Abstract
Objective To analyse the efficacy and safety of anifrolumab, a monoclonal antibody addressed against the type I interferon receptor sub-unit 1, as a therapeutic option in patients with a refractory cutaneous dermatomyositis (DM).
Methods Patients with DM presenting a cutaneous involvement refractory to different immunosuppressive treatments were enrolled. The Cutaneous Disease Area activity (CDASI-a) was used to evaluate the evolution of skin involvement; moreover, also manual muscle test 8 (MMT8) and patient global assessment (PGA) were collected, to evaluate both muscle involvement and patients' quality of life. Finally, we also registered the changes in glucocorticoid (GC) daily dose, to explore the possible steroid sparing effect of the drug.
Results We enrolled 4 patients (2 women, mean age 60 years). At the enrollment, they showed an active cutaneous disease (mean CDASI-a 27/100); the mean MMT8 value was 67.5/80; their mean daily dose of GC was 10 mg of prednisolone (PDN) and their mean value of PGA was 7.5/10. After treatment, all these parameters were improved, with a CDASI value decreased to 8.75/100, an MMT8 increased to 71.3/80, a daily dose of GC decreased to 4 mg and a PGA decreased to 1.5/10.
Conclusion The data we collected showed a significant reduction in CDASI-a values; furthermore, our results showed an improvement also in muscle involvement and in patients' perception of the disease's burden. Finally, a steroid sparing effect and a globally good safety profile of anifrolumab were observed, thus confirming anifrolumab as a new valid therapeutic option in this kind of patients.
