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Preliminary findings suggest rozibafusp alfa effective and tolerable in RA

For the first time, the safety and tolerability of multiple ascending doses of rozibafusp alfa was reported in patients with rheumatoid arthritis (RA) [1]. An interim analysis of a phase 1b study showed greater numerical improvement from baseline in Patient and Physician Global Assessments of Disease Activity (PtGA and PhGA) compared with placebo, as well as a non-linear, target-mediated disposition.

Rozibafusp alfa (AMG 570) is a first-in-class bispecific antibody-peptide conjugate targeting T-cell and B-cell activity by inhibiting both the inducible costimulator ligand (ICOSL) and the B cell-activating factor (BAFF). This phase 1b study reported on the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of rozibafusp alfa in RA patients. Enrolled in the study were 34 patients aged between 18 and 75 years with active RA defined as a disease activity score (DAS2...



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