medwireNews: Adalimumab may be beneficial for patients with chronic anterior uveitis related to juvenile idiopathic arthritis (JIA) and an inadequate response to topical therapy and methotrexate, results of the ADJUVITE trial suggest.
More than a fifth of children with early onset, rheumatoid factor-negative JIA develop chronic remitting anterior uveitis, and severe complications can develop as a result of inflammation and long-term steroid treatment, say Pierre Quartier (Necker-Enfants Malades University Hospital, Paris, France) and study co-authors.
“Treatment with methotrexate has been [associated] with an improvement of uveitis and a reduction of the number of flares” but many patients do not have an adequate response, they continue.
The ADJUVITE investigators randomly assigned 31 children aged 4 years or older with JIA-associated or idiopathic chronic active anterior uveitis, as measured by laser flare photometry (LFP), to receive subcutaneous adalimumab (24 mg/m2 in patients aged <13 years, 40 mg in those aged ≥13 years) or placebo every other week for 2 months, after which time all participants were given open-label adalimumab for a further 10 months.
After 2 months of treatment, 56% of children receiving adalimumab achieved a treatment response – defined as at least a 30% reduction of ocular inflammation quantified by LFP without worsening of cell counts or protein flare on slit lamp examination – compared with 20% of those in the placebo arm.
These results translate into a 2.81-fold increased likelihood of responding to treatment for patients in the adalimumab arm, report Quartier et al in the Annals of the Rheumatic Diseases.
Although the ADJUVITE findings support the use of adalimumab in this patient population, the difference between the groups did not reach statistical significance in the intention-to-treat population, and the researchers caution that “[t]he result of the primary end point should be interpreted with caution given the small size of this study.”
They explain that patient enrollment was “slower than anticipated” and it was not possible to extend the trial in order to reach the expected number of patients.
Of the 30 patients who took part in the open-label extension period, all but one continued adalimumab treatment until the 1-year follow-up. Six serious adverse events occurred during the open-label phase, none of which were considered by the investigators to be related to adalimumab treatment.
Describing the safety data as “reassuring,” the researchers note that most serious AEs were “linked to the underlying disease and to complications that had developed before trial onset, particularly ocular hypertonia.”
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