High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis: Analysis of a two-year, double-blind, randomized, controlled clinical trial

Clements, Philip J.; Fürst, Daniel E.; Wong, Weng Kee; Mayes, Maureen D.; White, Barbara; Wigley, Fredrick M.; Weisman, Michael H.; Barr, Walter G.; Moreland, Larry W.; Medsger, Thomas A.; Steen, Virginia D.; Martin, Richard W.; Collier, David H.; Weinstein, Arthur; Lally, Edward V.; Varga, John; Weiner, Saul J.; Andrews, Brian S.; Abeles, Moshe; Seibold, James R.

doi:10.1002/1529-0131(199906)42:6<1194::aid-anr16>3.0.co;2-7

Cited by 300 publications

(177 citation statements)

References 19 publications

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“…Immunomodulatory agents that have been evaluated include chlorambucil, methotrexate, and extracorporeal photopheresis (7)(8)(9). Putative antifibrotic or matrix-altering agents tested in SSc have included D-penicillamine, interferon-␣, ketanserin, and recombinant human relaxin (10)(11)(12)(13).…”

mentioning

confidence: 99%

Recombinant human anti–transforming growth factor β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo‐controlled phase I/II trial of CAT‐192

Denton

Merkel

Fürst

et al. 2007

Arthritis & Rheumatism

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423

261

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Results. Forty-five patients were enrolled. There was significant morbidity and mortality, including 1 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␤1 drug. In this pilot study, CAT-192, in doses up to 10 mg/kg, showed no evidence of efficacy. The utility of

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mentioning

confidence: 99%

Recombinant human anti–transforming growth factor β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo‐controlled phase I/II trial of CAT‐192

Denton

Merkel

Fürst

et al. 2007

Arthritis & Rheumatism

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423

261

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“…A large randomized double-blind trial involving patients with early diffuse cutaneous scleroderma demonstrated that a low dose of 125 mg every other day may be as effective as higher doses of 750-1000 mg/day [40]. In a recent study, a dose of 750 mg/day in patients with rapidly progressive diffuse systemic sclerosis caused a significant reduction in skin thickening and improvement of renal, cardiac and pulmonary involvement [41].…”

Section: Targeting the Immune Systemmentioning

confidence: 99%

Diagnosis and treatment of systemic and localized scleroderma

Khanna¹

2011

Expert Review of Dermatology

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“…However, laboratory monitoring at this dose is cumbersome and many side effects are seen [2]. Recently low dose penicillamine 125 mg on alternate days has been found to be as effective as high dose therapy with lesser side effects [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Low dose penicillamine in systemic sclerosis: is it effective?

Sameem¹,

Hassan²,

Majid³

et al. 2012

Our Dermatol Online

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Low dose D-penicillamine 150mg was given on alternate days to 23 patients of limited cutaneous systemic sclerosis (lcSSC) and 5 of diffuse cutaneous systemic sclerosis (dcSSC) subtypes. Modified Rodnan scoring remained unchanged in 19 and progressed in 3 patients of lcSSc. Only 1 female showed a decrease in the score. In the dcSSc, score decreased only in 1. She had a baseline score of 12 which went down to 4. No new systemic activity was seen in her. StreszczenieNiską dawkę D-penicylamine 150mg otrzymywało co drugi dzień 23 pacjentów z ograniczoną skórną postacią twardziny układowej (lcSSc) i 5 pacjentów z rozlaną skórną postacią twardziny układowej (dcSSC). Zmodyfikowana punktacja Rodnan pozostała niezmieniona w 19 przypadkach a postępowała u 3 chorych z lcSSc. Tylko jedna kobieta wykazała spadek w punktacji. W dcSSc, wynik zmniejszył się tylko w 1 przypadku. Pacjentka z 12 punktów bazowych ostatecznie otrzymała 4 punkty. Obserwowano u niej brak nowej ogólnoustrojowej aktywności choroby.

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High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis: Analysis of a two-year, double-blind, randomized, controlled clinical trial

Cited by 300 publications

References 19 publications

Recombinant human anti–transforming growth factor β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo‐controlled phase I/II trial of CAT‐192

Recombinant human anti–transforming growth factor β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo‐controlled phase I/II trial of CAT‐192

Diagnosis and treatment of systemic and localized scleroderma

Low dose penicillamine in systemic sclerosis: is it effective?

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