REAL-WORLD REGISTRY-BASED COMPARATIVE STUDY OF PATIENTS WITH PSORIASIS VULGARIS UNDER CONVENTIONAL SYSTEMIC TREATMENTS VS BIOLOGICS IN ROMANIA
Keywords:
psoriasis vulgaris, biological treatments, Methotrexate
Abstract
Psoriasis is largely a disease driven by the involvement of T-helper cell type 1 (Th1), type 17 (Th17) and their respective cytokines, the genetic predisposition and environmental components play a complex role in the pathogenesis of psoriasis. Choosing an individualized treatment for each patient is a key element in controlling the symptoms of the disease. The treatment for this multifactorial inflammatory disease was formerly limited to localized topical treatments with keratolytics, coal tar, vitamin D derivatives, corticosteroids or systemic therapies with Methotrexate, Cyclosporine, Apremilast and Retinoids along with ultraviolet phototherapy sessions. However, over the past 2 decades, therapeutical breakthrough regarding psoriasis treatment has been achieved with the introduction of biological treatments such as tumor necrosis factor (TNF) inhibitors and inhibitors of interleukin (IL)-17 and IL-23. The objective of this study is to highlight the evolution of patients according to the type of treatment followed: conventional systemic or biological and to highlight the importance of choosing the appropriate type of treatment for each patient according to severity and quality of life. A retrospective observational study, including 100 patients diagnosed with psoriasis vulgaris following conventional systemic therapies, and the rest biological therapies during 2020-2021, was carried out in the Oncological Dermatology Clinic of Elias University Emergency Hospital in Bucharest and it has been demonstrated in our study and in numerous studies found in literature biological agents, regardless of their class, are more effective in treating patients with psoriasis vulgaris and reaching PASI 75 and have been shown to have superior drug survival rates than conventional systemic therapies.
References
[1] R. Parisi, D.P. Symmons, C.E. Griffiths, et. al., ”Identification and Management of Psoriasis and Associated Comorbidity (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence,” J Invest Dermatol, vol.133(2), pp.377-385, 2013. doi: 10.1038/jid.2012.339.
[2] P. Gisondi, F. Bellinato, G. Girolomoni, C. Albanesi, ”Pathogenesis of Chronic Plaque Psoriasis and Its Intersection With Cardio-Metabolic Comorbidities,” Front Pharmacol, vol. 25, 11, pp.117, 2020. doi: 10.3389/fphar.2020.00117.
[3] F. Kerdel, M. Zaiac, ” Anevolutionins witching therapy for psoriasis patients who fail to meet treatment goal,” Dermatol Ther, 28(6), pp.390- 403, 2015. doi:10.1111/dth.12267.
[4] W.B. Kim, D. Jerome, J. Yeung, ”Diagnosis and management of psoriasis,” Can Fam Physician, vol.63(4), pp.278-285, 2017.
[5] K. Rønholt, L. Iversen, ”Old and new biological therapies for psoriasis,” Int J Mol Sci, vol.18(11), pii: E2297, 2017. doi:10.3390/ijms18112297.
[6] J.G. Krueger, ”The immunologic basis for the treatment of psoriasis with new biologic agents,” J Am Acad Dermatol, vol.46(1), pp.1-23, 2002. doi:10.1067/ mjd.2002.120568.
[7] C.L. Leonardi, J.L. Powers, R.T. Matheson, et. al., ”Etanercept as monotherapy in patients with psoriasis,” N Engl J Med, vol.349(21), pp.2014-2022, 2003. doi: 10.1056/NEJMoa030409.
[8] A.B. Gottlieb, R. Evans, S. Li, et. al., ”Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial,” J Am Acad Dermatol, vol.51(4), pp.534-542, 2004, doi: 10.1016/j.jaad.2004.02.021.
[9] K.B. Gordon, R.G. Langley, C. Leonardi, et. al.,”Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study,” J Am Acad Dermatol, vol.55(4), pp.598-606, 2006. doi: 10.1016/j.jaad.2006.05.027.
[10] C.L. Leonardi, A.B. Kimball, K.A. Papp, et. al.,”Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1),” Lancet, vol.371(9625), pp.1665-1674, May 2008. doi: 10.1016/S0140-6736(08)60725-4.
[11] R.N. Herrier, ”Advances in the treatment of moderate-to-severe plaque psoriasis,” Am J Health Syst Pharm, vol.68(9), pp.795-806, 2011. doi: 10.2146/ajhp100227.
[12] S. Piaserico, S. Cazzaniga, S. Chimenti, et. al., ”Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry,” J Am Acad Dermatol, vol.70(2), pp.257-262.e3, 2014. doi:10.1016/j.jaad.2013.10.019
[13] L.L. Lecluse, R.J. Driessen, P.I. Spuls et. al., ”Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis,” Arch Dermatol, vol.146(2): pp.127-132, 2010. doi: 10.1001/archdermatol.2009.347.
[14] M.T. Wan, J. Alvarez, D.B. Shin, et. al., ”Head-to-head trials of systemic psoriasis therapies: a systematic review of study design and maximum acceptable treatment differences,” J Eur Acad Dermatol Venereol, vol.33(1), pp.42-55, 2019. doi:10.1111/jdv.15174.
[15] A. Menter, B.E. Strober, D.H. Kaplan, et. al., ”Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics,” J Am Acad Dermatol, vol.80(4), pp.1029-1072, 2019. doi:10.1016/j.jaad.2018.11.057.
[16] C. Fink, L. Uhlmann, C Klose, H.A. Haenssle, ”Automated, computer-guided PASI measurements by digital image analysis versus conventional physicians' PASI calculations: study protocol for a comparative, single-centre, observational study,” BMJ Open, vol.8(5):e018461, 2018. doi: 10.1136/bmjopen-2017-018461.
[17] C.S. Carlin, S.R. Feldman, J.G. Krueger, et. al., ”A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis,” J Am Acad Dermatol, vol.50(6), pp.859-866, 2004. doi: 10.1016/j.jaad.2003.09.014.
[18] P.I. Spuls, L.L. Lecluse, M.L. Poulsen, et. al., ”How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review,” J Invest Dermatol, vol.130(4), pp.933-943, 2010. doi: 10.1038/jid.2009.391.
[19] A.Y. Finlay, G.K. Khan, ”Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use,” Clin Exp Dermatol, vol.19(3), pp.210-216, 1994. doi: 10.1111/j.1365-2230.1994.tb01167.x.
[20] R. Shikiar, M.K. Willian, M.M. Okun, et. al., ”The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study,” Health and quality of life outcomes, vol.4, p.71, 2006. https://doi.org/10.1186/1477-7525-4-71.
