A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis

I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease

Arnold Postlethwaite, Kee Wong Weng, Philip Clements, Soumya Chatterjee, Barri J. Fessler, Andrew Kang, Joseph Korn, Maureen Mayes, Peter A. Merkel, Jerry A. Molitor, Larry Moreland, Naomi Rothfield, Robert W. Simms, Edwin A. Smith, Robert Spiera, Virginia Steen, Kenneth Warrington, Barbara White, Frederick Wigley, Daniel E. Furst

Research output: Contribution to journalArticle

77 Citations (Scopus)

Abstract

Objective. To investigate the safety and efficacy of oral bovine type I collagen (CI) treatment in patients who have had diffuse cutaneous systemic sclerosis (dcSSc; scleroderma) for ≤10 years. Methods. One hundred sixty-eight patients with dcSSc were enrolled in a double-blind, placebo-controlled trial of oral CI (500 μg/day) or placebo administered over 12 months, with a followup visit at month 15. The primary outcome was the modified Rodnan skin thickness score (MRSS). Other clinical and immune system parameters were also assessed. Results. Intent-to-treat and modified intent-to-treat analyses showed that for the total population of patients with dcSSc, there were no significant differences in the mean change in MRSS or other key clinical parameters between the CI and placebo treatment groups at 12 months or at 15 months. However, in a subanalysis of the available data at month 15, the CI-treated group of patients with late-phase dcSSc experienced a significant reduction in the MRSS compared with that in the placebo-treated patients with late-phase dcSSc (change in MRSS at month 15 -7.9 versus -2.9; P = 0.0063). Conclusion. Although the results from this trial did not meet the primary outcome goals, the findings from exploratory analyses indicated that CI treatment may benefit patients with late-phase dcSSc. This new treatment strategy and preliminary clinical observations in patients with dcSSc need to be corroborated.

Original languageEnglish (US)
Pages (from-to)1810-1822
Number of pages13
JournalArthritis and rheumatism
Volume58
Issue number6
DOIs
StatePublished - Jun 1 2008

Fingerprint

Diffuse Scleroderma
Collagen Type I
Placebos
Skin
Therapeutics
Immune System
Safety
Population

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Pharmacology (medical)

Cite this

A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis : I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. / Postlethwaite, Arnold; Weng, Kee Wong; Clements, Philip; Chatterjee, Soumya; Fessler, Barri J.; Kang, Andrew; Korn, Joseph; Mayes, Maureen; Merkel, Peter A.; Molitor, Jerry A.; Moreland, Larry; Rothfield, Naomi; Simms, Robert W.; Smith, Edwin A.; Spiera, Robert; Steen, Virginia; Warrington, Kenneth; White, Barbara; Wigley, Frederick; Furst, Daniel E.

In: Arthritis and rheumatism, Vol. 58, No. 6, 01.06.2008, p. 1810-1822.

Research output: Contribution to journalArticle

Postlethwaite, A, Weng, KW, Clements, P, Chatterjee, S, Fessler, BJ, Kang, A, Korn, J, Mayes, M, Merkel, PA, Molitor, JA, Moreland, L, Rothfield, N, Simms, RW, Smith, EA, Spiera, R, Steen, V, Warrington, K, White, B, Wigley, F & Furst, DE 2008, 'A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease', Arthritis and rheumatism, vol. 58, no. 6, pp. 1810-1822. https://doi.org/10.1002/art.23501
Postlethwaite, Arnold ; Weng, Kee Wong ; Clements, Philip ; Chatterjee, Soumya ; Fessler, Barri J. ; Kang, Andrew ; Korn, Joseph ; Mayes, Maureen ; Merkel, Peter A. ; Molitor, Jerry A. ; Moreland, Larry ; Rothfield, Naomi ; Simms, Robert W. ; Smith, Edwin A. ; Spiera, Robert ; Steen, Virginia ; Warrington, Kenneth ; White, Barbara ; Wigley, Frederick ; Furst, Daniel E. / A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis : I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. In: Arthritis and rheumatism. 2008 ; Vol. 58, No. 6. pp. 1810-1822.
@article{deaff8a0f4154ec0b5ed9988b2520913,
title = "A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease",
abstract = "Objective. To investigate the safety and efficacy of oral bovine type I collagen (CI) treatment in patients who have had diffuse cutaneous systemic sclerosis (dcSSc; scleroderma) for ≤10 years. Methods. One hundred sixty-eight patients with dcSSc were enrolled in a double-blind, placebo-controlled trial of oral CI (500 μg/day) or placebo administered over 12 months, with a followup visit at month 15. The primary outcome was the modified Rodnan skin thickness score (MRSS). Other clinical and immune system parameters were also assessed. Results. Intent-to-treat and modified intent-to-treat analyses showed that for the total population of patients with dcSSc, there were no significant differences in the mean change in MRSS or other key clinical parameters between the CI and placebo treatment groups at 12 months or at 15 months. However, in a subanalysis of the available data at month 15, the CI-treated group of patients with late-phase dcSSc experienced a significant reduction in the MRSS compared with that in the placebo-treated patients with late-phase dcSSc (change in MRSS at month 15 -7.9 versus -2.9; P = 0.0063). Conclusion. Although the results from this trial did not meet the primary outcome goals, the findings from exploratory analyses indicated that CI treatment may benefit patients with late-phase dcSSc. This new treatment strategy and preliminary clinical observations in patients with dcSSc need to be corroborated.",
author = "Arnold Postlethwaite and Weng, {Kee Wong} and Philip Clements and Soumya Chatterjee and Fessler, {Barri J.} and Andrew Kang and Joseph Korn and Maureen Mayes and Merkel, {Peter A.} and Molitor, {Jerry A.} and Larry Moreland and Naomi Rothfield and Simms, {Robert W.} and Smith, {Edwin A.} and Robert Spiera and Virginia Steen and Kenneth Warrington and Barbara White and Frederick Wigley and Furst, {Daniel E.}",
year = "2008",
month = "6",
day = "1",
doi = "10.1002/art.23501",
language = "English (US)",
volume = "58",
pages = "1810--1822",
journal = "Arthritis and Rheumatology",
issn = "2326-5191",
publisher = "John Wiley and Sons Ltd",
number = "6",

