Giant cell arteritis: azathioprine had no clear benefit as a steroid-sparing drug.

Clinical bottom line (level 1b-)

Azathioprine did not produce a clinically significant decrease in the dose of steroids required to control polymyalgia rheumatica or giant cell arteritis.
Patients given azathioprine were more likely to have nausea, vomiting or diarrhoea or stopped medication.

de Silva and Hazelman: Annals of the Rheumatic Diseases 1986; 45: 136-138

Expires February 2004

The study

Double-blinded ?concealed randomised trial without intention-to-treat
Setting: general hospital, UK

31 patients (aged range 57 to 80 years; mean 69, 77% female) polymyalgia rheumatica or giant cell arteritis on 5 mg or more of prednisolone a day; on a minimum to control symptoms, and on a stable dose for at least 3 months
Control Group: (n = 15, 15 analysed): placebo
Experimental Group: (n = 16, 16 analysed): azathioprine 50 mg tds po
All patients were given metoclopramide prn.
100% followed for 12 months

The evidence

Outcome	Time to outcome	CER	EER	RRR (95% CI)	ARR (95% CI)	NNH (95% CI)
nausea/vomiting/diarrhoea	12 months	3 (20.0%)	7 (43.8%)	-119% (-594% to 31.0%)	-23.8% (-55.4% to 7.88%)	4 (NNT = 13 to infinity; NNH = 2 to infinity)
stopped medication	12 months	4 (26.7%)	7 (43.8%)	-64.0% (-349% to 40.0%)	-17.1% (-50.1% to 16.0%)	6 (NNT = 6 to infinity; NNH = 2 to infinity)

Outcome	Control Group (SD)	Experimental Group (SD)	Mean Difference (95% CI)
prednisolone dose/mg at 0 weeks	7.40 (0.37)	8.10 (0.37)	-0.70 (-0.97 to -0.42)
prednisolone dose/mg at one year	4.20 (0.58)	1.90 (0.84)	2.30 (1.77 to 2.83)

Comments

Patients were paired and stratified for age, duration of disease activity, result of temporal artery biopsy, and maintenance dose of steroid required. How randomised was the trial?
Significant drop-out rate- makes results uncertain.

Citation

de Silva M, and Hazelman BL: Azathioprine in giant cell arteritis/polymyalgia rheumatica. Annals of the Rheumatic Diseases 1986; 45: 136-138

Search Terms: arterit* in Cochrane
Contributor: Chris Ball and Clare Wotton, February 2000
Reviewer:

_{Clinical Question.}

_Patient	_{polymyalgia rheumatica or giant cell arteritis}
_{Intervention or Exposure}	_azathioprine
_Comparison	_placebo
_Outcome	_{decrease in steroid dose to control condition}