Macitentan Shows No Improvement in Digital Ulcers

Patients with systemic sclerosis found that macitentan did not reduce new digital ulcers.

Findings from a recent study show that the drug macitentan does not reduce the number of digital ulcers in systemic sclerosis patients.

Digital ulcers occur in 35 to 68% of patients with systematic sclerosis, according to the study published in JAMA.

In the study, 2 clinical trials included patients with systemic sclerosis and active digital ulcers who were assigned 3-mg of macitentan, 10-mg of macitentan, or a placebo once daily for 16 weeks.

In the first study, DUAL-1, 226 patients completed the study, while there were 216 patients who completed the DUAL-2 study.

Researchers found that the drug was not able to reduce the number of new digital ulcers during the treatment period. Patient’s digital ulcer conditions remained stable, according to the study.

Adverse effects such as headache, peripheral edema, skin ulcer, anemia, upper respiratory tract infection, and diarrhea were all associated with the drug.

"These results do not support the use of macitentan for the treatment of digital ulcers in this patient population," the researchers concluded.