Rocatinlimab Significantly Improves Atopic Dermatitis Severity Over 36 Weeks

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The novel OX40 inhibitor showed significant efficacy in 4 different doses versus placebo in Fall Clinical Dermatology data.

Subcutaneous investigative monoclonal antibody rocatinlimab was associated with significant and long-term skin clearance versus placebo in adults with moderate-to-severe atopic dermatitis, according to new data.

In results from a 56-week clinical trial assessing the OX40 inhibitor biologic, a team of multinational investigators observed improvements per Eczema Area Severity Index (EASI) and Investigator’s Global Assessment (IGA) scores, as well as tolerability and safety, among those treated with rocatinlimab. The findings could indicate potential for the agent as a novel therapy for atopic dermatitis.

Led by Emma Guttman, PhD, System Chair of The Kimberly and Eric J. Waldman Department of Dermatology and Director of the Center of Excellence in Eczema and Laboratory of Inflammatory Skin Diseases at Icahn School of Medicine, investigators sought to evaluate the efficacy and safety of the investigative agent in adults with moderate or worse atopic dermatitis.

As Guttman previously told HCPLive, rocatinlimab is an exciting therapy candidate due to its unique pathway to care. “The targeting is a novel way to target atopic dermatitis,” she said. “OX40 is involved in memory T-cells, and particularly activated in type 2 cells.”

She and her team randomized 274 adults with chronic atopic dermatitis to 1 of 5 treatment arms over 36 weeks.

  • Placebo for weeks 0-18, then 600 mg rocatinlimab every 2 weeks through week 26
  • 150 mg rocatinlimab every 4 weeks
  • 600 mg rocatinlimab every 4 weeks
  • 300 mg rocatinlimab every 2 weeks
  • 600 mg rocatinlimab every 2 weeks

Patients were additionally provided twice-daily emollient. Follow-up was conducted every 4 weeks from week 36 to 56.

Mean patient age was 38.0 years old; a majority (58.6%) were male. Mean duration of atopic dermatitis diagnosis at baseline was 7.3 years; mean EASI score was 31.5, mean body surface area (BSA) was 56.9%, and 54.2% of patients had an IGA score of 3.

Each of the 4 rocatinlimab treatment arms achieved a mean EASI score improvement of ≥48% from baseline to week 16:

  • 150 mg rocatinlimab (-48.3%; 95% CI, -62.6 to -34.0)
  • 600 mg rocatinlimab every 4 weeks (-49.7%; 95% CI, -64.3 to -35.2)
  • 300 mg rocatinlimab (-61.1%; 95% CI, -75.2 to -47.0)
  • 600 mg rocatinlimab every 2 weeks (-57.4%; 95% CI, -71.3 to -43.4)
  • Placebo (-15.0%; 95% CI, -28.6 to -1.4)

Each treatment arm additionally reported significantly greater proportions of patients to achieve each of EASI-75, IGA 0/1 scores and a ≥2-point reduction in pruritus-NRS from baseline to week 16 versus placebo.

Guttman and colleagues additionally reported that efficacy measures continued to improve in all roctainlimab-treated patients after week 16. Treatment response remained durable in patients who discontinued care after achieving EASI-75 by week 36.

Regarding safety, approximately 8 in 10 (81.0%) of of patients on therapy reported treatment-emergent adverse events (TEAEs), versus 71.9% of patients receiving placebo. Common TEAEs included pyrexia, nasopharyngitis, worsening eczema symptoms and chills.

The team concluded that the novel agent provided significant improvement to the signs and symptoms of atopic dermatitis in adult patients versus placebo.

“Improvements in efficacy measures were maintained after rocatinlimab treatment discontinuation,” they wrote. “Rocatinlimab may be a novel treatment option for patients with moderate-to-severe atopic dermatitis.”

The study, “Efficacy and Safety of Rocatinlimab (KHK4083/AMG 451) in Patients With Moderate to Severe Atopic Dermatitis,” was presented at the 2022 Fall Clinical Dermatology Meeting.