Risk of Cutaneous T Cell Lymphoma with Psoriasis Biologic Therapies

Overview

Journal Dermatol Ther (Heidelb)

Date 2023 Dec 3

PMID 38043065

Authors

Mitchell S Davis

Riley K Spencer

Chandler E Johnson

Kareem G Elhage

Joy Q Jin

Marwa Hakimi

Tina Bhutani

Wilson Liao

Affiliations

Soon will be listed here.

Abstract

Background: The risk of developing cutaneous T cell lymphoma (CTCL) in patients using psoriasis biologics has not been well characterized. The goals of this review were to investigate the incidence of CTCL in patients with psoriasis receiving biologic therapy in clinical trials and psoriasis registries, and to review cases of CTCL and biologic use reported in scientific publications.

Methods: The US National Library of Medicine clinical trials database (clinicaltrials.gov) was queried to identify phase 3 and 4 clinical trials of the 12 biologic agents currently FDA approved for psoriatic disease. The incidence of CTCL in these trials was examined and summarized. To examine the incidence of CTCL in psoriasis registries, a Medline search was conducted. Finally, we performed a systematic review of CTCL cases reported in the literature.

Results: Only two cases of CTCL were reported in 35,801 subjects with psoriasis receiving a biologic agent in the active arm of 108 psoriasis phase 3 clinical trials. One of these CTCL cases was determined by the investigator to be CTCL misdiagnosed as psoriasis prior to randomization. No cases of CTCL were reported in 5440 subjects with psoriasis in 34 phase 4 clinical trials. Only one case of CTCL was identified in 34,111 registry subjects. In the literature, tumor necrosis factor (TNF) inhibitors had the highest number of reported cases of CTCL (34 cases), followed by interleukin (IL)-17 inhibitors (7 cases), and IL-12/23 inhibitors (6 cases). No cases of CTCL were found to be reported with IL-23 inhibitors.

Conclusion: Our findings indicate that the development of CTCL is rare in the setting of psoriasis biologic use. Of the limited number of cases of CTCL found, most were in the setting of TNF inhibitor use and no cases of CTCL were reported in the setting of IL-23 inhibitor use.

Citing Articles

The Intersection of Psoriasis and Neoplasia: Risk Factors, Therapeutic Approaches, and Management Strategies.

Mateescu L, Savu A, Mutu C, Vaida C, Serban E, Bucur S Cancers (Basel). 2025; 16(24.

PMID: 39766123 PMC: 11674284. DOI: 10.3390/cancers16244224.

Increased Risk of Cutaneous T-Cell Lymphoma Development after Dupilumab Use for Atopic Dermatitis.

Mandel J, Mehta J, Hafer R, Ayub M, Nusrat F, Yang H Dermatol Ther. 2024; 2024.

PMID: 39668908 PMC: 11635927. DOI: 10.1155/2024/9924306.

The Role of Cytokines in Cutaneous T Cell Lymphoma: A Focus on the State of the Art and Possible Therapeutic Targets.

Guglielmo A, Zengarini C, Agostinelli C, Motta G, Sabattini E, Pileri A Cells. 2024; 13(7.

PMID: 38607023 PMC: 11012008. DOI: 10.3390/cells13070584.

References

Askling J, Fored C, Baecklund E, Brandt L, Backlin C, Ekbom A . Haematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonists. Ann Rheum Dis. 2005; 64(10):1414-20. PMC: 1755232. DOI: 10.1136/ard.2004.033241. View

CARSWELL E, Old L, Kassel R, Green S, Fiore N, Williamson B . An endotoxin-induced serum factor that causes necrosis of tumors. Proc Natl Acad Sci U S A. 1975; 72(9):3666-70. PMC: 433057. DOI: 10.1073/pnas.72.9.3666. View

Pixley J, Schaetzle T, Feldman S . A Review of Topical Roflumilast for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2022; 57(8):966-969. DOI: 10.1177/10600280221137750. View

