Discontinuation of Fumaric Acid Esters is Affected by Depressive Symptomatology: A Retrospective Analysis
DOI:
https://doi.org/10.2340/actadv.v104.12326Keywords:
Adverse events, Discontinuation, Depression, Fumaric Acid Esters, PsoriasisAbstract
Fumaric acid esters (FAEs) remain a widespread therapy option for moderate-to-severe psoriasis. However, drug survival of FAEs is limited by adverse events (AEs) or inadequate treatment response. Depressive disturbances are highly prevalent in psoriasis patients and are hypothesized to be associated with the reporting of AEs and therapy discontinuation. This study’s aim was to analyze whether psoriasis patients with comorbid depressive symptomatology are more likely to discontinue treatment with FAEs due to AEs and/or inadequate treatment response. Data were retrospectively extracted from the records of patients starting therapy with FAEs in the Department of Dermatology, University Hospital Essen, Germany between 2017 and 2022, covering the first 52 weeks of treatment. Psoriasis severity and depressive symptomatology, as well as AEs and therapy discontinuation, were analyzed. Psoriasis patients (N = 95, 47.37% female) with depressive symptomatology (42.11%) were more likely to discontinue therapy due to patient-reported AEs, while the total number of reported AEs was not associated with depression. The results support the hypothesis that among psoriasis patients with depressive symptoms, the associated introspection and somatization may result in increased sensitivity for AEs and thus in quicker therapy discontinuation. In these patients, the occurrence of nocebo effects should be minimized, e.g. by special communication techniques.
Downloads
References
Schäfer I, Rustenbach SJ, Radtke M, Augustin J, Glaeske G, Augustin M. Epidemiologie der Psoriasis in Deutschland - Auswertung von Sekundärdaten einer gesetzlichen Krankenversicherung. Gesundheitswesen 2011; 73: 308-313.
https://doi.org/10.1055/s-0030-1252022 DOI: https://doi.org/10.1055/s-0030-1252022
Dauden E, Blasco AJ, Bonanad C, Botella R, Carrascosa JM, Gonzalez-Parra E, et al. Position statement for the management of comorbidities in psoriasis. J Eur Acad Dermatol Venereol 2018; 32: 2058-2073.
https://doi.org/10.1111/jdv.15177 DOI: https://doi.org/10.1111/jdv.15177
Armesto S, Coto-Segura P, Osuna CG, Camblor PM, Santos-Juanes J. Psoriasis and hypertension: a case-control study. J Eur Acad Dermatol Venereol 2012; 26: 785-788.
https://doi.org/10.1111/j.1468-3083.2011.04108.x DOI: https://doi.org/10.1111/j.1468-3083.2011.04108.x
Setty AR, Curhan G, Choi HK. Obesity, waist circumference, weight change, and the risk of psoriasis in women: Nurses' Health Study II. Arch Intern Med 2007; 167: 1670-1675.
https://doi.org/10.1001/archinte.167.15.1670 DOI: https://doi.org/10.1001/archinte.167.15.1670
Correia B, Torres T. Obesity: a key component of psoriasis. Acta Biomed 2015; 86: 121-129.
Gyldenlove M, Storgaard H, Holst JJ, Vilsboll T, Knop FK, Skov L. Patients with psoriasis are insulin resistant. J Am Acad Dermatol 2015; 72: 599-605.
https://doi.org/10.1016/j.jaad.2015.01.004 DOI: https://doi.org/10.1016/j.jaad.2015.01.004
Lønnberg AS, Skov L, Skytthe A, Kyvik KO, Pedersen OB, Thomsen SF. Association of psoriasis with the risk for type 2 diabetes mellitus and obesity. JAMA Dermatol 2016; 152: 761-767.
https://doi.org/10.1001/jamadermatol.2015.6262 DOI: https://doi.org/10.1001/jamadermatol.2015.6262
Hölsken S, Krefting F, Schedlowski M, Sondermann W. Common fundamentals of psoriasis and depression. Acta Derm Venereol 2021; 101: adv00609.
https://doi.org/10.2340/actadv.v101.565 DOI: https://doi.org/10.2340/actadv.v101.565
Koo J, Marangell LB, Nakamura M, Armstrong A, Jeon C, Bhutani T, et al. Depression and suicidality in psoriasis: review of the literature including the cytokine theory of depression. J Eur Acad Dermatol Venereol 2017; 31: 1999-2009.
https://doi.org/10.1111/jdv.14460 DOI: https://doi.org/10.1111/jdv.14460
Tribo MJ, Turroja M, Castano-Vinyals G, Bulbena A, Ros E, Garcia-Martinez P, et al. Patients with moderate to severe psoriasis associate with higher risk of depression and anxiety symptoms: results of a multivariate study of 300 Spanish individuals with psoriasis. Acta Derm Venereol 2019; 99: 417-422.
https://doi.org/10.2340/00015555-3114 DOI: https://doi.org/10.2340/00015555-3114
Kurd SK, Troxel AB, Crits-Christoph P, Gelfand JM. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol 2010; 146: 891-895.
