MADRID – Tocilizumab was associated with improved vision in about half of 22 enrolled children with juvenile idiopathic arthritis (JIA) and uveitis refractory to tumor necrosis factor inhibitor (TNFi) therapy, based on results from an investigator-initiated phase 2 trial presented at the European Congress of Rheumatology.
At 12 weeks of treatment, 11 children in the study had some improvement in uveitis and 7 of them had achieved the primary study outcome, which was a two-step decrease in the level of inflammation as measured by the Standard of the Uveitis Nomenclature (SUN) criteria, Athimalaipet V. Ramanan, MBBS, of the department of paediatric rheumatology at the University Hospitals Bristol (England) NHS Foundation Trust, said. Ten of the 21 evaluable patients had no apparent response to tocilizumab. One study participant could not be included in the final analysis because of a violation in study protocol that involved use of disallowed concomitant medications.
“Although this study did not meet the prespecified criterion for efficacy (for most of those treated) ... almost half of those enrolled achieved some benefit,” reported Dr. Ramanan.
The multicenter investigator-initiated phase 2 trial conducted in the United Kingdom enrolled children with JIA and uveitis that was refractory to methotrexate and TNFi therapy. The study participants received methotrexate as well as 162 mg of tocilizumab administered subcutaneously every 2 weeks (those weighing less than 30 kg received tocilizumab treatment every 3 weeks).
Seven of 21 evaluable patients achieved the two-step reduction in inflammation that was the prespecified criterion for a response. For the study population overall, this fell short of statistical significance (P = .11).
However, Dr. Ramanan emphasized that another three patients achieved a one-step improvement, which he believes merits consideration as a sign of efficacy in a “very refractory group.” Moreover, three of four patients with macular edema at baseline had total resolution of this complication.
Other outcomes of interest monitored during the study included the safety and tolerability of tocilizumab and change in use of topical corticosteroids. There were no serious adverse events associated with tocilizumab in this study, according to Dr. Ramanan.
SOURCE: Ann Rheum Dis. Jun 2019;78(Suppl2)265, Abstract LB0011.