Adalimumab Improves Eye Inflammation of Children with Juvenile Arthritis, Phase 2/3 Trial Shows

Adalimumab Improves Eye Inflammation of Children with Juvenile Arthritis, Phase 2/3 Trial Shows

Adalimumab improves the eye inflammation of children with early-onset juvenile idiopathic arthritis, a Phase 2/3 clinical trial shows.

The study, published in the Annals of the Rheumatic Diseases, is titled “ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis.”

More than 20 percent of children who develop juvenile arthritis before age 6 end up with an eye inflammation called chronic, remitting, anterior uveitis. Long-term use of steroids may be needed to treat the disorder, which affects the middle layer of tissue in the eye wall. Extended steroid use can lead to severe complications, however.

The arthritis therapy methotrexate can improve uveitis, but some patients don’t respond well to it.

Researchers wanted to see if adalimumab, an approved therapy for juvenile arthritis, would improve uveitis as well.

Adalimumab, which is sold as Humira and under other brand names, reins in an inflammation-promoting cell signaling protein called tumor necrosis factor. Doctors use it to treat juvenile arthritis, either alone or in combination with methotrexate.

Previous trials demonstrated that adalimumab can improve juvenile arthritis-associated uveitis that failed to respond to methotrexate or steroids applied to the eyes.

But the trials used a slit lamp to assess inflammation, a method that may not generate the best results. A technique called laser flare photometry can detect even low-grade inflammation.

Another shortcoming of the other studies was that they did not compare adalimumab with a placebo.

The Phase 2/3 ADJUVITE trial (NCT01385826) looked at adalimumab’s ability to treat the uveitis of patients who had failed to respond well to methotrexate and steroids applied to the eye.

Researchers randomly assigned 32 patients with uveitis, aged 4 and older, to adalimumab injections or a placebo every other week. Patients aged 13 and younger received doses about half as large as those older than 13.

Researchers focused primarily on patients’ response to adalimumab at the end of their second month of treatment, compared with the placebo. The goal was to achieve a 30 percent decrease in laser flare photometry measures of inflammation and no worsening of patients’ slit lamp scores. Aadalimumab did reduce eye inflammation.

After the second month, researchers switched those who had been on the placebo to adalimumab. Twenty-nine of the patients ended up being treated for 12 months. The long-term treatment led to lasting uveitis improvements in most patients, the team said.

Researchers said adalimumab was safe, and patients tolerated it well. They found no adverse effects related to treatment.

The results should be interpreted with caution because of the small number of trial participants, the team noted. Another limitation was a small pool of ophthalmologists equipped with laser flare photometry who had experience using it with children.

Overall, “this trial is in favor of using adalimumab in patients with early-onset, chronic anterior uveitis, which is in most cases associated with” juvenile arthritis, when they fail to respond well to methotrexate and steroids applied to the eye, the team wrote.

They also said that laser flare photometry could be a good way to assess treatments’ early effectiveness.

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