To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.8307182.
Relapse is common after treatment discontinuation for patients with moderate-to-severe psoriasis. The objective of this study was to understand the remission duration and long-term outcomes in psoriasis patients after biologic withdrawal.
We retrospectively included the follow-up data of 184 patients with moderate-to-severe psoriasis after the end of 11 biologic or tofacitinib trials conducted between 2004 and 2016.
Among the 232 treatment courses, 95 achieved (psoriasis area and severity index) PASI 75 at the end of the studies. At 6 months after treatment discontinuation, the systemic treatment-free rates of our patients who entered the PRESTA, PRISTINE, PEARL, ERASURE, CLEAR, the global tofacitinib study, and the IXORA-P study were 66.7%, 66.7%, 75.0%, 16.7%, 22.2%, 33.3%, and 29.2%, respectively. Pooled data showed a serious adverse event incidence rate of 1.5/100 person-years. The proportions of systemic treatment-free episodes were 16.8%, 7.4%, 4.3%, 3.2%, and 3.2% at 1, 2, 3, 4, and 5 years, respectively. Biologics were reinitiated in 41.9%, 66.7%, 77.1%, 83.5%, and 86.1% at 1, 2, 3, 4, and 5 years, respectively. Multivariate generalized estimating equation (GEE) regression analysis demonstrated that predictors for a longer relapse-free duration were baseline PASI, PASI improvement, biologic naivety, and early biologic intervention. Patients who received early biologic intervention, who achieved PASI 90, and who were biologic naive showed significantly higher relapse-free rate by Kaplan–Meier analysis with log rank test.
Systemic treatment was required in 86.1% of patients within 12 months after biologic withdrawal and biologics were reinitiated in 77.1% of patients after 3 years. However, early biologic administration within 2 years after diagnosis demonstrated a lower risk of relapse in patients with moderate-to-severe psoriasis.
Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(2):205–12.
Ko W-C, Tsai T-F, Tang C-H. Health state utility, willingness to pay, and quality of life among Taiwanese patients with psoriasis. Dermatol Sin. 2016;34(4):185–91.
Tsai T-F, Ho J-C, Chen Y-J, et al. Health-related quality of life among patients with moderate-to-severe plaque psoriasis in Taiwan. Dermatol Sin. 2018;36(4):190–5.
Bechet PE. Psoriasis: a brief historical review. Arch Dermatol Syphilol. 1936;33(2):327–34.
Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645–53.
Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645–8.
Tsai T-F, Lee C-H, Huang Y-H, et al. Taiwanese Dermatological Association consensus statement on management of psoriasis. Dermatol Sin. 2017;35(2):66–77.
Tsai TF, Wang TS, Hung ST, et al. Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan. J Dermatol Sci. 2011;63(1):40–6.
Gardinal I, Ammoury A, Paul C. Moderate to severe psoriasis: from topical to biological treatment. J Eur Acad Dermatol Venereol. 2009;23(11):1324–6.
Iversen L, Eidsmo L, Austad J, 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(11):1930–9.
Saraceno R, Griffiths CE. A European perspective on the challenges of managing psoriasis. J Am Acad Dermatol. 2006;54(3 Suppl 2):S81–4.
Levin AA, Gottlieb AB, Au SC. A comparison of psoriasis drug failure rates and reasons for discontinuation in biologics vs conventional systemic therapies. J Drugs Dermatol. 2014;13(7):848–53.
Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol. 2008;22(3):345–52.
Huang PH, Liao YH, Wei CC, Tseng YH, Ho JC, Tsai TF. Clinical effectiveness and safety experience with alefacept in the treatment of patients with moderate-to-severe chronic plaque psoriasis in Taiwan: results of an open-label, single-arm, multicentre pilot study. J Eur Acad Dermatol Venereol. 2008;22(8):923–30.
Sterry W, Ortonne JP, Kirkham B, et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010;340:c147.
Strohal R, Puig L, Chouela E, et al. The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial). J Dermatolog Treat. 2013;24(3):169–78.
Tsai TF, Ho JC, Song M, et al. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011;63(3):154–63.
Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med. 2014;371(4):326–38.
Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: clear, a randomized controlled trial. J Am Acad Dermatol. 2015;73(3):400–9.
Papp KA, Menter MA, Abe M, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015;173(4):949–61.
Zhang J, Tsai TF, Lee MG, et al. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017;88(1):36–45.
Langley RG, Papp K, Gooderham M, et al. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315–23.
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(1):114–23.
Bissonnette R, Iversen L, Sofen H, et al. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395–406.
Maza A, Richard MA, Aubin F, et al. Significant delay in the introduction of systemic treatment of moderate to severe psoriasis: a prospective multicentre observational study in outpatients from hospital dermatology departments in France. Br J Dermatol. 2012;167(3):643–8.
Tsai YC, Tsai TF. A review of clinical trials of biologic agents and small molecules for psoriasis in Asian subjects. G Ital Dermatol Venereol. 2016;151(4):412–31.
Sizova L. Approaches to the treatment of early rheumatoid arthritis with disease-modifying antirheumatic drugs. Br J Clin Pharmacol. 2008;66(2):173–8.
Girolomoni G, Griffiths CE, Krueger J, et al. Early intervention in psoriasis and immune-mediated inflammatory diseases: a hypothesis paper. J Dermatolog Treat. 2015;26(2):103–12.
Barkham N, Keen HI, Coates LC, et al. Clinical and imaging efficacy of infliximab in HLA-B27-positive patients with magnetic resonance imaging-determined early sacroiliitis. Arthritis Rheum. 2009;60(4):946–54.
Nast A, Spuls PI, van der Kraaij G, et al. European S3-Guideline on the systemic treatment of psoriasis vulgaris—update apremilast and secukinumab—EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2017;31(12):1951–63.
Gordon KB, Feldman SR, Koo JY, Menter A, Rolstad T, Krueger G. Definitions of measures of effect duration for psoriasis treatments. Arch Dermatol. 2005;141(1):82–4.
Navarini AA, Poulin Y, Menter A, Gu Y, Teixeira HD. Analysis of body regions and components of PASI scores during adalimumab or methotrexate treatment for patients with moderate-to-severe psoriasis. J Drugs Dermatol. 2014;13(5):554–62.
Otero ME, van Geel MJ, Hendriks JC, van de Kerkhof PC, Seyger MM, de Jong EM. A pilot study on the psoriasis area and severity index (PASI) for small areas: presentation and implications of the low PASI score. J Dermatolog Treat. 2015;26(4):314–7.
Menter A, Thaci D, Papp KA, et al. Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis. J Am Acad Dermatol. 2015;73(3):410–9.
Moreno-Ramirez D, Ojeda-Vila T, Ferrandiz L. Disease control for patients with psoriasis receiving continuous versus interrupted therapy with adalimumab or etanercept: a clinical practice study. Am J Clin Dermatol. 2014;15(6):543–9.
Kamaria M, Liao W, Koo JY. How long does the benefit of biologics last? An update on time to relapse and potential for rebound of biologic agents for psoriasis. Psoriasis Forum. 2010;16(2):36–42.
Blauvelt A, Langley R, Szepietowski J, et al. Secukinumab withdrawal leads to loss of treatment responses in a majority of subjects with plaque psoriasis with retreatment resulting in rapid regain of responses: a pooled analysis of two phase 3 trials: 3719. J Am Acad Dermatol. 2016;74(5):AB273.
Mrowietz U, Leonardi CL, Girolomoni G, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1):27–36.
Martin G. Abstracts of poster presentations: mauiDerm 2017: March 20–24, 2017 Grand Wailea Maui, Hawaii. J Clin Aesthet Dermatol. 2017;10(Suppl):S7–31.
Umezawa Y, Torisu-Itakura H, Morisaki Y, et al. Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab. J Eur Acad Dermatol Venereol. 2019;33(3):568–76.
Okubo Y, Mabuchi T, Iwatsuki K, et al. Long-term efficacy and safety of ixekizumab in Japanese patients with erythrodermic or generalized pustular psoriasis: subgroup analyses of an open-label, phase 3 study (UNCOVER-J). J Eur Acad Dermatol Venereol. 2019;33(2):325–32.
