DOI: 10.12688/f1000research.190158.1 ISSN: 2046-1402

Efficacy and Safety of Rocatinlimab in Adults With Moderate‑to‑Severe Atopic Dermatitis: A Meta-analysis of Randomized Controlled Trials

Maaz Amir, Affaf Mahmood, Zehra Ali Khan, Waqar Ali, Iqra Ilyas, Zain Ul Abideen, Usama Ahmad, Talal Waheed, Laiba Mujahid, Zainab Ali Khan, Muhammad Anas Raza, Sohaib Raza, Danyal Paracha, Abdul Haseeb Hasan, Ahmad Rasheed
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Background Rocatinlimab, an anti-OX40 monoclonal antibody, is a novel therapy for moderate-to-severe atopic dermatitis (AD), a condition that significantly impairs quality of life. This meta-analysis evaluated its efficacy and safety. Methods Randomized controlled trials comparing rocatinlimab (150 mg and 300 mg) with placebo were included. Literature screening was performed using Zotero, and analyses were conducted with RevMan 5.4. Efficacy outcomes included EASI-75, EASI-90, vIGA-AD (0/1), pruritus NRS, and DLQI. Safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events, and specific side effects. Pooled odds ratios (ORs) with 95% CIs were calculated. Results Rocatinlimab significantly improved EASI-75 (OR 3.93), EASI-90 (OR 4.78), and vIGA-AD 0/1 (OR 3.33) at week 24. Pruritus and quality of life also improved. The 150 mg dose showed benefit for EASI-75 (OR 3.95) and pruritus (OR 2.98), though other outcomes were inconsistent. TEAEs were comparable to placebo. The 300 mg dose was associated with more mild adverse effects (e.g., headache, pyrexia, aphthous ulcers) but fewer severe events. Conclusion Rocatinlimab demonstrates dose-dependent efficacy with an acceptable safety profile, with 300 mg offering greater clinical benefit.

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