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TOPLINE:

In patients with autoimmune diseases who received adalimumab, more than one fifth developed antibodies against the drug. The presence of ocular inflammation, female sex, and treatment interruptions were independently associated with an increased risk of developing anti-adalimumab antibodies.

METHODOLOGY:

• Researchers used data from the US-based Stanford Research Repository to conduct a retrospective case-control study of patients who received adalimumab for at least 6 months between June 2005 and May 2024.
• A total of 704 patients with various autoimmune conditions (mean age, 34.52 years; 50% men) who had at least one documented test for adalimumab drug levels and/or anti-adalimumab antibodies were included in the analysis.
• The collected data comprised demographics, systemic diagnoses, age at initiation of adalimumab therapy, prior or concurrent immunosuppressive treatments, adalimumab dosing history, and ocular inflammation. Ocular inflammation was recorded only if it occurred at any time during adalimumab treatment and before the detection of antibodies to adalimumab.
• Patients were classified as anti-adalimumab antibody-positive or -negative based on the presence of antibodies at any point during follow-up.
• The study’s main aims were to examine whether ocular inflammation was linked to the development of antibodies against adalimumab and to report the proportion of antibody-positive patients in the tested cohort.

TAKEAWAY:

• Of 704 patients, 151 developed antibodies against adalimumab; among antibody-positive patients, the mean time to first detection was about 997 days, and ocular inflammation was independently associated with antibody formation (adjusted odds ratio [aOR], 2.19; P = .011).
• Patients with ocular inflammation developed antibodies earlier than those without (log-rank P = .006); ocular inflammation was also associated with a 67% higher risk for antibody detection (hazard ratio, 1.67; P = .006).
• Female sex was associated with higher odds of anti-adalimumab antibody positivity than male sex (aOR, 1.75; P = .024), and adalimumab interruption was also an independent risk factor (aOR, 1.74; P = .038).
• Prior exposure to TNF-alpha inhibitors other than adalimumab increased the risk of developing anti-adalimumab antibodies (aOR, 2.11; P = .005), whereas prior use of biologic therapy other than TNF-alpha inhibitors showed protective effects (aOR, 0.27; P = .046).

IN PRACTICE:

“These findings underscore the need for therapeutic drug monitoring and sustained treatment adherence, particularly among female patients and those with ocular involvement, to reduce immunogenicity in adalimumab-treated populations,” the researchers reported.

SOURCE:

The study was led by Osama Elaraby, MD, of the Byers Eye Institute at Stanford University School of Medicine in Stanford, California. It was published online on May 26 in Ophthalmology.

LIMITATIONS:

Because the study was retrospective, residual confounding could not be excluded. The analysis included only patients who underwent testing for antibodies against adalimumab, which introduced potential selection bias. Antibody testing was clinician-driven and not performed according to standardized criteria. In addition, the timing of antibody testing and the length of follow-up were inconsistent.

DISCLOSURES:

The Byers Eye Institute received support from the National Eye Institute and Research to Prevent Blindness, Inc. Unrestricted research support for the Uveitis Clinical Laboratory was provided by the Homer N. Allen Trust and the Global Ophthalmic Research Center. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.