X線学的異常を有するまたは有しない体軸性脊椎炎におけるイキセキズマブへの52週時反応性に関する性別ごとのベースライン特徴: フェーズ3無作為化対照試験結果
Advance Therapy,2022 Jun;39(6):2806-2819. doi.org/10.1007/s12325−022−02132−2
Data were analysed from three randomised controlled trials of ixekizumab through 52 weeks. Eligible patients were randomised to receive 80 mg subcutaneous administration of ixekizumab every 2/ 4 week. Patients were categorised by sex; methods included non-responder attribution for categorical variables, and modified baseline observation for continuous efficacy variables.
Results showed that ixekizumab is efficacious in treating male and female patients with axSpA. Following treatment, a higher proportion of males responded earlier in the study. The female patients experienced the maximum response later in their treatment course. Also, for the axSpA disease spectrum, female patients present with higher disease burden as reflected by higher scores in fatigue, spinal pain at night and pain/swelling in joints.