Digital ulcers have a significant clinical burden in patients with systemic sclerosis. In a study presented today, Feb. 19, at the 4th Systemic Sclerosis World Congress (Feb. 18-20) in Lisbon, Portugal, an international team of researchers revealed that a medical history of digital ulcers in the past 24 weeks should trigger a prevention strategy in patients with systemic sclerosis.
The presentation was titled “Prevention of Digital Ulcers in Systemic Sclerosis: Real Life Data From the DeSScipher Observational Study of the EUSTAR group,” (Co-07).
Recurrent digital ulcers are a manifestation of vascular disease in patients with systemic sclerosis, and they can lead to pain, impaired function, and tissue loss. Digital ulcers are usually managed with endothelin receptor antagonists, such as Bosentan or Sildenafil or both; iloprost; and other drugs, like calcium channel blockers (CCB) and ACE inhibitors (ACEI).
The DeSScipher study examined the efficacy of Sildenafil; Bosentan; Sildenafil plus Bosentan; iliprost; and CCB/ACEI in the prevention of new digital ulcers in systemic sclerosis patients. Data was gathered across 28 European centers over 24 months. A total of 1,394 systemic sclerosis patients who had a clinical history of digital ulcers were assessed through the different treatments.
The longitudinal endpoints of the study included time without new digital ulcers; proportion of systemic sclerosis patients with digital ulcers; the risk of developing new digital ulcers; and the mean number of new digital ulcers at six months follow-up.
The results revealed that 473 of the 1,394 systemic sclerosis patients had a clinical history of digital ulcers, and of these, 268 had available follow-up clinical records. In terms of treatment, of the 268 patients, 47 were on Bosentan; 33 on Sildenafil; 40 on iloprost; 31 on Sildenafil plus Bosentan; and 117 were on CCB/ACEI alone.
Researchers found that a clinical history of digital ulcers was a statistically significant risk factor for the development of new digital ulcers. Therefore, the team suggested that systemic sclerosis patients with a clinical history of digital ulcers in the past 24 weeks should be submitted to an active prevention approach.
Interestingly, treatment with CCB/ACEI alone was found to be statistically associated with a 7.1 percent increase in the risk of developing new digital ulcers, compared to all the other treatments tested.