medwireNews: Approximately half of the 21 patients with juvenile idiopathic arthritis (JIA)-associated uveitis in the APTITUDE trial experienced an improvement in uveitis assessment with 12 weeks of tocilizumab treatment.
However, the single-arm phase II study did not pass the prespecified efficacy criterion of a treatment response – defined as a two-step decrease or a decrease to zero in Standardization of Uveitis Nomenclature (SUN) criteria after 12 weeks of treatment – in eight participants, said Athimalaipet Ramanan (University Hospitals Bristol NHS Foundation Trust, UK), who presented the results at the EULAR 2019 congress in Madrid, Spain.
He said that this endpoint was met by just seven out of 21 children and adolescents aged 2–18 years with persistently active JIA-associated uveitis despite receipt of a TNF inhibitor who were treated with tocilizumab every 2–3 weeks (dosing based on bodyweight) in combination with methotrexate.
Nonetheless, Ramanan reported that three participants classified as nonresponders had a one-step improvement in SUN criteria over the course of the study, while one patient who was classified as a nonresponder had a two-step improvement in SUN criteria but then withdrew from the study.
Therefore, 52% of participants showed some improvement in response to tocilizumab treatment, including a two-step improvement in 38%, while 48% had neither a one- nor two-step improvement, he said.
The investigators also found that the average number of steroid eyedrops required decreased over the study period, from 4.48/day at baseline to 4.33/day at week 12, and macular edema resolved in three out of four participants.
Ramanan said that the safety profile of tocilizumab in the APTITUDE trial was “consistent” with earlier reports.
In all, 175 adverse events occurred over the study period in 20 patients, most commonly injection site reaction (n=24 events), arthralgia (n=8), headache (n=8), cough (n=7), and oropharyngeal pain (n=7). No serious adverse events were reported.
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