AD, a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell-dependent inflammatory pathways; the relative contribution of different inflammatory pathways in driving disease can vary across populations and within individuals over time.
Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease. Approximately 1 in 3 people living with AD worldwide are affected by moderate-to-severe disease. While several treatments are currently available, there remains a need for additional therapeutic options with a novel mechanism of action to treat across a heterogeneous AD patient population.
"We are pleased to share this additional data from the rocatinlimab Phase 2b study," said
e-Poster Title: Rocatinlimab improves lichenification compared with placebo in adults with moderate-to-severe atopic dermatitis in a Phase 2b trial
Author: Kenji Kabashima, MD, PhD.,
Date:
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo group switched to 600 mg Q2W), with a subsequent 20-week off-treatment follow-up period (Weeks 36–56).
e-Poster Title: Rocatinlimab improves SCORAD compared with placebo in adults with moderate-to-severe atopic dermatitis regardless of baseline demographics in a Phase 2b trial
Author:
Date:
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo switched to 600 mg Q2W) with a subsequent 20-week off-treatment follow-up period (Weeks 36–56). Overall, 267 patients were randomized (rocatinlimab: n=210; placebo: n=57). For the full analysis set at Week 16, the SCORing of Atopic Dermatitis (SCORAD) percentage changes from baseline for all rocatinlimab treatment groups were statistically significant vs. placebo (p<0.001 for all rocatinlimab groups). Furthermore, all baseline characteristic subgroup categories showed a similar pattern of reduction in SCORAD scores for all rocatinlimab treatment groups vs. placebo at Week 16 regardless of AD severity (by
e-Poster Title: Rocatinlimab improves SCORAD and DLQI in adults with moderate-to-severe atopic dermatitis and these effects were maintained in the 20-week off-treatment period in a double-blind randomized Phase 2b study
Author:
Date:
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg; rocatinlimab-rocatinlimab), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo switched to 600 mg Q2W; placebo-rocatinlimab) with a subsequent 20-week off-treatment follow-up period (Weeks 36–56). The full analysis set included 267 patients. Mean baseline scores ranged from 66.4–69.8 for SCORAD and 11.9–13.8 for Dermatology Life Quality Index (DLQI) among cohorts. At Week 16, percent change from baseline in SCORAD was significantly improved in all rocatinlimab cohorts vs. placebo (−41.04 to −55.83% vs. −19.99%, all p<0.001), as was DLQI (−38.28 to −50.42% vs. −5.28%; all p<0.02). SCORAD and DLQI improvements from baseline continued to Week 36 (−60.42 to −72.32% and −46.51 to −67.81%, respectively for all rocatinlimab-rocatinlimab cohorts) and were maintained during the 20-week off-treatment period until Week 56 (−59.76 to −69.23%; −47.76 to −60.76%, respectively). For the placebo-rocatinlimab cohort, after switching to active treatment from Week 18, SCORAD and DLQI were comparable to rocatinlimab-rocatinlimab cohorts by Week 36 (−57.47% and −51.41%, respectively) and were maintained during the off-treatment period (−67.42% and −58.43%, respectively). Consistent with significant
Adverse events with an incidence of ≥ 5% in all rocatinlimab groups combined and more frequently reported than in the placebo group included pyrexia, chills, headache, aphthous ulcer, and nausea. TEAEs (Treatment emergent adverse events) of pyrexia and chills were mild to moderate in intensity and were mostly observed only after the first administration of rocatinlimab without resulting treatment discontinuation. There were no hypersensitivity reactions or deaths.
An Amgen &
The Future of Atopic Dermatitis treatment with OX40 signaling will be presented by
Date:
Location: CET Hall A4
About rocatinlimab
Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between
Amgen and Kyowa Kirin Collaboration
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