[21] S. Piaserico, A. Conti, F. Lo Console, et. al., ”Efficacy and safety of systemic treatments for psoriasis in elderly patients,” Acta dermato-venereologica, vol.94(3), pp.293–297, 2014. https://doi.org/10.2340/00015555-1719.
[22] L. Török, L. Kádár, J.M. Geiger, ”Acitretin treatment of severe psoriasis,” Acta dermato-venereologica. Supplementum, vol.146, pp.104–106, 1989.
[23] H.E. Murray, A.W. Anhalt, R. Lessard, et. al., ”A 12-month treatment of severe psoriasis with acitretin: results of a Canadian open multicenter study,” Journal of the American Academy of Dermatology, vol.24(4), pp.598–602, 1991. https://doi.org/10.1016/0190-9622(91)70091-f.
[24] E.A. Olsen, W.W. Weed, C.J. Meyer, L.M. Cobo, ”A double-blind, placebo-controlled trial of acitretin for the treatment of psoriasis,” Journal of the American Academy of Dermatology, vol.21(4 Pt 1), pp.681–686, 1989. https://doi.org/10.1016/s0190-9622(89)70236-x.
[25] J.H. Saurat, R.G. Langley, K. Reich, et. al., ”Relationship between methotrexate dosing and clinical response in patients with moderate to severe psoriasis: subanalysis of the CHAMPION study,” The British journal of dermatology, vol.165(2), pp.399–406, 2011. https://doi.org/10.1111/j.1365-2133.2011.10399.x.
[26] K. Reich, R.G. Langley, K.A. Papp, et. al., ”A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis,” The New England journal of medicine, vol.365(17), pp.1586–1596, 2011. https://doi.org/10.1056/NEJMoa1010858.
[27] V. Lajevardi, Z. Hallaji, S. Daklan, et. al., ”The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque-type psoriasis: a single-blinded randomized controlled trial,” International journal of dermatology, vol.54(1), pp.95–101, 2015. https://doi.org/10.1111/ijd.12585.
[28] A. Al-Dabagh, S.A. Davis, M.A. Kinney, et. al., ”The effect of folate supplementation on methotrexate efficacy and toxicity in psoriasis patients and folic acid use by dermatologists in the USA,” American journal of clinical dermatology, vol.14(3), pp.155–161, 2013. https://doi.org/10.1007/s40257-013-0017-9.
[29] R.K. Sivamani, H. Goodarzi, M.S. Garcia, et. al., ”Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring,” Clinical reviews in allergy & immunology, vol.44(2), pp.121–140, 2013. https://doi.org/10.1007/s12016-012-8301-7.
[30] M. Kamata, Y. Tada, ”Efficacy and Safety of Biologics for Psoriasis and Psoriatic Arthritis and Their Impact on Comorbidities: A Literature Review,” International journal of molecular sciences, vol.21(5), pp.1690, 2020. https://doi.org/10.3390/ijms21051690.
[31] J. Vide, S. Magina, ”Moderate to severe psoriasis treatment challenges through the era of biological drugs,” Anais brasileiros de dermatologia, vol.92(5), pp.668–674, 2017. https://doi.org/10.1590/abd1806-4841.20175603.
[32] A. Menter, S.K. Tyring, K. Gordon, ”Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial,” Journal of the American Academy of Dermatology, vol.58(1), pp.106–115, 2008. https://doi.org/10.1016/j.jaad.2007.09.010.
[33] J.H. Saurat, G. Stingl, L. Dubertret, et. al., ”Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION),” The British journal of dermatology, vol.158(3), pp.558–566, 2008. https://doi.org/10.1111/j.1365-2133.2007.08315.x.
[34] K.A. Papp, R.G. Langley, M. Lebwohl, et. al., ”Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2),” Lancet (London, England), vol.371(9625), pp.1675–1684, 2008. https://doi.org/10.1016/S0140-6736(08)60726-6.
[35] G.G. Krueger, R.G. Langley, C. Leonardi et. al., ”A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis,” The New England journal of medicine, vol.356(6), pp.580–592, 2007. https://doi.org/10.1056/NEJMoa062382.
[36] C.E. Griffiths, B.E. Strober, P. van de Kerkhof et. al., ”Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis,” N Engl J Med, vol.362(2), pp.118-128, 2010. doi: 10.1056/NEJMoa0810652.
[37] M. Lebwohl, K. Papp, C. Han, et. al., ”Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial,” The British journal of dermatology, vol.162(1), pp.137–146, 2010. https://doi.org/10.1111/j.1365-2133.2009.09491.x.
[38] W. Carey, S. Glazer, A.B. Gottlieb, et. al., ”Relapse, rebound, and psoriasis adverse events: an advisory group report,” Journal of the American Academy of Dermatology, vol.54(4 Suppl 1), pp.S171–S181, 2006. https://doi.org/10.1016/j.jaad.2005.10.029.
[39] R.G. Langley, B.E. Elewski, M. Lebwohl, et. al., ”Secukinumab in plaque psoriasis--results of two phase 3 trials,” The New England journal of medicine, vol.371(4), pp.326–338 2014. https://doi.org/10.1056/NEJMoa1314258.
[40] A. López-Ferrer, E. Vilarrasa, L. Puig, ”Secukinumab (AIN457) for the treatment of psoriasis,” Expert Rev Clin Immunol, vol.11(11), pp.1177-1188, 2015. doi: 10.1586/1744666X.2015.1095092.
[41] M. Caproni, E.Antiga, L. Melani, et. al., ”Serum levels of IL-17 and IL-22 are reduced by etanercept, but not by acitretin, in patients with psoriasis: a randomized-controlled trial,” Journal of clinical immunology, vol.29(2), pp.210–214, 2009. https://doi.org/10.1007/s10875-008-9233-0.
[42] L. Barker, M. Hoffmann, G. Wozel, et. al., ”Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1),” The British journal of dermatology, vol.165(5), pp.1109–1117, 2011. https://doi.org/10.1111/j.1365-2133.2011.10615.x.
[43] A. B. Gottlieb, R. Evans, S. Li, et. al., ”Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial,” Journal of the American Academy of Dermatology, vol.51(4), pp.534–542, 2004. https://doi.org/10.1016/j.jaad.2004.02.021.
[44] K. Reich, F.O. Nestle, K. Papp, et. al., ”Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial,” Lancet (London, England), vol.366(9494), pp.1367–1374, 2005. https://doi.org/10.1016/S0140-6736(05)67566-6.
