FDA approves expansion of Humira's treatment of non-infectious vyreitis

viticulture is a group of eye diseases characterized by inflammation of the vine membrane (including irises, veins, eyelashes) that, if not treated in a timely manner, can seriously damage vision, leading to vision loss or blindness, including cataracts, glaucoma, macular cystomitisrecently, U.Sbiotech giant AbbVie announced that the U.SFood andDrug(
FDA() has approved the expansion of Humira (Shumel, general name: adalimumab, Adamu monoantigen) treatment of non-infectious vofheitis in the applicable population, including children 2 years and olderthe study
the approval was based on data from a multicenter, double-blind, randomized, placebo-controlled study of SYCAMOREThe study enrolled 90 children with active childhood iphalate arthritis (JIA)-related non-infectious vitis between the ages of 2 and 18In thestudy, patients received a stable dose of methotrexate (MTX) treatment, randomly assigned to receive a subcutaneous injection of symester (n-60, based on weight: weight 30 kg, dose of 20 mg; weight of 30 kg, dose of 40 mg) or placebo (n) at a 2:1 ratioUntil the treatment fails or the treatment is not up to 18 months, all patients follow up after randomization for 2 years, the main endpoint is the treatment failure time (TTF), according to the standardized naming of vititoitis (SUN) of multiple elements of intra-eye inflammation, specifically the patient from random grouping to the time of the deterioration of eye inflammation or continued improvement or deterioration of eye complicationsthe study had been planned to randomize 114 patients, but after treating 90 patients, the Independent Data Safety Monitoring Board (IDSMC) recommended early detectiondata showed that when combined stable dosem of MTX were treated, shummel significantly improved intra-eye inflammation control, significantly delayed treatment failure, and significantly reduced the risk of treatment failure by 75% compared to placebo: 27% of the failure rate in the Shummel-MTX treatment group (n?16// 60), the failure rate was 60% in the placebo-MTX treatment group (n-18/30), with statistically significant differences in the data (HR-0.25, 95% CI:0.12-0.49, p.0001)In terms of adverse event incidence rate, the Shumel group had more placebo sympathisers than the placebo group: 10.07 events per patient years (95% CI: 9.26-10.89) vs 6.51 events per patient year .95% CI: 5.26-7.7 7, the incidence of severe adverse events was also higher than in the placebo group: 0.29 events per patient years (95% CI: 0.15-0.43) vs 0.19 events per patient year .95% CI: 0.00-0.40 medication, the recommended dose of Sumeris is based on weight in children with an age of 2 years, and for children aged 2 years or 10 kg, there is no investigation into the efficacy and safety of Sumeral in this group of patients In addition to non-infectious vofheitis, the drug has previously been approved by the U.S FDA for pediatric indications including JIA and Crohn's disease