| Abstract | STUDY OBJECTIVE: To determine the benefit and corticosteroid-sparing potential of thalidomide in corticosteroid-dependent pulmonary sarcoidosis. METHODS: The study was a prospective open-label pilot study. Ten subjects were enrolled who had pulmonary sarcoidosis, required corticosteroid therapy for at least six months, and experienced a flare of pulmonary sarcoidosis within the previous 2 years when corticosteroids had been reduced or discontinued. Thalidomide was given at a dose of 200 mg/day for 24 weeks. Dose reductions were allowed in 50 mg/day increments for side effects. After 12 weeks, the baseline corticosteroid dose was halved for the remaining 12 weeks of the study. RESULTS: There were no clinically or statistically significant changes in spirometry (FVC% predicted: week 0: 72 +/- 4, week 12: 75 +/- 5, week 24: 73 +/- 4; p = NS), quality of life (as measured by the Short Form-36), or dyspnea (as measured by the Transitional Dyspnea Index) between weeks 0, 12, and 24. Three (30%) subjects demonstrated clinical evidence of a corticosteroid-sparing effect from thalidomide. Three (30%) subjects had to withdraw from the study; two at week 4 because of an acute pulmonary flare of sarcoidosis, and one because of possible side effects. Although nine of 10 (90%) of subjects required a reduction of the thalidomide dose because of side effects, no adverse effects were severe. The most common final dose of thalidomide was 100 mg/day. CONCLUSIONS: Thalidomide does not significantly improve pulmonary function or quality of life in patients with corticosteroid-dependent sarcoidosis. Few patients can tolerate doses of greater than 100 mg/day. Thalidomide may have been corticosteroid-sparing in a subgroup of these patients. |
| Authors | Marc A Judson, Joanne Silvestri, Cindy Hartung, Teresa Byars, Christopher E Cox
(Affiliation: Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina 29425, USA.)
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| Journal | Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG / World Association of Sarcoidosis and Other Granulomatous Disorders
(Sarcoidosis Vasc Diffuse Lung Dis)
Vol. 23
Issue 1
Pg. 51-7
(Mar 2006)
ISSN: 1124-0490 Italy |
| PMID | 16933470
(Publication Type: Clinical Trial, Comparative Study, Journal Article)
|
| Chemical References |
- Adrenal Cortex Hormones
- Hydroxyurea
- Thalidomide
- Prednisone
- Methotrexate
|
| Topics |
- Adrenal Cortex Hormones
(administration & dosage, therapeutic use)
- African Americans
(statistics & numerical data)
- Drug Therapy, Combination
- European Continental Ancestry Group
(statistics & numerical data)
- Female
- Humans
- Hydroxyurea
(therapeutic use)
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Pilot Projects
- Prednisone
(therapeutic use)
- Prospective Studies
- Quality of Life
- Questionnaires
- Sarcoidosis, Pulmonary
(drug therapy)
- Thalidomide
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
|
