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SIMPONI® (golimumab) - Rheumatology
Updated on 01/03/2019
IMMUNOLOGY
SIMPONI – Rheumatology indications
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
Find out more about SIMPONI in Rheumatology by watching this short animated video
An animated outline of the key clinical data, real world evidence and monthly dosing for SIMPONI
Prescribing information | Safety informationEfficacy
The GO studies: 5 year efficacy data across 3 indications2,3,4,5
SIMPONI is indicated for the treatment of:
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 years2
GO-AFTER
40% of RA patients, previously anti-TNF treated, were still responding to SIMPONI at 5 years3
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 years5
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 years4
Convenience
Just one Injection, Once a Month1
SIMPONI ® requires fewer injections under the skin than any anti-TNF sub-cut biologic medicine, from day one.1
1. Hidden needle – thin needle automatically deploys (first click), then retracts (second click), so your patients never have to see it.
2. Green safety sleeve – interlock prevents operation until the device is firmly pressed against injection site.
3. Activation button – patients press the raised part of the button to start the injection.
4. Large viewing window – makes it easy to see when the full dose of SIMPONI has been administered.
5. Expiration date – clearly printed on the side of the autoinjector.
6. Easy-to-grip shape – designed with patients in mind, with an easy-to-grip, oval-shaped body
Dosage and administration
SIMPONI should be injected subcutaneously (SC). Treatment should be initiated under the supervision of a physician experienced in the diagnosis and treatment of RA, PsA, AS, nr-Axial SpA or UC. After training, patients may self-inject. RA: 50 mg given once a month, on the same date each month, concomitantly with MTX. PsA, AS and nr-Axial SpA: 50 mg given once a month, on the same date each month. Clinical response is usually achieved within 12-14 weeks of treatment (3 or 4 doses). Reconsider continued therapy in patients showing no evidence of therapeutic benefit within this time period. RA, PsA, AS and nr-Axial SpA: Patients weighing > 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, consider increasing the dose to 100 mg once a month, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose.1
Number of injections yearly
Recommended dosing of anti-TNF treatments injected under the skin for adults with moderate to severe, active RA, active PsA, or active AS, as per directed in the SPC for each product
-
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector
12 dosesOne injection under the skin, once a month1 Humira®†ǂ§7
(adalimumab) pen
26 dosesOne injection, under the skin, every other week -
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector 12 dosesOne injection under the skin, once a month1 Cimzia®§8
(certolizumab pegol) prefilled syringe
28 dosesInjections are given at the start of treatment at Week 0, Week 2, and Week 4
These doses are 400 mg, given under the skin as 2 separate injections of 200 mg each
Maintenance dosing is either one 200-mg injection every 2 weeks or two 200-mg injections every 4 weeks8 -
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector 12 dosesOne injection under the skin, once a month1 Enbrel®ƚ§ǁ9
(etanercept) autoinjector
52 dosesOne injection under the skin, once a week9
-
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector 12 dosesOne injection under the skin, once a month1 Humira®†ǂ§7
(adalimumab) pen 26 dosesOne injection, under the skin, every other week -
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector 12 dosesOne injection under the skin, once a month1 Cimzia®§8
(certolizumab pegol) prefilled syringe 28 dosesInjections are given at the start of treatment at Week 0, Week 2, and Week 4
These doses are 400 mg, given under the skin as 2 separate injections of 200 mg each
Maintenance dosing is either one 200-mg injection every 2 weeks or two 200-mg injections every 4 weeks8 -
Minimum number of injections in or during first year Dosing schedule SIMPONI®*†1
(golimumab) autoinjector 12 dosesOne injection under the skin, once a month1 Enbrel®ƚ§ǁ9
(etanercept) autoinjector 52 dosesOne injection under the skin, once a week9
*SIMPONI is used with the medicine methotrexate (MTX) for RA treatment and alone or with MTX for PsA treatment.
†SIMPONI, Humira, and Enbrel are also available in a prefilled syringe.
‡Humira can be used alone, with MTX, or with certain other medicines for RA and PsA treatment. Once-a-week dosing can be considered for RA patients who are not receiving MTX.
§Indicated trademarks are the registered trademarks of their respective owners.
ǁEnbrel can be used alone or with MTX for RA and PsA treatment.
This table is not intended to compare the safety, effectiveness, or uses of these treatments. Please refer to each product’s Prescribing Information and Medication Guide for recommended dosing and administration.
Once you and your patient are comfortable with the self-injection process, they will inject SIMPONI under the skin, just once a month.
SIMPONI patient support materials View Now
Related content
References
- SIMPONI Summary of Product Characteristics.
- Keystone E, et al. J Rheumatol 2016;43:298–306.
- Smolen J, et al. Arthritis Res Ther 2015;17:14.
- Deodhar A, et al. Ann Rheum Dis 2015;74:757–761.
- Kavanaugh A et al. Ann Rheum Dis 2014; 73(9): 1689-1694.
- Sieper J et al. Arthritis Rheumatol 2015; doi: 10.1002/art.39257.
- Humira Summary of Product Characteristics.
- Cimzia Summary of Product Characteristics.
- Enbrel Summary of Product Characteristics.
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-00110 | Date of Preparation: March 2019