Toward the integration of biosimilars into pediatric rheumatology: adalimumab ABP 501 experience of PeRA research group

ABSTRACT

Objectives

To review the real-life data, to provide an input to the literature concerning treatment of juvenile idiopathic arthritis (JIA) with adalimumab (ADL) biosimilar.

Method

This multi-centric retrospective study was conducted among children with JIA, followed up for at least 24-weeks from the initiation of ADL biosimilar (ABP 501) treatment. Adverse events and alterations in disease activity scores were figured out.

Results

The median age of the group was 15.5 (5–18) years. JIA categories were oligoarticular (n =12), enthesitis-related (ERA) (n=24), psoriatic (PsA) (n=6), and polyarticular (n=4). Uveitis was detected at the initiation of the disease (n=3), during the disease course (n=5), or before the diagnosis (n=1). The first-line treatment preferences were ADL biosimilar (n=37) and etanercept (n=9). On the 6th month of ABP 501, 40 (86.9%) patients had achieved complete remission. Six patients (1 PsA, 1 polyarticular JIA, and 4 ERA) had ongoing active arthritis. Furthermore, all except one of the patients had remission of ophthalmologic findings. No life-threatening adverse events were observed.

Conclusions

ABP 501 has a gradual increase in prescription in pediatric rheumatology. Real-life data of the cohort announce that ADL biosimilar is a suitable and effective treatment option for patients with JIA in case of indication.

KEYWORDS:

• Adalimumab
• biosimilar
• amgevita
• juvenile idiopathic arthritis
• ABP-501

Availability of Data and Material

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki in 1964. Approval was granted by the Ethics Committee of Istanbul University, Turkey (Date 16.12.2020/No 256,375) in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.

Consent to participate

Informed consent was obtained from legal guardians.

Consent for publication

Legal guardians signed informed consent regarding publishing their data.

Authors’ contributions

All authors whose names appear on the submission 1) made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work; 2) drafted the work or revised it critically for important intellectual content; 3) approved the version to be published; and 4) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Supplementary Material

Supplemental data for this article can be accessed here.

Additional information

Funding

No specific funding was received from anybody in the public, commercial, or not-for-profit sectors to carry out the work described in this article.