J. Tamaoki et al., Effect of suplatast tosilate, a Th2 cytokine inhibitor, on steroid-dependent asthma: a double-blind randomised study, LANCET, 356(9226), 2000, pp. 273-278
Citations number
23
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Background Th2 cytokines play an important part in the pathogenesis of asth
ma. Our aim was to study the effect of suplatast tosilate, a selective Th2
cytokine inhibitor, on asthma control and asthma exacerbations during reduc
tion of inhaled corticosteroid dose in patients with steroid-dependent asth
ma.
Methods 85 patients with moderate to severe asthma taking high doses (great
er than or equal to 1500 mu g per day) of inhaled beclometasone dipropionat
e, were assigned suplatast tosilate (100 mg three times daily) or placebo f
or 8 weeks in a double-blind, randomised, parallel-group, multicentre trial
. During the first 4 weeks, other medications remained unchanged (add-on ph
ase); during the next 4 weeks, the doses of beclometasone were halved (ster
oid-reduction phase). Main outcome measures were pulmonary function, asthma
symptoms, and use of beta(2)-agonists.
Findings Data were available from 77 patients. During the add-on phase, sup
latast tosilate treatment, compared with placebo, was associated with highe
r forced expiratory volume in 1 s (mean difference between groups for chang
es from baseline at week 4, 0.20 L [95% CI 0.16-0.24], p=0.043), morning pe
ak expiratory flow (18.6 L/min [14.1-23.1], p=0.037), and less diurnal vari
ation in peak expiratory flow rate, asthma symptom scores (7.1[6.6-7.6], p=
0.029), and serum concentrations of eosinophil cationic protein and IgE. In
the steroid-reduction phase, pulmonary function, asthma symptoms, and use
of beta(2)-agonist deteriorated significantly more in the placebo group tha
n in the suplatast group.
Interpretation Treatment with a Th2 cytokine inhibitor in steroid-dependent
asthma improves pulmonary function and symptom control, and allows a decre
ase in dose of inhaled corticosteroid without significant side-effects. Som
e improvements in pharmacokinetics are, however, needed.