Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies

• Published in: Journal of the American Academy of Dermatology Vol. 85; no. 4; pp. 863 - 872
• Main Authors: Papp, Kim, Szepietowski, Jacek C., Kircik, Leon, Toth, Darryl, Eichenfield, Lawrence F., Leung, Donald Y.M., Forman, Seth B., Venturanza, May E., Sun, Kang, Kuligowski, Michael E., Simpson, Eric L.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2021
• Subjects: Adult; Anti-Inflammatory Agents - therapeutic use; Antipruritics - therapeutic use; atopic dermatitis; Dermatitis, Atopic - diagnosis; Dermatitis, Atopic - drug therapy; Double-Blind Method; Eczema; Emollients - therapeutic use; Humans; itch; JAK inhibitor; Janus kinase; Nitriles; Pyrazoles; Pyrimidines; ruxolitinib; topical; Treatment Outcome; topical; atopic dermatitis; WB; NRS; QoL; BSA; EASI; IC50; JAK inhibitor; Janus kinase; ruxolitinib; itch; NRS4; IGA; AD; AE; TRuE-AD1; VC; IGA-TS; TEAE; RUX; EASI-75; JAK; TRuE-AD2; EASI-90
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2021.04.085

Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD). To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD. Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline). In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .05). Application site reactions were infrequent (<1%) and lower with RUX versus vehicle; none were clinically significant. Longer-term safety data are not yet available. RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.