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Atacicept, a soluble recombinant fusion protein of the human immunoglobulin (Ig) G(1) Fc and the extracellular domain of the human transmembrane activator and calcium modulator and cyclophylin ligand interactor receptor, acts as an antagonist of both B lymphocyte stimulator and a proliferating-inducing ligand. Here we determined the nonclinical safety, pharmacokinetics and pharmacodynamics of atacicept in mice and cynomolgus monkeys. Subcutaneous atacicept treatment (twice weekly in cynomolgus monkeys, three times weekly in mice) was generally safe and well tolerated safe and well tolerated with dosing up to 10 mg/kg every other day for up to 39 weeks or up to 80 mg/kg when dosed for 4 weeks. At a dose of 1 mg/kg subcutaneous (sc) bioavailability of atacicept in mice and monkeys was 76 and 92%, with a mean serum t(1/2) of 44 and 179 h, respectively. In accord with its anticipated mechanism of action, repeated administration of atacicept decreased serum IgG concentrations up to 50%, IgM concentrations >99%, and circulating mature B-cell concentrations up to 60%. These effects were dose-related but reversible, as determined in a 25-week follow-up period. Microscopically, B cells numbers were reduced in the follicular marginal zone of the spleen and the mantle surrounding germinal centers of the lymph nodes. These data confirm the preclinical safety and the pharmacological activity of atacicept and support its clinical development.

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This scientific opinion focuses on the welfare of laying hens, pullets and layer breeders on farm. The most relevant husbandry systems used in Europe are described. For each system, highly relevant welfare consequences were identified, as well as related animal‐based measures (ABMs), and hazards leading to the welfare consequences. Moreover, measures to prevent or correct the hazards and/or mitigate the welfare consequences are recommended. The highly relevant welfare consequences based on severity, duration and frequency of occurrence are bone lesions, group stress, inability to avoid unwanted sexual behaviour, inability to perform comfort behaviour, inability to perform exploratory or foraging behaviour, isolation stress, predation stress, resting problems, restriction of movement, skin disorders and soft tissue lesions and integument damage. The welfare consequences of non‐cage compared to cage systems for laying hens are described and minimum enclosure characteristics are described for laying hens, pullets and layer breeders. Beak trimming, which causes negative welfare consequences and is conducted to reduce the prevalence and severity of pecking, is described as well as the risks associated with rearing of non‐beak‐trimmed flocks. Alternatives to reduce sharpness of the beak without trimming are suggested. Finally, total mortality, plumage damage, wounds, keel bone fractures and carcass condemnations are the most promising ABMs for collection at slaughterhouses to monitor the level of laying hen welfare on farm. Main recommendations include housing all birds in non‐cage systems with easily accessible, elevated platforms and provision of dry and friable litter and access to a covered veranda. It is further recommended to implement protocols to define welfare trait information to encourage progress in genetic selection, implement measures to prevent injurious pecking, rear pullets with dark brooders and reduce male aggression in layer breeders.