Abstract | STUDY OBJECTIVES: DESIGN: Double-blind, randomized, placebo-controlled phase II study. SETTING: Multicenter. PATIENTS: INTERVENTION:
Infliximab 5mg/kg (group I) or placebo (group II) at weeks 0 and 2 and open-label infliximab 5mg/kg for all subjects at weeks 6 and 14. MEASUREMENTS: Pulmonary function, chest radiographs, dyspnea stage, SF-36. RESULTS: Mean vital capacity (VC) at wk 0 was 2.47 +/- 0.2 (group I) and 2.37 +/- 0.31 (group II). At 6 weeks the mean +/- SD relative change in VC compared to baseline was 15.22 +/- 9.91% for group I (n=13) and 8.39 +/- 3.33% for group II (n=6) (p=0.65). Four patients had serious adverse events, including decreased WBC and elevated CPK (1 patient), pneumonia (1 patient), cellulitis, acute renal failure, pulmonary embolus and death (1 patient), and visual field defect (1 patient). CONCLUSIONS:
Infliximab may improve VC in patients with active PS resistant to steroids. Larger scale, longer term studies will be needed to assess both safety and efficacy.
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Authors | Milton D Rossman, Lee S Newman, Robert P Baughman, Alvin Teirstein, Steven E Weinberger, Wallace Miller Jr, Bruce E Sands |
Journal | Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG
(Sarcoidosis Vasc Diffuse Lung Dis)
Vol. 23
Issue 3
Pg. 201-8
(Oct 2006)
ISSN: 1124-0490 [Print] Italy |
PMID | 18038919
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Placebos
- Infliximab
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Topics |
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Humans
- Infliximab
- Male
- Middle Aged
- Placebos
- Radiography, Thoracic
- Sarcoidosis, Pulmonary
(diagnosis, drug therapy)
- Spirometry
- Treatment Outcome
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