Efficacy and Safety of Subcutaneous Rocatinlimab in Adults With Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Placebo-Controlled Trials.

BACKGROUND

Atopic dermatitis (AD) is a relapsing, chronic inflammatory skin disease. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, has been evaluated for moderate-to-severe AD. This systematic review and meta-analysis aimed to evaluate the short-term efficacy and trial-reported safety of subcutaneous rocatinlimab in patients with moderate-to-severe AD.

METHODS

We searched PubMed, Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov to identify randomised controlled trials (RCTs) comparing rocatinlimab with placebo in patients with moderate-to-severe AD. Only summary-level data from published reports were analysed. Outcomes of interest included treatment efficacy and safety. A random-effects model with Hartung-Knapp-Sidik-Jonkman adjustment was used for the primary pooled analyses. Exploratory subgroup analyses were conducted according to both dose and dosing frequency, with Wald-type confidence intervals used for subgroup-specific pooled estimates involving only two studies.

RESULTS

A total of 1767 patients from 3 RCTs were included. A total of 1305 patients (73.85%) received subcutaneous rocatinlimab. Rocatinlimab was associated with a significantly greater achievement of the pooled estimate for EASI-75 at Week 16 (OR 3.58, 95% CI 1.53-8.40; p = 0.02). The pooled estimate for the vIGA-AD score of 0 or 1 at Week 16 was directionally favourable but imprecise and did not reach statistical significance (OR 4.06, 95% CI 0.56-29.47; p = 0.09) No statistically significant differences were observed in serious adverse events (OR 1.60, 95% CI 0.41-6.26; p = 0.28) or treatment discontinuation due to adverse events (OR 1.28, 95% CI 0.14-11.60; p = 0.68), although confidence intervals were wide.

CONCLUSION

In adults with moderate-to-severe AD, subcutaneous rocatinlimab demonstrated potential short-term treatment efficacy compared with placebo. However, the available evidence does not establish durable remission, prevention of recurrence, long-term disease modification or a favourable long-term benefit-risk profile. Given the subsequent discontinuation of the rocatinlimab clinical development programme following safety review, these findings should be interpreted cautiously as a synthesis of short-term trial evidence rather than support for future clinical use.