[45] A. Menter, S.R. Feldman, G.D. Weinstein, et. al., ”A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis,” Journal of the American Academy of Dermatology, vol.56(1), pp.31.e1–31.e315, 2007. https://doi.org/10.1016/j.jaad.2006.07.017.
[46] C. Paul, C.E.M. Griffiths, P.C.M. van de Kerkhof, et. al., ”Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study,” Journal of the American Academy of Dermatology, vol.80(1), pp.70–79.e3, 2019. https://doi.org/10.1016/j.jaad.2018.06.039.
[47] A. Blauvelt, M. Gooderham, L. Iversen et. al., ”Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3),” Journal of the American Academy of Dermatology, vol.77(5), pp.855–862, 2017. https://doi.org/10.1016/j.jaad.2017.06.153.
[48] S. Imafuku, H. Torisu-Itakura, A. Nishikawa, et. al., ”Efficacy and safety of ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis: Subgroup analysis of a placebo-controlled, phase 3 study (UNCOVER-1),” The Journal of dermatology, vol.44(11), pp.1285–1290, 2017. https://doi.org/10.1111/1346-8138.13927.
[49] P. Nash, B. Kirkham, M. Okada, M.; Rahman, P.; Combe, B.; Burmester, G. R.; Adams, D. H.; Kerr, L.; Lee, C.; Shuler, C. L.; Genovese, M.; SPIRIT-P2 Study Group et. al., ”Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial,” Lancet (London, England), vol.389(10086), pp.2317–2327, 2017. https://doi.org/10.1016/S0140-6736(17)31429-0.
[50] H. Saeki, H. Nakagawa, K. Nakajo et. al., ”Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52- week, open-label, phase 3 study (UNCOVER-J),” J. Dermatol, vol.44, pp.355–362, 2017. doi: 10.1111/1346-8138.13622.
[51] K.B. Gordon, A. Blauvelt, K.A. Papp, et. al., ”Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis,” N Engl J Med, vol.375(4), pp.345-356, 2016. doi: 10.1056/NEJMoa1512711.
[52] C.E. Griffiths, K. Reich, M. Lebwohl, et. al., ”Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials,” Lancet (London, England), vol.386(9993), pp.541–551, 2015. https://doi.org/10.1016/S0140-6736(15)60125-8.
[53] K.B. Gordon, B. Strober, M. Lebwohl, 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 (London, England), vol.392(10148), pp.650–661, 2018. https://doi.org/10.1016/S0140-6736(18)31713-6.
[54] K. Reich, C.E.M Griffiths, K.B. Gordon, et. al., ”Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials,” Journal of the American Academy of Dermatology, vol.82(4), pp.936–945, 2020. https://doi.org/10.1016/j.jaad.2019.11.040.
[55] K. Reich, A.W. Armstrong, R.G. Langley et. al., ”Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial,” Lancet (London, England), vol.394(10201), pp.831–839, 2019. https://doi.org/10.1016/S0140-6736(19)31773-8.
[56] A. Blauvelt, K.A. Papp, C.E. Griffiths, et. al., ”Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial,” Journal of the American Academy of Dermatology, vol.76(3), pp.405–417, 2017. https://doi.org/10.1016/j.jaad.2016.11.041.
[57] K.B. Gordon, A. Blauvelt, P. Foley, et. al., ”Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies,” The British journal of dermatology, vol.178(1), pp.132–139, 2018. https://doi.org/10.1111/bjd.16008.
[58] P. Foley, K. Gordon, C.E.M. Griffiths, et. al., ”Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials,” JAMA dermatology, vol.154(6), pp.676–683, 2018. https://doi.org/10.1001/jamadermatol.2018.0793.
[59] L. Puig, M. Lebwohl, H. Bachelez, et. al., ”Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial,” Journal of the American Academy of Dermatology, vol.82(2), pp.352–359, 2020. https://doi.org/10.1016/j.jaad.2019.05.095.
[60] M. Lebwohl, B. Strober, A. Menter, et. al., ”Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis,” The New England journal of medicine, vol.373(14), pp.1318–1328, 2015. https://doi.org/10.1056/NEJMoa1503824.
[61] L. Puig, J.M. Carrascosa, E. Daudén, et. al., ”Drug survival of conventional systemic and biologic therapies for moderate-to-severe psoriasis in clinical practice in Spain: prospective results from the SAHARA study,” The Journal of dermatological treatment, vol.31(4), pp.344–351, 2020. https://doi.org/10.1080/09546634.2019.1597244.
[62] R. Gniadecki, B. Bang, L.E. Bryld, et. al., ”Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris,” The British journal of dermatology, vol.172(1), pp.244–252, 2015. https://doi.org/10.1111/bjd.13343.
[63] R.B. Warren, C.H. Smith, Z.Z.N. Yiu 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),” The Journal of investigative dermatology, vol.135(11), pp.2632–2640, 2015. https://doi.org/10.1038/jid.2015.208.
[64] I.Y.K. Iskandar, R.B. Warren, M. Lunt, et. al., ”Differential Drug Survival of Second-Line Biologic Therapies in Patients with Psoriasis: Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR),” The Journal of investigative dermatology, vol.138(4), pp.775–784, 2018. https://doi.org/10.1016/j.jid.2017.09.044.
[65] A. Menter, N.J. Korman, C.A. Elmets, et. al., ”Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions,” Journal of the American Academy of Dermatology, vol.65(1), pp.137–174, 2011. https://doi.org/10.1016/j.jaad.2010.11.055.
[66] A.W. Armstrong, J. Bagel, A.S. Van Voorhees, et. al., ”Combining biologic therapies with other systemic treatments in psoriasis: evidence-based, best-practice recommendations from the Medical Board of the National Psoriasis Foundation,” JAMA dermatology, vol.151(4), pp.432–438, 2015. https://doi.org/10.1001/jamadermatol.2014.3456.
[67] S.M. Prescott, G.A. Zimmerman, A.R. Morrison, ”The effects of a diet rich in fish oil on human neutrophils: identification of leukotriene B5 as a metabolite,” Prostaglandins, vol.30(2), pp.209–227, 1985. https://doi.org/10.1016/0090-6980(85)90186-8.
[68] T.H. Lee, R.L. Hoover, J.D. Williams, et. al., ”Effect of dietary enrichment with eicosapentaenoic and docosahexaenoic acids on in vitro neutrophil and monocyte leukotriene generation and neutrophil function,” The New England journal of medicine, vol.312(19), pp.1217–1224, 1985. https://doi.org/10.1056/NEJM198505093121903.
