A preliminary study of long-term treatment with interferon gamma-1b and low-dose prednisolone in patients with idiopathic pulmonary fibrosis

Background Patients with idiopathic pulmonary fibrosis have progressive sca rring of the lung and usually die within four to five years after symptoms develop. Treatment with oral glucocorticoids is often ineffective. We condu cted an open, randomized trial of treatment with a combination of interfero n gamma-1b, which has antifibrotic properties, and an oral glucocorticoid. Methods We studied 18 patients with idiopathic pulmonary fibrosis who had n ot had responses to glucocorticoids or other immunosuppressive agents. Nine patients were treated for 12 months with oral prednisolone alone (7.5 mg d aily, which could be increased to 25 to 50 mg daily), and nine with a combi nation of 200 mu g of interferon gamma-1b (given three times per week subcu taneously) and 7.5 mg of prednisolone (given once a day). Results All the patients completed the study. Lung function deteriorated in all nine patients in the group given prednisolone alone: total lung capaci ty decreased from a mean (+/-SD) of 66+/-8 percent of the predicted value a t base line to 62+/-6 percent at 12 months. In contrast, in the group recei ving interferon gamma-1b plus prednisolone, total lung capacity increased ( from 70+/-6 percent of the predicted value at base line to 79+/-12 percent at 12 months, P<0.001 for the difference between the groups). In the group that received interferon gamma-1b plus prednisolone, the partial pressure o f arterial oxygen at rest increased from 65+/-9 mm Hg at base line to 76+/- 8 mm Hg at 12 months, whereas in the group that received prednisolone alone it decreased from 65+/-6 to 62+/-4 mm Hg (P<0.001 for the difference in th e change from baseline values between the two groups); on maximal exertion, the value increased from 55+/-6 to 65+/-8 mm Hg in the group that received combined treatment and decreased from 55+/-6 mm Hg to 52+/-5 mm Hg in the group given prednisolone alone (P<0.001). The side effects of interferon ga mma-1b, such as fever, chills, and muscle pain, subsided within the first 9 to 12 weeks. Conclusions In a preliminary study, 12 months of treatment with interferon gamma-1b plus prednisolone was associated with substantial improvements in the condition of patients with idiopathic pulmonary fibrosis who had had no response to glucocorticoids alone. (N Engl J Med 1999;341:1264-9.) (C)1999 , Massachusetts Medical Society.