Rocatinlimab Improves SCORAD in Adults With Moderate to Severe AD

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A recent poster presentation from the 2024 Fall Clinical Dermatology Conference in Las Vegas, Nevada, detailed the results of a phase 2b trial evaluating rocatinlimab for the treatment of adults with moderate to severe atopic dermatitis. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor.

In the phase 2b trial, rocatinlimab significantly improved EASI scores compared with placebo and with continued improvement until week 36. Additionally, off-treatment responses were maintained in EASI responders up to week 56.

"Rocatinlimab is a fully human, subcutaneous, IgG1 anti-OX40 receptor monoclonal antibody for moderate to severe AD. Rocatinlimab reduces the expression of the OX40 receptor, resulting in reduced T-cell inflammatory responses.3 Latest data from phase 2b studies demonstrated that patients experienced progressive clinical improvement," wrote Aderonke Adeboye, PharmD, BCPS, in a recent Dermatology Times review.

SCORing of Atopic Dermatitis (SCORAD) was used to assess the extent of disease, disease severity, and subjective symptoms, and also supports improvements demonstrated with EASI in moderate to severe atopic dermatitis. The phase 2b trial evaluated the effect of rocatinlimab on SCORAD scores across baseline characteristic subgroups in adults with moderate to severe atopic dermatitis.

AD severity at baseline was defined as EASI and IGA scores, including moderate atopic dermatitis as an EASI score of ≥16–<21 and an IGA score of 3; and severe atopic dermatitis was defined by an EASI score ≥21 and an IGA score of 4. SCORAD was assessed at weeks 16, 24, 36, and 56 using analysis of covariance and data was considered statistically significant if p-values were less than 0.05. Patients were randomized 1:1:1:1:1 to received placebo and switch to rocatinlimab600mg subcutaneously every 2 weeks; rocatinlimab 150 mg subcutaneously every 4 weeks; rocatinlimab 300 mg subcutaneously every 2 weeks; rocatinlimab 600 mg subcutaneously every 2 weeks; and rocatinlimab 600 mg subcutaneously every 4 weeks. Follow-up visits were conducted at weeks 40, 44, 48, 52, and 56.

Results

After 16 weeks of treatment, SCORAD scores improved vs placebo in adults with moderate to severe atopic dermatitis in all rocatinlimab treatment cohorts, regardless of their baseline characteristics for age, BMI, duration of disease, and atopic dermatitis severity 

Overall, the average baseline characteristics included patients aged 37.9 (14.7) years; 59.2% male; 16.2 (14.9) years of duration from diagnosis to randomization; 25.2 (6.0) BMI; 31.5 (12.7) EASI score; 147 (55.1) IGA score; and 68.3 (13.8) SCORAD score.

SCORAD was significantly improved in all rocatinlimab treatment cohorts vs placebo at week 16. All baseline characteristic subgroups showed a similar pattern of reduction in SCORAD scores for all rocatinlimab treatment cohorts vs placebo at week 16

“Together with previous data showing continued improvements in SCORAD through the on-treatment period up to week 36 that were maintained during the 20-week off-treatment period up to week 56, SCORAD responses with rocatinlimab suggest the potential for disease modification. Rocatinlimabrepresents a potential novel treatment option for patients with moderate to severe atopic dermatitis and is being explored further in the comprehensive phase 3 ROCKET program,” wrote Guttman-Yassky et al.

Reference

Guttman-Yassky E, Esfandiari E, Mano H, Chong C, Kabashima K. Rocatinlimab improves SCORAD compared with placebo in adults with moderate-to-severe atopic dermatitis regardless of baseline demographics in a phase 2b trial. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, Nevada.