[69] Wolters M. ”Diet and psoriasis: experimental data and clinical evidence,” The British journal of dermatology, vol.153(4), pp.706–714, 2005. https://doi.org/10.1111/j.1365-2133.2005.06781.x.
[70] V.A. Ziboh, K.A. Cohen, C.N. Ellis, et. al., ”Effects of dietary supplementation of fish oil on neutrophil and epidermal fatty acids. Modulation of clinical course of psoriatic subjects,” Archives of dermatology, vol.122(11), pp.1277–1282, 1986.
[71] D. Schena, G.C. Chieregato, M. de Gironcoli, et. al., ”Increased erythrocyte membrane arachidonate and platelet malondialdehyde (MDA) production in psoriasis: normalization after fish-oil,” Acta dermato-venereologica. Supplementum, vol.146, pp.42–44, 1989.
[72] A. Lassus, A.L. Dahlgren, M.J. Halpern, et. al., ”Effects of dietary supplementation with polyunsaturated ethyl ester lipids (Angiosan) in patients with psoriasis and psoriatic arthritis,” The Journal of international medical research, vol.18(1), pp.68–73, 1990. https://doi.org/10.1177/030006059001800109.
[73] K. Kragballe, and Fogh, ”A low-fat diet supplemented with dietary fish oil (Max-EPA) results in improvement of psoriasis and in formation of leukotriene B5,” Acta dermato-venereologica, vol.69(1), pp.23–28, 1989.
[74] K. Kragballe, ”Dietary supplementation with a combination of n-3 and n-6 fatty acids (super gamma-oil marine) improves psoriasis,” Acta dermato-venereologica, vol.69(3), 265–268, 1989.
[75] S.B. Bittiner, W.F. Tucker, I. Cartwright, S.S. Bleehen, ”A double-blind, randomised, placebo-controlled trial of fish oil in psoriasis,” Lancet (London, England), vol.1(8582), pp.378–380, 1988. https://doi.org/10.1016/s0140-6736(88)91181-6.
[76] B. Guida, A. Napoleone, R. Trio, et. al., ”Energy-restricted, n-3 polyunsaturated fatty acids-rich diet improves the clinical response to immuno-modulating drugs in obese patients with plaque-type psoriasis: a randomized control clinical trial,” Clinical nutrition (Edinburgh, Scotland), vol.33(3), pp.399–405, 2014. https://doi.org/10.1016/j.clnu.2013.09.010.
[77] K. Danno, and N. Sugie, ”Combination therapy with low-dose etretinate and eicosapentaenoic acid for psoriasis vulgaris,” The Journal of dermatology, vol.25(11), pp.703–705, 1998. https://doi.org/10.1111/j.1346-8138.1998.tb02487.x.
78] E. Puzenat, V. Bronsard, S. Prey, et. al., ”What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature,” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.24 Suppl 2, pp.10–16, 2010. https://doi.org/10.1111/j.1468-3083.2009.03562.x.
[79] P.V. Chernyshov, ”The Evolution of Quality of Life Assessment and Use in Dermatology,” Dermatology (Basel, Switzerland), vol.235(3), pp.167–174, 2019. https://doi.org/10.1159/000496923.
[80] S. Sherman, E. Hodak, L. Pavlovsky, L. ”Can etanercept treatment failure in moderate-to-severe psoriasis be overcome by addition of low-dose methotrexate? A single-center experience,” The Journal of dermatological treatment, vol.29(7), pp.666–670, 2018. https://doi.org/10.1080/09546634.2018.1441491.
[81] Q. Yu, Y. Tong, L. Cui, et. al., ”Efficacy and safety of etanercept combined plus methotrexate and comparison of expression of pro-inflammatory factors expression for the treatment of moderate-to-severe plaque psoriasis,” International immunopharmacology, vol.73, pp.442–450, 2019. https://doi.org/10.1016/j.intimp.2019.05.042.
[82] P. Gisondi, F. Bellinato, M. Bruni, et. al., ”Methotrexate vs secukinumab safety in psoriasis patients with metabolic syndrome,” Dermatologic therapy, vol.33(6), e14281, 2020. https://doi.org/10.1111/dth.14281.
[83] K. Reich, M. Augustin, D. Thaçi, et. al., ”A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment,” The British journal of dermatology, vol.182(4), pp.869–879, 2020. https://doi.org/10.1111/bjd.18384.
[84] S. Khandpur, A. Singh, A. Kumar, A. Sharma, ”A preliminary prospective non-randomized controlled trial to compare the efficacy of subcutaneous etanercept versus oral methotrexate in moderate-to-severe chronic plaque psoriasis and correlation of response with T helper (th) 1, th2, th17 and T regulatory cytokine patterns,” Indian journal of dermatology, venereology and leprology, vol.86(4), pp.441–445, 2020. https://doi.org/10.4103/ijdvl.IJDVL_443_19.
[85] D. Thaçi, A. Pinter, M. Sebastian, et. al., ”Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS),” The British journal of dermatology, vol.183(2), pp.265–275, 2020. https://doi.org/10.1111/bjd.18696.
[86] G. Holzer, M. Hoke, S. Sabeti-Sandor, et. al., ”Disparate effects of adalimumab and fumaric acid esters on cardiovascular risk factors in psoriasis patients: results from a prospective, randomized, observer-blinded head-to-head trial,” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.35(2), pp.441–449, 2021. https://doi.org/10.1111/jdv.16635.
[87] A. Pinter, M. Hoffmann, K. Reich, et. al., ”A phase 4, randomized, head-to-head trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate-to-severe plaque psoriasis (CHANGE),” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.35(3), pp.701–711, 2021. https://doi.org/10.1111/jdv.16932.
[88] D. Thaçi, A.M. Soliman, K. Eyerich, et. al., ”Patient-reported outcomes with risankizumab versus fumaric acid esters in systemic therapy-naïve patients with moderate to severe plaque psoriasis: a phase 3 clinical trial,” Journal of the European Academy of Dermatology and Venereology : JEADV, 2021, vol.35(8), pp.1686–1691, 2021. https://doi.org/10.1111/jdv.17109.
[89] G. van der Kraaij, C. Busard, J. van den Reek, et. al.,”Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial,” The Journal of investigative dermatology, vol.142(9), pp.2375–2383, 2022. https://doi.org/10.1016/j.jid.2022.01.033.
[90] D. Thaçi, K. Eyerich, A. Pinter et. al., ”Direct comparison of risankizumab and fumaric acid esters in systemic therapy-naïve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial,” The British journal of dermatology, vol.186(1), pp.30–39, 2022. https://doi.org/10.1111/bjd.20481.
