Biologics (Use of Biological Agents in the Geriatric Patient Population)
Özet
The development of biological therapies in dermatology represents a significant milestone, driven by advances in understanding the pathophysiology of inflammatory skin diseases and the discovery of new therapeutic pathways. Biological therapies are molecules that specifically target cytokines involved in immune-mediated diseases. These treatments have been successfully utilized in dermatology for managing inflammatory dermatoses, particularly psoriasis, urticaria, autoimmune bullous diseases, and atopic dermatitis. However, due to the frequent underrepresentation of elderly patients in clinical trials, clinical and therapeutic data for this population remain relatively limited. The physiological changes associated with aging, along with comorbidities and polypharmacy, complicate treatment management in elderly patients. Traditional systemic anti-inflammatory agents, such as systemic corticosteroids, methotrexate, and cyclosporine, are often avoided in older adults due to the increased risk of toxicity and adverse effects. In contrast, biological agents, with their more favorable efficacy and safety profiles, may represent a more suitable therapeutic option for elderly patients.
Referanslar
Fathi R, Armstrong AW. The Role of Biologic Therapies in Dermatology. Med Clin North Am. 2015;99(6):1183-1194. doi:10.1016/j.mcna.2015.07.008
Megna M, Potestio L, Fabbrocini G, Camela E. Treating psoriasis in the elderly: biologics and small molecules. Expert Opin Biol Ther. 2022;22(12):1503-1520. doi:10.1080/14712598.2022.2089020
TÜRKDERM TÜRKİYE PSÖRİAZİS KILAVUZU 2022. 2022;56. doi:10.4274/turkderm.galenos.2022.81594
Rademaker M, Agnew K, Anagnostou N, et al. Psoriasis and infection. A clinical practice narrative. Australas J Dermatol. 2019;60(2):91-98. doi:10.1111/ajd.12895
Patel D, Maczuga S, Helm MF, Foulke GT. A retrospective cohort study confirms that prophylactic vaccination is underused in patients on tumor necrosis factor inhibitors. J Am Acad Dermatol. 2021;84(4):1150-1152. doi:10.1016/j.jaad.2020.07.018
Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39-52. doi:10.1136/annrheumdis-2019-215882
Pithadia DJ, Reynolds KA, Lee EB, Wu JJ. Translating the 2019 AAD-NPF Guidelines of Care for the Management of Psoriasis With Biologics to clinical practice. Cutis. 2019;104(2S):12-16.
Fahim C, Kim BW, Bourcier M, et al. Checklist for the Systemic Treatment of Psoriasis Using Biologics: A Delphi Study. J Cutan Med Surg. 2019;23(3):282-288. doi:10.1177/1203475419833605
Tavakolpour S, Alesaeidi S, Darvishi M, et al. A comprehensive review of rituximab therapy in rheumatoid arthritis patients. Clin Rheumatol. 2019;38(11):2977-2994. doi:10.1007/s10067-019-04699-8
Veilleux MS, Shear NH. Biologics in patients with skin diseases. J Allergy Clin Immunol. 2017;139(5):1423-1430. doi:10.1016/j.jaci.2017.03.012
Megna M, Camela E, Battista T, et al. Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part II: focus on elderly patients. Expert Opin Drug Saf. 2023;22(1):43-58. doi:10.1080/14740338.2023.2173171
Migliore A, Bizzi E, Laganà B, et al. The safety of anti-TNF agents in the elderly. Int J Immunopathol Pharmacol. 2009;22(2):415-426. doi:10.1177/039463200902200218
Di Lernia V, Goldust M. An overview of the efficacy and safety of systemic treatments for psoriasis in the elderly. Expert Opin Biol Ther. 2018;18(8):897-903. doi:10.1080/14712598.2018.1504016
Esposito M, Giunta A, Mazzotta A, et al. Efficacy and safety of subcutaneous anti-tumor necrosis factor-alpha agents, etanercept and adalimumab, in elderly patients affected by psoriasis and psoriatic arthritis: an observational long-term study. Dermatol Basel Switz. 2012;225(4):312-319. doi:10.1159/000345623
