Adalimumab may reduce inflammation in patients with chronic anterior uveitis
Treatment with adalimumab appears to yield reductions in ocular inflammation in patients with early onset idiopathic or juvenile idiopathic arthritis (JIA)-associated chronic uveitis and an inadequate response to topical steroids and methotrexate (MTX), according to data from the ADJUVITE trial.
ADJUVITE included 31 patients (median age 9.5 years; 90 percent female) with ocular inflammation quantified by laser flare photometry (LFP) ≥30 photon units/ms. These patients were randomized to receive either adalimumab subcutaneously (n=16) or placebo (n=15) every other week for 2 months. Adalimumab was administered at a dose of 24 mg/m2 in patients aged <13 years and at 40 mg in the others. From months 2 to 12, all patients received adalimumab.
The primary outcome of response at month 2 was observed in nine patients in the adalimumab group vs three in the placebo group (relative risk, 2.81; 95 percent CI, 0.94–8.45; risk difference, 36.3 percent; 2.1–60.6; p=0.038). Response was defined as a reduction of 30 percent in inflammation on LFP in the assessable eye, with more severe baseline inflammation and no worsening on slit lamp (SL) examination.
However, there was no significant between-group difference observed in terms of the proportion of patients who showed improvement according to the Standardised Uveitis Nomenclature classification criteria from baseline to month 2 in SL cellular or protein grading.
Of the 30 patients who continued the trial beyond month 2, 29 completed treatment at month 12. There were seven serious adverse events recorded, with none related to study treatment. Researchers noted that all events were linked to the underlying disease and to complications that had developed before trial onset, particularly ocular hypertonia.
The present data highlight the efficacy and safety of adalimumab in patients with early onset, chronic anterior uveitis, which is in most cases associated with JIA, and who have inadequate response to topical therapy and MTX, according to researchers, adding that the result for the primary outcome should be interpreted with caution given the small sample size.
Moreover, the findings show that “LFP assessment, which detects inflammation even in patients with low-grade inflammation and sometimes no cells on SL examination … enables an earlier documentation of improvement on adalimumab therapy,” they said.