Interferon-? does not improve outcome at one year in patients with diffuse cutaneous scleroderma: Results of a randomized, double-blind, placebo-controlled trial

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Abstract
Objective To determine whether interferon‐α (IFNα) reduces the severity of skin involvement in early (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 IFNα 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 IFNα −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 IFNα −8.2 versus placebo +1.3; P = 0.01) or the diffusing capacity for carbon monoxide (mean change IFNα −9.3 versus placebo +4.7; P = 0.002). Skin biopsy showed no significant decrease in collagen synthesis in the IFNα group, and no significant differences in the levels of procollagen peptides were seen between the 2 groups. Conclusion This study suggests that IFNα is of no value in the treatment of scleroderma, and that it may in fact be deleterious.