Borren NZ, Ananthakrishnan AN. Safety of Biologic Therapy in Older Patients With Immune-Mediated Diseases: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2019;17(9):1736-1743.e4. doi:10.1016/j.cgh.2018.12.032
Ricceri F, Bardazzi F, Chiricozzi A, et al. Elderly psoriatic patients under biological therapies: an Italian experience. J Eur Acad Dermatol Venereol JEADV. 2019;33(1):143-146. doi:10.1111/jdv.15139
Product label and information for Remicade avalilable at: https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_en.pdf
Chiricozzi A, Pavlidis A, Dattola A, et al. Efficacy and safety of infliximab in psoriatic patients over the age of 65. Expert Opin Drug Saf. 2016;15(11):1459-1462. doi:10.1080/14740338.2016.1226279
Product label and information for Enbrel avalilable at: https://www.ema.europa.eu/en/documents/product-information/enbrel-epar-product-information_en.pdf
Militello G, Xia A, Stevens SR, Van Voorhees AS. Etanercept for the treatment of psoriasis in the elderly. J Am Acad Dermatol. 2006;55(3):517-519. doi:10.1016/j.jaad.2006.02.010
Burmester GR, Gordon KB, Rosenbaum JT, et al. Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis. Adv Ther. 2020;37(1):364-380. doi:10.1007/s12325-019-01145-8
Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol. 2010;63(3):448-456. doi:10.1016/j.jaad.2009.09.040
Chiricozzi A, Zangrilli A, Bavetta M, Bianchi L, Chimenti S, Saraceno R. Real-life 9-year experience with adalimumab in psoriasis and psoriatic arthritis: results of a single-centre, retrospective study. J Eur Acad Dermatol Venereol JEADV. 2017;31(2):304-311. doi:10.1111/jdv.13771
Product label and information for Cimzia avalilable at: https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdf
Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5. doi:10.1016/j.jaad.2018.04.013
Megna M, Napolitano M, Balato N, et al. Efficacy and safety of ustekinumab in a group of 22 elderly patients with psoriasis over a 2-year period. Clin Exp Dermatol. 2016;41(5):564-566. doi:10.1111/ced.12850
Hayashi M, Umezawa Y, Fukuchi O, Ito T, Saeki H, Nakagawa H. Efficacy and safety of ustekinumab treatment in elderly patients with psoriasis. J Dermatol. 2014;41(11):974-980. doi:10.1111/1346-8138.12653
Momose M, Asahina A, Hayashi M, Yanaba K, Umezawa Y, Nakagawa H. Biologic treatments for elderly patients with psoriasis. J Dermatol. 2017;44(9):1020-1023. doi:10.1111/1346-8138.13853
Shary N, Kalb RE. Optimizing the Treatment of Moderate-to-Severe Psoriasis in Older Adults. Drugs Aging. 2020;37(10):715-723. doi:10.1007/s40266-020-00790-x
PHAN C, BENETON N, DELAUNAY J, et al. Effectiveness and Safety of Anti-interleukin-17 Therapies in Elderly Patients with Psoriasis. Acta Derm Venereol. 2020;100(18):5925. doi:10.2340/00015555-3678
Körber A, Papavassilis C, Bhosekar V, Reinhardt M. Efficacy and Safety of Secukinumab in Elderly Subjects with Moderate to Severe Plaque Psoriasis: A Pooled Analysis of Phase III Studies. Drugs Aging. 2018;35(2):135-144. doi:10.1007/s40266-018-0520-z
Wu JJ, Merola JF, Feldman SR, Menter A, Lebwohl M. Treatment of Psoriasis with Secukinumab in Challenging Patient Scenarios: A Review of the Available Evidence. Dermatol Ther. 2020;10(3):351-364. doi:10.1007/s13555-020-00373-z
Megna M, Camela E, Cinelli E, Fabbrocini G. Real-life efficacy and safety of secukinumab in elderly patients with psoriasis over a 2-year period. Clin Exp Dermatol. 2020;45(7):848-852. doi:10.1111/ced.14258