https://doi.org/10.1001/archdermatol.2010.186 DOI: https://doi.org/10.1001/archdermatol.2010.186
Nast A, Altenburg A, Augustin M, Boehncke WH, Härle P, Klaus J, et al. German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 1: Treatment goals and treatment recommendations. J Dtsch Dermatol Ges 2021; 19: 934-150.
https://doi.org/10.1111/ddg.14508 DOI: https://doi.org/10.1111/ddg.14508
Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csorgo Z, Boonen H, et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol 2020; 34: 2461-2498.
https://doi.org/10.1111/jdv.16915 DOI: https://doi.org/10.1111/jdv.16915
Kamata M, Tada Y. Efficacy and safety of biologics for psoriasis and psoriatic arthritis and their impact on comorbidities: a literature review. Int J Mol Sci 2020; 21: 1690.
https://doi.org/10.3390/ijms21051690 DOI: https://doi.org/10.3390/ijms21051690
Hur P, Kim N, Dai D, Piao OW, Zheng JZ, Yi E. Healthcare cost and utilization associated with biologic treatment patterns among patients with psoriatic arthritis: analyses from a large US claims database. Drugs Real World Outcomes 2021; 8: 29-38.
https://doi.org/10.1007/s40801-020-00217-4 DOI: https://doi.org/10.1007/s40801-020-00217-4
Gemeinsame Arbeitsgruppe Arzneimittel KVN, Verbände der gesetzlichen Krankenkassen in Niedersachsen. Medikamentöse Therapie bei Psoriasis vulgaris, 2022.
Mrowietz U, Szepietowski JC, Loewe R, van de Kerkhof P, Lamarca R, Ocker WG, et al. Efficacy and safety of LAS41008 (dimethyl fumarate) in adults with moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, Fumaderm((R)) - and placebo-controlled trial (BRIDGE). Br J Dermatol 2017; 176: 615-623.
https://doi.org/10.1111/bjd.14947 DOI: https://doi.org/10.1111/bjd.14947
Ismail N, Collins P, Rogers S, Kirby B, Lally A. Drug survival of fumaric acid esters for psoriasis: a retrospective study. Br J Dermatol 2014; 171: 397-402.
https://doi.org/10.1111/bjd.12849 DOI: https://doi.org/10.1111/bjd.12849
Corazza M, Odorici G, Conti A, Di Lernia V, Motolese A, Bardazzi F, et al. Dimethyl fumarate treatment for psoriasis in a real-life setting: a multicentric retrospective study. Dermatol Ther 2021; 34: e15066.
https://doi.org/10.1111/dth.15066 DOI: https://doi.org/10.1111/dth.15066
Pezzolo E, Cazzaniga S, Di Leo S, Naldi L, PsoReal Study G. Efficacy and safety of Dimethyl fumarate in comparison with conventional therapy for psoriasis: an Italian real-world clinical experience. J Eur Acad Dermatol Venereol 2022; 36: e534-e537.
https://doi.org/10.1111/jdv.17997 DOI: https://doi.org/10.1111/jdv.17997
Schedlowski M, Enck P, Rief W, Bingel U. Neuro-bio-behavioral mechanisms of placebo and nocebo responses: implications for clinical trials and clinical practice. Pharmacol Rev 2015; 67: 697-730.
https://doi.org/10.1124/pr.114.009423 DOI: https://doi.org/10.1124/pr.114.009423
Symon A, Williams B, Adelasoye QA, Cheyne H. Nocebo and the potential harm of 'high risk' labelling: a scoping review. J Adv Nurs 2015; 71: 1518-1529.
https://doi.org/10.1111/jan.12637 DOI: https://doi.org/10.1111/jan.12637
Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P, Albert US, et al. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol 2016; 27: 1909-1915.
https://doi.org/10.1093/annonc/mdw266 DOI: https://doi.org/10.1093/annonc/mdw266
Nast A, Altenburg A, Augustin M, Boehncke WH, Harle P, Klaus J, et al. Deutsche S3-Leitlinie zur Therapie der Psoriasis vulgaris, adaptiert von EuroGuiDerm - Teil 2: Therapiemonitoring, besondere klinische Situationen und Komorbiditat. J Dtsch Dermatol Ges 2021; 19: 1092-1117.
https://doi.org/10.1111/ddg.14507_g DOI: https://doi.org/10.1111/ddg.14507_g
Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csorgo Z, Boonen H, et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 2: specific clinical and comorbid situations. J Eur Acad Dermatol Venereol 2021; 35: 281-317.
https://doi.org/10.1111/jdv.16926 DOI: https://doi.org/10.1111/jdv.16926
Torres T, Puig L, Vender R, Lynde C, Piaserico S, Carrascosa JM, et al. Drug survival of IL-12/23, IL-17 and IL-23 inhibitors for psoriasis treatment: a retrospective multi-country, multicentric cohort study. Am J Clin Dermatol 2021; 22: 567-579.
https://doi.org/10.1007/s40257-021-00598-4 DOI: https://doi.org/10.1007/s40257-021-00598-4
Whooley MA, Avins AL, Miranda J, Browner WS. Case-finding instruments for depression: two questions are as good as many. J Gen Intern Med 1997; 12: 439-445.
