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SIMPONI - Rheumatology
SIMPONI® (golimumab) Rheumatology /
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SIMPONI® (golimumab) Rheumatology

Prescribing Information

SIMPONI (golimumab) was developed to fit with patient needs and lifestyle, whilst continuing to improve functionality and disease outcomes. It is the first and only subcutaneous anti-TNF therapy with convenient once-monthly dosing from day one, licenced for Rheumatoid Arthritis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis and Psoriatic Arthritis within Rheumatology.1

Efficacy

The GO studies: 5 year efficacy data across 3 indications2,3,4,5

Psoriatic Arthritis (PsA)

SIMPONI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active and progressive PsA in adult patients when response to disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.1

GO-REVEAL

66% of PsA patients still responding with an ACR20 at 5 years (n=96/146)*2

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Ankylosing Spondylitis (AS)

SIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy.1

GO-RAISE

66% of AS patients still responding with an ASAS20 at 5 years. (n=235/356)**3

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Rheumatoid Arthritis (RA)

SIMPONI is indicated in combination with MTX to treat moderate to severe, active RA in adults when the response to 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 RA patients still responding with ACR20 at 5 years (n=62/89)*4

GO-AFTER

42% of bio-experienced RA patients achieved an ACR20 at 5 years (n=84/201)**5

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Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

SIMPONI is indicated to treat adults with severe, active nr-axSpA 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.1

GO-AHEAD

84% of patients were still responding with an ASAS20 at week 52 (n= 78/93)*6

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ACR20: ≥20% improvement in the American College of Rheumatology criteria ASAS20 ≥20% assessment of SpondyloArthritis International Society

* SIMPONI 50 mg

** SIMPONI 50 mg or 100 mg
By study design, randomisation of weight; patients in the long term extension may have switched between the 50 mg and 100 mg SIMPONI doses at the discretion of study physician.

Dosage and administration

SIMPONI® SmartJect® autoinjector: Specially designed with patients in mind7

Just one injection, once a month.1

SIMPONI® SmartJect® autoinjector

Find out more about dosing

Patient support

Information for your SIMPONI patients

Patient support information leaflet
 

Our patient support website will help your patients:

  • Get started with SIMPONI
  • Self-dosing instructions
  • Safety information
  • Diet and exercise tips
Visit our patient website

Important safety information

References

  1. SIMPONI (golimumab). Summary of Product Characteristics. Available at www.medicines.org.uk/emc.
  2. Kavanaugh A et al. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis 2014; 73: 1689–1694.
  3. Deodhar A et al. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study. Ann Rheum Dis 2015; 74: 757-761.
  4. Keystone E, et al. Safety and efficacy of subcutaneous Golimumab in patients with active Rheumatoid Arthritis despite Methotrexate therapy: final 5-year results of the GO-FORWARD trial. J Rheumatol 2016; 43:2, 298-306.
  5. Smolen J et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther 2015; 17:229.
  6. Van der Heijde D, Dougados M, Maksymowych WP et al. Long-Term Efficacy and Tolerability of Golimumab in Active Nonradiographic Axial Spondyloarthritis: Results of the Open-Label Extension of a Randomized, Double-Blind Study. Poster SAT0388 presented at EULAR 2016.
  7. Vermeire, D’heygere, Nakad et al. Preference for a prefilled syringe or an auto injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. Patient Prefer Adherence 2018; 12: 1193–1202.

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

GB-GOL-00272 | Date of Preparation: September 2020