Objectives: To verify the effectiveness of G-CSF in the treatment of non-healing skin lesions in SSc patients.
Methods: 26 SSc patients (23 F and 3 M, age 54 +/-13,6 yrs) with skin ulcers were enrolled in a pilot study. Prior to the treatment with G-CSF, all ulcers failed to heal with conventional therapies carried out for a period of 1-5 years. All patients were treated with 5 microg/kg G-CSF subcutaneously for 5 days. Healing time, quality of wounds, VAS and HAQ-DI were used to evaluate the efficacy of the treatment.
Results: An improvement of skin ulcers was observed in 24/26 patients; in particular, 22/26 wounds completely healed, 2/26 showed a partial healing, in only 2 patients skin ulcers did not change during the 6-month follow-up. The quality of life improves as showed by VAS (from 88+/-13 to 55+/-28; p<.0001) and HAQ (from 2.12 +/-0.45 to 1.28+/-0.30; p<.0001). The eradication of pathogens from the infected ulcers was also observed in 12/12 patients; while no adverse side effects related to G-CSF were recorded. Our study suggests that G-CSF may be usefully employed in scleroderma skin ulcers refractory to conventional treatments.