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 receivedsubcutaneous 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.
RCT Entities:
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.
Authors: M Binks; J R Passweg; D Furst; P McSweeney; K Sullivan; C Besenthal; J Finke; H H Peter; J van Laar; F C Breedveld; W E Fibbe; D Farge; E Gluckman; F Locatelli; A Martini; F van den Hoogen; L van de Putte; A V Schattenberg; R Arnold; P A Bacon; P Emery; I Espigado; B Hertenstein; F Hiepe; A Kashyap; I Kötter; A Marmont; A Martinez; M J Pascual; A Gratwohl; H G Prentice; C Black; A Tyndall Journal: Ann Rheum Dis Date: 2001-06 Impact factor: 19.103
Authors: P A Merkel; N P Silliman; P J Clements; C P Denton; D E Furst; M D Mayes; J E Pope; R P Polisson; J B Streisand; J R Seibold Journal: Arthritis Rheum Date: 2012-10
Authors: Shervin Assassi; Maureen D Mayes; Frank C Arnett; Pravitt Gourh; Sandeep K Agarwal; Terry A McNearney; Damien Chaussabel; Nancy Oommen; Michael Fischbach; Kairav R Shah; Julio Charles; Virginia Pascual; John D Reveille; Filemon K Tan Journal: Arthritis Rheum Date: 2010-02
Authors: Vasiliki Kalliopi K Bournia; Panayiotis G Vlachoyiannopoulos; Carlo Selmi; Haralampos M Moutsopoulos; M Eric Gershwin Journal: Clin Rev Allergy Immunol Date: 2009-06 Impact factor: 8.667