Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Annals of the Rheumatic Diseases |
| Vol/bind | 68 |
| Udgave nummer | 9 |
| Sider (fra-til) | 1433-9 |
| Antal sider | 6 |
| ISSN | 0003-4967 |
| DOI | |
| Status | Udgivet - 2008 |
Bibliografisk note
Keywords: Adult; Antibodies, Monoclonal; Biological Markers; Biopsy; Cells, Cultured; Collagen Type I; Dermatologic Agents; Female; Fibroblasts; Humans; Male; Middle Aged; Pilot Projects; Scleroderma, Diffuse; Severity of Illness Index; Skin; Treatment Outcome; Tumor Necrosis Factor-alphaAdgang til dokumentet
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I: Annals of the Rheumatic Diseases, Bind 68, Nr. 9, 2008, s. 1433-9.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis
AU - Denton, C P
AU - Engelhart, M
AU - Tvede, N
AU - Wilson, H
AU - Khan, K
AU - Shiwen, X
AU - Carreira, P E
AU - Diaz Gonzalez, F
AU - Black, C M
AU - van den Hoogen, F H
N1 - Keywords: Adult; Antibodies, Monoclonal; Biological Markers; Biopsy; Cells, Cultured; Collagen Type I; Dermatologic Agents; Female; Fibroblasts; Humans; Male; Middle Aged; Pilot Projects; Scleroderma, Diffuse; Severity of Illness Index; Skin; Treatment Outcome; Tumor Necrosis Factor-alpha
PY - 2008
Y1 - 2008
N2 - AIM: The safety and potential efficacy of a chimaeric anti-tumour necrosis factor alpha monoclonal antibody (infliximab) were examined in diffuse cutaneous systemic sclerosis (dcSSc). METHODS: A 26-week open-label pilot study in which 16 cases of dcSSc received five infusions of infliximab (5 mg/kg). Clinical assessment included skin sclerosis score, scleroderma health assessment questionnaire, self-reported functional score and physician global visual analogue scale. Collagen turnover, skin biopsy analysis and full safety evaluation were performed. RESULTS: There was no significant change in skin score at 26 weeks but a trend for lower modified Rodnan skin score at 22 weeks (OR 17, 95% CI 6 to 46) compared with peak value (OR 29, 95% CI 11 to 44; p = 0.10). Serum aminoterminal propeptide of type III collagen level was significantly lower at week 26 compared with baseline (p = 0.03). Secretion of type I collagen by dermal fibroblasts was reduced at 26 weeks compared with baseline (p = 0.02). There were no deaths during the study and no suspected unexpected serious adverse reactions. 21 serious adverse events (AE) occurred in seven subjects, mostly attributable to dcSSc. 127 distinct AE occurred in 16 subjects. Of these, 19 AE (15%) were probably or definitely related to infliximab treatment. Eight (50%) patients prematurely discontinued infliximab. Anti-infliximab antibodies developed during the study in five subjects and were significantly associated with suspected infusion reactions (p = 0.025). CONCLUSION: In dcSSc infliximab did not show clear benefit at 26 weeks but was associated with clinical stabilisation and a fall in two laboratory markers of collagen synthesis. The frequency of suspected infusion reactions may warrant additional immunosuppression in any future studies in systemic sclerosis.
AB - AIM: The safety and potential efficacy of a chimaeric anti-tumour necrosis factor alpha monoclonal antibody (infliximab) were examined in diffuse cutaneous systemic sclerosis (dcSSc). METHODS: A 26-week open-label pilot study in which 16 cases of dcSSc received five infusions of infliximab (5 mg/kg). Clinical assessment included skin sclerosis score, scleroderma health assessment questionnaire, self-reported functional score and physician global visual analogue scale. Collagen turnover, skin biopsy analysis and full safety evaluation were performed. RESULTS: There was no significant change in skin score at 26 weeks but a trend for lower modified Rodnan skin score at 22 weeks (OR 17, 95% CI 6 to 46) compared with peak value (OR 29, 95% CI 11 to 44; p = 0.10). Serum aminoterminal propeptide of type III collagen level was significantly lower at week 26 compared with baseline (p = 0.03). Secretion of type I collagen by dermal fibroblasts was reduced at 26 weeks compared with baseline (p = 0.02). There were no deaths during the study and no suspected unexpected serious adverse reactions. 21 serious adverse events (AE) occurred in seven subjects, mostly attributable to dcSSc. 127 distinct AE occurred in 16 subjects. Of these, 19 AE (15%) were probably or definitely related to infliximab treatment. Eight (50%) patients prematurely discontinued infliximab. Anti-infliximab antibodies developed during the study in five subjects and were significantly associated with suspected infusion reactions (p = 0.025). CONCLUSION: In dcSSc infliximab did not show clear benefit at 26 weeks but was associated with clinical stabilisation and a fall in two laboratory markers of collagen synthesis. The frequency of suspected infusion reactions may warrant additional immunosuppression in any future studies in systemic sclerosis.
U2 - 10.1136/ard.2008.096123
DO - 10.1136/ard.2008.096123
M3 - Journal article
C2 - 18782794
SN - 0003-4967
VL - 68
SP - 1433
EP - 1439
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 9
ER -