title: Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study.
abstract: The aim of the study was to identify and describe the patterns of use of tocilizumab in clinical practice to ensure safety and optimal management of rheumatoid arthritis (RA). This is a 12-month prospective observational study in patients with moderate or severe RA of ≥6 months' duration who have started tocilizumab after failure of at least one previous disease-modifying antirheumatic drug (DMARD) including TNF inhibitors. For some analyses, patients were categorized by the use of tocilizumab as monotherapy or in combination, and by previous use of biological therapy. Overall, 379 were evaluable (84.4 % received tocilizumab after prior biologics and 78.4 % in combination with classic DMARDs). Tocilizumab was discontinued in 68/379 (17.9 %) patients after a median of 6.7 (3.7-10.4) months, mainly due to a lack of efficacy (24/379, 6.3 %) and adverse events (23/379, 6.1 %). Of 131 temporary interruptions of tocilizumab required in 101/379 (26.6 %) patients, 81/131 (61.8 %) were related to adverse events, and in 120/131 (91.6 %) cases, tocilizumab was reintroduced at 8 mg/kg. Thirty-six tocilizumab dose reductions occurred in 34/379 (9 %) patients due to abnormal laboratory values in 20/34 (55.6 %) cases. DAS28-ESR scores decreased from baseline (5.6 ± 1.0) to week 24 (3.0 ± 1.4) and week 52 (2.7 ± 1.3). DAS28 response differed between biologics-naive and biologics-experienced patients, both at weeks 24 and 52. In clinical practice, tocilizumab is effective in RA while retaining the expected safety and tolerability profile. Tocilizumab seems to be more effective for biologics-naive patients than for biologics-experienced patients, while it proves to be similarly effective when used in combination or monotherapy.
authors.affiliation: Department of Rheumatology, IdiPAZ, Hospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain, alejandro.balsa@salud.madrid.org.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Balsa
authors.forename: Juan Víctor
authors.initials: JV
authors.lastname: Tovar Beltrán
authors.forename: Rafael
authors.initials: R
authors.lastname: Cáliz Cáliz
authors.forename: Isabel
authors.initials: I
authors.lastname: Mateo Bernardo
authors.forename: Rosario
authors.initials: R
authors.lastname: García-Vicuña
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Gómez
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Belmonte Serrano
authors.forename: Carlos
authors.initials: C
authors.lastname: Marras
authors.forename: Eduardo
authors.initials: E
authors.lastname: Loza Cortina
authors.forename: Eva
authors.initials: E
authors.lastname: Pérez-Pampin
authors.forename: Vicente
authors.initials: V
authors.lastname: Vila
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C502936:tocilizumab