Rocatinlimab AD Combo Therapy Safe, Effective Over 24 Weeks

There are statistically significant and clinically meaningful benefits to combining rocatinlimab and topical corticosteroids and/or topical calcineurin inhibitors (TCS/TCI) to treat moderate to severe atopic dermatitis, according to late-breaking ROCKET program¹ data presented at the 2025 European Academy of Dermatology and Venereology Congress.²

New data from the phase 3 ROCKET-SHUTTLE trial (NCT05724199) show the anti-OX40 monoclonal antibody administered every 4 weeks for 24 weeks enabled enrolled patients to achieve skin clearance, as measured by the Eczema and Area Severity Index-75 (EASI-75) and the Validated Investigator Global Assessment for Atopic Dermatitis tool (vIGA-AD) that was progressive over the study period, “with no apparent plateau at week 24,” the investigators explained. They were presented in the abstract, “Rocatinlimab With Concomitant Topical Therapy Significantly Improved Clinical Signs and Symptoms of Atopic Dermatitis in Adults: Results From the Phase 3 ROCKET-SHUTTLE Trial,” which was presented on September 18.

In the ROCKET-SHUTTLE trial, patients were randomized to 1 of 2 doses of rocatinlimab, 300 mg (n = 287) or 150 mg (n = 229), plus TCS/TCI, or placebo plus TCS/TCI (n = 230). The overall mean patient age was 38.2 (14.6) years, and most patients were male (59.4%). Patients reported race as White (58.8%), Asian (31.5%), Black or African American (6.4%), and other (6.6%; American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and multiple races), and most were from Europe (37.1%) or North America (32.6%). Prior systemic treatment use was more common than prior biologic or Janus kinase (JAK) inhibitor use (59.1% vs 25.3%).

vIGA-AD is measured on a scale of 0 (clear) to 4 (severe disease),³ and most patients had moderate disease at baseline: 61.0% of the 300-mg group, 60.3% of the 150-mg group, and 59.6% of the placebo group. EASI total scores indicated severe/very severe disease in 69.4%, 76.5%, and 70.0%, respectively. Body surface area involvement was a mean of 45.41% (22.57%), 44.92% (21.14%), and 43.60% (22.00%). The baseline appraisal of each of these measures was taken on day 1 after the first study dose was administered.

At the end of week 24 of treatment, 52.3% of the 300-mg rocatinlimab group and 54.1% of the 150-mg rocatinlimab group were considered responders by EASI-75 criteria compared with 23.5% who received a placebo, as were 26.1% and 25.8% vs 12.2% according to a vIGA-AD scale reduction of 2 points or more (P < .001 for both measures).

Elevated rates of treatment-emergent adverse events (TEAEs), including serious AEs, were seen in all 3 groups, but these were often higher among those who received rocatinlimab (71.5%) compared with placebo (67.2%), with infection being the most common (35.4% of the 300-mg group, 39.9% of the 150-mg group, and 38.0% of the placebo group). Serious adverse event rates were low overall, however: 3.1%, 4.4%, and 0.9%. There were very few patient discontinuations, at 1.0%, 1.8%, and 0.4%, respectively. To be included in the safety analysis, patients had to receive at least 1 dose of rocatinlimab.

Over the course of the study, the TCS and TCI treatments were allowed to be tapered based on the clinical responses of patients. Secondary end points were EASI-90 at week 24, EASI-75 and a vIGA-AD score of 0 or 1 at week 16, and a reduction in the weekly average of the daily worst pruritic numeric rating scale by least 4 points—but these data were not included in the abstract.

Combining their newest data with previously announced data from the ROCKET-Horizon (NCT05651711) and ROCKET-IGNITE (NCT05398445) monotherapy studies, the study investigators concluded, “Rocatinlimab combination therapy was well tolerated, and TEAEs were consistent with adult monotherapy studies. With the ROCKET-HORIZON and IGNITE monotherapy studies, ROCKET-SHUTTLE supports the efficacy and safety of Rocatinlimab administered with TCS/TCI.”

References

1. Guttman Yassky E, Simpson EL, Bissonnette R, et al. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025;17(2):83-94. doi:10.1080/1750743X.2025.2464528
2. Simpson EL, Gooderham M, de Bruin MS, et al. Rocatinlimab with concomitant topical therapy significantly improved clinical signs and symptoms of atopic dermatitis in adults: results from the phase 3 ROCKET-SHUTTLE trial. Presented at: European Academy of Dermatology and Venereology Congress; September 17-20, 2025; Paris, France. Abstract LBA-78.
3. Simpson EL, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): the development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis. J Am Acad Dermatol. 2020;83(3):839-846. doi:10.1016/j.jaad.2020.04.104