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To determine whether interferon-alpha (IFNalpha) reduces the severity of skin involvement in early (<3 years) diffuse scleroderma.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.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.This study suggests that IFNalpha is of no value in the treatment of scleroderma, and that it may in fact be deleterious.

Original publication

DOI

10.1002/1529-0131(199902)42:2<299::aid-anr12>3.0.co;2-r

Type

Journal article

Journal

Arthritis and rheumatism

Publication Date

02/1999

Volume

42

Pages

299 - 305

Addresses

Royal Free Academic Unit of Rheumatology and Connective Tissue Diseases, Royal Free Hospital, London, UK.

Keywords

Fibroblasts, Skin, Dermis, Humans, Scleroderma, Systemic, Collagen, Collagen Type I, Peptides, Peptide Fragments, Interferon-alpha, Procollagen, Recombinant Proteins, Enzyme-Linked Immunosorbent Assay, Treatment Outcome, Injections, Subcutaneous, Double-Blind Method, Adolescent, Adult, Aged, Middle Aged, Female, Male