https://doi.org/10.1046/j.1525-1497.1997.00076.x DOI: https://doi.org/10.1046/j.1525-1497.1997.00076.x
Radtke MA, Mrowietz U, Feuerhahn J, Harter M, von Kiedrowski R, Nast A, et al. Early detection of comorbidity in psoriasis: recommendations of the National Conference on Healthcare in Psoriasis. J Dtsch Dermatol Ges 2015; 13: 674-690.
https://doi.org/10.1111/ddg.12643 DOI: https://doi.org/10.1111/ddg.12643
Hölsken S, Krefting F, Schneider L, Benson S, Schedlowski M, Sondermann W. A brief screening tool for depression in psoriasis patients: the Two Questions Test in clinical practice. J Dermatol 2022; 49: 341-348.
https://doi.org/10.1111/1346-8138.16241 DOI: https://doi.org/10.1111/1346-8138.16241
Beck AT, Steer RA. Internal consistencies of the original and revised Beck Depression Inventory. J Clin Psychol 1984; 40: 1365-1367.
https://doi.org/10.1002/1097-4679(198411)40:6<1365::AID-JCLP2270400615>3.0.CO;2-D DOI: https://doi.org/10.1002/1097-4679(198411)40:6<1365::AID-JCLP2270400615>3.0.CO;2-D
Bosanquet K, Bailey D, Gilbody S, Harden M, Manea L, Nutbrown S, et al. Diagnostic accuracy of the Whooley questions for the identification of depression: a diagnostic meta-analysis. BMJ Open 2015; 5: e008913.
https://doi.org/10.1136/bmjopen-2015-008913 DOI: https://doi.org/10.1136/bmjopen-2015-008913
von Glischinski M, von Brachel R, Hirschfeld G. How depressed is "depressed"? A systematic review and diagnostic meta-analysis of optimal cut points for the Beck Depression Inventory revised (BDI-II). Qual Life Res 2019; 28: 1111-1118.
https://doi.org/10.1007/s11136-018-2050-x DOI: https://doi.org/10.1007/s11136-018-2050-x
Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: twenty-five years of evaluation. Clin Psychol Rev 1988; 8: 77-100.
https://doi.org/10.1016/0272-7358(88)90050-5 DOI: https://doi.org/10.1016/0272-7358(88)90050-5
Fredriksson T, Pettersson U. Severe psoriasis: oral therapy with a new retinoid. Dermatologica 1978; 157: 238-244.
https://doi.org/10.1159/000250839 DOI: https://doi.org/10.1159/000250839
Team RC. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2022.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007; 39: 175-191.
https://doi.org/10.3758/BF03193146 DOI: https://doi.org/10.3758/BF03193146
Wickham H. ggplot2: elegant graphics for data analysis. New York: Springer-Verlag, 2009.
https://doi.org/10.1007/978-0-387-98141-3 DOI: https://doi.org/10.1007/978-0-387-98141-3
Van Gundy K, Schieman S. Looking inward: introspectiveness, physical disability, and depression across the life course. Int J Aging Hum Dev 2001; 53: 293-310.
https://doi.org/10.2190/XEYW-H4XR-JBAF-2L6K DOI: https://doi.org/10.2190/XEYW-H4XR-JBAF-2L6K
DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med 2000; 160: 2101-2107.
https://doi.org/10.1001/archinte.160.14.2101 DOI: https://doi.org/10.1001/archinte.160.14.2101
Enck P, Bingel U, Schedlowski M, Rief W. The placebo response in medicine: minimize, maximize or personalize? Nat Rev Drug Discov 2013; 12: 191-204.
https://doi.org/10.1038/nrd3923 DOI: https://doi.org/10.1038/nrd3923
Colloca L, Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. JAMA 2012; 307: 567-568.
https://doi.org/10.1001/jama.2012.115 DOI: https://doi.org/10.1001/jama.2012.115
Corsi N, Colloca L. Placebo and nocebo effects: the advantage of measuring expectations and psychological factors. Front Psychol 2017; 8: 308.
https://doi.org/10.3389/fpsyg.2017.00308 DOI: https://doi.org/10.3389/fpsyg.2017.00308
Sondermann W, Reinboldt-Jockenhöfer F, Dissemond J, Pfaar O, Bingel U, Schedlowski M. Effects of patients' expectation in dermatology: evidence from experimental and clinical placebo studies and implications for dermatologic practice and research. Dermatology 2021; 237: 857-871.
https://doi.org/10.1159/000513445 DOI: https://doi.org/10.1159/000513445
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2024 Frederik Krefting, Stefanie Hölsken, Manfred Schedlowski, Wiebke Sondermann
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All digitalized ActaDV contents is available freely online. The Society for Publication of Acta Dermato-Venereologica owns the copyright for all material published until volume 88 (2008) and as from volume 89 (2009) the journal has been published fully Open Access, meaning the authors retain copyright to their work.
Unless otherwise specified, all Open Access articles are published under CC-BY-NC licences, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for non-commercial purposes, provided proper attribution to the original work.
