• Biomed. Pharmacother. · Jun 2012

    Clinical Trial

    Thalidomide for improving cutaneous and pulmonary sarcoidosis in patients resistant or with contraindications to corticosteroids.

    • P Fazzi, E Manni, R Cristofani, G Cei, S Piazza, R Calabrese, A Antonelli, G Siciliano, P Barachini, and A Carpi.
    • Respiratory Pathophysiology Section, Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy.
    • Biomed. Pharmacother. 2012 Jun 1;66(4):300-7.

    BackgroundLimited data report thalidomide improves cutaneous sarcoidosis; no benefit has been reported for pulmonary localization.ObjectivesTo evaluate feasibility and efficacy of prolonged treatment with thalidomide for cutaneous sarcoidosis associated to pulmonary involvement in patients with resistance or contraindications to steroids.MethodsNineteen patients were treated with thalidomide for 24 months starting with 200 mg/d for first 2 weeks, followed by 100 mg/d for 11 weeks and a maintenance dose of 100mg on alternate days for 35 weeks, and a gradual scaling down until therapy interruption. Criteria of efficacy were: skin score, serum ACE levels (s-ACE), chest X-ray (CXR), lung function tests (LFTs), and diffusing lung capacity for CO (DLCO). The skin score was computed as arithmetic sum of seven score parameters (min: 0, max: 28).ResultsSkin score significantly decreased (P<0.001). Lower skin scores occurred after 3 and 6 months (P<0.05). s-ACE levels decreased over time at the third month (P<0.001). CXR assessed by radiological stage significantly improved during the first 6 months (P<0.001). DLCO showed a continuous trend of improvement. Minor side effects that have forced the suspension of the drug were drowsiness/sedation (74%), constipation (68%), and weight gain (53%). Deep vein thrombosis of the lower limbs occurred in one patient (who did not drop out the study). Eight patients (42%) abandoned thalidomide for axonal sensitive peripheral neuropathy (PN) between the ninth and the 24th month of treatment.ConclusionsThalidomide, long-term at mid-low doses, can be considered as an effective therapeutic alternative in chronic sarcoidosis with resistance or contraindications to steroids.Copyright © 2012 Elsevier Masson SAS. All rights reserved.

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