- The approval is based on SYCAMORE study assessing Humira (20mg, 40 mg, based on body wt.) + methotrexate vs methotrexate + PBO in 114 patients in a ratio (2:1) with active JIA-associated noninfectious anterior uveitis refractory to at least 12 weeks of methotrexate treatment aged > 2yrs.
- The SYCAMORE study resulted in meeting 1EPs, with delayed treatment failure (27% vs 60%)
- Humira (adalimumab, SC, q2w) is a mab blocking TNF-a protein targeted for an inflammatory response of immune-mediated diseases and is approved in 90 countries for 15 indications
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