[91] P. Gisondi, M. Del Giglio, C. Cotena, G. Girolomoni, ”Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial,” The British journal of dermatology, vol.158(6), pp.1345–1349, 2008. https://doi.org/10.1111/j.1365-2133.2008.08564.x.
[92] K. Reich, M. Gooderham, L. Green, et. al., ”The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE),” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.31(3), pp. 507–517, 2017. https://doi.org/10.1111/jdv.14015.
[93] M. Sticherling, U. Mrowietz, M. Augustin, et. al., ”Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial,” The British journal of dermatology, vol.177(4), pp.1024–1032, 2017. https://doi.org/10.1111/bjd.15707.
[2] P. Gisondi, F. Bellinato, G. Girolomoni, C. Albanesi, ”Pathogenesis of Chronic Plaque Psoriasis and Its Intersection With Cardio-Metabolic Comorbidities,” Front Pharmacol, vol. 25, 11, pp.117, 2020. doi: 10.3389/fphar.2020.00117.
[3] F. Kerdel, M. Zaiac, ” Anevolutionins witching therapy for psoriasis patients who fail to meet treatment goal,” Dermatol Ther, 28(6), pp.390- 403, 2015. doi:10.1111/dth.12267.
[4] W.B. Kim, D. Jerome, J. Yeung, ”Diagnosis and management of psoriasis,” Can Fam Physician, vol.63(4), pp.278-285, 2017.
[5] K. Rønholt, L. Iversen, ”Old and new biological therapies for psoriasis,” Int J Mol Sci, vol.18(11), pii: E2297, 2017. doi:10.3390/ijms18112297.
[6] J.G. Krueger, ”The immunologic basis for the treatment of psoriasis with new biologic agents,” J Am Acad Dermatol, vol.46(1), pp.1-23, 2002. doi:10.1067/ mjd.2002.120568.
[7] C.L. Leonardi, J.L. Powers, R.T. Matheson, et. al., ”Etanercept as monotherapy in patients with psoriasis,” N Engl J Med, vol.349(21), pp.2014-2022, 2003. doi: 10.1056/NEJMoa030409.
[8] A.B. Gottlieb, R. Evans, S. Li, et. al., ”Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial,” J Am Acad Dermatol, vol.51(4), pp.534-542, 2004, doi: 10.1016/j.jaad.2004.02.021.
[9] K.B. Gordon, R.G. Langley, C. Leonardi, et. al.,”Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study,” J Am Acad Dermatol, vol.55(4), pp.598-606, 2006. doi: 10.1016/j.jaad.2006.05.027.
[10] C.L. Leonardi, A.B. Kimball, K.A. Papp, et. al.,”Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1),” Lancet, vol.371(9625), pp.1665-1674, May 2008. doi: 10.1016/S0140-6736(08)60725-4.
[11] R.N. Herrier, ”Advances in the treatment of moderate-to-severe plaque psoriasis,” Am J Health Syst Pharm, vol.68(9), pp.795-806, 2011. doi: 10.2146/ajhp100227.
[12] S. Piaserico, S. Cazzaniga, S. Chimenti, et. al., ”Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry,” J Am Acad Dermatol, vol.70(2), pp.257-262.e3, 2014. doi:10.1016/j.jaad.2013.10.019
[13] L.L. Lecluse, R.J. Driessen, P.I. Spuls et. al., ”Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis,” Arch Dermatol, vol.146(2): pp.127-132, 2010. doi: 10.1001/archdermatol.2009.347.
[14] M.T. Wan, J. Alvarez, D.B. Shin, et. al., ”Head-to-head trials of systemic psoriasis therapies: a systematic review of study design and maximum acceptable treatment differences,” J Eur Acad Dermatol Venereol, vol.33(1), pp.42-55, 2019. doi:10.1111/jdv.15174.
[15] A. Menter, B.E. Strober, D.H. Kaplan, et. al., ”Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics,” J Am Acad Dermatol, vol.80(4), pp.1029-1072, 2019. doi:10.1016/j.jaad.2018.11.057.
[16] C. Fink, L. Uhlmann, C Klose, H.A. Haenssle, ”Automated, computer-guided PASI measurements by digital image analysis versus conventional physicians' PASI calculations: study protocol for a comparative, single-centre, observational study,” BMJ Open, vol.8(5):e018461, 2018. doi: 10.1136/bmjopen-2017-018461.
[17] C.S. Carlin, S.R. Feldman, J.G. Krueger, et. al., ”A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis,” J Am Acad Dermatol, vol.50(6), pp.859-866, 2004. doi: 10.1016/j.jaad.2003.09.014.
[18] P.I. Spuls, L.L. Lecluse, M.L. Poulsen, et. al., ”How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review,” J Invest Dermatol, vol.130(4), pp.933-943, 2010. doi: 10.1038/jid.2009.391.
[19] A.Y. Finlay, G.K. Khan, ”Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use,” Clin Exp Dermatol, vol.19(3), pp.210-216, 1994. doi: 10.1111/j.1365-2230.1994.tb01167.x.
[20] R. Shikiar, M.K. Willian, M.M. Okun, et. al., ”The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study,” Health and quality of life outcomes, vol.4, p.71, 2006. https://doi.org/10.1186/1477-7525-4-71.
[21] S. Piaserico, A. Conti, F. Lo Console, et. al., ”Efficacy and safety of systemic treatments for psoriasis in elderly patients,” Acta dermato-venereologica, vol.94(3), pp.293–297, 2014. https://doi.org/10.2340/00015555-1719.
[22] L. Török, L. Kádár, J.M. Geiger, ”Acitretin treatment of severe psoriasis,” Acta dermato-venereologica. Supplementum, vol.146, pp.104–106, 1989.
[23] H.E. Murray, A.W. Anhalt, R. Lessard, et. al., ”A 12-month treatment of severe psoriasis with acitretin: results of a Canadian open multicenter study,” Journal of the American Academy of Dermatology, vol.24(4), pp.598–602, 1991. https://doi.org/10.1016/0190-9622(91)70091-f.
[24] E.A. Olsen, W.W. Weed, C.J. Meyer, L.M. Cobo, ”A double-blind, placebo-controlled trial of acitretin for the treatment of psoriasis,” Journal of the American Academy of Dermatology, vol.21(4 Pt 1), pp.681–686, 1989. https://doi.org/10.1016/s0190-9622(89)70236-x.
