Lancet pheumatol: Under the skin to be treated with Anifrolumab systemic lupus erythematosus

Anifrolumab is a monoclonal antibody that targets type 1 interferon receptors for the treatment of moderate to severe, autoantibody-positive systemic lupus erythematosus (SLE), which is currently in clinical trials.
previous Phase 3 trials have shown that adding Anifrolumab (300 mg, static drops, 1/4 week) to SLE's standard treatment options reduces disease activity and glucoticoid dosing.
Given that patients may find it more convenient to administer drugs under the skin than intravenously, the researchers evaluated the pharmacogenetics, efficacy, safety and efficacy of patients treating SLE, active dermatology, and high-type interferon genetic characteristics with under-skin injections.
the trial was a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial that recruited SLE patients aged 18-70 with high type I interferon genetic characteristics with a CLASI activity score of ≥10.
subjects were divided into 4 groups at 3:1:3:1 and given subsuplisive injections of Anifrolumab 150 mg or 300 mg or corresponding placebos in addition to standard treatment.
March 14, 2017 - October 26, 2017, 36 patients were recruited, 14 of whom received 150 mg of Anifrolumab, 13 of whom received 300 mg of Annifrolumab, and 9 of whom received placebo.
two patients in the Anifrolumab 150 mg group were excluded from pharmacodynamic analysis.
10 (71%), 10 (77%), and 9 (100%) patients in the Placebo group completed 52 weeks of treatment.
12 weeks, the average dose serum level of Anifrolumab was greater than the dose ratio of the drug (150 mg group 19.82 μg/mL (SD 15.01), 300 mg group 60.28 μg/mL (43.66)), pharmacological nonlinear relationship.
12 weeks, the mesothorism of the type I interferon gene characteristics in the 150 mg and 300 mg groups was higher than in the placebo group (88.0% vs. 90.7% vs. 18.5%);
23 (85%) of the 27 patients treated with Anifrolumab had at least one adverse reaction, and 7 out of 9 patients in the placebo group (78%).
mild to moderate adverse reactions in the united States.
6 (22%) patients treated with Anifrolumab had severe adverse reactions, which were not in the placebo group.
3 patients in the Anifrolumab group and 1 patient in the placebo group reported a shingles virus infection.
treatment-related deaths.
addition, patients with moderate to severe skin manifestations of SLE were injected with Annifrolumab every two weeks subsultural, with nonlinear pharmacodynamics exceeding the dose ratio, and the genetic characteristics of type I interferon were neutralized in a dose-dependent manner.
the safety results of the study were consistent with previous intravenous medications and supported Anifrolumab's treatment of SLE through intraskinal administering.
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