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Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience
Cristina Bertoli1, Tiago Torres2, Paolo Romita3
1Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Insights
Adalimumab biosimilars are effective and safe for pediatric psoriasis patients, whether new to the drug or switching from the originator. Switching did not affect outcomes, though some patients discontinued biosimilars due to loss of efficacy.
Area of Science:
- Pediatric Dermatology
- Pharmacology
- Immunology
Background:
- Limited data exist on the efficacy and safety of adalimumab biosimilars in pediatric psoriasis patients.
- Several adalimumab biosimilars are approved for indications shared with the originator, Humira®.
Purpose of the Study:
- To evaluate the effectiveness and safety of adalimumab biosimilars in pediatric psoriasis.
- To compare outcomes in patients new to adalimumab versus those switching from the originator.
Main Methods:
- A 52-week, multi-center, observational, retrospective study.
- Included 102 pediatric patients with psoriasis, divided into naive (n=72) and switch (n=30) groups.
- Assessed Psoriasis Area Severity Index (PASI) scores and safety data.
Main Results:
- Both naive and switch groups showed low median PASI scores throughout the study.
- High PASI 75 and PASI 90 response rates were observed in both groups, with generally higher rates in the switch group.
- No serious adverse events were reported; three patients in the switch group discontinued therapy due to loss of efficacy.
Conclusions:
- Adalimumab biosimilars demonstrate a favorable effectiveness and safety profile in pediatric psoriasis.
- Switching from originator adalimumab to biosimilars did not negatively impact effectiveness or safety.
- A potential for discontinuation exists in patients switching from originator adalimumab to biosimilars.
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.
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