3 days popular7 days popular1 month popular3 months popular

New data presented on efficacy of Simponi® (golimumab) in treating patients with active non-radiographic axial spondyloarthritis

MSD () announced findings from the GO-AHEAD study[1] showing that patients with active non-radiographic axial (nr-AxSpA) treated with injections of Simponi® (golimumab) 50 mg every four weeks for 16 weeks had significantly greater improvements in disease activity and on (MRI) than patients treated with . These data were presented at the 2014 American College of Rheumatology (ACR) annual meeting in Boston, US. Additionally, Janssen Biologics B.V. (Janssen) has also announced that a Type II Variation has been filed with the seeking approval of golimumab for the treatment of severe active nr-AxSpA. The application is supported by data from the GO-AHEAD study.

GO-AHEAD was a Phase 3b, double-blind, randomised, placebo-controlled trial that, for the first time, evaluated subcutaneous golimumab 50 mg versus placebo, administered every four weeks, in patients aged 18-45 years, with active nr-AxSpA. The primary endpoint of the study was to determine the percentage of patients who achieved at least a 20 per cent improvement in Assessment in Ankylosing Spondylitis (ASAS 20) criteria at week 16. The study also assessed a subgroup of patients who showed objective signs of inflammation (OSI) by MRI or elevated C-reactive protein (CRP) at baseline. This subset of patients comprised approximately 80 per cent of the total population. Golimumab was well-tolerated and generally had a favorable benefit-risk profile.

Dr Paul Robinson, Medical Director, MSD UK commented: ‘These results show the value of golimumab in managing the disease activity and inflammation in patients with this debilitating disease, enabling them to function better in their day-to-day activities.’

Key findings

At week 16, ASAS 20 was achieved by a greater percentage of patients treated with golimumab than placebo (71.1 percent versus 40.0 percent, respectively; P< .0001) and ASAS 20 improvements were also seen in the OSI subpopulation (76.9 percent versus 37.5 percent, respectively; P<.0001). Similarly, key secondary endpoints at week 16 were attained in more golimumab-treated patients compared to placebo, including:

  • ASAS 40 response – All Patients: 56.7 per cent versus 23.0 per cent, respectively; P< .0001; OSI Population: 60.3 per cent versus 22.5 per cent, respectively; P<.0001
  • ASAS partial remission – All Patients: 33.0 per cent versus 18.0 per cent, respectively; P=.0136; OSI Population: 34.6 per cent versus 18.8 per cent, respectively; P=.0204
  • Attainment of at least 50 per cent improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) – All Patients: 57.7 percent versus 30.0 percent, respectively; P< .0001; OSI Population: 59.0 percent versus 28.8 percent, respectively; P<.0001

Mean Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint score improvements from baseline to week 16 were also greater in patients treated with golimumab than placebo: -5.3 versus -0.9, respectively in the overall population (P< .0001) and -6.4 versus -1.2, respectively in the OSI population (P<.0001).

NICE and spondyloarthritis

In the UK, NICE (National Institute for Health and Care Excellence) is currently reviewing the guidelines for the diagnosis and management of spondyloarthritic conditions, including nr-AxSpA.[2] Additionally, a NICE Multiple Technology Appraisal (MTA) is in progress evaluating the use of adalimumab, certolizumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and non-radiographic axial spondyloarthritis, with publication anticipated in July 2015.[3]

Source

1. J.Sieper et al. A Randomized, Double-Blind, Placebo-Controlled, 16-Week Study of Subcutaneous Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis. Abstract 2938. American College of Rheumatology, Boston, 15-19 November, 2014 http://acrabstracts.org/abstracts/a-randomized-double-blind-placebo-controlled-16-week-study-of-subcutaneous-golimumab-in-patients-with-active-nonradiographic-axial-spondyloarthritis/ Accessed November 2014.

2. NICE. Spondyloarthritis: the diagnosis and management of spondyloarthritis. Available at https://www.nice.org.uk/guidance/gid-cgwave0688/documents/spondyloarthritis-final-scope2. Accessed November 2014.

3. NICE. Ankylosing spondylitis and axial spondyloarthritis (non-radiographic) – adalimumab, etanercept infliximab and golimumab (incl rev TA 143 and TA 233). Available at http://www.nice.org.uk/guidance/indevelopment/gid-tag355. Accessed November 2014.

Source: MSD