Long-term safety and efficacy of anti-TNF-α biosimilars in psoriasis

Biosimilars/Research | Posted 24/09/2021 post-comment0

Biologicals have greatly improved treatment options and outcomes for patients with moderate-to severe psoriasis. Despite being significantly more effective than conventional systemic agents for psoriasis, the high cost of biologicals may limit their use [1].


Biosimilars, compounds that are structurally and functionally similar to biologicals, have been proposed as a means to lower the cost and increase the accessibility of biologicals [2, 3]. Currently, biosimilar anti-tumour necrosis factor-alpha (TNF-α) drugs are widely used in the treatment of psoriasis, but little data regarding long-term use of these agents in the real-world practice are available.

In this context, researchers from Italy present their long-term experience (up to 48 months of follow-up) with adalimumab, etanercept and infliximab biosimilars in patients with psoriasis. The retrospective, single centre study was conducted at the Psoriasis Center, Dermatology Unit, Department of Health Sciences, University of Florence, Italy [4].

The study population included 73 patients (52 males, 21 females; median age 57 years) with a mean of 26 years history of moderate-severe psoriasis. In particular, 19 patients were treated with adalimumab biosimilar Imraldi, 37 with etanercept biosimilar Benepali and 17 with infliximab biosimilar Inflectra. Among the 73 patients, only 9 were naïve to anti-TNF therapy and 64 were switched to biosimilar from the originator (15 from originator adalimumab, 36 from originator etanercept and 16 from originator infliximab).

Regarding the efficacy, we found that a significant proportion of patients treated with biosimilars showed sustained clinical benefit during all 48 months of follow-up. Across all biosimilar treatments combined, the mean absolute Psoriasis Area and Severity Index (PASI) score was ≤2 (1.2) after 12 months of treatment. After 24, 36 and 48 months of treatment the mean PASI score remained under 2 in all patient groups. With regard to tolerability and safety, 38 (28%) patients experienced adverse events during biosimilar therapy and 3 (4.3%) discontinued treatment. No severe adverse events, death or malignancy cases were recorded during the study period.

The authors concluded that their experience confirms that biosimilars are efficacious in inducing and maintaining disease improvement and are well-tolerated in the long-term treatment of psoriasis

Conflict of interest
The authors of the research paper [4] declared that there was no conflict of interest.

Abstracted by Professor Francesca Prignano, MD, PhD, Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.

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Editor’s comment
Readers interested to learn more about use of biosimilars in psoriasis are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report

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1. Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy and drug survival of biologics and bio-similars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509-19.
2. Carrascosa J-M, Jacobs I, Petersel D, et al. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther. 2018;8(2):173-94.
3. Cohen AD, Wu JJ, Puig L, et al. Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. Br J Dermatol. 2017;177(6):1495-502.
4. Ricceri F, Rosi E, Di Cesare A, et al. Long-term safety and efficacy of anti-tumor necrosis factor-alpha biosimilar agents in the treatment of psoriasis: a single Center study. J Dermatolog Treat. 2021 Apr 30:1-9.

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