Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001).

BACKGROUND: Rademikibart (CBP-201) is a next-generation IL-4 receptor alpha-targeting antibody. OBJECTIVE: We sought to evaluate rademikibart in adults with moderate to severe atopic dermatitis. METHODS: A total of 226 patients were randomized, double-blind, to subcutaneous rademikibart (300 mg every 2 weeks [Q2W], 150 mg Q2W, 300 mg every 4 weeks [Q4W]; plus 600-mg loading dose) or placebo. Randomization began in July 2020. The trial was completed in October 2021. RESULTS: The WW001 phase 2 trial achieved its primary end point: significant percent reduction from baseline in least-squares mean Eczema Area Severity Index (EASI) to week 16 with rademikibart 300 mg Q2W (-63.0%; P = .0007), 150 mg Q2W (-57.6%; P = .0067), 300 mg Q4W (-63.5%; P = .0004) versus placebo (-39.7%). EASI scores decreased significantly with 300 mg Q2W and Q4W at the earliest assessment (week 2), with no evidence of plateauing by week 16. Significant improvements were also observed in secondary end points, including pruritus. Across the primary and secondary end points, efficacy tended to be comparable with 300 mg Q2W and Q4W dosing. Rademikibart and placebo had similar, low incidence of treatment-emergent adverse events (TEAEs) (48% vs 54%), serious TEAEs (1.8% vs 3.6%), TEAEs leading to treatment discontinuation (1.2% vs 1.8%), conjunctivitis of unspecified cause (2.9% vs 0%), herpes (0.6% vs 1.8%), and injection-site reactions (1.8% vs 1.8%). Although no discontinuations were attributed to coronavirus disease 2019, pandemic-related restrictions likely had an impact on trial conduct. CONCLUSIONS: Rademikibart was efficacious and well tolerated at Q2W and Q4W intervals. Q4W dosing is a more convenient frequency than approved for current therapies.

An ecological momentary assessment of the effect of fasting during Ramadan on disordered eating behaviors.

Dietary restriction contributes to disordered eating (DE) behaviors and associated cognitions. However, it is unclear how these outcomes are impacted by dietary restriction for religious purposes, such as fasting observed by Muslims during Ramadan. Using ecological momentary assessment, this study assessed the impact of Ramadan fasting on DE behaviors and correlates. Muslim participants fasting during Ramadan (n = 28) and a control group of non-fasting participants (n = 74) completed baseline measures assessing demographic characteristics and eating pathology. A mobile phone application then prompted participants six times per day for seven days to self-report on dietary restriction efforts, body satisfaction, temptation to eat unhealthily, feelings of guilt or shame following food, and DE behaviors including bingeing, vomiting, and other purging behaviors (use of laxatives, diuretics, or diet pills). After controlling for eating pathology, multilevel modeling indicated that, as expected, the Ramadan fasting group spent significantly more time restricting food intake than the non-fasting group. The Ramadan fasting group also experienced significantly greater temptation to eat unhealthily than their non-fasting counterparts. However, this difference disappeared once models were adjusted for differences in time spent restricting food intake. There were no other significant differences between the groups on any DE variables. These findings suggest that while dietary restriction for health or appearance-related reasons is a known contributor to DE, dietary restriction for religious purposes, such as that observed during the practice of Ramadan, may not confer increased risk of DE symptoms.