Fiorentino D, Ho V, Lebwohl M, Leite L, Hopkins L, Galindo C . Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry. J Am Acad Dermatol. 2017; 77(5):845-854.e5. DOI: 10.1016/j.jaad.2017.07.013. View

Garcia-Doval I, Carretero G, Vanaclocha F, Ferrandiz C, Dauden E, Sanchez-Carazo J . Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. Arch Dermatol. 2012; 148(4):463-70. DOI: 10.1001/archdermatol.2011.2768. View

Gordon K, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y . 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. 2018; 392(10148):650-661. DOI: 10.1016/S0140-6736(18)31713-6. View

Amin M, No D, Egeberg A, Wu J . Choosing First-Line Biologic Treatment for Moderate-to-Severe Psoriasis: What Does the Evidence Say?. Am J Clin Dermatol. 2017; 19(1):1-13. DOI: 10.1007/s40257-017-0328-3. View

Ghosh S, Gensler L, Yang Z, Gasink C, Chakravarty S, Farahi K . Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019; 42(6):751-768. PMC: 6520311. DOI: 10.1007/s40264-019-00797-3. View

Brauchli Y, Jick S, Miret M, Meier C . Psoriasis and risk of incident cancer: an inception cohort study with a nested case-control analysis. J Invest Dermatol. 2009; 129(11):2604-12. DOI: 10.1038/jid.2009.113. View

10.

Strober B, Karki C, Mason M, Guo N, Holmgren S, Greenberg J . Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry. J Am Acad Dermatol. 2017; 78(2):323-332. DOI: 10.1016/j.jaad.2017.10.012. View

11.

Wolfe F, Michaud K . The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum. 2007; 56(5):1433-9. DOI: 10.1002/art.22579. View

12.

Mercer L, Galloway J, Lunt M, Davies R, Low A, Dixon W . Risk of lymphoma in patients exposed to antitumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Ann Rheum Dis. 2016; 76(3):497-503. PMC: 5446004. DOI: 10.1136/annrheumdis-2016-209389. View

13.

Burden A, Warren R, Kleyn C, McElhone K, Smith C, Reynolds N . The British Association of Dermatologists' Biologic Interventions Register (BADBIR): design, methodology and objectives. Br J Dermatol. 2012; 166(3):545-54. DOI: 10.1111/j.1365-2133.2012.10835.x. View

14.

Martinez-Escala M, Posligua A, Wickless H, Rutherford A, Sable K, Rubio-Gonzalez B . Progression of undiagnosed cutaneous lymphoma after anti-tumor necrosis factor-alpha therapy. J Am Acad Dermatol. 2018; 78(6):1068-1076. PMC: 5951749. DOI: 10.1016/j.jaad.2017.12.068. View

15.

Dauden E, Carretero G, Rivera R, Ferrandiz C, Llamas-Velasco M, de la Cueva P . Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. J Am Acad Dermatol. 2020; 83(1):139-150. DOI: 10.1016/j.jaad.2020.03.033. View

16.

Singh R, Chacharkar M . Dried gamma-irradiated amniotic membrane as dressing in burn wound care. J Tissue Viability. 2010; 20(2):49-54. DOI: 10.1016/j.jtv.2010.06.001. View

17.

Geborek P, Bladstrom A, Turesson C, Gulfe A, Petersson I, Saxne T . Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas. Ann Rheum Dis. 2005; 64(5):699-703. PMC: 1755491. DOI: 10.1136/ard.2004.030528. View

18.

Hellgren K, Dreyer L, Arkema E, Glintborg B, Jacobsson L, Kristensen L . Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers. Ann Rheum Dis. 2016; 76(1):105-111. DOI: 10.1136/annrheumdis-2016-209270. View

19.

Blauvelt A, Reich K, Papp K, Kimball A, Gooderham M, Tyring S . Safety of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials. Br J Dermatol. 2018; 179(3):615-622. DOI: 10.1111/bjd.16724. View

20.

Kalb R, Fiorentino D, Lebwohl M, Toole J, Poulin Y, Cohen A . Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015; 151(9):961-9. DOI: 10.1001/jamadermatol.2015.0718. View