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Recombinant human a...
Recombinant human anti-transforming growth factor beta 1 antibody therapy in systemic sclerosis - A multicenter, randomized, placebo-controlled phase I/II trial of CAT-192
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Denton, Christopher P. (author)
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Merkel, Peter A. (author)
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Furst, Daniel E. (author)
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Khanna, Dinesh (author)
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Emery, Paul (author)
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Hsu, Vivien M. (author)
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Silliman, Nancy (author)
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Streisand, James (author)
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Powell, John (author)
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- Åkesson, Anita (author)
- Lund University,Lunds universitet,Reumatologi och molekylär skelettbiologi,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Rheumatology,Section III,Department of Clinical Sciences, Lund,Faculty of Medicine
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Coppock, John (author)
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van den Hoogen, Frank (author)
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Herrick, Ariane (author)
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Mayes, Maureen D. (author)
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Veale, Douglas (author)
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Haas, Joanna (author)
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Ledbetter, Stephen (author)
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Korn, Joseph H. (author)
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Black, Carol M. (author)
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Seibold, James R. (author)
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(creator_code:org_t)
- 2006
- 2007
- English.
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In: Arthritis and Rheumatism. - : Wiley. - 1529-0131 .- 0004-3591. ; 56:1, s. 323-333
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Abstract
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- Objective. To evaluate CAT-192, a recombinant human antibody that neutralizes transforming growth factor beta 1 (TGF beta 1), in the treatment of early-stage diffuse cutaneous systemic sclerosis (dcSSc). Methods. Patients with SSc duration of < 18 months were randomly assigned to the placebo group or to 1 of 3 CAT-192 treatment groups: 10 mg/kg, 5 mglkg, 0.5 mg/kg. Infusions were given on day 0 and weeks 6, 12, and 18. The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of CAT-192. Secondary outcomes included the modified Rodnan skin thickness score (MRSS), the Scleroderma Health Assessment Questionnaire, assessment of organ-based disease, serum levels of soluble interleukin-2 receptor, collagen propeptides (N propeptide of type I [PINP] and type III collagen), and tissue levels of messenger RNA for procollagens I and III and for TGF beta 1 and TGF beta 2. Results. Forty-five patients were enrolled. There was significant morbidity and mortality, including I death in the group receiving 0.5 mg/kg of CAT-192 and 3 deaths in the group receiving 5 mg/kg of CAT-192. There were more adverse events and more serious adverse events in patients receiving CAT-192 than in those receiving placebo, although these events were not more frequent in the high-dose treatment group. The MRSS improved in all groups during the study, but there was no evidence of a treatment effect for CAT-192. Improvement in the MRSS correlated with the disease duration (r = -0.54, P = 0.0008). Changes in the PINP level from baseline correlated with changes in the MRSS (r = 0.37, P = 0.027). Conclusion. We report the first evaluation of a systemically administered and repeatedly dosed anti-TGF beta 1 drug. In this pilot study, CAT-192, in doses up to 10 mg/kg, showed no evidence of efficacy. The utility of clinical and biochemical outcome measures and the feasibility of multicenter trials of early dcSSc were confirmed.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
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- By the author/editor
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Denton, Christop ...
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Merkel, Peter A.
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Furst, Daniel E.
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Khanna, Dinesh
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Emery, Paul
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Hsu, Vivien M.
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show more...
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Silliman, Nancy
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Streisand, James
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Powell, John
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Åkesson, Anita
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Coppock, John
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van den Hoogen, ...
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Herrick, Ariane
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Mayes, Maureen D ...
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Veale, Douglas
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Haas, Joanna
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Ledbetter, Steph ...
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Korn, Joseph H.
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Black, Carol M.
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Seibold, James R ...
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show less...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Rheumatology and ...
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Arthritis and Rh ...
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Lund University