Kyowa Kirin Will Present New Rocatinlimab Phase 2b Data in Atopic Dermatitis at the American Academy of Dermatology Annual Meeting 2023
Atopic dermatitis (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.1 AD is prevalent in countries globally, with approximately 1 in 3 people with AD worldwide classifying their disease as moderate to severe.
"We are pleased to share this additional data from the rocatinlimab Phase 2b study," said
Title: Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate–severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial
Author: Emma Guttman-Yassky, MD, PhD.,
Presentation: Friday, March 17th
This double-blind, placebo-controlled Phase 2 trial (NCT03703102) randomized patients (n=274) 1:1:1:1:1 to subcutaneous rocatinlimab 150 or 600mg every 4 weeks (Q4W), 300 or 600mg every 2 weeks (Q2W) for 36 weeks, or placebo (Weeks 0–18; rocatinlimab 600mg Q2W Weeks 18–36), and a 20-week off-treatment follow-up period (Week 56).
Overall, 267 patients comprised the full analysis set; rocatinlimab: n=210 (78.7%), placebo: n=57 (21.3%). Rocatinlimab decreased mean serum IgE concentrations below baseline by Week 16(P ≤ 0.0005). These reductions continued to Week 36 and were maintained to Week 56.
In the placebo group, mean serum IgE concentrations increased to Week 16. After switching to 600mg Q2W at Week 18, concentrations decreased to Week 36 and continued to decrease below baseline to Week 56. Mean IgE reductions at Weeks 16, 36 and 56 were: -19.7%, -38.9%, -26.7% (150mg Q4W); -17.1%, -39.5%, -46.5% (600mg Q4W); -18.6%, -44.8%, -10.9% (300mg Q2W); -16.9%, -48.6%, -58.5% (600mg Q2W); 34.2%, -8.8%, -29.1% (placebo/600mg Q2W).
Adverse events reported were generally similar between rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers, and nausea.
Title: Rocatinlimab demonstrates improvements in patient-reported outcomes in adult patients with moderate–severe atopic dermatitis in a Phase 2 trial
Presentation: Friday, March 17th
Location: Ernest N. Morial Convention Center (Level 1, Hall E, Poster Center 2)
This Phase 2b, multicenter, double-blind, placebo-controlled trial, randomly assigned adult patients to subcutaneous rocatinlimab every 4 weeks (Q4W; 150 or 600mg) or every 2 weeks (300 or 600mg) or placebo, for 18 weeks, followed by an 18-week active treatment extension and a 20-week off-treatment follow-up (Week 56). Patient-reported outcomes (PROs) included pruritus and sleep disturbance (SD) scores, measured using a (Numerical Rating Scale (NRS), and the Dermatology Life Quality Index (DLQI). These were assessed at baseline to Week 16 and until Week 56.
Overall, 267 patients were randomized (rocatinlimab: n=210; placebo: n=57). From baseline to Week 16, percentage reductions in NRS-pruritus (p≤0.029) and NRS-SD scores (p≤0.025) were greater in the rocatinlimab groups compared with placebo. Improvement in pruritus and SD scores in the rocatinlimab groups was maintained until Week 56.
Greater reductions in DLQI scores in the rocatinlimab groups compared with placebo up to Week 16 (all p<0.05) were observed; scores continued to improve in the rocatinlimab groups to Week 36 and were maintained during the off-treatment period.
Treatment emergent adverse events (TEAEs) were reported for 175 of 216 (81.0%) subjects in rocatinlimab groups and 41 of 57 (71.9%) subjects in the placebo group in the initial 18-week double-blind treatment period. The most frequent TEAEs, reported in ≥ 10% of subjects in the combined rocatinlimab groups were nasopharyngitis, worsening of AD, pyrexia and chills. TEAEs 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.
Along with Amgen,
Rocatinlimab (KHK4083/AMG451) an investigational, is a potential first-in-class, anti-OX40 monoclonal antibody that inhibits and reduces 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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