Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study

• DOI: 10.1007/s40744-016-0043-1
• Publication Date: 2016-09-24T03:17:11Z
• Authors: Alan Kivitz; Thomas Wallace; Ewa Olech; Michael Borofsky; Jenny Devenport; Jinglan Pei; Margaret Michalska
• Keywords: Tocilizumab; Clinical endpoint; Safety profile

To assess the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) in US patients with rheumatoid arthritis (RA) who rolled over from two global phase 3 studies, SUMMACTA (NCT01194414) BREVACTA (NCT1232569), into this open-label, single-arm, 3b study. Patients continued to receive TCZ-SC 162 mg weekly or every other week switched intravenous TCZ qw for up 84 weeks. The primary endpoint was proportion serious adverse events (SAEs). Secondary endpoints included clinical efficacy, laboratory abnormalities, immunogenicity. Of 217 treated, 76.5% were female, mean age 58.4 years. A total 23 (10.6%) had ≥1 SAE. most common SAEs infections (3.7%). Alanine aminotransferase elevations (38.2%) not associated hepatic injury. Grade 3/4 neutropenia (3%) transient infections. Immunogenicity low (<1%) SAEs. No anaphylaxis deaths occurred. Thirteen (6.0%) withdrew due reasons. Mean Clinical Disease Activity Index Score 28 joints remained stable throughout trial. during extension period consistent profiles BREVACTA, no new signals. Efficacy improvements observed baseline time. These results demonstrated durability responses, immunogenicity, exposure RA. Funding: F. Hoffmann-La Roche, Ltd. Trial registration number: ClinicalTrials.gov identifier, NCT01662063.