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. 2025 Jun 28:15:233-241.
doi: 10.2147/PTT.S514115. eCollection 2025.

Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience

Cristina Bertoli  1 , Tiago Torres  2 , Paolo Romita  3 , Luca Stingeni  4 , Katharina Hansel  4 , Luca Mastorino  5 , Michela Ortoncelli  5 , Michele Panzone  5 , Maria João Cruz  6 , Luca Bianchi  7 , Arianna Zangrilli  7 , Maria Letizia Musumeci  8 , Giuseppe Micali  8 , Carlo Gerbino  8 , Oriana Simonetti  9 , Edoardo De Simoni  9 , Caterina Longo  1   10 , Emmanuel Mahé  11 , Vito Di Lernia  1
Affiliations

Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience

Cristina Bertoli et al. Psoriasis (Auckl). .

Abstract

Background: Many adalimumab biosimilars have been approved for the same indications as their originator (Humira ®). However, data on their efficacy and safety in children with psoriasis are scarce.

Objective: To assess the effectiveness and safety of adalimumab biosimilars in a group of adalimumab-naïve patients and another group of patients who switched from originator adalimumab to biosimilars. The co-primary endpoints were the PASI absolute mean, PASI 75, and PASI 90 at 16, 24 and 52 weeks.

Methods: In this 52-week, multi-center, non-interventional, observational, retrospective study, patients starting biosimilars in routine practice after January 2022 were enrolled at 10 sites across Italy, Portugal, and France. Disease activity scores such as the Psoriasis Area Severity Index (PASI) and safety data were captured during 12 months following adalimumab biosimilar initiation.

Results: A total of 102 pediatric patients with psoriasis receiving adalimumab biosimilar therapy either as naïve (n = 72) or switching from originator adalimumab (n = 30) were enrolled. Median absolute PASI remained low at weeks 16, 24, and 52 in both groups (naïve 5.4, 4.3, 2.8; switching 2.6; 2.0; 1.4 respectively). PASI 75 response at weeks 16, 24, and 52 was observed in 41.7, 55.0, and 77.8% of patients in the naive group and 82.8%, 86.2%, and 92.6% of patients in the switch group. PASI 90 response at weeks 16, 24, and 52 was achieved by 23.3%, 26.7%, and 46.3% of patients in the naïve group and 58.6%, 65.5%, and 55.6% of patients in the switch group. Three patients discontinued biosimilars after the switch due to loss of efficacy. No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects.

Conclusion: Adalimumab biosimilars showed a favorable effectiveness/safety profile in childhood psoriasis. Switching from reference adalimumab to biosimilars did not impact effectiveness and safety. A likelihood of discontinuation was noted in patients who switched from Humira to biosimilars.

Keywords: TNF-alpha; biologics; children; effectiveness; psoriasis; safety; treatment.

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Conflict of interest statement

L. Stingeni has been principal investigator in clinical trials sponsored by or has received personal fees for participation in advisory boards from AbbVie, Amgen, BMS, LEO Pharma, Lilly, Novartis, and Sanofi, outside the submitted work. K. Hansel received personal fees for participation in advisory boards from AbbVie, Amgen, BMS, LEO Pharma, Novartis, Sanofi, and UCB outside the submitted work. M. Ortoncelli has served as advisory board member and/or consultant and has received fees and speaker’s honoraria or has participated for clinical studies for AbbVie, Almirall, Lilly, Leo Pharma, Novartis, Pfizer and Sanofi Genzyme outside the submitted work. ML Musumeci has served as a consultant/investigator for AbbVie, Lilly, Janssen, Novartis, Biogen, UCB, Sandoz, Almirall, Leopharma outside the submitted work. C. Gerbino has served as sub-investigator for Galderma and UCB. E. Mahé has undertaken activities as a paid consultant, adviser or speaker for AbbVie, Almirall, Amgen, Biolane, Janssen-Cilag, Leo Pharma, Lilly, Novartis, Sanofi, and UCB outside the submitted work. V. Di Lernia has served as member of advisory boards and/or received speaker honoraria from Abbvie, Amgen, Eli Lilly outside the submitted work; has participated as Principal Investigator for clinical studies for Almirall, Sanofi, Jansen, Lilly, Novartis. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
The trend of mean PASI score median values during the 12 months of observation: comparison between switch and naïve Groups. Orange line: naïve patients; blue line: switchers from Adalimumab to a biosimilar. PASI scores were plotted at four time-points: at initiation of treatment with adalimumab biosimilar and at 16, 24, and 52 weeks after this switch. Overall, both groups experienced a reduction in PASI scores over time, with the switch group maintaining consistently lower PASI scores throughout the study.
Figure 2
Figure 2
The proportion of patients achieving PASI 75 Over Time: PASI 75 response rates continued to improve through week 24 in the biosimilar-naïve group, while remaining stable in the switch group.
Figure 3
Figure 3
The proportion of patients achieving PASI 90 Over Time: PASI 90 response rates continued to improve through week 24 in the biosimilar-naïve group. In the switch group, after an initial improvement, the percentage of patients who achieved PASI90 slightly decreased by week 52.
See this image and copyright information in PMC

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