Mouthon L1, Carpentier PH1, Lok C1, Clerson P1, Gressin V1, Hachulla E1, Bérezné A1, Diot E1, Khau Van Kien A1, Jego P1, Agard C1, Duval-Modeste AB1, Sparsa A1, Puzenat E1, Richard MA1; ECLIPSE Study Investigators.
ABSTRACT:
OBJECTIVE:
Ischemic digital ulcers (DU) are frequent and severe complications of systemic sclerosis (SSc). The purpose of our study was to assess the effect of DU on hand disability and pain in patients with SSc.
METHODS:
The Evaluation of the Impact of Recurrent Ischemic DU on Hand Disability in Patients with SSc (ECLIPSE) is a prospective, multicenter, noninterventional study with a 2-year followup. Patients with SSc who experienced at least 1 DU in the previous year and received bosentan therapy were included between October 2009 and March 2011. This cohort is described at the time of inclusion.
RESULTS:
There were 190 patients (132 females) from 53 centers. Mean age ± SD was 43 ± 15 years at SSc diagnosis and 53 ± 15 years at inclusion. In 105 patients (56.2%), DU were the first non-Raynaud symptoms of SSc. The mean time interval between the occurrence of Raynaud phenomenon and the first DU episode was 6.6 ± 9.1 years. The mean numbers of active DU and fingers affected per patient for both hands were 2.3 ± 1.8 and 2.2 ± 1.6, respectively. Presence of active DU at inclusion was significantly associated with pain and impaired hand function: Visual Analog Scale for pain (0 to 10) was 6.2 ± 2.6 versus 2.5 ± 2.4 (p < 0.0001) and Cochin Hand Function Scale for hand disability (0 to 90) was 38 ± 20 versus 25 ± 19 (p < 0.0001), respectively.
CONCLUSION:
DU represent a major sign of SSc, often affecting multiple fingers and both hands. They are significantly associated with pain and hand disability.
KEYWORDS:
BOSENTAN; DIGITAL ULCERS; DISABILITY; HAND; SYSTEMIC SCLEROSIS
