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Axial Spondyloarthritis Studies

Updated on 15/03/2018

IMMUNOLOGY
Axial Spondyloarthritis (AS) Studies

SIMPONI Axial Spondyloarthritis Indication

SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of severe, active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy;5

Non-Radiographic Axial Spondyloarthritis (nr-Axial SpA): To treat adults with severe, active nr-Axial SpA with objective signs of inflammation as indicated by elevated C reactive protein and/or MRI evidence, who have had an inadequate response to, or are intolerant to NSAIDs.5

“GO-RAISE: 72% of patients with AS were still responding to SIMPONI at 5 years1

Two-thirds of patients taking SIMPONI met the primary efficacy assessment at 5 years1

At week 256, SIMPONI patients achieved:1,2

Primary endpoint:3

ASAS20 response at week 14
SIMPONI 50 mg: 59.4% (n=138)
Placebo: 21.8% (n=78)
p<0.001

Adapted from:
Deodhar A et al. Ann Rheum Dis 2015; 74(4): 757-61.
Deodhar A et al. Presented at EULAR 2013 congress, Madrid, Spain, June 12-15, 2013. Abstract. THU0352.
Inman RD et al. Arthritis Rheum 2008; 58: 3402-12.

Abbreviations
AS: ankylosing spondylitis
ASAS20: 20% improvement in assessment of SpondyloArthritis International Society
BASDAI: Bath ankylosing spondylitis disease activity index
BASFI: Bath ankylosing spondylitis functional index
DMARD: disease-modifying anti-rheumatic drug
NSAID: non-steroidal anti-inflammatory drug
VAS: visual analogue scale

Study design

OLE, open-label extension

Adapted from Smolen JS et al. Arthritis Res Ther 2015; 17: 14.

Important safety information

RA

SIMPONI is indicated in combination with MTX to treat moderate to severe, active RA in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate and severe, active and progressive RA in adults not previously treated with MTX.1

GO-FORWARD
70% of bio-naïve patients with RA were still responding to SIMPONI at 5 years6

GO-AFTER
40% of RA patients, previously anti-TNF treated, were still responding to SIMPONI at 5 years7

Find out more

PsA

SIMPONI is indicated to treat active and progressive PsA in adults when the response to DMARD therapy has been inadequate.1

GO-REVEAL
69% of PsA patients, were still responding to SIMPONI at 5 years8

Find out more

Related content

 

References

  1. Deodhar A, et al. Ann Rheum Dis 2015;74:757–761.
  2. Deodhar A et al. Presented at EULAR 2013 congress, Madird, Spain, June 12-15, 2013. Abstract.
  3. Inman RD et al. Arthritis Rheum 2008; 58: 3402-12.
  4. Calin A et al. J Rheumatol 1994; 21: 2281-5.
  5. SIMPONI Summary of Product Characteristics.
  6. Keystone E, et al. J Rheumatol 2016;43: 298–306.
  7. Smolen J et al. Arthritis Res Ther 2015; 17:14.
  8. Kavanaugh A et al. Ann Rheum Dis 2014; 73(9): 1689-1694.

Supporting documentation

SIMPONI 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Syringe | Patient Information Leaflet for Pre-filled Pen

SIMPONI 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Pen

RHEU-1246538-0000 | Date of Preparation: March 2018