title: Maintenance of efficacy and safety with subcutaneous golimumab in rheumatoid arthritis patients with low disease activity who previously received TNF inhibitors.
abstract: The study was conducted to evaluate continued maintenance of the efficacy and safety of therapy by switching to subcutaneous golimumab (GLM-SC) in rheumatoid arthritis patients with low disease activity or remission who previously received a tumor necrosis factor (TNF) inhibitor. Thirty patients who had been treated with etanercept or infliximab were switched to GLM-SC in maintaining disease activity at a low level. The patients were divided into two groups through discussion with each patient, considering general condition and convenience: the low disease activity (LDA) group and the LDAq8w group, which included patients with low disease activity or remission who switched to 50 mg GLM therapy at 4- and 8-week intervals, respectively. The effects of the TNF inhibitors to GLM-SC switch were evaluated at 12, 24, and 52 weeks after switching. The mean DAS28-ESR and DAS-CRP values in the LDA groups (16 patients) and LDAq8w groups (14 patients) were maintained from baseline throughout the 52-week treatment period. DAS28-ESR remission (93.8 and 92.3%) rates were also maintained through week 52 from the baseline remission rate (75.0 and 78.6%) in the LDA and LDAq8w groups, respectively. Thus, both GLM-SC treatment regimens were effective in maintaining the clinical response achieved with LDA secondary to TNF inhibitors. No serious adverse events occurred, and the continuation rate at 52 weeks was 100% in both groups. Therapeutic efficacy is adequately maintained in most patients switching from TNF inhibitor to GLM-SC (50 mg/4-8 weeks). Patients receiving TNF inhibitor can seamlessly switch to GLM-SC without serious safety concerns.
authors.affiliation: Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan. whiroki@clin.medic.mie-u.ac.jp.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Wakabayashi
authors.affiliation: Department of Orthopaedic Surgery, Suzuka General Hospital, Suzuka, Mie, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Inada
authors.affiliation: Clinical Research Institute for Rheumatic Disease, Shima, Mie, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Nishioka
authors.affiliation: Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hasegawa
authors.affiliation: Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Sudo
authors.affiliation: Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.
authors.forename: Kusuki
authors.initials: K
authors.lastname: Nishioka
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D000069285:Infliximab; D000068800:Etanercept; D008727:Methotrexate
keywords: Golimumab; Maintenance; Rheumatoid arthritis; TNF inhibitor