Severe liver injury on avacopan in US practice, and thrombotic risk in ANCA vasculitis peaks in the first three months

The edition in brief

Five findings and one regulatory item for rheumatologists. In the US RISE registry, 238 patients with ANCA-associated vasculitis took avacopan; liver enzyme rises were uncommon, but two (0.8%) had highly probable drug-induced liver injury, one severe on biopsy, against a background of an FDA request for market withdrawal that the manufacturer declined. A Swedish nationwide cohort of 4,317 patients with GPA or MPA found a doubled risk of cardiovascular and thromboembolic events, rising to HR 7.69 in the three months after diagnosis, with no excess in siblings. An individual patient data analysis of 16 trials (11,883 patients) found JAK inhibitor ACR20 response fell steadily with BMI, to a relative risk of 0.78 in class 3 obesity, with no gradient on placebo. In the Canadian Early Arthritis Cohort, patients given parenteral rather than oral glucocorticoids in the first three months were about half as likely to remain on steroids at a year (26% vs 47%). A meta-analysis of six mainly observational studies found alendronate or zoledronic acid after stopping denosumab was associated with 71% fewer vertebral fractures (RR 0.29). The FDA recorded a supplement to the adalimumab biosimilar Yusimry.