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INTRODUCTION: Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China. METHODS: In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc. RESULTS: Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level. CONCLUSION: IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04285229.
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To explore the effect of atorvastatin combined with Zishen Qingqi Granules on the immune function and liver function of patients with mild to moderate activity systemic lupus erythematosus. The data of 120 patients with mild to moderate activity systemic lupus erythematosus admitted to our hospital from February 2019 to February 2020 were retrospectively analyzed and they were divided into experimental group (n=60) and the control group (n=60) according to the order of admission; the control group was treated with atorvastatin, and the experimental group was treated with Zishen Qingqi Granules plus. The immune function, liver function, TCM syndrome score and systemic lupus erythematosus disease activity index (SLEDAI) were compared between the two groups. The experimental group after treatment was superior to the control group with respect to immune function indexes, liver function indexes, SLEDAI and TCM syndromes (all P<0.001). Atorvastatin combined with Zishen Qingqi Granules can improve the liver function of patients with mild to moderate activity systemic lupus erythematosus, enhance their immunity, and relieve their clinical symptoms.
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Lupus Eritematoso Sistémico , Atorvastatina/uso terapéutico , Humanos , Inmunidad , Hígado , Lupus Eritematoso Sistémico/tratamiento farmacológico , Estudios Retrospectivos , SíndromeRESUMEN
To explore the effect of atorvastatin combined with Zishen Qingqi granules on the immune function and liver function of patients with mild to moderate activity systemic lupus erythematosus. The data of 120 patients with mild to moderate activity systemic lupus erythematosus admitted to our hospital from February 2019 to February 2020 were retrospectively analyzed and they were divided into experimental group (n=60) and the control group (n=60) according to the order of admission; the control group was treated with atorvastatin, and the experimental group was treated with Zishen Qingqi granules plus. The immune function, liver function, TCM syndrome score and systemic lupus erythematosus disease activity index (SLEDAI) were compared between the two groups. The experimental group after treatment was superior to the control group with respect to immune function indexes, liver function indexes, SLEDAI and TCM syndromes (all P<0.001). Atorvastatin combined with Zishen Qingqi granules can improve the liver function of patients with mild to moderate activity systemic lupus erythematosus, enhance their immunity, and relieve their clinical symptoms.