Patients with unresponsive atopic dermatitis saw improvement with rocatinlimab
Key takeaways:
- 32.8% of rocatinlimab-treated patients achieved the co-primary endpoint of EASI 75 by week 24.
- 19.3% reached the other co-primary endpoint, defined as a validated IGA-AD score of 0 or 1 by week 24.
ORLANDO — Treatment-experienced patients with moderate to severe atopic dermatitis attained higher efficacy rates on rocatinlimab compared with placebo, according to a presenter at the American Academy of Dermatology Annual Meeting
Rocatinlimab (Amgen, Kyowa Kirin) is a potential first and only T-cell rebalancing therapy that targets the OX40R receptor, a molecule responsible for releasing proinflammatory cytokines in patients with AD, according to the presentation.
“My excitement about this new class is that it may open the door to disease modification, so that patients will be able to receive treatment much less often than with existing treatments and, perhaps for some patients, even be able to stop after a while,” Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology and director of the Center of Excellence in Eczema and the Laboratory of Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai, told Healio. “This is due to the effect on the cells responsible for disease memory, which are the ones populating against previous lesional areas.”
Guttman-Yassky presented results from the phase 3 ROCKET-Horizon trial, which evaluated the efficacy and safety of rocatinlimab monotherapy in adults with moderate to severe AD and an inadequate topical medication response.
A total of 726 patients were randomly assigned to receive subcutaneous rocatinlimab 300 mg (n = 543) or placebo (n = 183) once every 4 weeks for 24 weeks. At week 2, patients also received a loading dose.
Results showed 32.8% of rocatinlimab-treated patients achieved the co-primary endpoint of EASI 75 by week 24 compared with 13.7% of placebo-treated patients (P < .001). The other co-primary endpoint, defined as a validated IGA-AD score of 0 or 1 by week 24, was reached by 19.3% and 6.6% of rocatinlimab- and placebo-treated patients, respectively (P < .001).
By week 24, 19.9% of the rocatinlimab group also reached EASI 90 vs. 4.9% of the placebo group (P < .001), and 24% achieved a 4-point reduction on the Worst Pruritus-Numerical Rating Scale vs. 10.5% of placebo (P < .001).
Rocatinlimab was generally well tolerated with similar rates of treatment-emergent adverse events occurring in the rocatinlimab and placebo groups (68.4% vs. 63.3%, respectively). A total of 1.8 and 4.4 serious adverse events occurred in the respective groups.
According to the presentation, rocatinlimab will be further assessed in upcoming trials as part of the ROCKET program.
“If successful in showing disease modification,” Guttman-Yassky told Healio, “this will have a great impact on the way we practice as patients would love to receive a drug only several times per year after an initial period where they get it every 4 weeks.”