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Imatinib mesylate in scleroderma-associated diffuse skin fibrosis: a phase II multicentre randomized double-blinded
S Prey1, K Ezzedine, A Doussau
1Department of Dermatology, Hôpital Saint André, CHU de Bordeaux, 1 rue Jean Burguet, 33075 Bordeaux, France. sorilla.prey@chu-bordeaux.fr
The British Journal of Dermatology
|October 9, 2012
Summary
Imatinib mesylate did not improve skin fibrosis in systemic sclerosis patients. The study found no significant difference in skin fibrosis or quality of life between imatinib and placebo groups after six months.
Area of Science:
- Rheumatology
- Dermatology
- Pharmacology
Background:
- Systemic sclerosis (SSc) involves debilitating skin fibrosis.
- Imatinib mesylate targets pathways implicated in SSc skin changes.
- Investigating novel treatments for SSc is crucial.
Purpose of the Study:
- To assess the efficacy of imatinib mesylate in treating scleroderma skin fibrosis.
- To evaluate imatinib's effect on skin thickness and quality of life in SSc patients.
Main Methods:
- Phase II, double-blind, placebo-controlled trial.
- 28 patients with morphoea or SSc received imatinib (400 mg/day) or placebo for 6 months.
- Skin fibrosis assessed by modified Rodnan Skin Score (mRSS) and dermal thickness; quality of life and pulmonary function also measured.
Main Results:
- No statistically significant difference in mRSS variation between imatinib and placebo groups at 6 months (P=0.098).
- Changes in dermal thickness, quality of life, and pulmonary function were also not significantly different between groups.
- The study included patients with extensive skin involvement (mRSS ≥ 20/51).
Conclusions:
- Imatinib mesylate (400 mg daily) did not demonstrate efficacy in improving skin fibrosis in diffuse scleroderma after 6 months.
- Validated outcome measurements showed no benefit of imatinib over placebo.
- Further research may be needed to explore other therapeutic targets or treatment durations.
