Rocatinlimab delivers efficacy and safety in atopic dermatitis

Rocatinlimab was associated with significantly improved SCORAD and DLQI scores in patients with moderate-to-severe atopic dermatitis (AD) in a phase 2b trial. These improvements appeared to be maintained during a 20-week off-treatment period.

Rocatinlimab, an investigational anti-OX40 monoclonal antibody, was assessed as a potential treatment option for adult patients with moderate-to-severe AD in a phase 2b trial (NCT03703102). The 274 participants were randomised 1:1:1:1:1 to 1 of 4 doses of subcutaneous rocatinlimab or a placebo for 36 weeks. The Eczema Area and Severity Index (EASI) results were previously published [1]. Prof. Emma Guttman-Yassky (Icahn School of Medicine at Mount Sinai, NY, USA) currently presented the post-hoc efficacy results of SCORing Atopic Dermatitis (SCORAD) and Dermatology Life Quality Index (DLQI) scores at several time points [2].

After 16 weeks of treatment, SCORAD scores were significantly improved in the active arms compared with placebo: least squares (LS)  mean changes ranged from -41.0 to -55.8, depending on dose level, versus -20.0 for placebo (P<0.001 for all doses). The scores in the active arms continued to drop until week 36 (-57.5 to -72.3) and were maintained during the 20-week off-treatment period that followed. Likewise, DLQI scores at week 16 were significantly improved in participants receiving rocatinlimab compared with those receiving placebo (-38.3 to -50.4 vs -5.3; P<0.02 for all doses). A maintained benefit was observed during the off-treatment period.

The safety profile of the agent was favourable. The most common treatment-emergent adverse events in the active arms were pyrexia (13–19%), nasopharyngitis (13–15%), and chills (4–22%). “Cases of pyrexia and chills were predominantly observed after the first dose of rocatinlimab, were mild or moderate in nature, and did not result in treatment discontinuation,” added Prof. Guttman-Yassky.

“Rocatinlimab is well tolerated and represents a potential novel treatment option for AD by inhibiting and reducing OX40-positive pathogenic T cells,” decided Prof. Guttman-Yassky. “The durability of response that is observed with rocatinlimab is unique among current AD therapies and may be suggestive of disease modification.”

1. Guttman-Yassky E, et al. Lancet 2023;401(10372):204–214.
2. Guttman-Yassky E, et al. Rocatinlimab improves SCORAD and DLQI in adults with moderate-to-severe atopic dermatitis and these effects were maintained in the 20-week off-treatment period in a double-blind randomized phase 2b study. Late-breaker Session 5, WCD 2023, 3–8 July, Singapore, Singapore.