Objective:
To determine whether interferon-alpha (ifnalpha) reduces the severity of skin involvement in early (<3 years) diffuse scleroderma.
Methods:
In a randomized, placebo-controlled, double-blind trial, 35 patients with early scleroderma received subcutaneous injections of either ifnalpha (13.5 x 10(6) units per week in divided doses) or indistinguishable placebo. outcomes assessed were the modified rodnan skin score, as determined by a single observer at baseline, 6 months, and 12 months, as well as data on renal, cardiac, and lung function. pre- and posttreatment skin biopsy samples were analyzed and blood was obtained for assessment of procollagen peptide levels.
Results:
There were 11 withdrawals from the ifnalpha group and 3 from the placebo group due to either toxicity, lack of efficacy, or death. in the intent-to-treat analysis, there was a greater improvement in the skin score in the placebo group between 0 and 12 months (mean change ifnalpha -4.7 versus placebo -7.5; p = 0.36). there was also a greater deterioration in lung function in patients receiving active therapy, as assessed by either the forced vital capacity (mean change ifnalpha -8.2 versus placebo +1.3; p = 0.01) or the diffusing capacity for carbon monoxide (mean change ifnalpha -9.3 versus placebo +4.7; p = 0.002). skin biopsy showed no significant decrease in collagen synthesis in the ifnalpha group, and no significant differences in the levels of procollagen peptides were seen between the 2 groups.
Conclusion:
This study suggests that ifnalpha is of no value in the treatment of scleroderma, and that it may in fact be deleterious.