Can Simponi Aria (golimumab) be administered at its standard dose in a patient with chronic kidney disease stage 3b (eGFR 30‑44 mL/min) and an ideal body weight ≤ 40 kg, or is a renal or weight‑based dose adjustment required?

Simponi Aria (Golimumab IV) Dosing in CKD Stage 3b with Low Body Weight

No renal or weight-based dose adjustment is required for Simponi Aria (golimumab IV) in patients with CKD stage 3b (eGFR 30-44 mL/min) and body weight ≤40 kg; the standard dose of 2 mg/kg at weeks 0,4, and then every 8 weeks should be administered. 1

Standard Dosing Regimen

• The FDA-approved dose for rheumatoid arthritis is 2 mg/kg administered intravenously at weeks 0,4, and then every 8 weeks thereafter, regardless of renal function 1
• This weight-based dosing inherently accounts for patients with lower body weight, as the dose is calculated per kilogram 1

Renal Impairment Considerations

• No formal trial of the effect of renal impairment on the pharmacokinetics of golimumab was conducted 1
• Population pharmacokinetic analyses from clinical trials showed that golimumab pharmacokinetics were not influenced by renal function 1
• The FDA label does not specify any dose adjustment requirements for patients with chronic kidney disease at any stage 1

Body Weight and Pharmacokinetic Relationship

• Population pharmacokinetic analyses demonstrated a trend toward higher apparent clearance of golimumab with increasing weight, but treatment with the recommended dose regimen did not result in meaningful differences in clinical efficacy among different weight groups 1
• Body weight was identified as an important covariate on volume of distribution in the central compartment (Vc), but there is no need to adjust the dosage of golimumab based on a patient's weight 1
• The weight-based dosing of 2 mg/kg automatically adjusts for lower body weight patients (e.g., a 40 kg patient would receive 80 mg per infusion) 1

Clinical Evidence Supporting Standard Dosing

• In clinical trials evaluating golimumab, subgroup analyses based on weight quartiles showed no meaningful differences in clinical efficacy across different weight groups in psoriatic arthritis and ankylosing spondylitis populations 1
• The pharmacokinetics of golimumab appeared to be linear over the dose range evaluated, with dose-proportional increases in maximum serum concentration and area under the curve 2

Safety Monitoring

• Standard safety monitoring for TNF antagonists should be maintained, including assessment for serious infections, tuberculosis screening, and monitoring for infusion reactions 3
• The incidence of infusion reactions with golimumab IV (3.6%) is significantly lower compared to other IV TNF antagonists 4

Common Pitfalls to Avoid

• Do not reduce the 2 mg/kg dose based solely on low body weight or moderate renal impairment (CKD stage 3b), as this is not supported by pharmacokinetic data or FDA labeling 1
• Do not delay or withhold treatment pending further renal function assessment if eGFR is stable at 30-44 mL/min, as no dose adjustment is indicated 1
• Ensure concomitant methotrexate use when treating rheumatoid arthritis, as this increases steady-state trough concentrations by approximately 52% and decreases anti-golimumab antibody formation from 7% to 2% 1