}

TY - JOUR

T1 - A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis

T2 - I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease

AU - Postlethwaite, Arnold

AU - Weng, Kee Wong

AU - Clements, Philip

AU - Chatterjee, Soumya

AU - Fessler, Barri J.

AU - Kang, Andrew

AU - Korn, Joseph

AU - Mayes, Maureen

AU - Merkel, Peter A.

AU - Molitor, Jerry A.

AU - Moreland, Larry

AU - Rothfield, Naomi

AU - Simms, Robert W.

AU - Smith, Edwin A.

AU - Spiera, Robert

AU - Steen, Virginia

AU - Warrington, Kenneth

AU - White, Barbara

AU - Wigley, Frederick

AU - Furst, Daniel E.

PY - 2008/6/1

Y1 - 2008/6/1

N2 - Objective. To investigate the safety and efficacy of oral bovine type I collagen (CI) treatment in patients who have had diffuse cutaneous systemic sclerosis (dcSSc; scleroderma) for ≤10 years. Methods. One hundred sixty-eight patients with dcSSc were enrolled in a double-blind, placebo-controlled trial of oral CI (500 μg/day) or placebo administered over 12 months, with a followup visit at month 15. The primary outcome was the modified Rodnan skin thickness score (MRSS). Other clinical and immune system parameters were also assessed. Results. Intent-to-treat and modified intent-to-treat analyses showed that for the total population of patients with dcSSc, there were no significant differences in the mean change in MRSS or other key clinical parameters between the CI and placebo treatment groups at 12 months or at 15 months. However, in a subanalysis of the available data at month 15, the CI-treated group of patients with late-phase dcSSc experienced a significant reduction in the MRSS compared with that in the placebo-treated patients with late-phase dcSSc (change in MRSS at month 15 -7.9 versus -2.9; P = 0.0063). Conclusion. Although the results from this trial did not meet the primary outcome goals, the findings from exploratory analyses indicated that CI treatment may benefit patients with late-phase dcSSc. This new treatment strategy and preliminary clinical observations in patients with dcSSc need to be corroborated.

AB - Objective. To investigate the safety and efficacy of oral bovine type I collagen (CI) treatment in patients who have had diffuse cutaneous systemic sclerosis (dcSSc; scleroderma) for ≤10 years. Methods. One hundred sixty-eight patients with dcSSc were enrolled in a double-blind, placebo-controlled trial of oral CI (500 μg/day) or placebo administered over 12 months, with a followup visit at month 15. The primary outcome was the modified Rodnan skin thickness score (MRSS). Other clinical and immune system parameters were also assessed. Results. Intent-to-treat and modified intent-to-treat analyses showed that for the total population of patients with dcSSc, there were no significant differences in the mean change in MRSS or other key clinical parameters between the CI and placebo treatment groups at 12 months or at 15 months. However, in a subanalysis of the available data at month 15, the CI-treated group of patients with late-phase dcSSc experienced a significant reduction in the MRSS compared with that in the placebo-treated patients with late-phase dcSSc (change in MRSS at month 15 -7.9 versus -2.9; P = 0.0063). Conclusion. Although the results from this trial did not meet the primary outcome goals, the findings from exploratory analyses indicated that CI treatment may benefit patients with late-phase dcSSc. This new treatment strategy and preliminary clinical observations in patients with dcSSc need to be corroborated.

UR - http://www.scopus.com/inward/record.url?scp=45349109299&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=45349109299&partnerID=8YFLogxK

U2 - 10.1002/art.23501

DO - 10.1002/art.23501

M3 - Article

VL - 58

SP - 1810

EP - 1822

JO - Arthritis and Rheumatology

JF - Arthritis and Rheumatology

SN - 2326-5191

IS - 6

ER -