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Psoriatic Arthritis (PsA) Studies

Updated on 15/03/2018

IMMUNOLOGY
Psoriatic Arthritis (PsA) Studies

SIMPONI PsA indication

SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of active and progressive PsA in adults when the response to DMARD therapy has been inadequate. Shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.3

“GO-REVEAL: 69% of patients with PsA were still responding to SIMPONI at 5 Years1

66% of patients taking SIMPONI achieved the primary efficacy endpoint1

At week 256, SIMPONI patients achieved:1

Adapted from Kavanaugh A et al.
n = total number in each endpoint
*patients who had ≥3% BSA affected by psoriasis at baseline

Primary endpoint:2

ACR20 response at week 14
SIMPONI 50 mg: 51% (n=146)
Placebo: 9% (n=113)
P<0.001

Study design

Multicentre, randomised, double-blind, placebo-controlled, 24 week study (with open label extension up to 256 weeks) of 405 patients with active PsA despite treatment with NSAIDs or DMARDs.1

Patients randomised to SIMPONI 50 mg baseline characteristics:2

  • anti-TNF naïve
  • mean age: 45.7 years
  • mean disease duration: 7.2 years
  • patients with nail psoriasis: 65%
  • patients with ≥3% BSA affected by psoriasis: 75%
  • patients with enthesitis: 75%
  • patients with dactylitis: 34%

Abbreviations
ACR20/70: ≥20/70% improvement in the American College of Rheumatology criteria
BSA: body surface area
CRP: C-reactive protein
DAS28: disease activity score in 28 joints
DMARD: disease-modifying anti-rheumatic drug
NSAID: non-steroidal anti-inflammatory drug
PsA: psoriatic arthritis

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 years4

GO-AFTER
40% of RA patients, previously anti-TNF treated, were still responding to SIMPONI at 5 years5

Find out more

AS

SIMPONI is indicated to treat severe, active AS in adults who have responded inadequately to conventional therapy.1

AS GO-RAISE
72% of AS patients, were still responding to SIMPONI at 5 years6

Find out more

Related content

 

References

  1. Kavanaugh A et al. Ann Rheum Dis 2014; 73(9): 1689-1694.
  2. Kavanaugh Al et al. Arthritis Rheum 2009; 60: 976-986.
  3. SIMPONI Summary of Product Characteristics.
  4. Keystone E, et al. J Rheumatol 2016;43: 298–306.
  5. Smolen J, et al. Arthritis Res Ther 2015;17:14.
  6. Deodhar A, et al. Ann Rheum Dis 2015;74:757–761.

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-1246539-0000 | Date of Preparation: March 2018