Sandhu VK, Ighani A, Fleming P, Lynde CW. Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review. J Cutan Med Surg. 2020;24(2):174-186. doi:10.1177/1203475419897578
Di Caprio R, Caiazzo G, Cacciapuoti S, Fabbrocini G, Scala E, Balato A. Safety concerns with current treatments for psoriasis in the elderly. Expert Opin Drug Saf. 2020;19(4):523-531. doi:10.1080/14740338.2020.1728253
Bakirtzi K, Sotiriou E, Papadimitriou I, et al. Elderly patients with psoriasis: long-term efficacy and safety of modern treatments. J Dermatol Treat. 2022;33(3):1339-1342. doi:10.1080/09546634.2020.1809623
Kostović K, Žužul K, Čeović R, Bukvić Mokos Z. Psoriasis in the mature patient: Therapeutic approach in the era of biologics. Clin Dermatol. 2018;36(2):222-230. doi:10.1016/j.clindermatol.2017.10.013
Di Lernia V, Bombonato C, Motolese A. COVID-19 in an elderly patient treated with secukinumab. Dermatol Ther. 2020;33(4):e13580. doi:10.1111/dth.13580
Megna M, Potestio L, Camela E, Fabbrocini G, Ruggiero A. Ixekizumab and brodalumab indirect comparison in the treatment of moderate to severe psoriasis: Results from an Italian single‐center retrospective study in a real‐life setting. Dermatol Ther. 2022;35(9):e15667. doi:10.1111/dth.15667
Megna M, Cinelli E, Balato A, Gallo L, Fabbrocini G. Efficacy and safety of ixekizumab in a group of 16 elderly patients with psoriasis over a 1-year period. J Eur Acad Dermatol Venereol JEADV. 2020;34(3):e152-e153. doi:10.1111/jdv.16063
Gallo L, Ruggiero A, Fabbrocini G, Megna M. A case of severe psoriasis in a 84-year-old women successfully treated with ixekizumab. Dermatol Ther. 2020;33(3):e13299. doi:10.1111/dth.13299
Puig L, Lebwohl M, Bachelez H, Sobell J, Jacobson AA. 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. J Am Acad Dermatol. 2020;82(2):352-359. doi:10.1016/j.jaad.2019.05.095
Product label and information for Bimzelx avalilable at: https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx#product-info
Orsini D, Megna M, Assorgi C, et al. Efficacy and Safety of bimekizumab in elderly patients: real-world multicenter retrospective study - IL PSO (Italian Landscape Psoriasis). J Dermatol Treat. 2024;35(1):2393376. doi:10.1080/09546634.2024.2393376
Product label and information for Skyrizi avalilable at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf
Ruggiero A, Fabbrocini G, Cinelli E, Ocampo Garza SS, Camela E, Megna M. Anti-interleukin-23 for psoriasis in elderly patients: guselkumab, risankizumab and tildrakizumab in real-world practice. Clin Exp Dermatol. 2022;47(3):561-567. doi:10.1111/ced.14979
A case of erythrodermic psoriasis successfully treated with guselkumab - Megna - 2020 - Dermatologic Therapy - Wiley Online Library. Accessed August 17, 2024. https://onlinelibrary.wiley.com/doi/abs/10.1111/dth.13238
Product label and information for Tremfya avalilable at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis - Crowley - 2019 - Journal of the European Academy of Dermatology and Venereology - Wiley Online Library. Accessed August 17, 2024. https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.15653
Caldarola G, Zangrilli A, Bernardini N, et al. Risankizumab for the treatment of moderate-to-severe psoriasis: A multicenter, retrospective, 1 year real-life study. Dermatol Ther. 2022;35(6):e15489. doi:10.1111/dth.15489
Megna M, Potestio L, Ruggiero A, Camela E, Fabbrocini G. Risankizumab treatment in psoriasis patients who failed anti-IL17: A 52-week real-life study. Dermatol Ther. 2022;35(7):e15524. doi:10.1111/dth.15524
Ruggiero A, Fabbrocini G, Cinelli E, Megna M. Real world practice indirect comparison between guselkumab and risankizumab: Results from an Italian retrospective study. Dermatol Ther. 2022;35(1):e15214. doi:10.1111/dth.15214
