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TOPLINE:

Discontinuing adalimumab increases relapse rates in patients with juvenile idiopathic arthritis (JIA)–associated uveitis. However, patients can regain inflammation control after resuming the treatment.

METHODOLOGY:

• Researchers conducted a randomized controlled trial across the United States, United Kingdom, and Australia to compare the efficacy and safety of discontinuing adalimumab against continuing it in patients who had achieved clinical remission while on the medication.
• The trial enrolled 87 children aged ≥ 2 years with JIA-associated uveitis from March 2020 to February 2024. All patients had controlled arthritis and uveitis for at least 1 year before enrollment.
• Patients were randomly assigned to continue adalimumab, which was administered subcutaneously every 2 weeks in weight-adjusted doses (n = 43; mean age, 12.56 years; 74% girls), or to discontinue adalimumab and receive identical-looking placebo injections (n = 44; mean age, 12.26 years; 73% girls).
• The primary outcome was time to treatment failure, defined by recurrence of uveitis (increase in anterior chamber cell grade from baseline at two consecutive visits) or arthritis, with trial visits scheduled at multiple intervals up to 48 weeks.
• Secondary outcomes included visual acuity, adalimumab and anti-adalimumab antibody concentrations, and the 27-joint Juvenile Arthritis Disease Activity Score. The time to reestablishing control of uveitis after treatment failure was also assessed.

TAKEAWAY:

• Patients who discontinued adalimumab had a higher rate of treatment failure than those who continued treatment (68% vs 14%), with an increased risk for treatment failure (hazard ratio, 8.7; P < .0001).
• The median time to treatment failure in the placebo group was 119 days, while all patients who restarted adalimumab after treatment failure across both groups regained control of ocular inflammation at a median time of 105 days, which was sustained through the end of the follow-up period.
• Patients who discontinued adalimumab had higher anti-adalimumab antibody concentrations (P = .01) and arthritis disease activity (P = .03) than those who continued it. Also, arthritis recurrence was noted in four patients in the adalimumab group and seven patients in the placebo group.
• Four serious adverse events were noted in those who continued adalimumab. The rate of COVID-19 infections was higher in patients who continued adalimumab than in those who discontinued it (50 vs 6 events per 100 person-years).

IN PRACTICE:

"The high rate of relapse after stopping adalimumab calls into question current recommendations regarding the timing for attempting withdrawal," the authors wrote. “Results from this study can be used to guide the counselling of patients and families who are considering discontinuing adalimumab.”

SOURCE:

The study was led by Nisha R. Acharya, MD, Francis I. Proctor Foundation, University of California, San Francisco. It was published online on January 25, 2025, in The Lancet.

LIMITATIONS:

The study used subjective grading of uveitis as a primary endpoint, which may have affected the objectivity of the results. Additionally, the smaller sample size owing to early enrollment cessation could have limited the power of secondary outcome analyses.

DISCLOSURES:

The study was supported by the US National Institutes of Health (National Eye Institute). Some authors reported having financial relationships with several pharmaceutical companies, and some reported receiving research funding from the National Eye Institute and support from various foundations.

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