[25] J.H. Saurat, R.G. Langley, K. Reich, et. al., ”Relationship between methotrexate dosing and clinical response in patients with moderate to severe psoriasis: subanalysis of the CHAMPION study,” The British journal of dermatology, vol.165(2), pp.399–406, 2011. https://doi.org/10.1111/j.1365-2133.2011.10399.x.
[26] K. Reich, R.G. Langley, K.A. Papp, et. al., ”A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis,” The New England journal of medicine, vol.365(17), pp.1586–1596, 2011. https://doi.org/10.1056/NEJMoa1010858.
[27] V. Lajevardi, Z. Hallaji, S. Daklan, et. al., ”The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque-type psoriasis: a single-blinded randomized controlled trial,” International journal of dermatology, vol.54(1), pp.95–101, 2015. https://doi.org/10.1111/ijd.12585.
[28] A. Al-Dabagh, S.A. Davis, M.A. Kinney, et. al., ”The effect of folate supplementation on methotrexate efficacy and toxicity in psoriasis patients and folic acid use by dermatologists in the USA,” American journal of clinical dermatology, vol.14(3), pp.155–161, 2013. https://doi.org/10.1007/s40257-013-0017-9.
[29] R.K. Sivamani, H. Goodarzi, M.S. Garcia, et. al., ”Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring,” Clinical reviews in allergy & immunology, vol.44(2), pp.121–140, 2013. https://doi.org/10.1007/s12016-012-8301-7.
[30] M. Kamata, Y. Tada, ”Efficacy and Safety of Biologics for Psoriasis and Psoriatic Arthritis and Their Impact on Comorbidities: A Literature Review,” International journal of molecular sciences, vol.21(5), pp.1690, 2020. https://doi.org/10.3390/ijms21051690.
[31] J. Vide, S. Magina, ”Moderate to severe psoriasis treatment challenges through the era of biological drugs,” Anais brasileiros de dermatologia, vol.92(5), pp.668–674, 2017. https://doi.org/10.1590/abd1806-4841.20175603.
[32] A. Menter, S.K. Tyring, K. Gordon, ”Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial,” Journal of the American Academy of Dermatology, vol.58(1), pp.106–115, 2008. https://doi.org/10.1016/j.jaad.2007.09.010.
[33] J.H. Saurat, G. Stingl, L. Dubertret, et. al., ”Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION),” The British journal of dermatology, vol.158(3), pp.558–566, 2008. https://doi.org/10.1111/j.1365-2133.2007.08315.x.
[34] K.A. Papp, R.G. Langley, M. Lebwohl, et. al., ”Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2),” Lancet (London, England), vol.371(9625), pp.1675–1684, 2008. https://doi.org/10.1016/S0140-6736(08)60726-6.
[35] G.G. Krueger, R.G. Langley, C. Leonardi et. al., ”A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis,” The New England journal of medicine, vol.356(6), pp.580–592, 2007. https://doi.org/10.1056/NEJMoa062382.
[36] C.E. Griffiths, B.E. Strober, P. van de Kerkhof et. al., ”Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis,” N Engl J Med, vol.362(2), pp.118-128, 2010. doi: 10.1056/NEJMoa0810652.
[37] M. Lebwohl, K. Papp, C. Han, et. al., ”Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial,” The British journal of dermatology, vol.162(1), pp.137–146, 2010. https://doi.org/10.1111/j.1365-2133.2009.09491.x.
[38] W. Carey, S. Glazer, A.B. Gottlieb, et. al., ”Relapse, rebound, and psoriasis adverse events: an advisory group report,” Journal of the American Academy of Dermatology, vol.54(4 Suppl 1), pp.S171–S181, 2006. https://doi.org/10.1016/j.jaad.2005.10.029.
[39] R.G. Langley, B.E. Elewski, M. Lebwohl, et. al., ”Secukinumab in plaque psoriasis--results of two phase 3 trials,” The New England journal of medicine, vol.371(4), pp.326–338 2014. https://doi.org/10.1056/NEJMoa1314258.
[40] A. López-Ferrer, E. Vilarrasa, L. Puig, ”Secukinumab (AIN457) for the treatment of psoriasis,” Expert Rev Clin Immunol, vol.11(11), pp.1177-1188, 2015. doi: 10.1586/1744666X.2015.1095092.
[41] M. Caproni, E.Antiga, L. Melani, et. al., ”Serum levels of IL-17 and IL-22 are reduced by etanercept, but not by acitretin, in patients with psoriasis: a randomized-controlled trial,” Journal of clinical immunology, vol.29(2), pp.210–214, 2009. https://doi.org/10.1007/s10875-008-9233-0.
[42] L. Barker, M. Hoffmann, G. Wozel, et. al., ”Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1),” The British journal of dermatology, vol.165(5), pp.1109–1117, 2011. https://doi.org/10.1111/j.1365-2133.2011.10615.x.
[43] A. B. Gottlieb, R. Evans, S. Li, et. al., ”Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial,” Journal of the American Academy of Dermatology, vol.51(4), pp.534–542, 2004. https://doi.org/10.1016/j.jaad.2004.02.021.
[44] K. Reich, F.O. Nestle, K. Papp, et. al., ”Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial,” Lancet (London, England), vol.366(9494), pp.1367–1374, 2005. https://doi.org/10.1016/S0140-6736(05)67566-6.
[45] A. Menter, S.R. Feldman, G.D. Weinstein, et. al., ”A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis,” Journal of the American Academy of Dermatology, vol.56(1), pp.31.e1–31.e315, 2007. https://doi.org/10.1016/j.jaad.2006.07.017.
[46] C. Paul, C.E.M. Griffiths, P.C.M. van de Kerkhof, et. al., ”Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study,” Journal of the American Academy of Dermatology, vol.80(1), pp.70–79.e3, 2019. https://doi.org/10.1016/j.jaad.2018.06.039.
[47] A. Blauvelt, M. Gooderham, L. Iversen et. al., ”Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3),” Journal of the American Academy of Dermatology, vol.77(5), pp.855–862, 2017. https://doi.org/10.1016/j.jaad.2017.06.153.
[48] S. Imafuku, H. Torisu-Itakura, A. Nishikawa, et. al., ”Efficacy and safety of ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis: Subgroup analysis of a placebo-controlled, phase 3 study (UNCOVER-1),” The Journal of dermatology, vol.44(11), pp.1285–1290, 2017. https://doi.org/10.1111/1346-8138.13927.
