Copay assistance interferon gamma 1b trial#

New England Journal of Medicine 322: 16–21, 1990īernhisel-Broadbent J, Camargo EE, Jaffe HS, Lederman HM. Treatment of visceral leishmaniasis with pentavalent antimony and interferon gamma. Activation of the NADPH oxidase involves the small GTP-binding protein p21 rac1. The dose should be halved or the drug withdrawn in the event of serious adverse reactions, and caution is required when treating patients with pre-existing cardiac or CNS disorders.Ībo A, Pick E, Hall A, Totty N, Teaham C, et al. The dose was administered on the basis of body surface area if ⩾ 0.5m 2 (50 μg/m 2) and on the basis of bodyweight if 10 years compared with 0.5m 2, and 1.5 μg/kg if body surface is ⩽ 0.5m 2, administered subcutaneously 3 times weekly. After randomisation and stratification patients received IFNγ-1b or placebo by subcutaneous injection 3 times weekly for up to 12 months.

Copay assistance interferon gamma 1b trial#

The clinical efficacy (and tolerability) of IFNγ-1b is essentially based on the results of a multicentre double-blind placebo-controlled parallel-group trial in 128 evaluable patients with x-linked or autosomal recessive chronic granulomatous disease. The drug is not detected in urine after parenteral administration to humans, and animal studies indicated clearance by the liver and kidneys.

No accumulation was evident after repeated once daily administration of IFNγ-1b 100 μg/m 2 subcutaneously for 12 days.

Mean elimination half-lives were 0.6, 2.9 and 5.9 hours after intravenous, intramuscular and subcutaneous injection, respectively, while mean peak plasma concentration occurred at 4 hours (1.5 μg/L) and 7 hours (0.6 μg/L) after intramuscular and subcutaneous injection, respectively.

The greatest therapeutic benefit was found in patients aged 89% of the dose absorbed). The relative risk of serious infection and the number of days in hospital were each reduced by about two-thirds, and the mean duration of hospital stay by about one-third in those who did experience infection. Long term treatment with a therapeutic dosage of IFNγ-1b produced a significant reduction in the incidence of serious clinical events necessitating hospitalisation. Following the finding that interferon gamma-1b (IFNγ-1b) can potentiate phagocyte activity in some other disease states as well as restoring defective phagocyte NADPH oxidase system activity in at least some patients with chronic granulomatous disease, a large-scale placebo-controlled trial was undertaken with IFNγ-1b in patients with chronic granulomatous disease. It is manifested by a common phenotype consisting of recurrent serious, life-threatening infection and granuloma formation. Owing to the size and duration of the trial, a clinically significant survival benefit could not be ruled out.Chronic granulomatous disease is a group of rare x-linked or autosomal genetic disorders of the phagocytic NADPH oxidase system involved in host defence against various microorganisms. In a well-defined population of patients with idiopathic pulmonary fibrosis, interferon gamma-1b did not affect progression-free survival, pulmonary function, or the quality of life. More pneumonias were reported among patients in the interferon gamma-1b group, but the incidence of severe or life-threatening respiratory tract infections was similar in the two groups. However, the rates of treatment adherence and premature discontinuation of treatment were similar in the two groups. Treatment with interferon gamma-1b was associated with more frequent constitutional symptoms. Ten percent of patients in the interferon gamma-1b group died, as compared with 17 percent of patients in the placebo group (P=0.08). Over a median of 58 weeks, interferon gamma-1b therapy did not significantly affect the primary end point of progression-free survival, defined as the time to disease progression or death, and no significant treatment effect was observed on measures of lung function, gas exchange, or the quality of life. In a double-blind, multinational trial, we randomly assigned 330 patients with idiopathic pulmonary fibrosis that was unresponsive to corticosteroid therapy to receive subcutaneous interferon gamma-1b or placebo. Idiopathic pulmonary fibrosis is a progressive, fatal disease with no known efficacious therapy.