1. At week 16, all rocatinlimab groups reported significant improvements in eczema severity.
2. Most treatment-related adverse events were mild-to-moderate, with no fatalities reported.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Despite advances in biologic therapy, there remains a lack of safe and effective treatment for moderate-to-severe atopic dermatitis. OX40 is a receptor known to be important for T-cell differentiation and its inhibition may potentially lead to improvements in immune function. Through the inhibition of these antigen-specific T-cell mediated responses, it is theorized that symptoms of atopic dermatitis may also improve. This randomized controlled trial aimed to compare the safety and efficacy of rocatinlimab, an anti-OX40 antibody, in patients with moderate-to-severe atopic dermatitis. Patients were randomly assigned to either the intervention (rocatinlimab every 4 weeks: 150 mg or 600 mg, and rocatinlimab every 2 weeks: 300 mg or 600 mg) or placebo group and monitored for 16 weeks. According to study results, more patients in the rocatinlimab groups reported significant improvements in eczema compared to the placebo group. This study was strengthened by comparing the safety and efficacy of rocatinlimab at various doses and frequencies, thus increasing its validity.
Click to read the study in The Lancet
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In-depth [randomized-controlled trial]: Between Oct 22, 2018, and Oct 21, 2019, 351 patients were assessed for eligibility from 65 sites in the USA, Canada, Japan, and Germany. Included were patients ≥ 18 years old with moderate-to-severe atopic dermatitis, as defined by an Eczema Area and Severity Index (EASI) score ≥ 16 and affected body surface area ≥ 10%. Altogether, 274 patients (217 in rocatinlimab and 57 in placebo) were included in the final analysis. The primary outcome of a reduction in EASI score at week 16 was observed in all rocatinlimab groups (rocatinlimab 150 mg every 4 weeks mean percent reduction [MPR] -48.3%, p=0.0003; rocatinlimab 600 mg every 4 weeks MPR -49.7%, p=0.0002; rocatinlimab 300 mg every 2 weeks MPR -61.1%, p<0.0001; and rocatinlimab 600 mg every 2 weeks MPR -57.4%, p<0.0001). The majority of adverse events were mild-to-moderate in nature with pyrexia (17%), nasopharyngitis (14%), and chills (11%) being the most common. Overall, findings from this study suggest that rocatinlimab may be used clinically for the treatment of moderate-to-severe atopic dermatitis.
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