A recent phase II clinical trial has shown promising results for dazukibart, a novel monoclonal antibody targeting interferon beta (IFNβ), in treating dermatomyositis, a chronic systemic autoimmune disease. The study, involving 125 patients across 25 sites in Europe and the U.S., found that dazukibart led to significant reductions in disease activity, particularly in patients with skin-predominant dermatomyositis.
Patients treated with dazukibart at doses of 150 mg and 600 mg showed clinically meaningful and statistically significant decreases in week-12 scores on the Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) compared to placebo. The 600 mg dose resulted in a placebo-adjusted difference of -16.3, while the 150 mg dose showed a difference of -13.7, both with P<0.0001.
Dermatomyositis is characterized by cutaneous eruptions, muscle weakness, and systemic manifestations, significantly impacting patients' quality of life. Current treatments, including corticosteroids and intravenous immunoglobulins (IVIG), are not very effective and come with known side effects. The study's findings suggest that dazukibart could offer a more specific and effective therapeutic strategy by targeting the molecular pathology of dermatomyositis.
The trial also noted that dazukibart was well tolerated, with adverse events mostly mild and similar between the treatment and placebo groups. However, severe adverse events were reported in a small number of patients, including one death in the muscle-predominant cohort, which was considered unlikely related to the treatment.
This study represents a significant step forward in the treatment of dermatomyositis, offering hope for a more effective and targeted therapy. A phase III trial is currently underway to further evaluate dazukibart's efficacy and safety in patients with active idiopathic inflammatory myopathies, including dermatomyositis and polymyositis.
