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Golimumab

Classification: A

Drug products: Simponi

ATC code: L04AB06

Substances: golimumab

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [1]. 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 [1]. Dose adjustment based on sex or body weight is not recommended by the manufacturer [4].

Effects

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 [1]. 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) [3].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of golimumab have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

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) [5].

Updated: 2019-02-26

Date of litterature search: 2015-08-07

References

  1. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SIMPONI (golimumab). Food and Drug Administration [www]. [cited 2009-04-24]. länk
  2. Xu ZH, Lee H, Vu T, Hu C, Yan H, Baker D et al. Population pharmacokinetics of golimumab in patients with ankylosing spondylitis: impact of body weight and immunogenicity. Int J Clin Pharmacol Ther. 2010;48:596-607. PubMed
  3. Inman RD, Davis JC, Heijde Dv, Diekman L, Sieper J, Kim SI et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58:3402-12. PubMed
  4. Simponi (golimumab). Summary of Product Characteristics. European Medicines Ageny; 2016.
  5. Dasgupta B, Combe B, Louw I, Wollenhaupt J, Zerbini CA, Beaulieu A et al. Patient and physician expectations of add-on treatment with golimumab for rheumatoid arthritis: relationships between expectations and clinical and quality of life outcomes. Arthritis Care Res (Hoboken). 2014;66:1799-807. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson