AS Drug Seems Safe, But Does It Help?

Apremilast for ankylosing spondylitis led to slight improvements in disease activity and disability

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) Patients with ankylosing spondylitis have a number of drugs to choose from. When a new drug comes along, it must go through strict testing to see if it is safe and effective.

Ankylosing spondylitis patients taking apremilast had slightly greater improvements in disease activity and disability compared to those taking placebo, according to a small Phase II study.

Even though this study was small (only 36 participants completed the study), the results suggest that apremilast may be safe and effective in patients with ankylosing spondylitis, the researchers concluded.

"Seek treatment if you have ankylosing spondylitis."

Peter Taylor, PhD, of the University of Oxford in the UK, and colleagues set out to study the safety and effectiveness of apremilast, which is part of a class of drugs called phosphodiesterase-4 (PDE4) inhibitors.

PDE4 inhibitors work by blocking the action of the PDE4 molecule, which is involved in inflammation - a central aspect of ankylosing spondylitis.

Dr. Taylor and colleagues found that compared to placebo, apremilast use was associated with:

  • greater improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - a scale of one through 10 in which one means no problem and 10 means the worst problem
  • greater improvements in Bath Ankylosing Spondylitis Functional Index (BASFI) - a measure of disability in ankylosing spondylitis
  • greater improvements in Bath Ankylosing Spondylitis Metrology Index (BASMI) - a measure of spinal mobility in ankylosing spondylitis

Despite these greater improvements, the difference between apremilast and placebo was not significant, the researchers said.

Results also showed that these improvements went away when patients stopped taking apremilast. By 4 weeks after quitting the drug, patients ended up back where they were at the beginning of the study.

A total of six patients (35.3 percent) taking apremilast reached ASAS-20 responses, which indicates an improvement of 20 percent or more in overall disease activity. In comparison, three placebo patients (15.8 percent) reached ASAS-20 responses.

Due to the size of the study and the minimal improvements experienced by patients, more research of apremilast is needed.

This double-blind, placebo-controlled, single-center, Phase II study lasted 12 weeks.

The authors did not disclose potential conflicts of interest.

The research was published September 14 in the Annals of the Rheumatic Diseases

Reviewed by: 
Review Date: 
October 17, 2012
Last Updated:
October 31, 2012