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

Abstract

ObjectiveTo assess the efficacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis.MethodsAt 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.ResultsAt 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.ConclusionClinical 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.

Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

“…No further ethical approval was required to conduct the additional data analyses reported herein. Patient entrance criteria and study designs for each trial have been reported [8][9][10][11][12][13][14][15][16][17]18,19,20,21,22,23,24 and are summarized in Table 1. Additionally, further details of each trial are available at clinicaltrials.gov (GO-BEFORE: NCT00264537, GO-FORWARD: NCT00264550, GO-AFTER: NCT00299546, GO-REVEAL: NCT00265096, GO-RAISE: NCT00265083).…”

“…Our current study was a pooled analysis of previously collected safety data from 5 large multicenter trials [8][9][10][11][12][13][14][15][16][17]18,19,20,21,22,23,24 , each of which was conducted according to the Declaration of Helsinki and the International Committee on Harmonisation Good Clinical Practices. Each of the phase 3 study protocols was approved by central or individual site institutional review boards/ethics committees, and all patients provided written informed consent prior to any study-related procedures.…”

Behçet Disease-associated Uveitis Successfully Treated with Golimumab

“…1,2 Golimumab (GLM) is a novel fully human anti-TNF monoclonal antibody, recently approved for a variety of rheumatic conditions, [3][4][5] with very promising results. Herein we describe a case that exemplifies the efficacy of GLM in a patient with refractory Behçet uveitis, and represents, to our knowledge, the first report about the use of GLM in Behçet uveitis.…”

“…Biological therapy with TNF antagonists has created new possibilities to control this condition, particularly in those patients refractory to conventional immunosuppressive agents. 8 GLM is a recent development in TNF antagonism and has been recently approved for the treatment of a variety of rheumatic inflammatory conditions, [3][4][5] with an acceptable safety profile, and remains the only TNF antagonist that has shown efficacy in patients refractory to other anti-TNF agents. 9 Due to GLM molecular structure, a fully human monoclonal antibody, GLM has a lower probability of developing neutralizing antibodies compared to other anti-TNF such as IFX, a chimeric monoclonal antibody, decreasing the risk of an allergic infusion reaction and any loss of efficacy.…”

Serum Vascular Endothelial Growth Factor Levels Lack Predictive Value in Patients with Active Ankylosing Spondylitis Treated with Golimumab

“…All patients provided written informed consent. The GO-RAISE patient selection criteria and study design have been described elsewhere 14,15 . Patients had definite AS according to the modified New York criteria 16 , and active disease defined as a Bath Ankylosing Spondylitis Disease Activity Index 17 score ≥ 4 and a total back pain visual analog scale score ≥ 4.…”