Background Digital ulcers are frequent in patients with systemic sclerosis and have a high morbidity. No previous studies have evaluated the efficacy of immunosuppression on digital ulcers risk. Current treatment guidelines do not include the use of immunosuppressants as routine treatment for digital ulcers.
Objectives To asses the efficacy of imunosuppresive therapy on the digital ulcer prevention in patients with systemic sclerosis
Methods Prospective study on EUSTAR cohort 096 during september 2005-september 2015. Patients with systemic sclerosis (SSc) without previous digital ulcers at their first presentation in the clinic were selected. Immunosupression was started based on current recommandations according to specific organ involvement. Patients were evaluated every 6 month according to MEDS evaluation sheets and a special evaluation form for digital ulcer (number, type of ulcer, date of onset).
Results 116 systemic sclerosis (SSc) patients were evaluated, but only those without previous ulcers at their first presentation in the clinic were selected – 60 patients; 12 of them were lost to follow-up.
There were 40 females, 8 males, 23 diffuse and 25 limited SSc. 26 out of the 48 patients received immunosupressants. The mean (±SD) interval of follow up was 72.67 (±60.75) months. No significant statistical difference was identified between patients with immunosuppression and those without regarding the age, the disease duration, the visceral involvement and the follow-up period. 69.23% received Methotrexate, 3,84% received Mycophenolate and 26.92% received monthly pulses of Cyclophosphamide. The use of immunosupresants was related to diffuse subset (R=0.631,p=0.001), antiSCL70 positivity (R=0.624, p=0.001) and lung involvement (R=0.331, p=0.034). There was no difference of the immunosuppressants efficacy regarding the new digital ulcers onset. The incidence of digital ulcers was 15.38% in patients receiving immunosuppression and 68.18% in patients without immunosuppression (p=0.001). The mean (±SD) number of ulcers in the follow-up period was 0.85 (±1.4) in immunosuppresed patients and 6.18 (±4.79) in the other group, p=0.001. The onset of new digital ulcers was also correlated with advanced age (R=0.392, p=0.032) and longer follow-up interval (R=0.036, p=0.049). The mean (±SD) interval from first visit of the patient until the appearence of the first digital ulcer was 7.3 (±5.43) month in patients with immunosuppression and 30 (±11.78) months in patients without immunosuppression.
Conclusions Immunosupression might decrease the risk and the number of digital ulcers of patients with SSc, but they do not seem to extend the interval until their first appearance. More prospective, multicentric studies on larger cohorts with longer follow-up interval are needed in order to aasses the efficacy of immunosuppression on digital ulcers onset, number, rate and time to healing.
Disclosure of Interest None declared