j.jaad.2016.10.017

Puig L, Carrascosa J, Carretero G, De La Cueva P, Lafuente-Urrez R, Belinchón I, et al. Spanish evidence-based guidelines on the treatment of psoriasis with biologic agents, 2013. Part 1: on efficacy and choice of treatment. Actas Dermosifiliogr 2013; 104: 694-709.

DOI: https://doi.org/10.1016/j.ad.2013.04.003

Fernández-Torres RM, Paradela S, Fonseca E. Long-term response to etanercept monotherapy in moderate to severe psoriasis: assessment in daily practice by the maintenance of low values of PASI and BSA. J Dermatolog Treat 2014; 25: 54-56.

DOI: https://doi.org/10.3109/09546634.2012.755254

Grine L, de la Brassinne M, Ghislain PD, Hillary T, Lambert J, Segaert S, et al. A Belgian consensus on the definition of a treat-to-target outcome set in psoriasis management. J Eur Acad Dermatol Venereol 2020; 34: 676-684.

DOI: https://doi.org/10.1111/jdv.16104

Carretero G, Puig L, Carrascosa J, Ferrándiz L, Ruiz-Villaverde R, De la Cueva P, et al. Redefining the therapeutic objective in psoriatic patients candidates for biological therapy. J Dermatolog Treat 2018; 29: 334-346.

DOI: https://doi.org/10.1080/09546634.2017.1395794

Egeberg A, Thyssen JP. Factors associated with patient-reported importance of skin clearance among adults with psoriasis and atopic dermatitis. J Am Acad Dermatol 2019; 81: 943-949.

DOI: https://doi.org/10.1016/j.jaad.2019.06.018

Published

2021-01-04

How to Cite

Loft, N., Egeberg, A., Rasmussen, M. K., Bryld, L. E., Nissen, C. V., Dam, T. N., … Skov, L. (2021). 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 Dermato-Venereologica, 101(1), adv00357. https://doi.org/10.2340/00015555-3722