Effect of suplatast tosilate, a Th2 cytokine inhibitor, on steroid-dependent asthma: a double-blind randomised study

Citation
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
Language
INGLESE
art.tipo
Article
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Journal title
LANCET
ISSN journal
0140-6736 → ACNP
Volume
356
Issue
9226
Year of publication
2000
Pages
273 - 278
Database
ISI
SICI code
0140-6736(20000722)356:9226<273:EOSTAT>2.0.ZU;2-W
Abstract
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.