A double-blinded, randomized, placebo-controlled trial of infliximab in subjects with active pulmonary sarcoidosis.
OBJECTIVE
To evaluate the safety and tolerability of infliximab in the treatment of active pulmonary sarcoidosis, and to provide an initial assessment of the efficacy of infliximab in the treatment of active pulmonary sarcoidosis.


METHODS
Double-blind, randomized, placebo-controlled phase II study.


METHODS
Multicenter.


METHODS
Active Radiographic Stage II, III, and IV active pulmonary sarcoidosis despite corticosteroids or previous intolerance to corticosteroids.


METHODS
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.


METHODS
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.
Rossman
Milton D
MD
Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
Newman
Lee S
LS
Baughman
Robert P
RP
Teirstein
Alvin
A
Weinberger
Steven E
SE
Miller
Wallace
W
Sands
Bruce E
BE
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013902:Radiography, Thoracic; D017565:Sarcoidosis, Pulmonary / Q000175:diagnosis / Q000188:drug therapy*; D013147:Spirometry; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D010919:Placebos; D000069285:Infliximab