Chiu H-Y, Hui RC, Tsai T-F, et al. Predictors of time to relapse following ustekinumab withdrawal in patients with psoriasis who had responded to therapy: an eight-year multicenter study. J Am Acad Dermatol. 2019. https://doi.org/10.1016/j.jaad.2019.01.035.
Papp KA, Lebwohl MG. Onset of action of biologics in patients with moderate-to-severe psoriasis. J Drugs Dermatol. 2017;17(3):247–50.
Koo K, Nakamura M, Lebwohl M. Article commentary: the natural course of psoriasis: data from a rare ‘experiment of nature’ in Maoist China. J Psoriasis Psoriatic Arthritis. 2017;2(3):39–40.
Mansouri Y, Goldenberg G. Biologic safety in psoriasis: review of long-term safety data. J Clin Aesthet Dermatol. 2015;8(2):30–42.
Papp KA, Poulin Y, Bissonnette R, et al. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012;66(2):e33–45.
Reich K, Papp KA, Griffiths CE, et al. An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. J Drugs Dermatol. 2012;11(3):300–12.
Eder L, Haddad A, Rosen CF, et al. The incidence and risk factors for psoriatic arthritis in patients with psoriasis: a prospective cohort study. Arthritis Rheumatol. 2016;68(4):915–23.
Wang TS, Hsieh CF, Tsai TF. Epidemiology of psoriatic disease and current treatment patterns from 2003 to 2013: a nationwide, population-based observational study in Taiwan. J Dermatol Sci. 2016;84(3):340–5.
Eder L, Widdifield J, Rosen CF, et al. Trends in the prevalence and incidence of psoriasis and psoriatic arthritis in Ontario, Canada: a population-based study. Arthritis Care Res (Hoboken). 2018. https://doi.org/10.1002/acr.23743.
Busquets-Perez N, Rodriguez-Moreno J, Gomez-Vaquero C, Nolla-Sole JM. Relationship between psoriatic arthritis and moderate-severe psoriasis: analysis of a series of 166 psoriatic arthritis patients selected from a hospital population. Clin Rheumatol. 2012;31(1):139–43.
Napolitano M, Balato N, Caso F, et al. Paradoxical onset of psoriatic arthritis during treatment with biologic agents for plaque psoriasis: a combined dermatology and rheumatology clinical study. Clin Exp Rheumatol. 2017;35(1):137–40.
Wu NL, Hsu CJ, Sun FJ, Tsai TF. Efficacy and safety of secukinumab in Taiwanese patients with moderate to severe plaque psoriasis: subanalysis from ERASURE phase III study. J Dermatol. 2017;44(10):1129–37.
Visvanathan S, Baum P, Vinisko R, et al. Psoriatic skin molecular and histopathologic profiles after treatment with risankizumab versus ustekinumab. J Allergy Clin Immunol. 2018;143:2158–69.
Brodmerkel C, Li K, Garcet S, et al. Modulation of inflammatory gene transcripts in psoriasis vulgaris: differences between ustekinumab and etanercept. J Allergy Clin Immunol. 2019;143:1965–9.
Tian S, Krueger JG, Li K, et al. Meta-analysis derived (MAD) transcriptome of psoriasis defines the “core” pathogenesis of disease. PLoS One. 2012;7(9):e44274.
Suarez-Farinas M, Fuentes-Duculan J, Lowes MA, Krueger JG. Resolved psoriasis lesions retain expression of a subset of disease-related genes. J Invest Dermatol. 2011;131(2):391–400.
Zaba LC, Suarez-Farinas M, Fuentes-Duculan J, et al. Effective treatment of psoriasis with etanercept is linked to suppression of IL-17 signaling, not immediate response TNF genes. J Allergy Clin Immunol. 2009;124(5):1021–395.
- Remission Duration and Long-Term Outcomes in Patients with Moderate-to-Severe Psoriasis Treated by Biologics or Tofacitinib in Controlled Clinical Trials: A 15-Year Single-Center Experience
- Springer Healthcare
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
Sommerakademie-Visual, Mail Icon II