Drug products: Simponi
ATC code: L04AB06
Golimumab is a TNF-alpha blocker and is used in several autoimmune conditions.
The efficacy of golimumab is equivalent in men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
According to the original manufacturer, population pharmacokinetic analysis suggests no differences between men and women after body weight adjustment in patients with rheumatoid arthritis or psoriasis arthritis . In a randomized, double-blind, placebo-controlled trial in patients with ankylosing spondylitis (225 men, 87 women), women had 13 % higher apparent clearance than men after body weight adjustment [1, 2]. However, as clinical response was similar in men and women this difference was not considered to be of clinically importance (see Effects) [2, 3].
A study conducted by the manufacturer showed that clinical efficacy was reduced with increasing body weight. However, increased exposure by increasing dose gave no increased efficacy . Dose adjustment based on sex or body weight is not recommended by the manufacturer .
According to the original manufacturer, phase 3 trials have not shown clinically relevant differences between men and women in golimumab efficacy. Subgroup analyses in rheumatoid arthritis, psoriasis arthritis and ankylosing spondylitis have shown treatment benefit versus placebo in both men and women at the proposed clinical dose . A randomized, double-blind, placebo-controlled study in patients with ankylosing spondylitis showed that the benefit of golimumab was similar in men and women (no data shown in the paper) .
No studies with a clinically relevant sex analysis regarding adverse effects of golimumab have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Patient expectations of add-on treatment with golimumab for rheumatoid arthritis patients have been investigated in an open-label, multinational, prospective study (564 men, 2716 women). At baseline, women reported higher treatment expectations than men (p=0.0023) .
Date of litterature search: 2015-08-07
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson