Study subjects
The majority of patients tolerated the treatment well and no adverse
events were recorded. Patient 1-4 and 6-11 were classified as responders
(n=10) and 12-13 as non-responders (n=2), see Table 2. Both patients
with stage I disease (patient number 2 and 6) had lung parenchymal
nodules but they were only visible on CT scan, not on chest X-ray. The
non-responders had a clearly deteriorating disease as assessed by CT
scan and prednisone dose was increased (patient number 12) or started
(number 13) after the follow-up bronchoscopy. Patient number 5 developed
a slight increase of liver enzymes after the 3rd infusion but they
returned to just above normal without any specific treatment and
therefore infliximab infusions were continued. However, after the 5th
infusion the liver enzymes started to increase again. Auto-antibodies
and hepatitis serology were negative and ultra-sound of the liver
disclosed no abnormalities. A liver biopsy showed chronic inflammation
and a slight fibrosis. The prednisolone dose was increased and
thereafter liver enzymes normalized. Due to the adverse event the
patient was excluded from the study and did not take part in the
follow-up.