Megna M, Cinelli E, Gallo L, Camela E, Ruggiero A, Fabbrocini G. Risankizumab in real life: preliminary results of efficacy and safety in psoriasis during a 16-week period. Arch Dermatol Res. 2022;314(6):619-623. doi:10.1007/s00403-021-02200-7
Gordon KB, Strober B, Lebwohl M, 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 Lond Engl. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
Product label and information for ilumetri avalilable at: https://www.ema.europa.eu/en/documents/product-information/ilumetri-epar-product-information_en.pdf
Megna M, Potestio L, Fabbrocini G, Cinelli E. Tildrakizumab: A new therapeutic option for erythrodermic psoriasis? Dermatol Ther. 2021;34(5):e15030. doi:10.1111/dth.15030
Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet Lond Engl. 2017;390(10091):276-288. doi:10.1016/S0140-6736(17)31279-5
Product label and information for Spevigo avalilable at: https://www.ema.europa.eu/en/medicines/human/EPAR/spevigo#product-info
Potestio L, Camela E, Cacciapuoti S, et al. Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation. Expert Opin Drug Saf. 2023;22(11):1003-1010. doi:10.1080/14740338.2023.2265295
Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766. doi:10.1111/all.15090
Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924-935. doi:10.1056/NEJMoa1215372
Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306
Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy - ScienceDirect. Accessed August 17, 2024. https://www.sciencedirect.com/science/article/pii/S0091674913008300?casa_token=JIDZJRjbAPQAAAAA:aJepQOCmbZ13vzcdvLUt3V5HamwCbsBzopwB-wUo2TB7W0BpcOZe47yYeRqGlj7lAsKByDe2Pw
Nettis E, Cegolon L, Di Leo E, et al. Omalizumab in elderly patients with chronic spontaneous urticaria: an Italian real-life experience. Ann Allergy Asthma Immunol. 2018;120(3):318-323.
Hamilton JD, Suárez-Fariñas M, Dhingra N, et al. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014;134(6):1293-1300. doi:10.1016/j.jaci.2014.10.013
Guttman-Yassky E, Bissonnette R, Ungar B, et al. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019;143(1):155-172. doi:10.1016/j.jaci.2018.08.022
Wang FP, Tang XJ, Wei CQ, Xu LR, Mao H, Luo FM. Dupilumab treatment in moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. J Dermatol Sci. 2018;90(2):190-198. doi:10.1016/j.jdermsci.2018.01.016
Product label and information for Mabthera avalilable at: https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf
Payet S, Soubrier M, Perrodeau E, et al. Efficacy and safety of rituximab in elderly patients with rheumatoid arthritis enrolled in a French Society of Rheumatology registry. Arthritis Care Res. 2014;66(9):1289-1295. doi:10.1002/acr.22314
Timlin H, Lee SM, Manno RL, Seo P, Geetha D. Rituximab for remission induction in elderly patients with ANCA-associated vasculitis. Semin Arthritis Rheum. 2015;45(1):67-69. doi:10.1016/j.semarthrit.2015.02.005
Thietart S, Karras A, Augusto JF, et al. Evaluation of Rituximab for Induction and Maintenance Therapy in Patients 75 Years and Older With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis. JAMA Netw Open. 2022;5(7):e2220925. doi:10.1001/jamanetworkopen.2022.20925
Mielnik P, Sexton J, Lie E, et al. Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register. Drugs Aging. 2020;37(8):617-626. doi:10.1007/s40266-020-00782-x
Megna M, Potestio L, Battista T, et al. Immune response to COVID-19 mRNA vaccination in patients with psoriasis undergoing treatment with biologics. Clin Exp Dermatol. 2022;47(12):2310-2312. doi:10.1111/ced.15395