BACKGROUND: In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated. METHODS: We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period. RESULTS: A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy. CONCLUSIONS: Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.
Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study / NUNZIATI, Giulia; DI CESARE, Antonella; ROSI, Elia; SCANDAGLI, Ilaria; SILVI, Gianmarco; GUERRA, Prisca; PRIGNANO, Francesca. - In: ITALIAN JOURNAL OF DERMATOLOGY AND VENEREOLOGY. - ISSN 2784-8450. - STAMPA. - 160:(2025), pp. 204-211. [10.23736/s2784-8671.25.08060-0]
Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study
NUNZIATI, Giulia;DI CESARE, Antonella;ROSI, Elia;SCANDAGLI, Ilaria;SILVI, Gianmarco;GUERRA, Prisca;PRIGNANO, Francesca
2025
Abstract
BACKGROUND: In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated. METHODS: We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period. RESULTS: A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy. CONCLUSIONS: Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.



