title: Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study.
abstract: BACKGROUND
  To assess the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) in US patients with rheumatoid arthritis (RA) who rolled over from the two global phase 3 studies, SUMMACTA (NCT01194414) and BREVACTA (NCT1232569), into this open-label, single-arm, phase 3b study.
  
  
  METHODS
  Patients continued to receive TCZ-SC 162 mg weekly or every other week or switched from intravenous TCZ to TCZ-SC 162 mg qw for up to 84 weeks. The primary endpoint was the proportion of patients with serious adverse events (SAEs). Secondary endpoints included clinical efficacy, laboratory abnormalities, and immunogenicity.
  
  
  RESULTS
  Of the 217 patients treated, 76.5% were female, and the mean age was 58.4 years. A total of 23 patients (10.6%) had ≥1 SAE. The most common SAEs were infections (3.7%). Alanine aminotransferase elevations (38.2%) were not associated with hepatic injury. Grade 3/4 neutropenia (3%) was transient and not associated with serious infections. Immunogenicity was low (<1%) and not associated with SAEs. No anaphylaxis or deaths occurred. Thirteen patients (6.0%) withdrew due to safety reasons. Mean Clinical Disease Activity Index and Disease Activity Score in 28 joints remained stable throughout the trial.
  
  
  CONCLUSIONS
  The long-term safety of TCZ-SC during the long-term extension period was consistent with the safety profiles from SUMMACTA and BREVACTA, with no new safety signals. Efficacy improvements observed from baseline remained stable over time. These results demonstrated the durability of the safety and efficacy responses, and low immunogenicity, with long-term exposure to TCZ-SC in patients with RA.
  
  
  BACKGROUND
  F. Hoffmann-La Roche, Ltd.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01662063.
authors.affiliation: Altoona Arthritis and Osteoporosis Center, 175 Meadowbrook Lane, PO Box 909, Duncansville, PA, USA. ajkivitz@yahoo.com.
authors.forename: Alan
authors.initials: A
authors.lastname: Kivitz
authors.affiliation: Genentech Inc., South San Francisco, CA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wallace
authors.affiliation: University of Nevada School of Medicine, Las Vegas, NV, USA.
authors.forename: Ewa
authors.initials: E
authors.lastname: Olech
authors.affiliation: Clinical Research Center of Reading, Reading, PA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Borofsky
authors.affiliation: Genentech Inc., South San Francisco, CA, USA.
authors.forename: Jenny
authors.initials: J
authors.lastname: Devenport
authors.affiliation: Genentech Inc., South San Francisco, CA, USA.
authors.forename: Jinglan
authors.initials: J
authors.lastname: Pei
authors.affiliation: Genentech Inc., South San Francisco, CA, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Michalska
keywords: Rheumatoid arthritis; Safety; Subcutaneous; Tocilizumab