[49] P. Nash, B. Kirkham, M. Okada, M.; Rahman, P.; Combe, B.; Burmester, G. R.; Adams, D. H.; Kerr, L.; Lee, C.; Shuler, C. L.; Genovese, M.; SPIRIT-P2 Study Group et. al., ”Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial,” Lancet (London, England), vol.389(10086), pp.2317–2327, 2017. https://doi.org/10.1016/S0140-6736(17)31429-0.
[50] H. Saeki, H. Nakagawa, K. Nakajo et. al., ”Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52- week, open-label, phase 3 study (UNCOVER-J),” J. Dermatol, vol.44, pp.355–362, 2017. doi: 10.1111/1346-8138.13622.
[51] K.B. Gordon, A. Blauvelt, K.A. Papp, et. al., ”Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis,” N Engl J Med, vol.375(4), pp.345-356, 2016. doi: 10.1056/NEJMoa1512711.
[52] C.E. Griffiths, K. Reich, M. Lebwohl, et. al., ”Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials,” Lancet (London, England), vol.386(9993), pp.541–551, 2015. https://doi.org/10.1016/S0140-6736(15)60125-8.
[53] K.B. Gordon, B. Strober, M. Lebwohl, 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 (London, England), vol.392(10148), pp.650–661, 2018. https://doi.org/10.1016/S0140-6736(18)31713-6.
[54] K. Reich, C.E.M Griffiths, K.B. Gordon, et. al., ”Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials,” Journal of the American Academy of Dermatology, vol.82(4), pp.936–945, 2020. https://doi.org/10.1016/j.jaad.2019.11.040.
[55] K. Reich, A.W. Armstrong, R.G. Langley et. al., ”Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial,” Lancet (London, England), vol.394(10201), pp.831–839, 2019. https://doi.org/10.1016/S0140-6736(19)31773-8.
[56] A. Blauvelt, K.A. Papp, C.E. Griffiths, et. al., ”Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial,” Journal of the American Academy of Dermatology, vol.76(3), pp.405–417, 2017. https://doi.org/10.1016/j.jaad.2016.11.041.
[57] K.B. Gordon, A. Blauvelt, P. Foley, et. al., ”Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies,” The British journal of dermatology, vol.178(1), pp.132–139, 2018. https://doi.org/10.1111/bjd.16008.
[58] P. Foley, K. Gordon, C.E.M. Griffiths, et. al., ”Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials,” JAMA dermatology, vol.154(6), pp.676–683, 2018. https://doi.org/10.1001/jamadermatol.2018.0793.
[59] L. Puig, M. Lebwohl, H. Bachelez, et. al., ”Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial,” Journal of the American Academy of Dermatology, vol.82(2), pp.352–359, 2020. https://doi.org/10.1016/j.jaad.2019.05.095.
[60] M. Lebwohl, B. Strober, A. Menter, et. al., ”Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis,” The New England journal of medicine, vol.373(14), pp.1318–1328, 2015. https://doi.org/10.1056/NEJMoa1503824.
[61] L. Puig, J.M. Carrascosa, E. Daudén, et. al., ”Drug survival of conventional systemic and biologic therapies for moderate-to-severe psoriasis in clinical practice in Spain: prospective results from the SAHARA study,” The Journal of dermatological treatment, vol.31(4), pp.344–351, 2020. https://doi.org/10.1080/09546634.2019.1597244.
[62] R. Gniadecki, B. Bang, L.E. Bryld, et. al., ”Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris,” The British journal of dermatology, vol.172(1), pp.244–252, 2015. https://doi.org/10.1111/bjd.13343.
[63] R.B. Warren, C.H. Smith, Z.Z.N. Yiu 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),” The Journal of investigative dermatology, vol.135(11), pp.2632–2640, 2015. https://doi.org/10.1038/jid.2015.208.
[64] I.Y.K. Iskandar, R.B. Warren, M. Lunt, et. al., ”Differential Drug Survival of Second-Line Biologic Therapies in Patients with Psoriasis: Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR),” The Journal of investigative dermatology, vol.138(4), pp.775–784, 2018. https://doi.org/10.1016/j.jid.2017.09.044.
[65] A. Menter, N.J. Korman, C.A. Elmets, et. al., ”Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions,” Journal of the American Academy of Dermatology, vol.65(1), pp.137–174, 2011. https://doi.org/10.1016/j.jaad.2010.11.055.
[66] A.W. Armstrong, J. Bagel, A.S. Van Voorhees, et. al., ”Combining biologic therapies with other systemic treatments in psoriasis: evidence-based, best-practice recommendations from the Medical Board of the National Psoriasis Foundation,” JAMA dermatology, vol.151(4), pp.432–438, 2015. https://doi.org/10.1001/jamadermatol.2014.3456.
[67] S.M. Prescott, G.A. Zimmerman, A.R. Morrison, ”The effects of a diet rich in fish oil on human neutrophils: identification of leukotriene B5 as a metabolite,” Prostaglandins, vol.30(2), pp.209–227, 1985. https://doi.org/10.1016/0090-6980(85)90186-8.
[68] T.H. Lee, R.L. Hoover, J.D. Williams, et. al., ”Effect of dietary enrichment with eicosapentaenoic and docosahexaenoic acids on in vitro neutrophil and monocyte leukotriene generation and neutrophil function,” The New England journal of medicine, vol.312(19), pp.1217–1224, 1985. https://doi.org/10.1056/NEJM198505093121903.
[69] Wolters M. ”Diet and psoriasis: experimental data and clinical evidence,” The British journal of dermatology, vol.153(4), pp.706–714, 2005. https://doi.org/10.1111/j.1365-2133.2005.06781.x.
[70] V.A. Ziboh, K.A. Cohen, C.N. Ellis, et. al., ”Effects of dietary supplementation of fish oil on neutrophil and epidermal fatty acids. Modulation of clinical course of psoriatic subjects,” Archives of dermatology, vol.122(11), pp.1277–1282, 1986.
[71] D. Schena, G.C. Chieregato, M. de Gironcoli, et. al., ”Increased erythrocyte membrane arachidonate and platelet malondialdehyde (MDA) production in psoriasis: normalization after fish-oil,” Acta dermato-venereologica. Supplementum, vol.146, pp.42–44, 1989.
[72] A. Lassus, A.L. Dahlgren, M.J. Halpern, et. al., ”Effects of dietary supplementation with polyunsaturated ethyl ester lipids (Angiosan) in patients with psoriasis and psoriatic arthritis,” The Journal of international medical research, vol.18(1), pp.68–73, 1990. https://doi.org/10.1177/030006059001800109.
[73] K. Kragballe, and Fogh, ”A low-fat diet supplemented with dietary fish oil (Max-EPA) results in improvement of psoriasis and in formation of leukotriene B5,” Acta dermato-venereologica, vol.69(1), pp.23–28, 1989.
