Real-life data on efficacy and safety of original Adalimumab and biosimilar Adalimumab (ABP 501) in pediatric rheumatic diseases

ABSTRACT

Background

We aimed to compare the efficacy and safety of the original product (OP) and biosimilar product (BP) of adalimumab in pediatric rheumatic diseases.

Research design and methods

The study group consisted of patients who had received original or biosimilar adalimumab (ABP 501) therapy for at least 3 months. The patients were divided into uveitis and arthritis groups based on the indication of adalimumab treatment. Assessment of disease activity was performed by Juvenile Arthritis Disease Activity Score in patients with juvenile idiopathic arthritis, and by standardization of uveitis nomenclature criteria in patients with uveitis.

Results

The study included 140 patients, of which 87 were treated with OP and 53 with BP. In the arthritis group, 26 (63.4%) and 20 (57.1%) patients reached inactive disease according to JADAS-27 in the original and biosimilar adalimumab groups, respectively. In the uveitis group the mean number of exacerbations throughout the treatment period was 0.84 ± 1.07 in the OP group, and 0.58 ± 0.79 in the BP group. There were 71 treatment-emergent adverse events in the OP group and 38 in the BP group.

Conclusion

There was no significant difference between the biosimilar and the original product in efficacy and safety.

KEYWORDS:

• ABP 501
• biosimilar
• juvenile idiopathic arthritis
• uveitis
• adalimumab

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

Conceptualization: B Sözeri. Design of the study: B Sözeri, K Ulu, M Çakan, F Demir and E Kardeş. Data analysis: B Sözeri, K Ulu. Acquisition of data: K Ulu, Ş Çağlayan, RE Yiğit, T Coşkuner and E Kardeş. All authors made substantial contributions to the interpretation of data for the work. All authors were involved in drafting the article or revising it critically, and all authors approved the final version of the manuscript.

Ethics approval

The study was approved by the local ethical board and was performed according to the tenets of the declaration of Helsinki. (Approval date: 04.05.2022, Approval number: B.10.1.TKH.4.34.H.GP.0.01/166, Approving institution: University of Health Sciences, Umraniye Research and Training Hospital). Informed consent was obtained from legal guardians.

Data availability statement

The data and materials from this study can be made available on reasonable request.

Additional information

Funding

This paper was not funded.