title: Clinical evaluation of tocilizumab for patients with active rheumatoid arthritis refractory to anti-TNF biologics: tocilizumab in combination with methotrexate.
abstract: We retrospectively observed the clinical efficacy and safety of tocilizumab (TCZ) in 74 patients with rheumatoid arthritis (RA) at 13 hospitals, without any restrictions on disease duration or stage, treatment history, and other influencing factors. TCZ was infused by the approved method, and disease activity was evaluated every 4 weeks until week 24 using a joint disease activity score (DAS28). Remission and treatment response were categorised using European League Against Rheumatism (EULAR) definitions. We also analysed the impact of previous treatment with other biologics and of concomitant methotrexate (MTX) therapy on the efficacy of TCZ. At week 24, the DAS28 had improved from 5.5 to 2.7 and the EULAR remission rate was 55.2%. Good and moderate responses according to the EULAR criteria were obtained in 61 and 36% of the patients, respectively. The biologic-naïve group had a significantly better DAS28 (2.1 vs. 2.8) and a significantly higher "good" response rate (86% vs. 54%) than the biologic-exposed group. Although the TCZ + MTX treatment group and the TCZ monotherapy group had a good response rate of 71 and 48%, respectively, the difference was not significant. Based on these results, we conclude that TCZ is able to significantly alleviate disease symptoms in a wide range of patients with RA in a normal clinical context.
authors.affiliation: Department of Orthopaedic Surgery, Kyushu University, Higashi-ku, Fukuoka, Japan. yasunaka@ortho.med.kyushu-u.ac.jp
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Nakashima
authors.forename: Masakazu
authors.initials: M
authors.lastname: Kondo
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Harada
authors.forename: Takahiko
authors.initials: T
authors.lastname: Horiuchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishinishi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Jojima
authors.forename: Koji
authors.initials: K
authors.lastname: Kuroda
authors.forename: Hisaaki
authors.initials: H
authors.lastname: Miyahara
authors.forename: Ryuji
authors.initials: R
authors.lastname: Nagamine
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nakashima
authors.forename: Takeshi
authors.initials: T
authors.lastname: Otsuka
authors.forename: Isao
authors.initials: I
authors.lastname: Saikawa
authors.forename: Eisuke
authors.initials: E
authors.lastname: Shono
authors.forename: Eiichi
authors.initials: E
authors.lastname: Suematsu
authors.forename: Tomomi
authors.initials: T
authors.lastname: Tsuru
authors.forename: Ken
authors.initials: K
authors.lastname: Wada
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Iwamoto
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; C502936:tocilizumab; D008727:Methotrexate