Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-Week results of the GO-RAISE study

Jürgen Braun, Atul Deodhar, Robert D. Inman, Désirée Van Der Heijde, Michael Mack, Stephen Xu, Benjamin Hsu

Research output: Contribution to journalArticle

76 Scopus citations

Abstract

Objective: To assess the efficacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis. Methods: At baseline, patients with active ankylosing spondylitis (n=356) were randomly assigned (1:1.8:1.8) to subcutaneous injections of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3) every 4 weeks. At week 16, patients in groups 1 and 2 with <20% improvement in total back pain and morning stiffness entered early escape to 50 or 100 mg, respectively. At week 24, patients still receiving placebo crossed over to golimumab 50 mg. Findings through week 24 were previously reported; those through week 104 are presented herein. Results: At week 104, 38.5%, 60.1% and 71.4% of patients in groups 1, 2 and 3, respectively, had at least 20% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20); 38.5%, 55.8% and 54.3% had an ASAS40 response and 21.8%, 31.9% and 30.7% were in ASAS partial remission. Mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were <3 at week 104 for all the treatment regimens. Golimumab safety through week 104 was similar to that through week 24. Conclusion: Clinical response that was achieved by patients receiving golimumab through 24 weeks was sustained through 52 and 104 weeks. The golimumab safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors.

Original languageEnglish (US)
Pages (from-to)661-667
Number of pages7
JournalAnnals of the rheumatic diseases
Volume71
Issue number5
DOIs
StatePublished - May 2012

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Fingerprint Dive into the research topics of 'Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-Week results of the GO-RAISE study'. Together they form a unique fingerprint.

  • Cite this