title: Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).
abstract: OBJECTIVE
  To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).
  
  
  METHODS
  Patients (n=1262) were randomised 1:1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11:1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SC-IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.
  
  
  RESULTS
  The proportions of patients who achieved American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index ≥0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed.
  
  
  CONCLUSIONS
  The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.
  
  
  BACKGROUND
  NCT01194414.
authors.affiliation: Free University and Humboldt University of Berlin, Berlin, Germany.
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
authors.affiliation: Klinikum der Universität zu Köln, Köln, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rubbert-Roth
authors.affiliation: Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cantagrel
authors.affiliation: Cabrini Medical Centre, Malvern, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hall
authors.affiliation: Poznan Medical University, Poznan, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Leszczynski
authors.affiliation: Universidade Federal de São Paulo, São Paulo, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Feldman
authors.affiliation: Arthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA.
authors.forename: Madura J
authors.initials: MJ
authors.lastname: Rangaraj
authors.affiliation: Rheumatology Associates of South Carolina, Charleston, South Carolina, USA.
authors.forename: Georgia
authors.initials: G
authors.lastname: Roane
authors.affiliation: East Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Ludivico
authors.affiliation: Genentech Inc, South San Francisco, California, USA.
authors.forename: Min
authors.initials: M
authors.lastname: Bao
authors.affiliation: Roche Products Limited, Welwyn Garden City, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Rowell
authors.affiliation: Roche Products Limited, Welwyn Garden City, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Davies
authors.affiliation: Organizacion Medica de Investigación, Buenos Aires, Argentina.
authors.forename: Eduardo F
authors.initials: EF
authors.lastname: Mysler
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004333:Drug Administration Routes; D004359:Drug Therapy, Combination; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C502936:tocilizumab
keywords: DMARDs (biologic); Rheumatoid Arthritis; Treatment