SIMPONI (Golimumab) Dosing Recommendations
Standard Dosing for Inflammatory Arthritis
For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the recommended dose of SIMPONI is 50 mg administered by subcutaneous injection once monthly (every 4 weeks). 1
Specific Indications and Dosing:
Rheumatoid Arthritis: 50 mg subcutaneously once monthly, must be given in combination with methotrexate 1
Psoriatic Arthritis: 50 mg subcutaneously once monthly, may be given with or without methotrexate or other non-biologic DMARDs 1, 2
Ankylosing Spondylitis: 50 mg subcutaneously once monthly, may be given with or without methotrexate or other non-biologic DMARDs 1
Ulcerative Colitis: Different dosing regimen—200 mg subcutaneously at Week 0, followed by 100 mg at Week 2, then 100 mg every 4 weeks for maintenance 1
Key Dosing Considerations
There is no evidence that the 100 mg dose provides superior efficacy compared to the 50 mg dose for inflammatory arthritis. Phase III trials (GO-BEFORE, GO-FORWARD, GO-AFTER, GO-REVEAL, GO-RAISE) showed no clear improvement in ACR or ASAS response rates with 100 mg versus 50 mg dosing. 3, 4
Administration Details:
- Allow the prefilled syringe or autoinjector to sit at room temperature for at least 30 minutes before injection 1
- Rotate injection sites; avoid areas where skin is tender, bruised, red, or hard 1
- If multiple injections required (as in ulcerative colitis induction), administer at different body sites 1
- Patients sensitive to latex should not handle the needle cover (contains dry natural rubber) 1
Concomitant Medications
Corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during SIMPONI treatment for RA, PsA, or AS. 1
Comparative Context
Golimumab offers the advantage of less frequent dosing (once monthly) compared to other subcutaneous TNF inhibitors: adalimumab requires dosing every 2 weeks, and etanercept requires weekly or twice-weekly dosing. 5, 6 This monthly administration schedule may improve patient convenience and adherence. 5, 7
Efficacy Data:
- In psoriatic arthritis (GO-REVEAL), 51% of patients achieved ACR20 response at week 14 with golimumab 2
- In patients who previously failed other TNF inhibitors (GO-AFTER), 35% on 50 mg and 38% on 100 mg achieved ACR20 at week 14, compared to 18% on placebo 4
- The tolerability profile is consistent with other anti-TNF agents 3, 7
Mandatory Pre-Treatment Screening
- Test for latent tuberculosis before initiating SIMPONI and periodically during therapy 1
- Test for hepatitis B viral infection prior to initiation 1
- Do not initiate in patients with active infection 1
Important Safety Warnings
SIMPONI increases risk of serious infections (including tuberculosis, invasive fungal infections, and opportunistic infections) that may lead to hospitalization or death. 1 Patients over 65 years, those with comorbidities, or taking concomitant immunosuppressants (corticosteroids, methotrexate) are at greater risk. 1
Do not use SIMPONI concomitantly with abatacept or anakinra due to increased infection risk. 1