Immunosuppression: lower lymphocyte counts, lymphoid depletion and reduced TDAR to KLH in rats; reduced TDAR in monkeys
“In rats, dose-dependent minimally to moderately decreased lymphocyte counts (including total T, helper T, cytotoxic T, B, and NK cells) generally correlated with decreased spleen and thymus size and weights, decreased lymphoid cellularity in lymph nodes, thymus and splenic white pulp, and decreased TDAR to KLH-specific IgM and IgG responses.”
Substantial but reversible melanin binding (eye uveal tract), not in pigmented skin
“In pigmented rats, there was substantial, but reversible binding of [14C]BMS-986165-derived radioactivity to certain melanin-containing tissues, such as the eye uveal tract, but not in pigmented skin.”
Immunosuppression (expected pharmacology), reversible after dosing stopped
“In summary, at clinically relevant doses, deucravacitinib-related toxicological effects were mostly related to immunosuppression, which was reversable after dosing termination.”
✓ VerifiedFDA multi-discipline review, p. 56Source ↗