Subcutaneous Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis (SpA)

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SCIENCE
Subcutaneous Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis (SpA)
Key Take-Away: 

This is the first study of TNF blockers in patients with non-radiographic axial SpA that analyzed that golimumab is well tolerated in young population and demonstrate a favorable risk/benefit profile treatment in patients with this disease.

Axial spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammation of the sacroiliac (SI) joints and spine and patients with this disease may experience chronic back pain and spinal stiffness as well as a reduction in mobility and quality of life (QoL). The term axial SpA encompasses patients with evident radiographic changes in the SI joints and also termed ankylosing spondylitis (AS), and patients who have no evident radiographic signs of structural damage but who may have evidence of sacroiliitis visible by magnetic resonance imaging (MRI) and/or share other features with AS such as spinal inflammation, chronic back pain, and other non-articular symptoms.

ABSTRACT: 
Background: 

Axial spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammation of the sacroiliac (SI) joints and spine and patients with this disease may experience chronic back pain and spinal stiffness as well as a reduction in mobility and quality of life (QoL). The term axial SpA encompasses patients with evident radiographic changes in the SI joints and also termed ankylosing spondylitis (AS), and patients who have no evident radiographic signs of structural damage but who may have evidence of sacroiliitis visible by magnetic resonance imaging (MRI) and/or share other features with AS such as spinal inflammation, chronic back pain, and other non-articular symptoms.

The current standard of care for axial SpA is nonsteroidal anti-inflammatory drugs (NSAIDs). If there is an insufficient response to or intolerance of NSAIDs the next line of treatment is tumor necrosis factor (TNF)–targeted therapies, which have demonstrated efficacy in recent trials in patients with non-radiographic axial SpA.

Rationale for research

  1. Compared with other drugs used for the treatment of axial spondyloarthritis or If there is an insufficient response to or intolerance of NSAIDs then the next line of treatment is tumor necrosis factor inhibitors
  2. Therefore, Golimumab, a fully human anti-TNF antibody has shown promising effects in SpA
  • Objective

To determine whether golimumab is superior to placebo in patients with non-radiographic axial  spondyloarthritis

Methods: 

 

Study outcomes

  • Primary outcome:  Reduction in pain according to ASAS criteria at week 16.
  • Secondary outcome: An ASAS40 response, ASAS partial remission, 50% improvement in the BASDAI (BASDAI 50 response), and change in the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI index for SI joint inflammation, all at 16 weeks.
  • Time-points
    • Efficacy: Baseline and 16 weeks
    • Safety measures: Clinical evaluations and routine laboratory measurements, including serum chemistry and hematology testing, were performed at screening, on day 1, and at weeks 4 and 16 or the time of early termination. Vital signs were measured at screening, on day 1, and at weeks 4, 8, 12, and 16 or the time of early termination.
Results: 

 

  • Baseline: The two treatment groups were similar with respect to baseline demographics and disease characteristics, except sex.
  • Primary outcomes
  • At week 16, the percentage of patients achieving an ASAS20 response was significantly higher in the golimumab group compared with the placebo group (71.1% versus 40.0%; change in response 31.2% [95% confidence interval (95% CI) 17.5%, 43.6%]; P < 0.0001)
  • Analysis of the ASAS20 response in the OSI patient population (n=158 [78 in the golimumab group and 80 in the placebo group]) demonstrated a greater difference in response between golimumab- and placebo-treated patients (76.9% versus 37.5%)
  • Among the subgroup of patients achieving an ASAS20 response at week 16 who had baseline evidence of sacroiliitis on MRI, the response was greater in those receiving golimumab compared with those receiving placebo (73.8% versus 37.9%; change in response 36.0% [95% CI 19.3%, 50.7%]; P <0.0001)
  • Secondary outcomes
  • An ASAS40 response, the treatment group difference was similar to that observed for the primary end point (56.7% of patients in the golimumab group versus 23.0% of those in the placebo group; change in response 33.8% [95% CI 20.4%, 46.1%]; P < 0.0001).
  • The BASDAI 50, ASAS partial remission, and mean change in the SPARCC MRI SI joint score, revealed significant improvement in patients treated with golimumab (P< 0.0001, P=0.0136, and P<0.0001, respectively.
Conclusion: 

The result demonstrated that golimumab, administered subcutaneously every 4 weeks, is efficacious and generally well tolerated in patients with non-radiographic axial SpA. Golimumab treatment led to a rapid reduction in the signs and symptoms of Nonradiographic axial SpA, and this effect was sustained through week 16.

Furthermore, golimumab provided substantial benefits to patients with non-radiographic axial SpA by also improving multiple disease features including inflammation identified by MRI, range of motion, physical function, and health-related QoL. These results demonstrate a favorable risk/benefit profile for golimumab treatment in patients with non-radiographic axial SpA.Treatment with golimumab every 4 weeks resulted in significant and sustained improvements in the signs and symptoms of non-radiographic axial SpA through week 16, with improvement occurring after the first injection of golimumab. Golimumab was safe and generally well tolerated in this study, and its safety profile was consistent with the known safety profile of golimumab when used for other indications. These data indicate that the treatment response to golimumab in patients with non-radiographic axial SpA is similar to the response observed in patients with AS treated with golimumab.

Arthritis & Rheumatology. 2015 Oct; Vol 67(10) : pg 2702–2712
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