O07: Efficacy of abrocitinib monotherapy in patients with prior exposure to systemic treatments: pooled results from the JADE MONO‐1 and JADE MONO‐2 studies

Abstract

O07 Efficacy of abrocitinib monotherapy in patients with prior exposure to systemic treatments: pooled results from the JADE MONO-1 and JADE MONO-2 studies M. Ameen, W. Sin Chiu, R. Rojo, P. Biswas, W. Romero and M. Ardern-Jones Royal Free Hampstead NHS Trust, London, UK; Pfizer Inc., Surrey, UK; Pfizer Inc., Groton, CT, USA; Pfizer Inc., New York, NY, USA; Clinical Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK Effective options for previously treated moderate-to-severe atopic dermatitis (AD) are needed. Monotherapy of abrocitinib, an oral, once-daily, Janus kinase 1 selective inhibitor, was shown to be effective and safe for moderate-to-severe AD in two phase III trials [JADE MONO-1 (NCT03349060) and JADE MONO-2 (NCT03575871)]. In this post-hoc analysis of pooled data from the aforementioned studies, we investigated the efficacy of abrocitinib monotherapy (200 mg or 100 mg) or placebo in patients aged ≥ 12 years previously exposed to systemic therapies (except systemic corticosteroids), including dupilumab. Response was evaluated at week 12 using Investigator’s Global Assessment (IGA) response [clear (0) or almost clear (1) with ≥ 2 points improvement], a ≥ 75% improvement in Eczema Area and Severity Index (EASI 75), and a composite of ≥ 50% improvement in EASI (EASI 50) and ≥ 4point improvement in Dermatology Life Quality Index (DLQI). Of 778 patients, 26 0% had received prior systemic agents, including ciclosporin (12 7%), other nonbiologics (i.e. methotrexate, azathioprine and mycophenolate; 9 3%) and dupilumab (5 7%). At week 12, more patients exposed to prior systemic treatment who received abrocitinib 200 mg or 100 mg achieved IGA 0/1 (37 5% and 17 9%, respectively), EASI 75 (59 2% and 32 1%, respectively) and the EASI 50/ DLQI composite response (72 6% and 47 3%, respectively) than placebo-treated patients (2 4%, 9 5%, and 9 1%, respectively; Table 1). Some patients who had an unsatisfactory response to ciclosporin or dupilumab achieved disease improvement with abrocitinib, with the 200-mg dose more effective than 100-mg one.