[74] K. Kragballe, ”Dietary supplementation with a combination of n-3 and n-6 fatty acids (super gamma-oil marine) improves psoriasis,” Acta dermato-venereologica, vol.69(3), 265–268, 1989.
[75] S.B. Bittiner, W.F. Tucker, I. Cartwright, S.S. Bleehen, ”A double-blind, randomised, placebo-controlled trial of fish oil in psoriasis,” Lancet (London, England), vol.1(8582), pp.378–380, 1988. https://doi.org/10.1016/s0140-6736(88)91181-6.
[76] B. Guida, A. Napoleone, R. Trio, et. al., ”Energy-restricted, n-3 polyunsaturated fatty acids-rich diet improves the clinical response to immuno-modulating drugs in obese patients with plaque-type psoriasis: a randomized control clinical trial,” Clinical nutrition (Edinburgh, Scotland), vol.33(3), pp.399–405, 2014. https://doi.org/10.1016/j.clnu.2013.09.010.
[77] K. Danno, and N. Sugie, ”Combination therapy with low-dose etretinate and eicosapentaenoic acid for psoriasis vulgaris,” The Journal of dermatology, vol.25(11), pp.703–705, 1998. https://doi.org/10.1111/j.1346-8138.1998.tb02487.x.
78] E. Puzenat, V. Bronsard, S. Prey, et. al., ”What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature,” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.24 Suppl 2, pp.10–16, 2010. https://doi.org/10.1111/j.1468-3083.2009.03562.x.
[79] P.V. Chernyshov, ”The Evolution of Quality of Life Assessment and Use in Dermatology,” Dermatology (Basel, Switzerland), vol.235(3), pp.167–174, 2019. https://doi.org/10.1159/000496923.
[80] S. Sherman, E. Hodak, L. Pavlovsky, L. ”Can etanercept treatment failure in moderate-to-severe psoriasis be overcome by addition of low-dose methotrexate? A single-center experience,” The Journal of dermatological treatment, vol.29(7), pp.666–670, 2018. https://doi.org/10.1080/09546634.2018.1441491.
[81] Q. Yu, Y. Tong, L. Cui, et. al., ”Efficacy and safety of etanercept combined plus methotrexate and comparison of expression of pro-inflammatory factors expression for the treatment of moderate-to-severe plaque psoriasis,” International immunopharmacology, vol.73, pp.442–450, 2019. https://doi.org/10.1016/j.intimp.2019.05.042.
[82] P. Gisondi, F. Bellinato, M. Bruni, et. al., ”Methotrexate vs secukinumab safety in psoriasis patients with metabolic syndrome,” Dermatologic therapy, vol.33(6), e14281, 2020. https://doi.org/10.1111/dth.14281.
[83] K. Reich, M. Augustin, D. Thaçi, et. al., ”A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment,” The British journal of dermatology, vol.182(4), pp.869–879, 2020. https://doi.org/10.1111/bjd.18384.
[84] S. Khandpur, A. Singh, A. Kumar, A. Sharma, ”A preliminary prospective non-randomized controlled trial to compare the efficacy of subcutaneous etanercept versus oral methotrexate in moderate-to-severe chronic plaque psoriasis and correlation of response with T helper (th) 1, th2, th17 and T regulatory cytokine patterns,” Indian journal of dermatology, venereology and leprology, vol.86(4), pp.441–445, 2020. https://doi.org/10.4103/ijdvl.IJDVL_443_19.
[85] D. Thaçi, A. Pinter, M. Sebastian, et. al., ”Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS),” The British journal of dermatology, vol.183(2), pp.265–275, 2020. https://doi.org/10.1111/bjd.18696.
[86] G. Holzer, M. Hoke, S. Sabeti-Sandor, et. al., ”Disparate effects of adalimumab and fumaric acid esters on cardiovascular risk factors in psoriasis patients: results from a prospective, randomized, observer-blinded head-to-head trial,” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.35(2), pp.441–449, 2021. https://doi.org/10.1111/jdv.16635.
[87] A. Pinter, M. Hoffmann, K. Reich, et. al., ”A phase 4, randomized, head-to-head trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate-to-severe plaque psoriasis (CHANGE),” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.35(3), pp.701–711, 2021. https://doi.org/10.1111/jdv.16932.
[88] D. Thaçi, A.M. Soliman, K. Eyerich, et. al., ”Patient-reported outcomes with risankizumab versus fumaric acid esters in systemic therapy-naïve patients with moderate to severe plaque psoriasis: a phase 3 clinical trial,” Journal of the European Academy of Dermatology and Venereology : JEADV, 2021, vol.35(8), pp.1686–1691, 2021. https://doi.org/10.1111/jdv.17109.
[89] G. van der Kraaij, C. Busard, J. van den Reek, et. al.,”Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial,” The Journal of investigative dermatology, vol.142(9), pp.2375–2383, 2022. https://doi.org/10.1016/j.jid.2022.01.033.
[90] D. Thaçi, K. Eyerich, A. Pinter et. al., ”Direct comparison of risankizumab and fumaric acid esters in systemic therapy-naïve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial,” The British journal of dermatology, vol.186(1), pp.30–39, 2022. https://doi.org/10.1111/bjd.20481.
[91] P. Gisondi, M. Del Giglio, C. Cotena, G. Girolomoni, ”Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial,” The British journal of dermatology, vol.158(6), pp.1345–1349, 2008. https://doi.org/10.1111/j.1365-2133.2008.08564.x.
[92] K. Reich, M. Gooderham, L. Green, et. al., ”The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE),” Journal of the European Academy of Dermatology and Venereology : JEADV, vol.31(3), pp. 507–517, 2017. https://doi.org/10.1111/jdv.14015.
[93] M. Sticherling, U. Mrowietz, M. Augustin, et. al., ”Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial,” The British journal of dermatology, vol.177(4), pp.1024–1032, 2017. https://doi.org/10.1111/bjd.15707.
Published
2023-04-15
How to Cite
Șandru, F., Giurcăneanu, C., Becheru, O., Popa, A., & Al-Shami, S. (2023). REAL-WORLD REGISTRY-BASED COMPARATIVE STUDY OF PATIENTS WITH PSORIASIS VULGARIS UNDER CONVENTIONAL SYSTEMIC TREATMENTS VS BIOLOGICS IN ROMANIA. Romanian Journal of Clinical Research, 6(1). Retrieved from https://rjcronline.com/index.php/rjcr/article/view/186
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