A placebo-controlled multicenter study of auranofin in the treatment of patients with corticosteroid-dependent asthma☆,☆☆,★,★★
Section snippets
Patient selection
Patient eligibility was determined by the following inclusion criteria: (1) a diagnosis of asthma as defined by the American Thoracic Society15 and a 15% increase in FEV1 after treatment with an inhaled β2-agonist, (2) a history of perennial asthma with symptoms of equivalent severity throughout the year, (3) optimal concomitant therapy with β2-agonists and/or methylxanthines, and (4) dependency on oral corticosteroid dosages of at least 10 mg of prednisone or 8 mg of methylprednisolone per day
RESULTS
Of 334 patients screened, 140 were randomized to the auranofin group and 139 to the placebo group. Four patients in the auranofin group were excluded from the intent-to-treat efficacy analyses because of noncompliance in the initial 2 weeks of phase I. Therefore 136 patients were analyzed in the auranofin group. Eighty-two patients treated with auranofin and 75 patients treated with placebo completed the study. Forty-eight subjects withdrew because of adverse experiences: 47 because of protocol
DISCUSSION
Evaluation of the steroid-sparing effects of a novel drug in the treatment of steroid-dependent asthma has been approached from two perspectives: (1) drug evaluation while patients continue to receive a maintenance or minimally effective dose of oral corticosteroids3 or (2) deliberate reduction of maintenance corticosteroid dosages after patients have been stabilized while receiving the steroid-sparing drug.2 Improvement in symptoms and lung function have been the primary efficacy end points
References (18)
- et al.
Methotrexate in the treatment of steroid-dependent asthma
J ALLERGY CLIN IMMUNOL
(1991) - et al.
Trial of cyclosporin in corticosteroid-dependent chronic severe asthma
Lancet
(1992) - et al.
Troleandomycin in the treatment of difficult asthma
J ALLERGY CLIN IMMUNOL
(1993) - et al.
Bronchial responsiveness to acetylcholine in patients with bronchial asthma after long-term treatment with gold salt
J ALLERGY CLIN IMMUNOL
(1981) - et al.
Inhibition by auranofin of pharmacologic and antigen-induced contractions of the isolated guinea pig trachea
J ALLERGY CLIN IMMUNOL
(1986) - et al.
An open study of auranofin in the treatment of steroid-dependent asthma
J ALLERGY CLIN IMMUNOL
(1988) - et al.
Modulation of bronchial inflammation: corticosteroids and other therapeutic agents
Am J Respir Crit Care Med
(1994) - et al.
Gold salt in the treatment of bronchial asthma: a double-blind study
Ann Allergy
(1978) - et al.
Modulation of the release of histamine and arachidonic acid metabolites from human basophils and mast cells by auranofin
Agents Actions
(1986)
Cited by (73)
Severe Asthma
2012, Kendig and Chernick's Disorders of the Respiratory Tract in ChildrenPhenotypes of refractory/severe asthma
2011, Paediatric Respiratory ReviewsCitation Excerpt :Having entered these caveats, if a child is thought to be steroid sensitive, it makes sense to try to maintain the child on as low a dose as possible of prednisolone. If the dose cannot be reduced to an acceptable level, options would be omalizumab (if eligible, and every reasonable effort has been made to reduce environmental allergen exposure) [43–5], or steroid sparing agents such as methotrexate, cyclosporin or immunoglobulin infusions [46–8]. These are also the options for the steroid resistant child.
New Insight into the Pathogenesis and Management of Refractory Childhood Asthma
2010, Pediatric Allergy: Principles and Practice Expert Consult: Second EditionManagement of severe asthma in children
2010, The LancetTherapeutic targets for persistent airway inflammation in refractory asthma
2010, Biomedicine and PharmacotherapyManaging patients with chronic severe asthma: Rise to the challenge
2009, European Journal of Internal Medicine
- ☆
From aUniversity of Cincinnati College of Medicine, Department of Medicine, Division of Immunology; bSmithKline Beecham, King of Prussia, Pa.; and cAbbott Laboratories, Abbott Park.
- ☆☆
Supported by a grant from the SmithKline Beecham Pharmaceuticals, King of Prussia, Pa.
- ★
Reprint requests: I. Leonard Bernstein, MD, University of Cincinnati College of Medicine, 231 Bethesda Ave., M.L. 563 Cincinnati, OH 45267.
- ★★
0091-6749/96 $5.00 + 0 1/1/71782